114 results on '"Ravdin PM"'
Search Results
2. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years
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Pan, H, Gray, R, Braybrooke, J, Davies, C, Taylor, C, Mcgale, P, Peto, R, Pritchard, Ki, Bergh, J, Dowsett, M, Hayes, Df, Albain, K, Anderson, S, Arriagada, R, Barlow, W, Bartlett, J, Bergsten‐nordström, E, Bliss, J, Boccardo, F, Bradley, R, Brain, E, Cameron, D, Clarke, M, Coates, A, Coleman, R, Correa, C, Costantino, J, Cuzick, J, Davidson, N, Dodwell, D, Di Leo, A, Ewertz, M, Forbes, J, Gelber, R, Gnant, M, Goldhirsch, A, Goodwin, P, Hill, C, Ingle, J, Jagsi, R, Janni, W, Loibl, S, Mackinnon, E, Martin, M, Mukai, H, Norton, L, Ohashi, Y, Paik, S, Perez, E, Piccart, M, Pierce, L, Poortmans, P, Raina, V, Ravdin, P, Regan, M, Robertson, J, Rutgers, E, Slamon, D, Sparano, J, Swain, S, Tutt, A, Viale, G, Von Minckwitz, G, Wang, X, Whelan, T, Wilcken, N, Winer, E, Wolmark, N, Wood, W, Zambetti, M, Alberro, Ja, Ballester, B, Deulofeu, P, Fábregas, R, Fraile, M, Gubern, Jm, Janer, J, Moral, A, De Pablo Jl, Peñalva, G, Puig, P, Ramos, M, Rojo, R, Santesteban, P, Serra, C, Solà, M, Solarnau, L, Solsona, J, Veloso, E, Vidal, S, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Garaud, P, Collett, V, Delmestri, A, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Balic, M, Bartsch, R, Fesl, C, Fitzal, F, Fohler, H, Greil, R, Jakesz, R, Marth, C, Mlineritsch, B, Pfeiler, G, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hma, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Hupperets, Psgj, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Dal, Patnick, J, Pinder, S, Lohrisch, C, Nichol, A, Bramwell, Vh, Chen, Be, Gelmon, K, Goss, Pe, Levine, Mn, Parulekar, W, Pater, Jl, Shepherd, Le, Tu, D, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Weiss, Rb, Abu‐zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett‐lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Sestak, I, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesec’h, J, De La Lande, B, Mouret‐fourme, E, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Shao, Yf, Zhao, Db, Chen, Zm, Howell, A, Swindell, R, Boddington, C, Burrett, Ja, Cutter, D, Duane, F, Evans, V, Gettins, L, Godwin, J, James, S, Kerr, A, Liu, H, Mannu, G, Mchugh, T, Morris, P, Read, S, Wang, Y, Wang, Z, Albano, J, De Oliveira Cf, Gervásio, H, Gordilho, J, Ejlertsen, B, Jensen, Mb, Johansen, H, Mouridsen, H, Palshof, T, Gelman, Rs, Harris, Jr, Henderson, C, Shapiro, Cl, Christiansen, P, Mouridsen, Ht, Fehm, T, Trampisch, Hj, Dalesio, O, De Vries Ege, Rodenhuis, S, Van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jgm, Treurniet‐donker, Ad, Van Putten Wlj, Rotmensz, N, Veronesi, U, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, Van De Velde Cjh, Cunningham, Mp, Brufsky, Am, Coleman, Re, Llombart, Ha, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Carrasco, E, Segui, Ma, Eiermann, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, B, Jackisch, C, De Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Galligioni, E, Leone, B, Vallejo, Ct, Zwenger, A, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Fountzilas, G, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Tinterri, C, Margreiter, R, De Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, André, F, Delaloge, S, Koscielny, S, Michiels, S, Rubino, C, A'Hern, R, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, Van De Velde Ao, Van Dongen Ja, Vermorken, Jb, Castiglione, M, Colleoni, M, Collins, J, Gelber, Rd, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ced, Coombes, Rc, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Bighin, C, Bruzzi, P, Del Mastro, L, Dozin, B, Pastorino, S, Pronzato, P, Sertoli, Mr, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Peretz, T, Robinson, E, Camerini, T, Formelli, F, Martelli, G, Di Mauro Mg, Perrone, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Musolino, A, Passalacqua, R, Iwata, H, Shien, T, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Sadoon, M, Tulusan, Ah, Kohno, N, Miyashita, M, Takao, S, Ahn, Jh, Jung, Kh, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, Liefers, Gj, Christiaens, R, Neven, P, Paridaens, R, Van Den Bogaert, W, Braun, S, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, De La Huerta, R, Sainz, Mg, Ro, J, Camphausen, K, Danforth, D, Lichter, A, Lippman, M, Smart, D, Steinberg, S, D’Amico, C, Lioce, M, Paradiso, A, Ohno, S, Bass, G, Brown, A, Bryant, J, Dignam, J, Fisher, B, Geyer, C, Mamounas, Ep, Redmond, C, Wickerham, L, Aihara, T, Hozumi, Y, Baum, M, Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Venturini, M, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Reinertsen, Kv, Varhaug, Je, Gundersen, S, Hauer‐jensen, M, Høst, H, Nissen‐meyer, R, Mitchell, Ak, Robertson, Jfr, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, Cocconi, G, Di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Hadji, P, A’Hern, R, Makris, A, Parton, M, Pennert, K, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Clack, G, Van Poznak, C, Deshpande, N, Di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Ajs, Ewing, Gh, Firth, La, Krushen‐kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Ravdin, Pm, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, Af Trampe, E, Wadström, C, Maibach, R, Thürlimann, B, Holli, K, Rouhento, K, Safra, T, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ahg, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Lemonnier, J, Martin, Al, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Deutsch, Gp, Kwong, Dlw, Pai, Vr, Senanayake, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Bell, R, Hinsley, S, Marshall, Hc, Pierce, Lj, Solomayer, E, Horsman, Jm, Lester, J, Winter, Mc, Buzdar, Au, Hsu, L, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Aft, R, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Other departments, CCA - Cancer Treatment and Quality of Life, Radiotherapy, Pan, Hongchao, Gray, Richard, Braybrooke, Jeremy, Davies, Christina, Taylor, Carolyn, Mcgale, Paul, Peto, Richard, Pritchard, Kathleen I, Bergh, Jona, Dowsett, Mitch, Hayes, Daniel F, De Laurentiis, Michelino, MUMC+: MA Medische Oncologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, and Interne Geneeskunde
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0301 basic medicine ,Oncology ,medicine.medical_treatment ,Kaplan-Meier Estimate ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Recurrence ,Receptors ,Neoplasm Metastasis ,AMERICAN SOCIETY ,Adjuvant ,CLINICAL-PRACTICE GUIDELINE ,Absolute risk reduction ,Estrogen Antagonists ,General Medicine ,Estrogen Antagonist ,CHEMOTHERAPY ,Middle Aged ,Prognosis ,Neoplasm Metastasi ,Local ,POSTMENOPAUSAL WOMEN ,Receptors, Estrogen ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Meta-analysis ,Lymphatic Metastasis ,Female ,Human ,Estrogen Antagonists/therapeutic use ,Adult ,Risk ,medicine.medical_specialty ,Prognosi ,medicine.drug_class ,DISCONTINUATION ,Breast Neoplasms ,Article ,Drug Administration Schedule ,LATE DISTANT RECURRENCE ,03 medical and health sciences ,Breast cancer ,Breast Neoplasms/drug therapy ,Internal medicine ,SCORE ,medicine ,Humans ,SURGICAL ADJUVANT BREAST ,Aged ,Proportional Hazards Models ,Chemotherapy ,business.industry ,Proportional hazards model ,Lymphatic Metastasi ,TAMOXIFEN THERAPY ,ta3122 ,medicine.disease ,Estrogen ,RANDOMIZED-TRIALS ,Discontinuation ,Surgery ,Neoplasm Recurrence ,030104 developmental biology ,Proportional Hazards Model ,Neoplasm Grading ,Neoplasm Recurrence, Local ,business - Abstract
Background The administration of endocrine therapy for 5 years substantially reduces recurrence rates during and after treatment in women with early-stage, estrogen-receptor (ER)–positive breast cancer. Extending such therapy beyond 5 years offers further protection but has additional side effects. Obtaining data on the absolute risk of subsequent distant recurrence if therapy stops at 5 years could help determine whether to extend treatment. Methods In this meta-analysis of the results of 88 trials involving 62,923 women with ER-positive breast cancer who were disease-free after 5 years of scheduled endocrine therapy, we used Kaplan–Meier and Cox regression analyses, stratified according to trial and treatment, to assess the associations of tumor diameter and nodal status (TN), tumor grade, and other factors with patients’ outcomes during the period from 5 to 20 years. Results Breast-cancer recurrences occurred at a steady rate throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status. Among the patients with stage T1 disease, the risk of distant recurrence was 13% with no nodal involvement (T1N0), 20% with one to three nodes involved (T1N1–3), and 34% with four to nine nodes involved (T1N4–9); among those with stage T2 disease, the risks were 19% with T2N0, 26% with T2N1–3, and 41% with T2N4–9. The risk of death from breast cancer was similarly dependent on TN status, but the risk of contralateral breast cancer was not. Given the TN status, the factors of tumor grade (available in 43,590 patients) and Ki-67 status (available in 7692 patients), which are strongly correlated with each other, were of only moderate independent predictive value for distant recurrence, but the status regarding the progesterone receptor (in 54,115 patients) and human epidermal growth factor receptor type 2 (HER2) (in 15,418 patients in trials with no use of trastuzumab) was not predictive. During the study period from 5 to 20 years, the absolute risk of distant recurrence among patients with T1N0 breast cancer was 10% for low-grade disease, 13% for moderate-grade disease, and 17% for high-grade disease; the corresponding risks of any recurrence or a contralateral breast cancer were 17%, 22%, and 26%, respectively. Conclusions After 5 years of adjuvant endocrine therapy, breast-cancer recurrences continued to occur steadily throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status, with risks ranging from 10 to 41%, depending on TN status and tumor grade. (Funded by Cancer Research UK and others.)
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- 2017
3. Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials
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Alberro, JA, Ballester, B, Deulofeu, P, Fabregas, R, Fraile, M, Gubern, JM, Janer, J, Moral, A, de Pablo, JL, Penalva, G, Puig, P, Ramos, M, Rojo, R, Santesteban, P, Serra, C, Sola, M, Solarnau, L, Solsona, J, Veloso, E, Vidal, S, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Ohashi, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Coles, CE, Haybittle, JL, Moebus, V, Leonard, CF, Calais, G, Garaud, P, Collett, V, Davies, C, Delmestri, A, Sayer, J, Harvey, VJ, Holdaway, IM, Kay, RG, Mason, BH, Forbe, JF, Franci, PA, Wilcken, N, Balic, M, Bartsch, R, Fesl, C, Fitzal, F, Fohler, H, Gnant, M, Greil, R, Jakesz, R, Marth, C, Mlineritsch, B, Pfeiler, G, Singer, CF, Steger, GG, Stoeger, H, Canney, P, Yosef, HMA, Focan, C, Peek, U, Oates, GD, Powell, J, Durand, M, Mauriac, L, Di Leo, A, Dolci, S, Larsimont, D, Nogaret, JM, Philippson, C, Piccart, MJ, Masood, MB, Parker, D, Price, JJ, Lindsay, MA, Mackey, J, Martin, M, Hupperets, PSGJ, Bates, T, Blamey, RW, Chetty, U, Ellis, IO, Mallon, E, Morgan, DAL, Patnick, J, Pinder, S, Lohrisch, C, Nichol, A, Bartlett, JMS, Bramwell, VH, Chen, BE, Chia, SKL, Gelmon, K, Goss, PE, Levine, MN, Parulekar, W, Pater, JL, Pritchard, KI, Shepherd, LE, Tu, D, Whelan, T, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Norton, L, Weiss, RB, Abu-Zahara, HT, Karpov, A, Portnoj, SL, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, PJ, Manse, RE, Monypenny, IJ, Gordon, NH, Davis, HL, Cuzick, J, Sestak, I, Lehingue, Y, Romestaing, P, Dubois, JB, Delozier, T, Griffon, B, Lesec'h, J Mace, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, JR, Meier, P, Shan, Y, Shao, YF, Wang, X, Zhao, DB, Howell, A, Swindell, R, Albano, J, de Oliveira, CF, Gervasio, H, Gordilho, J, Ejlertsen, B, Jensen, M-B, Mouridsen, H, Gelman, RS, Harris, JR, Hayes, D, Henderson, C, Shapiro, CL, Christiansen, P, Ewertz, M, Jensen, MB, Mouridsen, HT, Fehm, T, Trampisch, HJ, Dalesio, O, de Vries, EGE, Rodenhuis, S, van Tinteren, H, Comis, RL, Davidson, NE, Gray, R, Robert, N, Sledge, G, Solin, LJ, Sparano, JA, Tormey, DC, Wood, W, Cameron, D, Dixon, JM, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, JGM, Treurniet-Donker, AD, van Putten, WLJ, Rotmensz, N, Veronesi, U, Viale, G, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, JP, Poortmans, PM, Rutgers, E, van de Velde, CJH, Cunningham, MP, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, LJ, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Lupors, E, Namer, M, Carrasco, E, Segui, MA, Eierman, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, JU, Costa, SD, Eidtmann, H, Gerber, B, Jackisch, C, Loib, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, MC, Sacco, M, Valentini, M, McArdle, CS, Smith, DC, Stallard, S, Dent, DM, Gudgeon, CA, Hacking, A, Murray, E, Panieri, E, Werner, ID, De Salvo, GL, Del Bianco, P, Zavagno, G, Leone, B, Vallejo, CT, Zwenger, A, Galligioni, E, Lopez, M, Erazo, A, Medina, JY, Horiguchi, J, Takei, H, Fentiman, IS, Hayward, JL, Rubens, RD, Skilton, D, Scheurlen, H, Sohn, HC, Untch, M, Dafni, U, Markopoulos, C, Bamia, C, Fountzilas, G, Koliou, G-A, Manousou, K, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Canavese, G, Tinterri, C, Margreiter, R, de Lafontan, B, Mihura, J, Roche, H, Asselain, B, Salmon, RJ, Vilcoq, JR, Brain, E, de La Lande, B, Mouret-Fourme, E, Andre, F, Arriagada, R, Delaloge, S, Hill, C, Koscienly, S, Michiels, S, Rubino, C, A'Hern, R, Bliss, J, Ellis, P, Kilburn, L, Yarnold, JR, Benraadt, J, Kooi, M, van de Velde, AO, van Dongen, JA, Vermorken, JB, Castiglione, M, Coates, A, Colleoni, M, Collins, J, Forbes, J, Gelbe, RD, Goldhirsch, A, Lindtner, J, Price, KN, Regan, MM, Rudenstam, CM, Senn, HJ, Thuerlimann, B, Bliss, JM, Chilvers, CED, Coombes, RC, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, WD, Stewart, HJ, Stroner, P, Borovik, R, Hayat, H, Inbar, MJ, Peretz, T, Robinson, E, Camerini, T, Formelli, F, Martelli, G, Di Mauro, MG, Perrone, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Musolino, A, Passalacqua, R, Iwata, H, Shien, T, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Sadoon, M, Tulusan, AH, Kohno, N, Miyashita, M, Takao, S, Ahn, J-H, Jung, KH, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, Liefers, GJ, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Gazet, JC, Corcoran, N, Deshpande, N, di Martino, L, Douglas, P, Host, H, Lindtner, A, Notter, G, Bryant, AJS, Ewing, GH, Firth, LA, Krushen-Kosloski, JL, Nissen-Meyer, R, Anderson, H, Killander, F, Malmstrom, P, Ryden, L, Arnesson, L-G, Carstense, J, Dufmats, M, Fohlin, H, Nordenskjold, B, Soderberg, M, Sundqvist, M, Carpenter, TJ, Murray, N, Royle, GT, Simmonds, PD, Albain, K, Barlow, W, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, CK, Ravdin, PM, Bergh, J, Bondesso, T, Celebiogl, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Goransson, E, Iiristo, M, Johansson, U, Lenner, E, Lofgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadstrom, C, Janni, W, Maibach, R, Thurlimann, B, Hadji, P, Hozumi, J, Holli, K, Rouhento, K, Safra, T, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, AHG, Fyles, A, Meakin, JW, Panzarella, T, Bahi, J, Lemonnier, J, Martin, AL, Reid, M, Spittle, M, Bishop, H, Bundred, NJ, Forbes, JF, Forsyth, S, George, WS, Pinder, SE, Deutsch, GP, Kwong, DLW, Pai, VR, Peto, R, Senanayake, F, Boccardo, F, Rubagotti, A, Baum, M, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, JS, Carlomagno, C, De Laurentiis, M, De Placido, S, Schem, C, Williams, L, Bell, R, Coleman, RE, Dodwell, D, Hinsley, S, Marshall, HC, Pierce, LJ, Basso, SMM, Lumachi, F, Solomayer, E, Horsman, JM, Lester, J, Winter, MC, Buzdar, AU, Hsu, L, Love, RR, Ahlgren, J, Garmo, H, Holmberg, L, Lindman, H, Warnberg, F, Asmar, L, Jones, SE, Aft, R, Gluz, O, Harbeck, N, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, BK, Chlebowski, RT, Caffier, H, Brufsky, AM, Llombart, HA, Asselain, B, Barlow, W, Bartlett, J, Bradley, R, Braybrooke, J, Davies, C, Dodwell, D, Gray, R, Mannu, G, Taylor, C, Peto, R, McGale, P, Pan, H, Wang, Y, Wang, Z, Department of Oncology, Clinicum, HUS Comprehensive Cancer Center, Medical Oncology, Cancer Research UK, and Pfizer Limited
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0301 basic medicine ,Oncology ,Time Factors ,SURGERY ,medicine.medical_treatment ,menopause ,chemotherapy ,Mastectomy, Segmental ,Rate ratio ,THERAPY ,aromatase inhibitors ,CEA ,0302 clinical medicine ,Risk Factors ,Medicine and Health Sciences ,Breast ,Neoplasm Metastasis ,Randomized Controlled Trials as Topic ,RISK ,tamoxifen ,breast tumor ,CA15-3 ,axillary dissection ,mastectomy ,Middle Aged ,Neoadjuvant Therapy ,METHOTREXATE ,3. Good health ,trastuzumab ,Treatment Outcome ,quadrantectomy ,Chemotherapy, Adjuvant ,axillary lymphnodes ,030220 oncology & carcinogenesis ,Meta-analysis ,SURVIVAL ,Disease Progression ,Female ,Life Sciences & Biomedicine ,axillary clearance ,RADIOTHERAPY ,medicine.drug ,Adult ,medicine.medical_specialty ,Anthracycline ,3122 Cancers ,Antineoplastic Agents ,Breast Neoplasms ,axillary nodes ,sentinel node biopsy ,03 medical and health sciences ,breast cancer ,Breast cancer ,SDG 3 - Good Health and Well-being ,HER2 ,Internal medicine ,Journal Article ,medicine ,cancer ,Humans ,Breast, breast cancer, breast diseases, cancer, malignancy, menopause, surgery, mastectomy, quadrantectomy, lumpectomy, axillary nodes, axillary lymphnodes, axillary dissection, axillary clearance, sentinel node biopsy, sentinel node, BRCA1, BRCA2, tamoxifen, aromatase inhibitors, breast tumor, osteoporosis, bisphosphonates, denosumab, trastuzumab, HER2, CEA, CA15-3, tumor marker, chemotherapy, endocrine therapy ,Oncology & Carcinogenesis ,RECURRENCE ,bisphosphonates ,Pathological ,Neoplasm Staging ,lumpectomy ,Chemotherapy ,Science & Technology ,breast diseases ,endocrine therapy ,business.industry ,denosumab ,BRCA1 ,medicine.disease ,BRCA2 ,osteoporosis ,Radiation therapy ,STIMULATING FACTOR ,030104 developmental biology ,sentinel node ,tumor marker ,Methotrexate ,Neoplasm Recurrence, Local ,business ,1112 Oncology And Carcinogenesis ,malignancy - Abstract
BACKGROUND: Neoadjuvant chemotherapy (NACT) for early breast cancer can make breast-conserving surgery more feasible and might be more likely to eradicate micrometastatic disease than might the same chemotherapy given after surgery. We investigated the long-term benefits and risks of NACT and the influence of tumour characteristics on outcome with a collaborative meta-analysis of individual patient data from relevant randomised trials. METHODS: We obtained information about prerandomisation tumour characteristics, clinical tumour response, surgery, recurrence, and mortality for 4756 women in ten randomised trials in early breast cancer that began before 2005 and compared NACT with the same chemotherapy given postoperatively. Primary outcomes were tumour response, extent of local therapy, local and distant recurrence, breast cancer death, and overall mortality. Analyses by intention-to-treat used standard regression (for response and frequency of breast-conserving therapy) and log-rank methods (for recurrence and mortality). FINDINGS: Patients entered the trials from 1983 to 2002 and median follow-up was 9 years (IQR 5-14), with the last follow-up in 2013. Most chemotherapy was anthracycline based (3838 [81%] of 4756 women). More than two thirds (1349 [69%] of 1947) of women allocated NACT had a complete or partial clinical response. Patients allocated NACT had an increased frequency of breast-conserving therapy (1504 [65%] of 2320 treated with NACT vs 1135 [49%] of 2318 treated with adjuvant chemotherapy). NACT was associated with more frequent local recurrence than was adjuvant chemotherapy: the 15 year local recurrence was 21·4% for NACT versus 15·9% for adjuvant chemotherapy (5·5% increase [95% CI 2·4-8·6]; rate ratio 1·37 [95% CI 1·17-1·61]; p=0·0001). No significant difference between NACT and adjuvant chemotherapy was noted for distant recurrence (15 year risk 38·2% for NACT vs 38·0% for adjuvant chemotherapy; rate ratio 1·02 [95% CI 0·92-1·14]; p=0·66), breast cancer mortality (34·4% vs 33·7%; 1·06 [0·95-1·18]; p=0·31), or death from any cause (40·9% vs 41·2%; 1·04 [0·94-1·15]; p=0·45). INTERPRETATION: Tumours downsized by NACT might have higher local recurrence after breast-conserving therapy than might tumours of the same dimensions in women who have not received NACT. Strategies to mitigate the increased local recurrence after breast-conserving therapy in tumours downsized by NACT should be considered-eg, careful tumour localisation, detailed pathological assessment, and appropriate radiotherapy. FUNDING: Cancer Research UK, British Heart Foundation, UK Medical Research Council, and UK Department of Health. ispartof: LANCET ONCOLOGY vol:19 issue:1 pages:27-39 ispartof: location:England status: published
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- 2017
4. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials
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Mcgale, P., Taylor, C., Correa, C., Cutter, D., Duane, F., Ewertz, M., Gray, R., Mannu, G., Peto, R., Whelan, T., Wang, Y., Wang, Z., Darby, S., Albain, K., Anderson, S., Arriagada, R., Barlow, W., Bergh, J., Bergsten Nordström, E., Bliss, J., Burrett, J. A., Buyse, M., Cameron, D., Carrasco, E., Clarke, M., Coleman, R., Coates, A., Collins, R., Costantino, J., Cuzick, J., Davidson, N., Davies, C., Davies, K., Delmestri, A., Di Leo, A., Dowsett, M., Elphinstone, P., Evans, V., Forbes, J., Gelber, R., Gettins, L., Geyer, C., Gianni, L., Gnant, M., Goldhirsch, A., Godwin, J., Gregory, C., Hayes, D., Hill, C., Ingle, J., Jakesz, R., James, S., Janni, W., Kaufmann, M., Kerr, A., Liu, H., Mackinnon, E., Martín, M., Mchugh, T., Morris, P., Norton, L., Ohashi, Y., Paik, S., Pan, H. C., Perez, E., Piccart, M., Pierce, L., Pritchard, K., Pruneri, G., Raina, V., Ravdin, P., Robertson, J., Rutgers, E., Shao, Y. F., Sparano, J., Swain, S., Valagussa, P., Viale, G., Von Minckwitz, G., Winer, E., Wiang, X., Wood, Abe O, W., Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Ohashi, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Geraud, P, Collett, V, Davies, C, Delmestri, A, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Wilcken, N, Bartsch, R, Dubsky, P, Fesl, C, Fohler, H, Gnant, M, Greil, R, Jakesz, R, Lang, A, Luschin-Ebengreuth, G, Marth, C, Mlineritsch, B, Samonigg, H, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hm, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Di Leo, A, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Martin, M, Hupperets, Ps, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Da, Patnick, J, Pinder, S, Olivotto, I, Ragaz, J, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Norton, L, Weiss, Rb, Abu-Zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Cuzick, J, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesech, J, Brain, E, de La Lande, B, Mouret-Fourme, E, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Shao, Yf, Wang, X, Zhao, Db, Chen, Zm, Pan, Hc, Howell, A, Swindell, R, Burrett, Ja, Clarke, M, Collins, R, Correa, C, Cutter, D, Darby, S, Davies, K, Elphinstone, P, Evans, V, Gettins, L, Godwin, J, Gray, R, Gregory, C, Hermans, D, Hicks, C, James, S, Kerr, A, Liu, H, Mackinnon, E, Lay, M, Mcgale, P, Mchugh, T, Morris, P, Peto, R, Taylor, C, Wang, Y, Albano, J, de Oliveira CF, Gervásio, H, Gordilho, J, Ejlertsen, B, Jensen, Mb, Johansen, H, Mouridsen, H, Palshof, T, Gelman, Rs, Harris, Jr, Hayes, D, Henderson, C, Shapiro, Cl, Winer, E, Christiansen, P, Ewertz, M, Møller, S, Mouridsen, Ht, Trampisch, Hj, Dalesio, O, de Vries EG, Rodenhuis, S, van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Wood, W, Cameron, D, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jg, Treurniet-Donker, Ad, van Putten WL, Rotmensz, N, Veronesi, U, Viale, G, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, Rutgers, E, van de Velde CJ, Cunningham, Mp, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Eiermann, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, B, Jackisch, C, Loibl, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Carrasco, E, Segui, Ma, Galligioni, E, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Fountzilas, G, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Tinterri, C, Margreiter, R, de Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, André, F, Arriagada, R, Delaloge, S, Hill, C, Koscielny, S, Michiels, S, Rubino, C, A'Hern, R, Bliss, J, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, van de Velde AO, van Dongen JA, Vermorken, Jb, Castiglione, M, Coates, A, Colleoni, M, Collins, J, Forbes, J, Gelber, Rd, Goldhirsch, A, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ce, Coombes, Rc, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Peretz, T, Robinson, E, Bruzzi, P, Del Mastro, L, Pronzato, P, Sertoli, Mr, Venturini, M, Camerini, T, De Palo, G, Di Mauro MG, Formelli, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Cocconi, G, Colozza, A, Passalacqua, R, Aogi, K, Takashima, S, Abe, O, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, van de Water, W, van Nes JG, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Braun, S, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, de la Huerta, R, Sainz, Mg, Altemus, R, Camphausen, K, Cowan, K, Danforth, D, Lichter, A, Lippman, M, O'Shaughnessy, J, Pierce, Lj, Steinberg, S, Venzon, D, Zujewski, Ja, D'Amico, C, Lioce, M, Paradiso, A, Chapman, Ja, Gelmon, K, Goss, Pe, Levine, Mn, Meyer, R, Parulekar, W, Pater, Jl, Pritchard, Ki, Shepherd, Le, Tu, D, Whelan, T, Ohno, S, Anderson, S, Bass, G, Brown, A, Bryant, J, Costantino, J, Dignam, J, Fisher, B, Geyer, C, Mamounas, Ep, Paik, S, Redmond, C, Swain, S, Wickerham, L, Wolmark, N, Baum, M, Jackson, Im, Palmer, Mk, Perez, E, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Varhaug, Je, Gundersen, S, Hauer-Jensen, M, Høst, H, Nissen-Meyer, R, Reinertsen, K, Mitchell, Ak, Robertson, Jf, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Dowsett, M, Makris, A, Parton, M, Pennert, K, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Businico, A, Deshpande, N, di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Aj, Ewing, Gh, Firth, La, Krushen-Kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Albain, K, Barlow, W, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Ravdin, Pm, Adolfsson, J, Bergh, J, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadström, C, Janni, W, Maibach, R, Thürlimann, B, Hakama, M, Holli, K, Isola, J, Rouhento, K, Saaristo, R, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ah, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Sestak, I, Deutsch, Gp, Kwong, Dl, Pai, Vr, Senanayake, F, Martin, Al, Boccardo, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Broglio, K, Buzdar, Au, Hsu, L, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H., McGale, P, Taylor, C, Correa, C, Cutter, D, Duane, F, Ewertz, M, Gray, R, Mannu, G, Peto, R, Whelan, T, Wang, Y, Wang, Z, Darby, S, Biomedische Technologie, RS: GROW - Oncology, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Mcgale, P, DE LAURENTIIS, Michelino, Other departments, CCA -Cancer Center Amsterdam, and Radiotherapy
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medicine.medical_specialty ,medicine.medical_treatment ,Breast Neoplasms ,Rate ratio ,Lower risk ,Systemic therapy ,Statistical significance ,Medicine ,Humans ,Mastectomy ,Randomized Controlled Trials as Topic ,business.industry ,Articles ,General Medicine ,Surgery ,Radiation therapy ,Axilla ,Neoplasm Recurrence ,medicine.anatomical_structure ,Local ,Meta-analysis ,Lymphatic Metastasis ,Lymph Node Excision ,Female ,Neoplasm Recurrence, Local ,business ,Breast Neoplasm ,Human - Abstract
BACKGROUND: Postmastectomy radiotherapy was shown in previous meta-analyses to reduce the risks of both recurrence and breast cancer mortality in all women with node-positive disease considered together. However, the benefit in women with only one to three positive lymph nodes is uncertain. We aimed to assess the effect of radiotherapy in these women after mastectomy and axillary dissection.METHODS: We did a meta-analysis of individual data for 8135 women randomly assigned to treatment groups during 1964-86 in 22 trials of radiotherapy to the chest wall and regional lymph nodes after mastectomy and axillary surgery versus the same surgery but no radiotherapy. Follow-up lasted 10 years for recurrence and to Jan 1, 2009, for mortality. Analyses were stratified by trial, individual follow-up year, age at entry, and pathological nodal status.FINDINGS: 3786 women had axillary dissection to at least level II and had zero, one to three, or four or more positive nodes. All were in trials in which radiotherapy included the chest wall, supraclavicular or axillary fossa (or both), and internal mammary chain. For 700 women with axillary dissection and no positive nodes, radiotherapy had no significant effect on locoregional recurrence (two-sided significance level [2p]>0·1), overall recurrence (rate ratio [RR], irradiated vs not, 1·06, 95% CI 0·76-1·48, 2p>0·1), or breast cancer mortality (RR 1·18, 95% CI 0·89-1·55, 2p>0·1). For 1314 women with axillary dissection and one to three positive nodes, radiotherapy reduced locoregional recurrence (2pINTERPRETATION: After mastectomy and axillary dissection, radiotherapy reduced both recurrence and breast cancer mortality in the women with one to three positive lymph nodes in these trials even when systemic therapy was given. For today's women, who in many countries are at lower risk of recurrence, absolute gains might be smaller but proportional gains might be larger because of more effective radiotherapy.FUNDING: Cancer Research UK, British Heart Foundation, UK Medical Research Council.
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- 2016
5. Abstract PD7-07: Discovery of molecular predictors of late breast cancer specific events (BCSE) in ER+, node+ breast cancer – new transcriptome expression whole gene analysis of the phase III adjuvant trial SWOG S8814
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Albain, KS, primary, Crager, MR, additional, Barlow, WE, additional, Baehner, FL, additional, Bergamaschi, A, additional, Rae, JM, additional, Ravdin, PM, additional, Tripathy, D, additional, Gralow, JR, additional, Livingston, RB, additional, Osborne, CK, additional, Ingle, JN, additional, Pritchard, KI, additional, Davidson, NE, additional, Carey, LA, additional, Cherbavaz, DB, additional, Sing, AP, additional, Shak, S, additional, Hortobagyi, GN, additional, and Hayes, DF, additional
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- 2017
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6. Abstract P5-07-01: Successful whole transcriptome analysis of 25-year-old breast tumor samples from the phase III trial SWOG-8814 by next generation sequencing (NGS): Standardized analytical methods for exploratory and validation studies
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Cherbavaz, DB, primary, Hayes, DF, additional, Qu, K, additional, Crager, MR, additional, Barlow, WR, additional, Goddard, AD, additional, Beasley, EM, additional, Jeong, J, additional, Collin, F, additional, Liu, M-L, additional, Rae, JM, additional, Ravdin, PM, additional, Tripathy, D, additional, Gralow, JR, additional, Livingston, RB, additional, Osborne, CK, additional, Ingle, JN, additional, Pritchard, KI, additional, Davidson, NE, additional, Carey, LA, additional, Sing, AP, additional, Baehner, FL, additional, Hortobagyi, GN, additional, Shak, S, additional, and Albain, KS, additional
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- 2016
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7. Abstract S3-02: Molecular predictors of outcome on adjuvant CAF plus tamoxifen (T) vs T in postmenopausal patients (pts) with ER+, node+ breast cancer – Transcriptome expression analysis of the phase III trial SWOG-8814
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Albain, KS, primary, Crager, MR, additional, Barlow, WE, additional, Baehner, FL, additional, Bergamaschi, A, additional, Rae, JM, additional, Ravdin, PM, additional, Tripathy, D, additional, Gralow, JR, additional, Livingston, RB, additional, Osborne, CK, additional, Ingle, JN, additional, Pritchard, KI, additional, Davidson, NE, additional, Carey, LA, additional, Cherbavaz, DB, additional, Sing, AP, additional, Shak, S, additional, Hortobagyi, GN, additional, and Hayes, DF, additional
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- 2016
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8. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials
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EBCTCG, Abe, O., Abe, R., Enomoto, K., Kikuchi, K., Koyama, H., Masuda, H., Nomura, Y., Sakai, K., Sugimachi, K., Tominaga, T., Uchino, J., Yoshida, M., Haybittle, Jl, Davies, C., Harvey, Vj, Holdaway, Tm, Kay, Rg, Mason, Bh, Forbes, Jf, Wilcken, N., Gnant, M., Jakesz, R., Ploner, M., Yosef, Hma, Focan, C., Lobelle, Jp, Peek, U., Oates, Gd, Powell, J., Durand, M., Mauriac, L., Di Leo, A., Dolci, S., Piccart, Mj, Masood, Mb, Parker, D., Price, Jj, Hupperets, Psgj, Jackson, S., Ragaz, J., Berry, D., Broadwater, G., Cirrincione, C., Muss, H., Norton, L., Weiss, Rb, Abu-Zahra, Ht, Portnoj, Sm, Baum, M., Cuzick, J., Houghton, J., Riley, D., Gordon, Nh, Davis, Hl, Beatrice, A., Mihura, J., Naja, A., Lehingue, Y., Romestaing, P., Dubois, Jb, Delozier, T., Mace-Lesec H, J., Rambert, P., Andrysek, O., Barkmanova, J., Owen, Jr, Meier, P., Howell, A., Ribeiro, Gc, Swindell, R., Alison, R., Boreham, J., Clarke, M., Collins, R., Darby, S., Elphinstone, P., Evans, V., Godwin, J., Gray, R., Harwood, C., Hicks, C., James, S., Mackinnon, E., Mcgale, P., Mchugh, T., Mead, G., Peto, R., Wang, Y., Albano, J., Oliveira, Cf, Gervasio, H., Gordilho, J., Johansen, H., Mouridsen, Ht, Gelman, Rs, Harris, Jr, Henderson, Ic, Shapiro, Cl, Andersen, Kw, Axelsson, Ck, Blichert-Toft, M., Moller, S., Overgaard, J., Overgaard, M., Rose, C., Cartensen, B., Palshof, T., Trampisch, Hj, Dalesio, O., Vries, Ege, Rodenhuis, S., Tinteren, H., Comis, Rl, Davidson, Ne, Robert, N., Sledge, G., Tormey, Dc, Wood, W., Cameron, D., Chetty, U., Forrest, P., Jack, W., Rossbach, J., Klijn, Jgm, Treurniet-Donker, Ad, Putten, Wlj, Costa, A., Veronesi, U., Bartelink, H., Duchateau, L., Legrand, C., Sylvester, R., Hage, Ja, Velde, Cjh, Cunningham, Mp, Catalano, R., Creech, Rh, Bonneterre, J., Fargeot, P., Fumoleau, P., Kerbrat, P., Namer, M., Jonat, W., Kaufmann, M., Schumacher, M., Minckwitz, G., Bastert, G., Rauschecker, H., Sauer, R., Sauerbrei, W., Schauer, A., Schryver, A., Vakaet, L., Belfiglio, M., Nicolucci, A., Pellegrini, F., Sacco, M., Valentini, M., Mcardle, Cs, Smith, Dc, Galligioni, E., Boccardo, F., Rubagotti, A., Dent, Dm, Gudgeon, Ca, Hacking, A., Erazo, A., Medina, Jy, Izuo, M., Morishita, Y., Takei, H., Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D., Graeff, H., Janicke, F., Meisner, C., Scheurlen, H., Fournier, D., Dafni, U., Fountzilas, G., Klefstrom, P., Blomqvist, C., Saarto, T., Margreiter, R., Asselain, B., Salmon, Rj, Vilcoq, Jr, Rodrigo Arriagada, Hill, C., Laplanche, A., Le, Mg, Spielmann, M., Bruzzi, P., Montanaro, E., Rosso, R., Sertoli, MR, Venturini, M., Amadori, D., Benraadt, J., Kooi, M., Velde, Ao, Dongen, Ja, Vermorken, Jb, Castiglione, M., Cavalli, F., Coates, A., Collins, J., Forbes, J., Gelber, Rd, Goldhirsch, A., Lindtner, J., Price, Kn, Rudenstam, Cm, Senn, Hj, Bliss, Jm, Chilvers, Ced, Coombes, Rc, Hall, E., Marty, M., Borovik, R., Brufman, G., Hayat, H., Robinson, E., Wigler, N., Bonadonna, G., Camerini, T., Palo, G., Del Vecchio, M., Formelli, F., Valagussa, P., Martoni, A., Pannuti, F., Cocconi, G., Colozza, A., Camisa, R., Aogi, K., Takashima, S., Ikeda, T., Inokuchi, K., Sawa, K., Sonoo, H., Korzeniowski, S., Skolyszewski, J., Ogawa, M., Yamashita, J., Bonte, J., Christiaens, R., Paridaens, R., Den Boegart, W., Martin, P., Romain, S., Hakes, T., Hudis, Ca, Wittes, R., Giokas, G., Kondylis, D., Lissaios, B., La Huerta, R., Sainz, Mg, Altemus, R., Cowan, K., Danforth, D., Lichter, A., Lippman, M., O Shaughnessy, J., Pierce, Lj, Steinberg, S., Venzon, D., Zujewski, J., Paradiso, A., Lena, M., Schittulli, F., Myles, Jd, Pater, Jl, Pritchard, Ki, Anderson, S., Bass, G., Brown, A., Bryant, J., Costantino, J., Dignam, J., Fisher, B., Redmond, C., Wieand, S., Wolmark, N., Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Jonsson, H., Larsson, Lg, Lythgoe, Jp, Kissin, M., Erikstein, B., Hannisdal, E., Jacobsen, Ab, Varhaug, Je, Gundersen, S., Hauer-Jensen, M., Host, H., Nissen-Meyer, R., Blamey, Rw, Mitchell, Ak, Morgan, Dal, Robertson, Jfr, Di Palma, M., Mathe, G., Misset, Jl, Clark, Rm, Levine, M., Morimoto, K., Takatsuka, Y., Crossley, E., Harris, A., Talbot, D., Taylor, M., Di Blasio, B., Ivanov, V., Semiglazov, V., Brockschmidt, J., Cooper, MR, Ueo, H., Falkson, Ci, A Hern, R., Ashley, S., Powles, Tj, Smith, Ie, Yarnold, Jr, Gazet, Jc, Cocoran, N., Deshpande, N., Di Martino, L., Douglas, P., Lindtner, A., Notter, G., Bryant, Ajs, Ewing, Gh, Firth, La, Krushen-Kosloski, Jl, Foster, L., George, Wd, Stewart, Hj, Stroner, P., Malmstrom, P., Moller, Tr, Ryden, S., Tengrup, I., Tennvall-Nittby, L., Carstenssen, J., Dufmats, M., Hatschek, T., Nordenskjold, B., Soderberg, M., Carpenter, Jt, Albain, K., Crowley, J., Green, S., Martino, S., Osborne, Ck, Ravdin, Pm, Glas, U., Johansson, U., Rutqvist, Le, Singnomklao, T., Wallgren, A., Maibach, R., Thurlimann, B., Brenner, H., Hercbergs, A., Yoshimoto, M., Deboer, G., Paterson, Ahg, Meakin, Jw, Panzarella, T., Shan, Y., Shao, Yf, Wang, X., Zhao, Db, Chen, Zm, Pan, Hc, Bahi, J., Reid, M., Spittle, M., Deutsch, Gp, Senanayake, F., Kwong, Dlw, Bianco, Ar, Carlomagno, C., Laurentiis, M., Placido, S., Buzdar, Au, Smith, T., Bergh, J., Holmberg, L., Liljegren, G., Nilsson, J., Seifert, M., Sevelda, P., Zielinsky, Cc, Buchanan, Rb, Cross, M., Royle, Gt, Dunn, Ja, Hills, Rk, Lee, M., Morrison, Jm, Spooner, D., Litton, A., Chlebowski, Rt, Caffier, H., Faculteit Medische Wetenschappen/UMCG, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Early Breast Cancer Trialists' Collaborative, Group, DE LAURENTIIS, Michelino, and DE PLACIDO, Sabino
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Oncology ,medicine.medical_specialty ,Antineoplastic Agents, Hormonal ,DEATHS ,Ovariectomy ,Antineoplastic Agents ,Breast Neoplasms ,Aged ,Anthracyclines ,Antineoplastic Combined Chemotherapy Protocols ,Cause of Death ,Chemotherapy, Adjuvant ,Female ,Humans ,Middle Aged ,Neoplasm Metastasis ,Neoplasm Recurrence, Local ,Ovary ,Randomized Controlled Trials as Topic ,Receptors, Estrogen ,Survival Rate ,Tamoxifen ,Medicine (all) ,Breast cancer ,MammaPrint ,Internal medicine ,Receptors ,medicine ,Chemotherapy ,TAMOXIFEN ,skin and connective tissue diseases ,Survival rate ,Adjuvant ,Gynecology ,Hormonal ,medicine.diagnostic_test ,Oncotype DX Breast Cancer Assay ,business.industry ,General Medicine ,medicine.disease ,Estrogen ,Neoplasm Recurrence ,Local ,Hormonal therapy ,Oncotype DX ,business ,medicine.drug ,Epirubicin - Abstract
Background Quinquennial overviews (1985–2000) of the randomised trials in early breast cancer have assessed the 5 year and 10-year effects of various systemic adjuvant therapies on breast cancer recurrence and survival. Here, we report the 10-year and 15-year effects. Methods Collaborative meta-analyses were undertaken of 194 unconfounded randomised trials of adjuvant chemotherapy or hormonal therapy that began by 1995. Many trials involved CMF (cyclophosphamide, methotrexate, fluorouracil), anthracycline-based combinations such as FAC (fluorouracil, doxorubicin, cyclophosphamide) or FEC (fluorouracil, epirubicin, cyclophosphamide), tamoxifen, or ovarian suppression: none involved taxanes, trastuzumab, raloxifene, or modern aromatase inhibitors. Findings Allocation to about 6 months of anthracycline-based polychemotherapy (eg, with FAC or FEC) reduces the annual breast cancer death rate by about 38% (SE 5) for women younger than 50 years of age when diagnosed and by about 20% (SE 4) for those of age 50–69 years when diagnosed, largely irrespective of the use of tamoxifen and of oestrogen receptor (ER) status, nodal status, or other tumour characteristics. Such regimens are significantly (2p=0·0001 for recurrence, 2p For ER-positive disease only, allocation to about 5 years of adjuvant tamoxifen reduces the annual breast cancer death rate by 31% (SE 3), largely irrespective of the use of chemotherapy and of age ( These results combine six meta-analyses: anthracycline-based versus no chemotherapy (8000 women); CMF-based versus no chemotherapy (14 000); anthracycline-based versus CMF-based chemotherapy (14 000); about 5 years of tamoxifen versus none (15 000); about 1–2 years of tamoxifen versus none (33 000); and about 5 years versus 1–2 years of tamoxifen (18 000). Finally, allocation to ovarian ablation or suppression (8000 women) also significantly reduces breast cancer mortality, but appears to do so only in the absence of other systemic treatments. For middle-aged women with ER-positive disease (the commonest type of breast cancer), the breast cancer mortality rate throughout the next 15 years would be approximately halved by 6 months of anthracycline-based chemotherapy (with a combination such as FAC or FEC) followed by 5 years of adjuvant tamoxifen. For, if mortality reductions of 38% (age Interpretation Some of the widely practicable adjuvant drug treatments that were being tested in the 1980s, which substantially reduced 5-year recurrence rates (but had somewhat less effect on 5-year mortality rates), also substantially reduce 15-year mortality rates. Further improvements in long-term survival could well be available from newer drugs, or better use of older drugs.
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- 2005
9. Classical versus new prognostic factors for adjuvant treatment selection based on line software to estimate risk and benefit
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Ravdin, PM, primary
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- 2005
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10. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller.
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Gonzalez-Angulo AM, Litton JK, Broglio KR, Meric-Bernstam F, Rakkhit R, Cardoso F, Peintinger F, Hanrahan EO, Sahin A, Guray M, Larsimont D, Feoli F, Stranzl H, Buchholz TA, Valero V, Theriault R, Piccart-Gebhart M, Ravdin PM, Berry DA, and Hortobagyi GN
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- 2009
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11. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine.
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Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, and Hortobagyi GN
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The human epidermal growth factor receptor (HER-2) oncogene encodes a transmembrane tyrosine kinase receptor that has evolved as a major classifier of invasive breast cancer and target of therapy for the disease. The validation of the general prognostic significance of HER-2 gene amplification and protein overexpression in the absence of anti-HER-2 targeted therapy is discussed in a study of 107 published studies involving 39,730 patients, which produced an overall HER-2-positive rate of 22.2% and a mean relative risk for overall survival (OS) of 2.74. The issue of HER-2 status in primary versus metastatic breast cancer is considered along with a section on the features of metastatic HER-2-positive disease. The major marketed slide-based HER-2 testing approaches, immunohistochemistry, fluorescence in situ hybridization, and chromogenic in situ hybridization, are presented and contrasted in detail against the background of the published American Society of Clinical Oncology-College of American Pathologists guidelines for HER-2 testing. Testing issues, such as the impact of chromosome 17 polysomy and local versus central HER-2 testing, are also discussed. Emerging novel HER-2 testing techniques, including mRNA-based testing by real-time polymerase chain reaction and DNA microarray methods, HER-2 receptor dimerization, phosphorylated HER-2 receptors, and HER-2 status in circulating tumor cells, are also considered. A series of biomarkers potentially associated with resistance to trastuzumab is discussed with emphasis on the phosphatase and tensin homologue deleted on chromosome ten/Akt and insulin-like growth factor receptor pathways. The efficacy results for the more recently approved small molecule HER-1/HER-2 kinase inhibitor lapatinib are also presented along with a more limited review of markers of resistance for this agent. Additional topics in this section include combinations of both anti-HER-2 targeted therapies together as well as with novel agents including bevacizumab, everolimus, and tenespimycin. A series of novel HER-2-targeting agents is also presented, including pertuzumab, ertumaxomab, HER-2 vaccines, and recently discovered tyrosine kinase inhibitors. Biomarkers predictive of HER-2 targeted therapy toxicity are included, and the review concludes with a consideration of HER-2 status in the prediction of response to non-HER-2 targeted treatments including hormonal therapy, anthracyclines, and taxanes. [ABSTRACT FROM AUTHOR]
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- 2009
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12. Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features.
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Goldstein LJ, Gray R, Badve S, Childs BH, Yoshizawa C, Rowley S, Shak S, Baehner FL, Ravdin PM, Davidson NE, Sledge GW Jr., Perez EA, Shulman LN, Martino S, Sparano JA, Goldstein, Lori J, Gray, Robert, Badve, Sunil, Childs, Barrett H, and Yoshizawa, Carl
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- 2008
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13. Prediction model for estimating the survival benefit of adjuvant radiotherapy for gallbladder cancer.
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Wang SJ, Fuller CD, Kim JS, Sittig DF, Thomas CR Jr, and Ravdin PM
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- 2008
14. The decrease in breast-cancer incidence in 2003 in the United States.
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Ravdin PM, Cronin KA, Howlader N, Berg CD, Chlebowski RT, Feuer EJ, Edwards BK, and Berry DA
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- 2007
15. Decreased use of adjuvant breast cancer therapy in a randomized controlled trial of a decision aid with individualized risk information.
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Peele PB, Siminoff LA, Xu Y, and Ravdin PM
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OBJECTIVE: Oncology patients often seek involvement in their medical consultations. Such involvement is endorsed by most health care providers and mirrored in practice guidelines. However, oncologists exhibit great variation in how they provide patients with disease-relevant information, and many remain reluctant to do so at all. The authors examined the impact of a patient-specific decision aid on women's decisions about adjuvant therapy for breast cancer. METHOD: 386 women with breast cancer were randomized to receive either an informational pamphlet about adjuvant therapy (usual care) or a patient-specific, evidence-based decision aid about adjuvant therapy. The authors compared rates of adjuvant therapy between the groups controlling for age, education, marital status, race, tumor severity, and practice type of their physician (university-based or community-based). RESULTS: Among women with low tumor severity, only 58% (35/60) of women in the decision aid group chose adjuvant therapy, compared to 87% (33/38) of their counterparts in usual care (P<0.01). CONCLUSIONS: This study illustrates the important impact of medical decision aids on treatment choices, particularly for patients for whom treatment has little benefit. In the case of adjuvant therapy for breast cancer, providing individualized, evidence-based risk information for shared decision making resulted in fewer women with low tumor severity choosing adjuvant treatment. [ABSTRACT FROM AUTHOR]
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- 2005
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16. Ovarian ablation in early breast cancer: Overview of the randomised trials
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Clarke, M., Collins, R., Davies, C., Godwin, J., Gray, R., Peto, R., Abe, O., Abe, R., Enomoto, K., Kikuchi, K., Koyama, H., Nomura, Y., Sakai, K., Sugimachi, K., Tominaga, T., Uchino, J., Yoshida, M., Vandevelde, Ao, Vandongen, Ja, Vermorken, Jb, Arvelakis, A., Giokas, G., Lissaios, B., Harvey, Vj, Holdaway, Tm, Kay, Rg, Mason, Bh, Coates, A., Forbes, Jf, Focan, C., Lobelle, Jp, Peek, U., Oates, Gd, Powell, J., Bastert, G., Rauschecker, H., Sauer, R., Sauerbrei, W., Schauer, A., Schumacher, M., Durand, M., Mauriac, L., Bartholomeus, S., Piccart, Mj, Gelman, Rs, Henderson, Ic, Shapiro, Cl, Hancock, Ak, Masood, Mb, Parker, D., Price, Jj, Jackson, S., Ragaz, J., Delozier, T., Macelesech, J., Haybittle, Jl, Cirrincione, C., Korzun, A., Weiss, Rb, Wood, Wc, Baum, M., Houghton, J., Riley, D., Dent, Dm, Gudgeon, Ca, Hacking, A., Horgan, K., Hughes, L., Stewart, Hj, Gordon, Nh, Davis, Hl, Lehingue, Y., Owen, Jr, Meier, P., Howell, A., Ribeiro, Gc, Swindell, R., Albano, J., Deoliveira, Cf, Gervasio, H., Gordilho, J., Carstensen, B., Palshof, T., Johansen, H., Korzeniowski, S., Skolyszewski, J., Andersen, Kw, Axelsson, Ck, Blicherttoft, M., Mouridsen, Ht, Overgaard, M., Rose, C., Corcoran, N., Trampisch, Hj, Abeloff, Md, Carbone, Pc, Glick, J., Tormey, Dc, Rossbach, J., Scanlon, Ef, Schurman, S., Deschryver, A., Yosef, Hma, Mcardle, Cs, Smith, Dc, Lara, Pc, Boccardo, F., Erazo, A., Medina, Jy, Izuo, M., Morishita, Y., Bentley, A., Doran, Z., Fentiman, Is, Hayward, Jl, Rubens, Rd, Kaufmann, M., Jonat, W., Scheurlen, H., Vonfournier, D., Fountzilas, G., Klefstrom, P., Blomqvist, C., Cuzick, J., Margreiter, R., Castiglione, M., Cavalli, F., Collins, J., Forbes, J., Gelber, Rd, Goldhirsch, A., Lindtner, J., Price, Kn, Rudenstam, Cm, Senn, Hj, Bliss, Jm, Chilvers, Ced, Coombes, Rc, Marty, M., Borovik, R., Brufman, G., Hayat, H., Robinson, E., Wigler, N., Pannuti, F., Takashima, S., Tasutomi, T., Sonoo, H., Yamashita, J., Ogawa, M., Hupperets, Psgj, Bonte, J., Tengrup, I., Tennvallnittby, L., Martin, P., Romain, S., Ahmann, D., Schaid, Dj, Buzdar, Au, Smith, T., Hakes, T., Norton, L., Wittes, R., Delahuerta, R., Sainz, Mg, Bonadonna, G., Delvecchio, M., Valagussa, P., Veronesi, U., Dubois, Jb, Bianco, Ar, Lippman, Me, Pierce, Lj, Simon, R., Steinberg, Sm, Brown, A., Fisher, B., Redmond, C., Wolmark, N., Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Larsson, Lg, Lythgoe, Jp, Kissin, M., Hannisdal, E., Varhaug, Je, Nissenmeyer, R., Blamey, Rw, Mitchell, Ak, Robertson, Jfr, Nakamura, Y., Mathe, G., Misset, Jl, Abuzahra, Ht, Clarke, Ea, Mclaughlin, Jr, Clark, Rm, Levine, M., Myles, Jd, Pater, Jl, Pritchard, Ki, Morimoto, K., Sawa, K., Takatsuka, Y., Gundersen, S., Hauerjensen, M., Host, A., Crossley, E., Durrant, K., Harris, A., Beighton, A., Evans, V., Greaves, E., Harwood, C., James, S., Lau, E., Mead, G., Muldal, A., Naughton, A., Tooth, A., Wheatley, K., Rambert, P., Asselain, B., Salmon, Rj, Vilcoq, Jr, Rodrigo Arriagada, Hill, C., Laplanche, A., Le, Mg, Speilmann, M., Cocconi, G., Diblasio, B., Catalano, R., Creech, Rh, Brockschmidt, J., Cooper, MR, Andrysek, O., Barkmanova, J., Falkson, Cj, Abraham, M., Klijn, Jgm, Treurnietdonker, Ad, Vanputten, Wlj, Easton, D., Powles, Tj, Gazet, Jc, Semiglazov, V., Deshpande, N., Dimartino, L., Douglas, P., Host, H., Bryant, Ajs, Ewing, Gh, Krushenkosloski, Jl, Forrest, Apm, Jack, W., Mcdonald, C., Moller, Tr, Ryden, S., Carstensen, J., Hatschek, T., Soderberg, M., Carpenter, Jt, Albain, K., Crowley, J., Green, S., Martino, S., Osborne, Ck, Ravdin, Pm, Rutqvist, Le, Wallgren, A., Holm, Le, Yoshimoto, M., Deboer, G., Paterson, Ahg, Meakin, Jw, Panzarella, T., Naja, A., Bahi, J., Reid, M., Spittle, M., Senanayake, F., Bergh, J., Holmberg, L., Sevelda, P., Zielinsky, Cc, Jakesz, R., Gnant, M., Buchanan, Rb, Cross, M., Dunn, Ja, Gillespie, Wm, Kelly, K., Morrison, Jm, Litton, A., Chlebowski, Rt, Bezwoda, Wr, Caffier, H., Clarke, M, Collins, R, Davies, C, Godwin, J, Gray, R, Peto, R, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Nomura, Y, Sakai, K, Sugimachi, K, Tominaga, T, Uchino, J, Yoshida, M, vandeVelde, A, vanDongen, J, Vermorken, J, Arvelakis, A, Giokas, G, Lissaios, B, Harvey, V, and Holdaway, T
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Oncology ,medicine.medical_specialty ,Breast cancer ,business.industry ,Internal medicine ,medicine ,Ovarian Ablation ,General Medicine ,business ,medicine.disease ,Early breast cancer - Abstract
Background Among women with early breast cancer, the effects of ovarian ablation on recurrence and death have been assessed by several randomised trials that now have long follow-up. In this report, the Early Breast Cancer Trialists' Collaborative Group present their third 5-yearly systematic overview (meta-analysis), now with 15 years' follow-up. Methods In 1995, information was sought on each patient in any randomised trial of ovarian ablation or suppression versus control that began before 1990. Data were obtained for 12 of the 13 studies that assessed ovarian ablation by irradiation or surgery, all of which began before 1980, but not for the four studies that assessed ovarian suppression by drugs, all of which began after 1985. Menopausal status was not consistently defined across trials; therefore, the main analyses are limited to women aged under 50 (rather than “premenopausal”) when randomised. Oestrogen receptors were measured only in the trials of ablation plus cytotoxic chemotherapy versus the same chemotherapy alone. Findings Among 2102 women aged under 50 when randomised, most of whom would have been premenopausal at diagnosis, 1130 deaths and an additional 153 recurrences were reported. 15-year survival was highly significantly improved among those allocated ovarian ablation (52·4 vs46·1%, 6·3 [SD 2·3] fewer deaths per 100 women, logrank 2p=0·001), as was recurrence-free survival (45·0 vs 39·0%, 2p=0·0007). The numbers of events were too small for any subgroup analyses to be reliable. The benefit was, however, significant both for those with (“node positive”) and for those without (“node negative”) axillary spread when diagnosed. In the trials of ablation plus cytotoxic chemotherapy versus the same chemotherapy alone, the benefit appeared smaller (even for women with oestrogen receptors detected on the primary tumour) than in the trials of ablation in the absence of chemotherapy (where the observed survival improvements were about six per 100 node-negative women and 12 per 100 node-positive women). Among 1354 women aged 50 or over when randomised, most of whom would have been perimenopausal or postmenopausal, there was only a nonsignificant improvement in survival and recurrence-free survival. improves long-term survival, at least in the absence of chemotherapy. Further randomised evidence is needed on the additional effects of ovarian ablation in the presence of other adjuvant treatments, and to assess the relevance of hormone-receptor measurements. Interpretation In women aged under 50 with early breast cancer, ablation of functioning ovaries significantly.
17. Internalization of alpha-bungarotoxin on neurons induced by a neurotoxin that blocks neuronal acetylcholine sensitivity
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Ravdin, PM, primary, Nitkin, RM, additional, and Berg, DK, additional
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- 1981
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18. A decline in breast-cancer incidence.
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Bluming AZ, Elfenbein GJ, Kliewer EV, Demers AA, Nugent ZJ, Zahl P, Maehlen J, Cady B, Chung BC, Chung MA, Michaelson JS, Robbins AS, Clarke CA, Signorello LB, Tarone RE, Ravdin PM, Cronin KA, and Chlebowski RT
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- 2007
19. Association Between 21-Gene Assay Recurrence Score and Locoregional Recurrence Rates in Patients With Node-Positive Breast Cancer.
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Woodward WA, Barlow WE, Jagsi R, Buchholz TA, Shak S, Baehner F, Whelan TJ, Davidson NE, Ingle JN, King TA, Ravdin PM, Osborne CK, Tripathy D, Livingston RB, Gralow JR, Hortobagyi GN, Hayes DF, and Albain KS
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- Adult, Aged, Aged, 80 and over, Breast Neoplasms genetics, Breast Neoplasms pathology, Breast Neoplasms surgery, Chemotherapy, Adjuvant adverse effects, Female, Humans, Lymph Nodes drug effects, Lymph Nodes pathology, Lymph Nodes surgery, Lymphatic Metastasis genetics, Lymphatic Metastasis pathology, Mastectomy, Mastectomy, Segmental, Middle Aged, Neoplasm Recurrence, Local genetics, Neoplasm Recurrence, Local pathology, Neoplasm Recurrence, Local surgery, Prognosis, Receptor, ErbB-2 genetics, Receptors, Estrogen genetics, Receptors, Progesterone genetics, Tamoxifen adverse effects, Breast Neoplasms drug therapy, Lymphatic Metastasis drug therapy, Neoplasm Recurrence, Local drug therapy, Tamoxifen administration & dosage
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Importance: The 21-gene assay recurrence score is increasingly used to personalize treatment recommendations for systemic therapy in postmenopausal women with estrogen receptor (ER)- or progesterone receptor (PR)-positive, node-positive breast cancer; however, the relevance of the 21-gene assay to radiotherapy decisions remains uncertain., Objective: To examine the association between recurrence score and locoregional recurrence (LRR) in a postmenopausal patient population treated with adjuvant chemotherapy followed by tamoxifen or tamoxifen alone., Design, Setting, and Participants: This cohort study was a retrospective analysis of the Southwest Oncology Group S8814, a phase 3 randomized clinical trial of postmenopausal women with ER/PR-positive, node-positive breast cancer treated with tamoxifen alone, chemotherapy followed by tamoxifen, or concurrent tamoxifen and chemotherapy. Patients at North American clinical centers were enrolled from June 1989 to July 1995. Medical records from patients with recurrence score information were reviewed for LRR and radiotherapy use. Primary analysis included 316 patients and excluded 37 who received both mastectomy and radiotherapy, 9 who received breast-conserving surgery without documented radiotherapy, and 5 with unknown surgical type. All analyses were performed from January 22, 2016, to August 9, 2019., Main Outcomes and Measures: The LRR was defined as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes. Time to LRR was tested with log-rank tests and Cox proportional hazards regression for multivariate models., Results: The final cohort of this study comprised 316 women with a mean (range) age of 60.4 (44-81) years. Median (interquartile range) follow-up for those without LRR was 8.7 (7.0-10.2) years. Seven LRR events (5.8%) among 121 patients with low recurrence score and 27 LRR events (13.8%) among 195 patients with intermediate or high recurrence score occurred. The estimated 10-year cumulative incidence rates were 9.7% for those with a low recurrence score and 16.5% for the group with intermediate or high recurrence score (P = .02). Among patients who had a mastectomy without radiotherapy (n = 252), the differences in the 10-year actuarial LRR rates remained significant: 7.7 % for the low recurrence score group vs 16.8% for the intermediate or high recurrence score group (P = .03). A multivariable model controlling for randomized treatment, number of positive nodes, and surgical type showed that a higher recurrence score was prognostic for LRR (hazard ratio [HR], 2.36; 95% CI, 1.02-5.45; P = .04). In a subset analysis of patients with a mastectomy and 1 to 3 involved nodes who did not receive radiation therapy, the group with a low recurrence score had a 1.5% rate of LRR, whereas the group with an intermediate or high recurrence score had a 11.1% LRR (P = .051)., Conclusions and Relevance: This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes. This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision-making.
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- 2020
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20. Germline Genetic Variants in GATA3 and Breast Cancer Treatment Outcomes in SWOG S8897 Trial and the Pathways Study.
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Larsen V, Barlow WE, Yang JJ, Zhu Q, Liu S, Kwan ML, Ergas IJ, Roh JM, Hutchins LF, Kadlubar SA, Albain KS, Rae JM, Yeh IT, Ravdin PM, Martino S, Lyss AP, Osborne CK, Hortobagyi GN, Kushi LH, Hayes DF, Ambrosone CB, and Yao S
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- Adult, Aged, Aged, 80 and over, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Breast Neoplasms pathology, Cyclophosphamide administration & dosage, Female, Fluorouracil administration & dosage, Follow-Up Studies, Humans, Methotrexate administration & dosage, Middle Aged, Prognosis, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor genetics, Breast Neoplasms mortality, GATA3 Transcription Factor genetics, Germ-Line Mutation, Polymorphism, Single Nucleotide
- Abstract
Introduction: GATA3 is a critical transcription factor in maintaining the differentiated state of luminal mammary epithelial cells. We sought to determine the prognostic and predictive roles of GATA3 genotypes for breast cancer., Patients and Methods: Twelve single nucleotide polymorphisms (SNPs) were genotyped in 2 breast cancer cohorts, including the SWOG S8897 trial where patients were treated with adjuvant chemotherapy (CAF [cyclophosphamide, doxorubicin, 5-fluorouracil] vs. CMF [cyclophosphamide, methotrexate, 5-fluorouracil]) or untreated, and the observational Pathways Study., Results: In the S8897 trial, rs3802604 and rs568727 were associated with disease-free survival and overall survival in the treated group, regardless of chemotherapy regimen. The GG genotype of rs3802604 conferred poorer overall survival (adjusted hazard ratio, 2.45; 95% confidence interval, 1.48-4.05) and disease-free survival (adjusted hazard ratio, 1.95; 95% confidence interval, 1.27-2.99) compared with the AA genotype. Similar associations were found for rs568727. In contrast, no association with either SNP was found in the untreated group. Subgroup analyses indicated that these 2 SNPs more strongly influenced outcomes in the patients who also received tamoxifen. However, the associations in the subgroup with tamoxifen treatment were not replicated in the Pathways Study, possibly owing to substantial differences between the 2 patient cohorts, such as chemotherapy regimen and length of follow-up. Results from joint analyses across these 2 cohorts were marginally significant, driven by the results in S8897. Bioinformatic analyses support potential functional disruption of the GATA3 SNPs in breast tissue., Conclusions: The present study provides some evidence for the predictive value of GATA3 genotypes for breast cancer adjuvant therapies. Future replication studies in appropriate patient populations are warranted., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2019
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21. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer.
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Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, and Sledge GW Jr
- Subjects
- Adult, Age Factors, Aged, Algorithms, Breast Neoplasms surgery, Chemotherapy, Adjuvant, Disease-Free Survival, Estrogen Antagonists therapeutic use, Female, Humans, Middle Aged, Neoplasm Recurrence, Local genetics, Neoplasm Recurrence, Local prevention & control, Premenopause, Prognosis, Proportional Hazards Models, Prospective Studies, Receptor, ErbB-2, Risk Factors, Antineoplastic Agents, Hormonal therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Gene Expression Profiling, Tamoxifen therapeutic use
- Abstract
Background: The use of adjuvant chemotherapy in patients with breast cancer may be guided by clinicopathological factors and a score based on a 21-gene assay to determine the risk of recurrence. Whether the level of clinical risk of breast cancer recurrence adds prognostic information to the recurrence score is not known., Methods: We performed a prospective trial involving 9427 women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, axillary node-negative breast cancer, in whom an assay of 21 genes had been performed, and we classified the clinical risk of recurrence of breast cancer as low or high on the basis of the tumor size and histologic grade. The effect of clinical risk was evaluated by calculating hazard ratios for distant recurrence with the use of Cox proportional-hazards models. The initial endocrine therapy was tamoxifen alone in the majority of the premenopausal women who were 50 years of age or younger., Results: The level of clinical risk was prognostic of distant recurrence in women with an intermediate 21-gene recurrence score of 11 to 25 (on a scale of 0 to 100, with higher scores indicating a worse prognosis or a greater potential benefit from chemotherapy) who were randomly assigned to endocrine therapy (hazard ratio for the comparison of high vs. low clinical risk, 2.73; 95% confidence interval [CI], 1.93 to 3.87) or to chemotherapy plus endocrine (chemoendocrine) therapy (hazard ratio, 2.41; 95% CI, 1.66 to 3.48) and in women with a high recurrence score (a score of 26 to 100), all of whom were assigned to chemoendocrine therapy (hazard ratio, 3.17; 95% CI, 1.94 to 5.19). Among women who were 50 years of age or younger who had received endocrine therapy alone, the estimated (±SE) rate of distant recurrence at 9 years was less than 5% (≤1.8±0.9%) with a low recurrence score (a score of 0 to 10), irrespective of clinical risk, and 4.7±1.0% with an intermediate recurrence score and low clinical risk. In this age group, the estimated distant recurrence at 9 years exceeded 10% among women with a high clinical risk and an intermediate recurrence score who received endocrine therapy alone (12.3±2.4%) and among those with a high recurrence score who received chemoendocrine therapy (15.2±3.3%)., Conclusions: Clinical-risk stratification provided prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00310180.)., (Copyright © 2019 Massachusetts Medical Society.)
- Published
- 2019
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22. Communicating Risks of Adjuvant Chemotherapy for Breast Cancer: Getting Beyond the Laundry List.
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Brauer ER, Long EF, Melnikow J, Ravdin PM, and Ganz PA
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- Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Cancer Survivors, Chemotherapy, Adjuvant adverse effects, Chemotherapy, Adjuvant methods, Clinical Decision-Making, Female, Humans, Medical Oncology methods, Medical Oncology standards, Medical Oncology statistics & numerical data, Oncologists, Quality of Health Care, Risk Assessment, Risk Factors, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms epidemiology, Communication
- Abstract
Purpose: According to the Institute of Medicine, high-quality cancer care should include effective communication between clinicians and patients about the risks and benefits, expected response, and impact on quality of life of a recommended therapy. In the delivery of oncology care, the barriers to and facilitators of communication about potential long-term and late effects, post-treatment expectations, and transition to survivorship care have not been fully defined., Patients and Methods: We collected qualitative data through semistructured interviews with medical oncologists and focus groups with breast cancer survivors and applied the Theoretical Domains Framework to systematically analyze and identify the factors that may influence oncologists' communication with patients with breast cancer about the long-term and late effects of adjuvant therapy., Results: Eight key informant interviews with medical oncologists and two focus groups with breast cancer survivors provided data. Both oncologists and patients perceived information on long-term effects as valuable in terms of improved clinical communication but had concerns about the feasibility of inclusion before treatment. They described the current approaches to communication of therapy risks as a brief laundry list that emphasized acute adverse effects and minimized more long-term issues. We describe the barriers to communication about potential long-term effects from the perspectives of both groups., Conclusion: This study provides insight into oncologists' communication with patients with breast cancer regarding the potential long-term and late effects of adjuvant chemotherapy and about setting realistic expectations for life after treatment. Opportunities to improve oncologists' communication about the potential toxicities of therapy, particularly regarding long-term and late effects, should be examined further.
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- 2019
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23. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
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Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, and Sledge GW Jr
- Subjects
- Adult, Age Factors, Aged, Breast Neoplasms surgery, Chemotherapy, Adjuvant, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Invasiveness, Neoplasm Recurrence, Local genetics, Neoplasm Recurrence, Local prevention & control, Prospective Studies, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone, Young Adult, Antineoplastic Agents, Hormonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Gene Expression Profiling
- Abstract
Background: The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score., Methods: We performed a prospective trial involving 10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease-free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death)., Results: Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease-free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease-free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25., Conclusions: Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180 .).
- Published
- 2018
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24. Accuracy of the online prognostication tools PREDICT and Adjuvant! for early-stage breast cancer patients younger than 50 years.
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Engelhardt EG, van den Broek AJ, Linn SC, Wishart GC, Rutgers EJT, van de Velde AO, Smit VTHBM, Voogd AC, Siesling S, Brinkhuis M, Seynaeve C, Westenend PJ, Stiggelbout AM, Tollenaar RAEM, van Leeuwen FE, van 't Veer LJ, Ravdin PM, Pharaoh PDP, and Schmidt MK
- Subjects
- Adult, Breast Neoplasms mortality, Chemotherapy, Adjuvant methods, Chemotherapy, Adjuvant mortality, Female, Humans, Middle Aged, Netherlands epidemiology, Prognosis, Receptors, Estrogen metabolism, Receptors, Progesterone metabolism, Sensitivity and Specificity, Severity of Illness Index, Young Adult, Breast Neoplasms drug therapy
- Abstract
Importance: Online prognostication tools such as PREDICT and Adjuvant! are increasingly used in clinical practice by oncologists to inform patients and guide treatment decisions about adjuvant systemic therapy. However, their validity for young breast cancer patients is debated., Objective: To assess first, the prognostic accuracy of PREDICT's and Adjuvant! 10-year all-cause mortality, and second, its breast cancer-specific mortality estimates, in a large cohort of breast cancer patients diagnosed <50 years., Design: Hospital-based cohort., Setting: General and cancer hospitals., Participants: A consecutive series of 2710 patients without a prior history of cancer, diagnosed between 1990 and 2000 with unilateral stage I-III breast cancer aged <50 years., Main Outcome Measures: Calibration and discriminatory accuracy, measured with C-statistics, of estimated 10-year all-cause and breast cancer-specific mortality., Results: Overall, PREDICT's calibration for all-cause mortality was good (predicted versus observed) mean
difference : -1.1% (95%CI: -3.2%-0.9%; P = 0.28). PREDICT tended to underestimate all-cause mortality in good prognosis subgroups (range meandifference : -2.9% to -4.8%), overestimated all-cause mortality in poor prognosis subgroups (range meandifference : 2.6%-9.4%) and underestimated survival in patients < 35 by -6.6%. Overall, PREDICT overestimated breast cancer-specific mortality by 3.2% (95%CI: 0.8%-5.6%; P = 0.007); and also overestimated it seemingly indiscriminately in numerous subgroups (range meandifference : 3.2%-14.1%). Calibration was poor in the cohort of patients with the lowest and those with the highest mortality probabilities. Discriminatory accuracy was moderate-to-good for all-cause mortality in PREDICT (0.71 [95%CI: 0.68 to 0.73]), and the results were similar for breast cancer-specific mortality. Adjuvant!'s calibration and discriminatory accuracy for both all-cause and breast cancer-specific mortality were in line with PREDICT's findings., Conclusions: Although imprecise at the extremes, PREDICT's estimates of 10-year all-cause mortality seem reasonably sound for breast cancer patients <50 years; Adjuvant! findings were similar. Prognostication tools should be used with caution due to the intrinsic variability of their estimates, and because the threshold to discuss adjuvant systemic treatment is low. Thus, seemingly insignificant mortality overestimations or underestimations of a few percentages can significantly impact treatment decision-making., (Copyright © 2017 Elsevier Ltd. All rights reserved.)- Published
- 2017
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25. Epidemiology of GIST in the Era of Histology Codes--Letter.
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Lin A, Hsing AW, and Ravdin PM
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- Female, Humans, Male, Gastrointestinal Stromal Tumors epidemiology
- Published
- 2015
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26. The EORTC 10041/BIG 03-04 MINDACT trial is feasible: results of the pilot phase.
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Rutgers E, Piccart-Gebhart MJ, Bogaerts J, Delaloge S, Veer LV, Rubio IT, Viale G, Thompson AM, Passalacqua R, Nitz U, Vindevoghel A, Pierga JY, Ravdin PM, Werutsky G, and Cardoso F
- Subjects
- Adult, Aged, Breast Neoplasms pathology, Chemotherapy, Adjuvant, Female, Humans, Middle Aged, Patient Compliance, Pilot Projects, Breast Neoplasms drug therapy
- Abstract
Background: The MINDACT (Microarray In Node-negative and 1-3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. We present the results of the pilot phase consisting of first 800 patients included., Methods: MINDACT has enrolled 6600 patients, classified into high or low risk by MammaPrint and clinicopathological risk through Adjuvant! Online. Patients with both clinical (C) and genomic (G) high risks are offered adjuvant CT; those with both C and G low risks do not receive CT; patients with discordant risk are randomised for the decision of adjuvant CT based on C or G risk. CT randomisation of anthracycline-based versus docetaxel/capecitabine and endocrine therapy randomisation between letrozole and tamoxifen→letrozole are offered., Results: During the pilot phase 46% of screened patients were enrolled. Main reasons for non-enrolment were node positivity before trial amendment, sample quality problems and failure to meet logistic settings. Among the 800 patients, 386 (48%) were C-low/G-low, 198 (24.8%) as C-high/G-high, 75 (9.4%) as C-low/G-high and 141 (17.6%) as C-high/G-low. In total 216 (27%) cases were discordant. The difference between patients with C-high (42%) and G-high risk (34%) is 8.25% (95% confidence interval (CI), 4.7-11.8%; P<.0001). Compliance with the treatment decision was high (>92%)., Conclusions: The logistically complex MINDACT trial is feasible in a multinational setting. The proportion of discordant patients, the potential reduction in CT by using the genomic signature and compliance to treatment assignment are in accordance with the trial hypotheses., (Copyright © 2011. Published by Elsevier Ltd.)
- Published
- 2011
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27. Cancer and Leukemia Group B Pathology Committee guidelines for tissue microarray construction representing multicenter prospective clinical trial tissues.
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Rimm DL, Nielsen TO, Jewell SD, Rohrer DC, Broadwater G, Waldman F, Mitchell KA, Singh B, Tsongalis GJ, Frankel WL, Magliocco AM, Lara JF, Hsi ED, Bleiweiss IJ, Badve SS, Chen B, Ravdin PM, Schilsky RL, Thor A, and Berry DA
- Subjects
- Clinical Trials as Topic, Humans, Multicenter Studies as Topic, Specimen Handling methods, Biomarkers, Tumor analysis, Tissue Array Analysis methods
- Abstract
Practice-changing evidence requires confirmation, preferably in multi-institutional clinical trials. The collection of tissue within such trials has enabled biomarker studies and evaluation of companion diagnostic tests. Tissue microarrays (TMAs) have become a standard approach in many cooperative oncology groups. A principal goal is to maximize the number of assays with this precious tissue. However, production strategies for these arrays have not been standardized, possibly decreasing the value of the study. In this article, members of the Cancer and Leukemia Group B Pathology Committee relay our experiences as array facility directors and propose guidelines regarding the production of high-quality TMAs for cooperative group studies. We also discuss statistical issues arising from having a proportion of patients available for TMAs and the possibility that patients with TMAs fail to represent the greater study population.
- Published
- 2011
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28. Independent prognostic value of screen detection in invasive breast cancer.
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Mook S, Van 't Veer LJ, Rutgers EJ, Ravdin PM, van de Velde AO, van Leeuwen FE, Visser O, and Schmidt MK
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- Adult, Aged, Breast Neoplasms mortality, Breast Neoplasms pathology, Carcinoma, Ductal, Breast mortality, Carcinoma, Ductal, Breast pathology, Early Detection of Cancer, Female, Humans, Kaplan-Meier Estimate, Lymphatic Metastasis, Middle Aged, Multivariate Analysis, Odds Ratio, Predictive Value of Tests, Prognosis, Proportional Hazards Models, Breast Neoplasms diagnostic imaging, Carcinoma, Ductal, Breast diagnostic imaging, Mammography, Mass Screening methods
- Abstract
Background: Mammographic screening has led to a proportional shift toward earlier-stage breast cancers at presentation. We assessed whether the method of detection provides prognostic information above and beyond standard prognostic factors and investigated the accuracy of predicted overall and breast cancer-specific survival by the computer tool Adjuvant! among patients with screen-detected, interval, and nonscreening-related carcinomas., Methods: We studied 2592 patients with invasive breast cancer who were treated at the Netherlands Cancer Institute from January 1, 1990, through December 31, 2000. Overall and breast cancer-specific survival probabilities among patients with mammographically screen-detected (n = 958), interval (n = 417), and nonscreening-related (n = 1217) breast carcinomas were compared. Analyses were adjusted for clinicopathologic characteristics and adjuvant systemic therapy. Because of gradual implementation of population-based screening in the Netherlands, analyses were stratified a priori according to two periods of diagnosis. All statistical tests were two-sided., Results: Screen detection was associated with reduced mortality (adjusted hazard ratio for all-cause mortality = 0.74, 95% confidence interval = 0.63 to 0.87, P < .001, and adjusted hazard ratio for breast cancer-specific mortality = 0.62, 95% confidence interval = 0.50 to 0.78, P < .001, respectively) compared with nonscreening-related detection. The absolute adjusted reduction in breast cancer-specific mortality was 7% at 10 years. The prognostic value of the method of detection was independent of the period of diagnosis and was similar across tumor size and lymph node status categories, indicating its prognostic value beyond stage migration. Adjuvant! underestimated breast cancer-specific survival in patients with screen-detected (-3.2%) and interval carcinomas (-5.4%)., Conclusions: Screen detection was found to be independently associated with better prognosis for overall and breast cancer-specific survival and to provide prognostic information beyond stage migration among patients with invasive breast cancer. We propose that the method of detection should be taken into account when estimating individual prognosis.
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- 2011
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29. Gene polymorphisms in cyclophosphamide metabolism pathway,treatment-related toxicity, and disease-free survival in SWOG 8897 clinical trial for breast cancer.
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Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff M, Hortobagyi GN, Hayes DF, and Ambrosone CB
- Subjects
- Adult, Aged, Aged, 80 and over, Algorithms, Antineoplastic Agents, Alkylating adverse effects, Antineoplastic Agents, Alkylating metabolism, Antineoplastic Agents, Alkylating pharmacokinetics, Antineoplastic Agents, Alkylating therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols pharmacokinetics, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Aryl Hydrocarbon Hydroxylases genetics, Breast Neoplasms genetics, Breast Neoplasms metabolism, Carcinoma genetics, Carcinoma metabolism, Cyclophosphamide metabolism, Cyclophosphamide therapeutic use, Cytochrome P-450 CYP2B6, Cytochrome P-450 CYP3A genetics, Disease-Free Survival, Female, Glutathione S-Transferase pi genetics, Glutathione Transferase genetics, Humans, Inactivation, Metabolic genetics, Middle Aged, North America, Oxidoreductases, N-Demethylating genetics, Breast Neoplasms drug therapy, Carcinoma drug therapy, Cyclophosphamide adverse effects, Cyclophosphamide pharmacokinetics, Metabolic Networks and Pathways genetics, Polymorphism, Genetic physiology
- Abstract
Purpose: There are no established genetic markers for prediction of outcomes after cyclophosphamide (CP)-containing adjuvant therapy for breast cancer. In an ancillary study to a SWOG (Southwest Oncology Group) trial (S8897), we investigated functional polymorphisms in 4 genes in CP pharmacokinetic pathways in relation to hematologic toxicity and disease-free survival (DFS)., Experimental Design: Germline DNA was available from 458 women who were at high risk of relapse and was randomized to CAF (CP, intravenous doxorubicin, and 5-fluorouracil) versus CMF (CP, intravenous methotrexate, and 5-fluorouracil) ± tamoxifen, and from 874 women who had a presumed favorable prognosis and did not receive adjuvant therapy. Odds ratios for grade 3 and 4 hematologic toxicity in the treated group and hazard ratios for DFS associated with selected functional polymorphisms in CYP2B6CYP3A4GSTA1 and GSTP1 were estimated by logistic regression and Cox proportional hazard regression., Results: Compared with women with AA genotypes, those with at least 1 GSTP1 variant G allele had reduced risk of grade 3 and 4 neutropenia [odds ratios (OR) = 0.63, 95% CI = 0.41-0.97] and leucopenia (OR = 0.59, 95% CI = 0.39-0.89). No other associations between single nucleotide polymorphisms and toxicity or survival were found in the treated or untreated group., Conclusion: Known genetic variants in genes involved in CP pharmacokinetics may not have major effects on DFS in breast cancer patients. The lower risk of developing high-grade hematologic toxicity among women with variant GSTP1 alleles suggests that genetic markers in combination with clinical factors may be useful in defining a subgroup of women who are less susceptible to adverse hematologic toxicities with CP-containing therapies., (©2010 AACR)
- Published
- 2010
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30. Manganese superoxide dismutase polymorphism, treatment-related toxicity and disease-free survival in SWOG 8897 clinical trial for breast cancer.
- Author
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Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hortobagyi GN, Hayes DF, and Ambrosone CB
- Subjects
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms enzymology, Breast Neoplasms mortality, Chemotherapy, Adjuvant, Cyclophosphamide administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Female, Fluorouracil administration & dosage, Gene Frequency, Genetic Predisposition to Disease, Humans, Logistic Models, Methotrexate administration & dosage, Middle Aged, Neutropenia chemically induced, Neutropenia enzymology, Neutropenia genetics, Odds Ratio, Phenotype, Prospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Southwestern United States, Superoxide Dismutase metabolism, Tamoxifen administration & dosage, Time Factors, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Polymorphism, Genetic, Superoxide Dismutase genetics
- Abstract
To date, the few studies of associations between a functional polymorphism in the oxidative stress-related gene manganese superoxide dismutase (SOD2) and breast cancer survival have been inconsistent. In a homogeneous patient population from a large cooperative group trial Southwest Oncology Group (SWOG) 8897, we evaluated this polymorphism in relation to both treatment-related toxicity and disease-free survival (DFS). Among 458 women who received cyclophosphamide-containing adjuvant chemotherapy, those with variant C alleles, related to higher antioxidant activity, experienced less grade 3-4 neutropenia (OR = 0.52, 95% CI = 0.29-0.92) but had worse DFS (HR = 1.59, 95% CI = 0.99-2.55) than women with TT genotypes. No associations were observed among 874 women who were followed without adjuvant therapy. Our results are consistent with the hypothesis that women with higher SOD2 antioxidant activity may experience less treatment-related toxicity but shorter time to disease recurrence or death after breast cancer adjuvant chemotherapy, supporting the modifying effects of oxidative stress-related enzymes on cancer treatment toxicity and efficacy.
- Published
- 2010
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31. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women.
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Chlebowski RT, Anderson GL, Gass M, Lane DS, Aragaki AK, Kuller LH, Manson JE, Stefanick ML, Ockene J, Sarto GE, Johnson KC, Wactawski-Wende J, Ravdin PM, Schenken R, Hendrix SL, Rajkovic A, Rohan TE, Yasmeen S, and Prentice RL
- Subjects
- Aged, Drug Combinations, Estrogens, Conjugated (USP) therapeutic use, Female, Follow-Up Studies, Humans, Incidence, Lymphatic Metastasis, Medroxyprogesterone Acetate therapeutic use, Middle Aged, Neoplasm Invasiveness, Neoplasm Staging, Prognosis, United States epidemiology, Breast Neoplasms mortality, Breast Neoplasms pathology, Estrogens, Conjugated (USP) adverse effects, Hormone Replacement Therapy adverse effects, Medroxyprogesterone Acetate adverse effects, Postmenopause
- Abstract
Context: In the Women's Health Initiative randomized, placebo-controlled trial of estrogen plus progestin, after a mean intervention time of 5.6 (SD, 1.3) years (range, 3.7-8.6 years) and a mean follow-up of 7.9 (SD, 1.4) years, breast cancer incidence was increased among women who received combined hormone therapy. Breast cancer mortality among participants in the trial has not been previously reported., Objective: To determine the effects of therapy with estrogen plus progestin on cumulative breast cancer incidence and mortality after a total mean follow-up of 11.0 (SD, 2.7) years, through August 14, 2009., Design, Setting, and Participants: A total of 16,608 postmenopausal women aged 50 to 79 years with no prior hysterectomy from 40 US clinical centers were randomly assigned to receive combined conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, or placebo pill. After the original trial completion date (March 31, 2005), reconsent was required for continued follow-up for breast cancer incidence and was obtained from 12,788 (83%) of the surviving participants., Main Outcome Measures: Invasive breast cancer incidence and breast cancer mortality., Results: In intention-to-treat analyses including all randomized participants and censoring those not consenting to additional follow-up on March 31, 2005, estrogen plus progestin was associated with more invasive breast cancers compared with placebo (385 cases [0.42% per year] vs 293 cases [0.34% per year]; hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.07-1.46; P = .004). Breast cancers in the estrogen-plus-progestin group were similar in histology and grade to breast cancers in the placebo group but were more likely to be node-positive (81 [23.7%] vs 43 [16.2%], respectively; HR, 1.78; 95% CI, 1.23-2.58; P = .03). There were more deaths directly attributed to breast cancer (25 deaths [0.03% per year] vs 12 deaths [0.01% per year]; HR, 1.96; 95% CI, 1.00-4.04; P = .049) as well as more deaths from all causes occurring after a breast cancer diagnosis (51 deaths [0.05% per year] vs 31 deaths [0.03% per year]; HR, 1.57; 95% CI, 1.01-2.48; P = .045) among women who received estrogen plus progestin compared with women in the placebo group., Conclusions: Estrogen plus progestin was associated with greater breast cancer incidence, and the cancers are more commonly node-positive. Breast cancer mortality also appears to be increased with combined use of estrogen plus progestin., Trial Registration: clinicaltrials.gov Identifier: NCT00000611.
- Published
- 2010
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32. The lack, need, and opportunities for decision-making and informational tools to educate primary-care physicians and women about breast cancer chemoprevention.
- Author
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Ravdin PM
- Subjects
- Adenocarcinoma epidemiology, Breast Neoplasms epidemiology, Drug Utilization, Female, Humans, Incidence, Internet, Multicenter Studies as Topic statistics & numerical data, Neoplasms, Hormone-Dependent epidemiology, Physicians, Family psychology, Practice Patterns, Physicians' trends, Raloxifene Hydrochloride adverse effects, Raloxifene Hydrochloride pharmacology, Randomized Controlled Trials as Topic statistics & numerical data, Risk Assessment, Risk Reduction Behavior, Selective Estrogen Receptor Modulators adverse effects, Selective Estrogen Receptor Modulators pharmacology, Tamoxifen adverse effects, Tamoxifen pharmacology, Adenocarcinoma prevention & control, Breast Neoplasms prevention & control, Decision Support Techniques, Estrogens, Neoplasms, Hormone-Dependent prevention & control, Patient Education as Topic, Physicians, Family education, Practice Patterns, Physicians' statistics & numerical data, Raloxifene Hydrochloride therapeutic use, Selective Estrogen Receptor Modulators therapeutic use, Tamoxifen therapeutic use
- Abstract
This perspective on Vogel et al. (beginning on page 696 in this issue of the journal) examines tamoxifen and raloxifene prescription patterns and why these agents are little used for breast cancer prevention despite their effectiveness in definitive trials, Food and Drug Administration approval, and American Society of Clinical Oncology Guidelines Committee endorsement for this purpose. The complexity of weighing the positive and negative aspects of the drugs and estimating net benefit is discussed, as is the need for informational resources such as interactive Internet-based tools to allow better individualized decisions about the options for chemoprevention., (2010 AACR.)
- Published
- 2010
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33. Ki67 in breast cancer: prognostic and predictive potential.
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Yerushalmi R, Woods R, Ravdin PM, Hayes MM, and Gelmon KA
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- Biomarkers analysis, Female, Humans, Predictive Value of Tests, Prognosis, Breast Neoplasms genetics, Ki-67 Antigen genetics
- Abstract
The leading parameters that define treatment recommendations in early breast cancer are oestrogen-receptor, progesterone-receptor, and human epidermal growth-factor status. Although some pathologists report Ki67 in addition to other biological markers, the existing guidelines of the American Society of Clinical Oncology do not include Ki67 in the list of required routine biological markers. The advent of new genetic tests has emphasised the role of proliferative genes, including Ki67, as prognostic and predictive markers. Additionally, randomised studies have retrospectively reviewed data and reported on the role of Ki67 in breast cancer. In light of new data, we have re-assessed evidence that could change guidelines to include Ki67 in the standard pathological assessment of early breast cancers. This review provides an update on the current knowledge on Ki67 and of the evidence in the published work about the prognostic and predictive role of this marker, and provides information on the laboratory techniques used to determine Ki67., (Copyright 2010 Elsevier Ltd. All rights reserved.)
- Published
- 2010
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34. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised controlled trial.
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Albain KS, Barlow WE, Ravdin PM, Farrar WB, Burton GV, Ketchel SJ, Cobau CD, Levine EG, Ingle JN, Pritchard KI, Lichter AS, Schneider DJ, Abeloff MD, Henderson IC, Muss HB, Green SJ, Lew D, Livingston RB, Martino S, and Osborne CK
- Subjects
- Adenocarcinoma mortality, Adult, Aged, Antibiotics, Antineoplastic administration & dosage, Antimetabolites, Antineoplastic administration & dosage, Antineoplastic Agents, Alkylating administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms mortality, Chemotherapy, Adjuvant, Cyclophosphamide administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Female, Fluorouracil administration & dosage, Humans, Lymphatic Metastasis, Middle Aged, Postmenopause, Receptors, Estrogen analysis, Receptors, Progesterone analysis, Adenocarcinoma drug therapy, Antineoplastic Agents, Hormonal administration & dosage, Breast Neoplasms drug therapy, Lymph Nodes pathology, Tamoxifen administration & dosage
- Abstract
Background: Tamoxifen is standard adjuvant treatment for postmenopausal women with hormone-receptor-positive breast cancer. We assessed the benefit of adding chemotherapy to adjuvant tamoxifen and whether tamoxifen should be given concurrently or after chemotherapy., Methods: We undertook a phase 3, parallel, randomised trial (SWOG-8814, INT-0100) in postmenopausal women with hormone-receptor-positive, node-positive breast cancer to test two major objectives: whether the primary outcome, disease-free survival, was longer with cyclophosphamide, doxorubicin, and fluorouracil (CAF) given every 4 weeks for six cycles plus 5 years of daily tamoxifen than with tamoxifen alone; and whether disease-free survival was longer with CAF followed by tamoxifen (CAF-T) than with CAF plus concurrent tamoxifen (CAFT). Overall survival and toxicity were predefined, important secondary outcomes for each objective. Patients in this open-label trial were randomly assigned by a computer algorithm in a 2:3:3 ratio (tamoxifen:CAF-T:CAFT) and analysis was by intention to treat of eligible patients. Groups were compared by stratified log-rank tests, followed by Cox regression analyses adjusted for significant prognostic factors. This trial is registered with ClinicalTrials.gov, number NCT00929591., Findings: Of 1558 randomised women, 1477 (95%) were eligible for inclusion in the analysis. After a maximum of 13 years of follow-up (median 8.94 years), 637 women had a disease-free survival event (tamoxifen, 179 events in 361 patients; CAF-T, 216 events in 566 patients; CAFT, 242 events in 550 patients). For the first objective, therapy with the CAF plus tamoxifen groups combined (CAFT or CAF-T) was superior to tamoxifen alone for the primary endpoint of disease-free survival (adjusted Cox regression hazard ratio [HR] 0.76, 95% CI 0.64-0.91; p=0.002) but only marginally for the secondary endpoint of overall survival (HR 0.83, 0.68-1.01; p=0.057). For the second objective, the adjusted HRs favoured CAF-T over CAFT but did not reach significance for disease-free survival (HR 0.84, 0.70-1.01; p=0.061) or overall survival (HR 0.90, 0.73-1.10; p=0.30). Neutropenia, stomatitis, thromboembolism, congestive heart failure, and leukaemia were more frequent in the combined CAF plus tamoxifen groups than in the tamoxifen-alone group., Interpretation: Chemotherapy with CAF plus tamoxifen given sequentially is more effective adjuvant therapy for postmenopausal patients with endocrine-responsive, node-positive breast cancer than is tamoxifen alone. However, it might be possible to identify some subgroups that do not benefit from anthracycline-based chemotherapy despite positive nodes., Funding: National Cancer Institute (US National Institutes of Health)., (Copyright 2009 Elsevier Ltd. All rights reserved.)
- Published
- 2009
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35. Calibration and discriminatory accuracy of prognosis calculation for breast cancer with the online Adjuvant! program: a hospital-based retrospective cohort study.
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Mook S, Schmidt MK, Rutgers EJ, van de Velde AO, Visser O, Rutgers SM, Armstrong N, van't Veer LJ, and Ravdin PM
- Subjects
- Adult, Age Factors, Aged, Breast Neoplasms diagnosis, Breast Neoplasms secondary, Calibration, Chemotherapy, Adjuvant, Disease-Free Survival, Female, Hospitalization, Humans, Internet, Kaplan-Meier Estimate, Lymphatic Metastasis, Middle Aged, Neoplasm Staging, Netherlands epidemiology, Practice Guidelines as Topic, Predictive Value of Tests, Proportional Hazards Models, Receptors, Estrogen analysis, Registries, Reproducibility of Results, Retrospective Studies, Risk Assessment, Time Factors, Treatment Outcome, Antineoplastic Agents therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms mortality, Decision Support Techniques, Discriminant Analysis, Models, Biological, Online Systems standards, Patient Selection
- Abstract
Background: Adjuvant! is a web-based program that calculates individualised 10-year survival probabilities and predicted benefit of adjuvant systemic therapy. The Adjuvant! model has not been validated in any large European series. The aim of our study was to validate Adjuvant! in Dutch patients, investigating both its calibration and discriminatory accuracy., Methods: Patients who were at least partly treated at the Netherlands Cancer Institute for breast cancer between 1987 and 1998 were included if they met the following criteria: tumour size T1 (< or =2 cm), T2 (2-5 cm), or T3 (>5 cm), invasive breast carcinoma, with information about involvement of axillary lymph nodes available, no distant metastases, primary surgery, axillary staging, and radiotherapy according to national guidelines. Clinicopathological characteristics and adjuvant treatment data were retrieved from hospital records and medical registries and were entered into the Adjuvant! (version 8.0) batch processor with blinding to outcome. Endpoints were overall survival and the proportion of patients that did not die from breast cancer (breast-cancer-specific survival [BCSS])., Findings: 5380 patients were included with median follow-up of 11.7 years (range 0.03-21.8). The 10-year observed overall survival (69.0%) and BCSS (78.6%) and Adjuvant! predicted overall survival (69.1%) and BCSS (77.8%) were not statistically different (p=0.87 and p=0.18, respectively). Moreover, differences between predicted and observed outcomes were within 2% for most relevant clinicopathological subgroups. In patients younger than 40 years, Adjuvant! overestimated overall survival by 4.2% (p=0.04) and BCSS by 4.7% (p=0.01). The concordance index, which indicates discriminatory accuracy at the individual level, was 0.71 for BCSS in the entire cohort., Interpretation: Adjuvant! accurately predicted 10-year outcomes in this large-scale Dutch validation study and is of use for adjuvant treatment decision making, although the results may be less reliable in some subgroups.
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- 2009
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36. Myeloperoxidase genotypes and enhanced efficacy of chemotherapy for early-stage breast cancer in SWOG-8897.
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Ambrosone CB, Barlow WE, Reynolds W, Livingston RB, Yeh IT, Choi JY, Davis W, Rae JM, Tang L, Hutchins LR, Ravdin PM, Martino S, Osborne CK, Lyss AP, Hayes DF, and Albain KS
- Subjects
- Adult, Aged, Aged, 80 and over, Breast Neoplasms pathology, Cyclophosphamide administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Female, Fluorouracil administration & dosage, Genotype, Humans, Methotrexate administration & dosage, Middle Aged, Prognosis, Risk Factors, Tamoxifen administration & dosage, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Peroxidase genetics
- Abstract
Purpose: Myeloperoxidase (MPO) generates reactive oxygen species and also activates xenobiotics. In a rigorous clinical trial (Southwest Oncology Group SWOG-8897), we examined relationships between genotypes and disease-free survival (DFS) among women treated for breast cancer, as well as those who did not receive adjuvant chemotherapy., Patients and Methods: Patients were assigned to risk groups according to standard prognostic features; the low-risk group (n = 753 genotyped) received follow-up only, and the high-risk group (n = 401 genotyped) was randomly assigned to adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) or cyclophosphamide, doxorubicin, and fluorouracil (CAF), with or without tamoxifen. DNA from archived normal lymph node tissue was genotyped, and Cox proportional hazard models were used to calculate DFS associated with MPO genotypes., Results: Among women in the treatment arm, those with MPO G alleles had more than a two-fold reduction in hazard of recurrence (adjusted hazard ratio [HR] for GA genotypes, 0.51; 95% CI, 0.21 to 0.99; HR for GG genotypes, 0.41; 95% CI, 0.21 to 0.77). Effects were greatest among women who were further randomly assigned to tamoxifen (HR for GA genotypes, 0.28; 95% CI, 0.12 to 0.69; HR for GG genotypes, 0.19; 95% CI, 0.08 to 0.45). There were no significant associations between genotypes and DFS among women in the untreated arm, and relationships between genotypes and DFS did not differ by CAF or CMF., Conclusion: These results, observed in two independent study populations, indicate that high-activity MPO genotypes are associated with better survival among women receiving cyclophosphamide-containing therapy, particularly when followed by tamoxifen therapy. MPO can be inhibited and/or upregulated by commonly used drugs; thus, our findings merit further investigation for optimization of therapeutics for breast cancer.
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- 2009
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37. Sustained lower rates of breast cancer in the United States.
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Cronin KA, Ravdin PM, and Edwards BK
- Subjects
- Aged, Breast Neoplasms metabolism, Female, Humans, Incidence, Middle Aged, Receptors, Estrogen metabolism, SEER Program, United States epidemiology, Breast Neoplasms epidemiology
- Published
- 2009
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38. Nitric oxide synthase variants and disease-free survival among treated and untreated breast cancer patients in a Southwest Oncology Group clinical trial.
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Choi JY, Barlow WE, Albain KS, Hong CC, Blanco JG, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hayes DF, and Ambrosone CB
- Subjects
- Adult, Aged, Aged, 80 and over, Algorithms, Breast Neoplasms diagnosis, Breast Neoplasms genetics, Carcinoma diagnosis, Carcinoma genetics, Cisplatin therapeutic use, Clinical Trials as Topic, Cyclophosphamide therapeutic use, Disease-Free Survival, Doxorubicin therapeutic use, Female, Fluorouracil therapeutic use, Humans, Medical Oncology methods, Methotrexate therapeutic use, Middle Aged, Polymorphism, Genetic physiology, Prognosis, Southwestern United States, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Carcinoma drug therapy, Nitric Oxide Synthase Type III genetics
- Abstract
Purpose: Numerous chemotherapeutic agents are cytotoxic through generation of reactive species, and variability in genes related to oxidative stress may influence disease-free survival (DFS). We examined relationships between DFS and variants in NOS3, as well as NQO1, NQO2, and CBR3, among treated and untreated breast cancer patients in a Southwest Oncology Group clinical trial (S8897)., Experimental Design: In the parent trial, women were assigned according to prognostic features; the high-risk group was randomized to cyclophosphamide, i.v. methotrexate, and 5-fluorouracil or to cyclophosphamide, i.v. doxorubicin, and 5-fluorouracil +/- tamoxifen, and the low-risk group did not receive adjuvant therapy. We extracted DNA from normal lymph node tissue and examined functional polymorphisms in NOS3, NQO1, NQO2, and CBR3, in relation to DFS, using Cox proportional hazard model., Results: There were significant interactions between DFS, adjuvant therapy, and NOS3 Glu298Asp and -786 polymorphisms, alone and in combination (P for interaction = 0.008). When NOS3 genotypes were combined, women with genotypes encoding for lower nitric oxide who received chemotherapy had a >2-fold increase in hazard of progression (hazard ratio, 2.32; 95% confidence interval, 1.26-4.25), whereas there was reduced risk for those who did not receive adjuvant therapy (hazard ratio, 0.42; 95% confidence interval, 0.19-0.95). There were no associations between the other genotypes and DFS in either group., Conclusion: Variants encoding lower activity of NOS3 may affect outcomes in breast cancer patients, with the direction of risk differing depending on chemotherapy status. These results may mirror the known dual functions of nitric oxide and nitric oxide synthase, depending on oxidative environment.
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- 2009
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39. Breast cancer after use of estrogen plus progestin in postmenopausal women.
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Chlebowski RT, Kuller LH, Prentice RL, Stefanick ML, Manson JE, Gass M, Aragaki AK, Ockene JK, Lane DS, Sarto GE, Rajkovic A, Schenken R, Hendrix SL, Ravdin PM, Rohan TE, Yasmeen S, and Anderson G
- Subjects
- Aged, Breast Neoplasms chemically induced, Causality, Drug Combinations, Female, Follow-Up Studies, Humans, Incidence, Middle Aged, Postmenopause, Risk Factors, United States epidemiology, Breast Neoplasms epidemiology, Estrogen Replacement Therapy adverse effects, Estrogens, Conjugated (USP) adverse effects, Mammography statistics & numerical data, Medroxyprogesterone Acetate adverse effects
- Abstract
Background: Following the release of the 2002 report of the Women's Health Initiative (WHI) trial of estrogen plus progestin, the use of menopausal hormone therapy in the United States decreased substantially. Subsequently, the incidence of breast cancer also dropped, suggesting a cause-and-effect relation between hormone treatment and breast cancer. However, the cause of this decrease remains controversial., Methods: We analyzed the results of the WHI randomized clinical trial--in which one study group received 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate daily and another group received placebo--and examined temporal trends in breast-cancer diagnoses in the WHI observational-study cohort. Risk factors for breast cancer, frequency of mammography, and time-specific incidence of breast cancer were assessed in relation to combined hormone use., Results: In the clinical trial, there were fewer breast-cancer diagnoses in the group receiving estrogen plus progestin than in the placebo group in the initial 2 years of the study, but the number of diagnoses increased over the course of the 5.6-year intervention period. The elevated risk decreased rapidly after both groups stopped taking the study pills, despite a similar frequency of mammography. In the observational study, the incidence of breast cancer was initially about two times as high in the group receiving menopausal hormones as in the placebo group, but this difference in incidence decreased rapidly in about 2 years, coinciding with year-to-year reductions in combined hormone use. During this period, differences in the frequency of mammography between the two groups were unchanged., Conclusions: The increased risk of breast cancer associated with the use of estrogen plus progestin declined markedly soon after discontinuation of combined hormone therapy and was unrelated to changes in frequency of mammography., (2009 Massachusetts Medical Society)
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- 2009
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40. Hormone replacement therapy and the increase in the incidence of invasive lobular cancer.
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Ravdin PM
- Subjects
- Aged, Carcinoma, Ductal, Breast etiology, Carcinoma, Lobular etiology, Female, Humans, Incidence, Middle Aged, Postmenopause, Randomized Controlled Trials as Topic, Risk Factors, Carcinoma, Ductal, Breast epidemiology, Carcinoma, Lobular epidemiology, Hormone Replacement Therapy adverse effects
- Abstract
Individual epidemiologic studies and a meta-analysis of those studies suggest that the relative risk of invasive lobular and compared to invasive ductal cancer is particularly affected by combined hormone replacement therapy (HRT) in postmenopausal women, with an approximate doubling of risk of invasive lobular breast cancer in current users. However, this was not seen in the Women's Health Initiative trial comparing combined HRT and placebo, although this trial had only modest statistical power to demonstrate the effect. In the absence of some obvious source of bias (screening mammography rates were well balanced between HRT users and non-users in most studies), this evidence supports the hypothesis that combined HRT increases the risk of lobular breast cancer.
- Published
- 2008
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41. Breast cancer trends: a marriage between clinical trial evidence and epidemiology.
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Berry DA and Ravdin PM
- Subjects
- Adult, Aged, Breast Neoplasms diagnostic imaging, Causality, Databases, Factual, Disease Progression, Early Diagnosis, Estrogens adverse effects, Estrogens therapeutic use, Female, Hormone Replacement Therapy adverse effects, Hormone Replacement Therapy statistics & numerical data, Humans, Incidence, Mammography statistics & numerical data, Mass Screening statistics & numerical data, Menopause, Middle Aged, Morbidity trends, Neoplasms, Hormone-Dependent diagnostic imaging, Neoplasms, Hormone-Dependent epidemiology, Progestins adverse effects, Progestins therapeutic use, Randomized Controlled Trials as Topic, Research Design, Risk Factors, SEER Program, United States epidemiology, Breast Neoplasms epidemiology, Clinical Trials as Topic
- Published
- 2007
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42. A decision aid to assist in adjuvant therapy choices for breast cancer.
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Siminoff LA, Gordon NH, Silverman P, Budd T, and Ravdin PM
- Subjects
- Adult, Aged, Antineoplastic Agents adverse effects, Antineoplastic Agents, Hormonal adverse effects, Breast Neoplasms mortality, Breast Neoplasms pathology, Breast Neoplasms surgery, Chemotherapy, Adjuvant, Disease-Free Survival, Female, Humans, Male, Middle Aged, Neoplasm Staging, Patient Participation statistics & numerical data, Probability, SEER Program statistics & numerical data, Survival Rate, Tamoxifen adverse effects, United States, Antineoplastic Agents administration & dosage, Antineoplastic Agents, Hormonal administration & dosage, Breast Neoplasms drug therapy, Decision Support Techniques, Software, Tamoxifen administration & dosage
- Abstract
Background: Decision aids are tools that help patients make specific and deliberative choices among options. This study was a group randomized controlled trial of a novel decision aid to help patients with breast cancer make adjuvant therapy (AT) decisions., Methods: Fourteen oncology practices (n=58 physicians) were randomized to receive the decision aid or a control pamphlet. Complete data were obtained from 405 patient-oncologist pairs. Eligible patients had stage I-III disease and had completed their primary treatment. The decision aid is a simple to use computer program, titled Adjuvant!, that provides estimates of outcome with and without AT. Graphical representations of outcome are shared with patients. Consultations were audiotaped, patients interviewed, and physicians completed a self-administered survey., Results: In a multivariable model, the 54 patients (13.3%) who took no AT were more likely to have received the decision aid (p=0.02). A differential effect of the Adjuvant! Decision Guide was noted between node negative and positive patients. It was stated by 86.2% of patients that the decision aid was influential when making their treatment decision. Over 95% of patients reported that the Adjuvant Decision Guide was easy to understand and 75% of physicians believed that it helped them understand their patient's treatment preferences and 81.4% reported the information as useful for themselves., Conclusions: This study showed that a decision aid made a difference in the choice of whether or not to take AT. The decision aid allowed patients and physicians to consider the benefits of AT in an easy to understand format. Treatment decisions were more individualized for patients in the intervention than in the control group. The use of the decision aid was acceptable to both patients and physicians.
- Published
- 2006
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43. Prognosis of patients with resected non-small cell lung cancer: impact of clinical and pathologic variables.
- Author
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Ravdin PM and Davis G
- Subjects
- Adult, Aged, Carcinoma, Non-Small-Cell Lung mortality, Carcinoma, Non-Small-Cell Lung surgery, Disease Progression, Female, Follow-Up Studies, Humans, Lung Neoplasms mortality, Lung Neoplasms surgery, Male, Middle Aged, Neoplasm Staging, Prognosis, Retrospective Studies, Severity of Illness Index, Survival Rate, Carcinoma, Non-Small-Cell Lung pathology, Lung Neoplasms pathology, Pneumonectomy
- Abstract
The objective of this study was to determine whether AJCC staging, supplemented by additional clinical and pathologic variables could identify a subpopulation of pathologically staged NSCLC patients who had been resected for cure with a low risk (<20%) of 5-year disease specific mortality. The Surveillance, Epidemiology, and End Results (SEER) registry was analyzed to identify and evaluate the disease specific 5-year mortality of 17,130 patients with resected and pathologically defined Stage I-IIIA disease initially diagnosed from 1988 to 1997. The analyses showed that American Joint Commission on Cancer (AJCC) T and N defined stage Stage I-IIIA subgroups had approximately a 30, 60, and 75% 5-year disease specific mortality, respectively. The 5,366 Stage IA patients were identified as having a 5-year disease specific mortality of 25%. Further multivariate analyses of Stage IA cases showed predictors of favorable outcome to be tumor size (< 10 mm), histologic grade (well differentiated), and histologic subtype (bronchoalveolar cell). Subgroups identified with two or all three of these additional features had an approximately 10% 5-year lung cancer specific mortality. Although nearly all patient subgroups with Stages I-IIIA resected and pathologically staged NSCLC have substantial (>20%) risk of death from their cancer within 5 years of diagnosis, for Stage IA patients additional information (tumor size, histologic grade, and histologic subtype) allows additional refinement in prognostic estimates and identification of some low risk subgroups.
- Published
- 2006
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44. Randomized, controlled trial of cyclophosphamide, methotrexate, and fluorouracil versus cyclophosphamide, doxorubicin, and fluorouracil with and without tamoxifen for high-risk, node-negative breast cancer: treatment results of Intergroup Protocol INT-0102.
- Author
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Hutchins LF, Green SJ, Ravdin PM, Lew D, Martino S, Abeloff M, Lyss AP, Allred C, Rivkin SE, and Osborne CK
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms pathology, Cyclophosphamide administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Female, Fluorouracil administration & dosage, Humans, Methotrexate administration & dosage, Middle Aged, Proportional Hazards Models, Prospective Studies, Survival Analysis, Tamoxifen administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy
- Abstract
Purpose: We evaluated the efficacy of cyclophosphamide, methotrexate, and fluorouracil (CMF) versus cyclophosphamide, doxorubicin, and fluorouracil (CAF) in node-negative breast cancer patients with and without tamoxifen (TAM), overall and by hormone receptor (HR) status., Patients and Methods: Node-negative patients identified by tumor size (> 2 cm), negative HR, or high S-phase fraction (n = 2,690) were randomly assigned to CMF, CAF, CMF + TAM (CMFT), or CAF + TAM (CAFT). Cox regression evaluated overall survival (OS) and disease-free survival (DFS) for CAF versus CMF and TAM versus no TAM separately. Two-sided CIs and one-sided P values for planned comparisons were calculated., Results: Ten-year estimates indicated that CAF was not significantly better than CMF (P = .13) for the primary outcome of DFS (77% v 75%; HR = 1.09; 95% CI, 0.94 to 1.27). CAF had slightly better OS than CMF (85% v 82%, HR = 1.19 for CMF v CAF; 95% CI, 0.99 to 1.43); values were statistically significant in the planned one-sided test (P = .03). Toxicity was greater with CAF and did not increase with TAM. Overall, TAM had no benefit (DFS, P = .16; OS, P = .37), but the TAM effect differed by HR groups. For HR-positive patients, TAM was beneficial (DFS, HR = 1.32 for no TAM v TAM; 95% CI, 1.09 to 1.61; P = .003; OS, HR = 1.26; 95% CI, 0.99 to 1.61; P = .03), but not for HR-negative patients (DFS, HR = 0.81 for no TAM v TAM; 95% CI, 0.64 to 1.03; OS, HR = 0.79; 95% CI, 0.60 to 1.05)., Conclusion: CAF did not improve DFS compared with CMF; there was a slight effect on OS. Given greater toxicity, we cannot conclude CAF to be superior to CMF. TAM is effective in HR-positive disease, but not in HR-negative disease.
- Published
- 2005
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45. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer.
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Jones SE, Erban J, Overmoyer B, Budd GT, Hutchins L, Lower E, Laufman L, Sundaram S, Urba WJ, Pritchard KI, Mennel R, Richards D, Olsen S, Meyers ML, and Ravdin PM
- Subjects
- Adenocarcinoma pathology, Adult, Aged, Aged, 80 and over, Breast Neoplasms pathology, Chi-Square Distribution, Disease Progression, Docetaxel, Female, Humans, Infusions, Intravenous, Logistic Models, Middle Aged, Proportional Hazards Models, Quality of Life, Treatment Outcome, Adenocarcinoma drug therapy, Antineoplastic Agents, Phytogenic therapeutic use, Breast Neoplasms drug therapy, Paclitaxel therapeutic use, Taxoids therapeutic use
- Abstract
Purpose: This randomized, controlled, multicenter, open-label, phase III study compared docetaxel versus paclitaxel in patients with advanced breast cancer that had progressed after an anthracycline-containing chemotherapy regimen., Patients and Methods: Patients (n = 449) were randomly assigned to receive either docetaxel 100 mg/m2 (n = 225) or paclitaxel 175 mg/m2 (n = 224) on day 1, every 21 days until tumor progression, unacceptable toxicity, or withdrawal of consent., Results: In the intent-to-treat population, both the median overall survival (OS, 15.4 v 12.7 months; hazard ratio [HR], 1.41; 95% CI, 1.15 to 1.73; P = .03) and the median time to progression (TTP, 5.7 months v 3.6 months; HR, 1.64; 95% CI, 1.33 to 2.02; P < .0001) for docetaxel were significantly longer than for paclitaxel, and the overall response rate (ORR, 32% v 25%; P = .10) was higher for docetaxel. These results were confirmed by multivariate analyses. The incidence of treatment-related hematologic and nonhematologic toxicities was greater for docetaxel than for paclitaxel; however, quality-of-life scores were not statistically different between treatment groups over time., Conclusion: Docetaxel was superior to paclitaxel in terms of OS and TTP. ORR was higher for docetaxel. Hematologic and nonhematologic toxicities occurred more frequently in the docetaxel group. The global quality-of-life scores were similar for both agents over time.
- Published
- 2005
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46. Population-based validation of the prognostic model ADJUVANT! for early breast cancer.
- Author
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Olivotto IA, Bajdik CD, Ravdin PM, Speers CH, Coldman AJ, Norris BD, Davis GJ, Chia SK, and Gelmon KA
- Subjects
- Adult, Age Factors, Aged, Aged, 80 and over, Disease-Free Survival, Female, Humans, Middle Aged, Prognosis, Software, Breast Neoplasms pathology, Internet, Models, Theoretical
- Abstract
Purpose: Adjuvant! (www.adjuvantonline.com) is a web-based tool that predicts 10-year breast cancer outcomes with and without adjuvant systemic therapy, but it has not been independently validated., Methods: Using the British Columbia Breast Cancer Outcomes Unit (BCOU) database, demographic, pathologic, staging, and treatment data on 4,083 women diagnosed between 1989 and 1993 in British Columbia with T1-2, N0-1, M0 breast cancer were abstracted and entered into Adjuvant! to calculate predicted 10-year overall survival (OS), breast cancer-specific survival (BCSS), and event-free survival (EFS) for each patient. Individual BCOU observed outcomes at 10 years were independently determined. Predicted and observed outcomes were compared., Results: Across all 4,083 patients, 10-year predicted and observed outcomes were within 1% for OS, BCSS, and EFS (all P > .05). Predicted and observed outcomes were within 2% for most demographic, pathologic, and treatment-defined subgroups. Adjuvant! overestimated OS, BCSS, and EFS in women younger than age 35 years (predicted-observed = 8.6%, 9.6%, and 13.6%, respectively; all P < .001) or with lymphatic or vascular invasion (LVI; predicted-observed = 3.6%, 3.8%, and 4.2%, respectively; all P < .05); these two prognostic factors were not automatically incorporated within the Adjuvant! algorithm. After adjusting for the distribution of LVI, using the prognostic factor impact calculator in Adjuvant!, 10-year predicted and observed outcomes were no longer significantly different., Conclusion: Adjuvant! performed reliably. Patients younger than age 35 or with known additional adverse prognostic factors such as LVI require adjustment of risks to derive reliable predictions of prognosis without adjuvant systemic therapy and the absolute benefits of adjuvant systemic therapy.
- Published
- 2005
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47. Managing the risk of osteoporosis in women with a history of early breast cancer.
- Author
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Ravdin PM
- Subjects
- Age Factors, Breast Neoplasms metabolism, Diphosphonates therapeutic use, Female, Humans, Menopause, Premature metabolism, Osteoporosis prevention & control, Risk Assessment, Severity of Illness Index, Tamoxifen therapeutic use, Antineoplastic Agents adverse effects, Aromatase Inhibitors adverse effects, Bone Density drug effects, Breast Neoplasms drug therapy, Osteoporosis chemically induced, Osteoporosis drug therapy, Selective Estrogen Receptor Modulators therapeutic use
- Abstract
Estrogen is known to play an important role in skeletal health. Female breast cancer patients who receive treatments that reduce estrogen levels, such as aromatase inhibitors, may increase their risk of developing osteoporosis and their risk of fracture. Clinical guidelines enable the physician to assess the risk of osteoporosis by patient history and physical examination. For patients identified as being at risk, it is necessary to test bone mineral density (BMD), using the result to determine which patients require treatment. Two groups can be identified as requiring BMD assessment according to general guidelines: patients < 45 years old who become menopausal due to treatment, and breast cancer patients receiving aromatase inhibitors. Bisphosphonates appear to be the logical treatment of choice for breast cancer patients, as they do not interact with the estrogen receptor. Although not all women receiving aromatase inhibitors will require additional treatment for bone health, postmenopausal women with a history of breast cancer at risk of osteoporosis should be identified, monitored, and managed according to practice guidelines.
- Published
- 2004
48. A method for making estimates of the benefit of the late use of letrozole in patients completing 5 years of tamoxifen.
- Author
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Ravdin PM and Davis GJ
- Subjects
- Aged, Antineoplastic Agents administration & dosage, Antineoplastic Agents therapeutic use, Antineoplastic Agents, Hormonal administration & dosage, Antineoplastic Agents, Hormonal therapeutic use, Breast Neoplasms economics, Breast Neoplasms metabolism, Chemotherapy, Adjuvant, Cost-Benefit Analysis methods, Female, Humans, Letrozole, Lymph Nodes pathology, Middle Aged, Neoplasm Recurrence, Local, Nitriles administration & dosage, Prognosis, Receptors, Estrogen metabolism, Tamoxifen administration & dosage, Time Factors, Triazoles administration & dosage, Breast Neoplasms drug therapy, Nitriles therapeutic use, Tamoxifen therapeutic use, Triazoles therapeutic use
- Abstract
This article discusses the rationale for 2 methods of making estimates of the benefit of letrozole as extended adjuvant hormonal therapy after 5 years of tamoxifen. It uses information from the Overview metaanalyses to develop general rules for making estimates of remaining risk of relapse for women completing 5 years of adjuvant tamoxifen without relapse. The first derived method shows that the expected benefit for such a woman is approximately one tenth of her risk of relapse in years 0-10 if untreated. The second method uses a modification of Adjuvant!, a decision support tool, and makes similar estimates. The decision tool supplies needed estimates of initial risk and allows adjustment for competing mortality. Uncertainties involved in making these estimates are also discussed.
- Published
- 2004
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49. A Southwest Oncology Group Randomized Phase II Study of doxorubicin and paclitaxel as frontline chemotherapy for women with metastatic breast cancer.
- Author
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Lyman GH, Green SJ, Ravdin PM, Geyer CE Jr, Russell CA, Balcerzak SP, Thomas Budd G, and Martino S
- Subjects
- Adult, Aged, Breast Neoplasms pathology, Cyclophosphamide administration & dosage, Doxorubicin administration & dosage, Female, Humans, Infusions, Intravenous, Middle Aged, Neoplasm Metastasis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy
- Abstract
Purpose: To evaluate whether the high complete response (CR) rates for the combination of doxorubicin and paclitaxel in metastatic breast cancer observed in two European studies could be replicated in a multi-institutional cooperative group trial., Patients and Methods: This was a phase II study with 91 patients randomized between either doxorubicin (60 mg/m(2)) followed immediately by paclitaxel (200 mg/m(2) over 3 h) (AT), or with doxorubicin (60 mg/m(2)) followed immediately by cyclophosphamide (600 mg/m(2)) (AC). Treatment was limited to six cycles of therapy for the doxorubicin and paclitaxel combination. Left ventricular ejection fraction was evaluated at on study and after four and six cycles of treatment on AT., Results: Estimates of overall objective response were 31% (with 9% CR) and 39% (with 11% CR) for patients on the AT and AC regimens, respectively. Response was lower than anticipated on the standard AC arm. On average the reduction of LVEF was similar in the two groups, with no patients developing congestive heart failure during the six cycles of therapy, although one patient in the AT group died of delayed congestive heart failure., Conclusions: The results of this multi-institutional study in patients with metastatic breast cancer suggest that the combination of doxorubicin and paclitaxel is well tolerated with relatively low rates of cardiac toxicity if the total dose of doxorubicin is held to
- Published
- 2004
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50. Decision-making for patients with resectable breast cancer: individualized decisions for and by patients and their physicians.
- Author
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Loprinzi CL and Ravdin PM
- Subjects
- Antineoplastic Agents therapeutic use, Antineoplastic Agents, Hormonal, Chemotherapy, Adjuvant, Female, Humans, Patient Acceptance of Health Care, Practice Guidelines as Topic, Breast Neoplasms drug therapy, Decision Making, Computer-Assisted, Decision Support Techniques
- Abstract
Decisions regarding the use of adjuvant cytotoxic and hormonal therapies for women with breast cancer ideally should be made jointly by the patient and oncologist. For patients to be adequately involved in this decision-making process, they must be provided with appropriate education regarding the potential benefits and risks of adjuvant therapies. The recommended steps for doing this are: 1) understand baseline prognosis with locoregional therapy (surgery, radiation, or both) alone for the individual patient at hand; 2) determine the estimated benefit afforded by adjuvant therapy options for the individual patient; 3) estimate the risk of side effects of adjuvant therapy options; 4) convey the above information to the individual patient; 5) facilitate the individual patient's decision regarding adjuvant systemic therapy; and 6) support the patient's decision. Two computer-based tools (Numeracy and Adjuvant!) are available to facilitate this process.
- Published
- 2003
- Full Text
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