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7. Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials

Author

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

Subjects
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

Published
2017
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8. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

D. Miles, E. Ciruelos, A. Schneeweiss, F. Puglisi, T. Peretz-Yablonski, M. Campone, I. Bondarenko, Z. Nowecki, H. Errihani, S. Paluch-Shimon, A. Wardley, J.-L. Merot, P. Trask, Y. du Toit, C. Pena-Murillo, V. Revelant, D. Klingbiel, T. Bachelot, K. Bouzid, I. Desmoulins, B. Coudert, I. Glogowska, E. Ciruelos Gil, F. Dalenc, F. Ricci, V. Dieras, B. Kaufman, A. Ferreira, M. Mano, H. Kalofonos, C. Andreetta, F. Montemurro, S. Barrett, Q. Zhang, D. Mavroudis, J. Matus, C. Villarreal Garza, C. Beato, G. Ismael, X. Hu, H. Abdel Azeem, R. Gaafar, C. Perrin, P. Kerbrat, J. Ettl, S. Paepke, E. Hitre, I. Lang, M. Trudeau, S. Verma, H. Li, O. Hoffmann, B. Aktas, A. Cariello, G. Cruciani, A. Tienghi, C. Tondini, T. Al-Twegieri, N. Loman, R. Laing, E. Brain, P. Fasching, M. Lux, A. Frassoldati, Z. Aziz, J. Salas, J. Streb, K. Krzemieniecki, A. Wronski, J. Garcia Garcia, S. Menjon Beltran, I. Cicin, P. Schmid, C. Gallagher, N. Turner, Z. Tong, K. Boer, B. Juhász, Z. Horvath, G. Bianchini, L. Gianni, G. Curigliano, A. Juarez Ramiro, S. Susnjar, E. Matos, E. Sevillano, L. Garcia Estevez, E. Gokmen, R. Uslu, H. Wildiers, F. Schutz, M. Cruz, H. Bourgeois, R. von Schumann, S. Stemmer, A. Dominguez, F. Morales-Vásques, M. Wojtukiewicz, J. Trifunovic, M.J. Echarri Gonzalez, J. Illarramendi Mañas, E. Martinez De Dueñas, N. Voitko, J. Hicks, S. Waters, P. Barrett-Lee, D. Wheatley, R. De Boer, V. Cocquyt, G. Jerusalem, C. Barrios, L. Panasci, J. Mattson, M. Tanner, M. Gozy, G. Vasilopoulos, C. Papandreou, J. Revesz, N. Battelli, G. Benedetti, L. Latini, C. Gridelli, J. Lazaro Leon, J. Alarcón Company, A. Arance Fernandez, A. Barnadas Molins, I. Calvo Plaza, R. Bratos, A. Gonzalez Martin, Y. Izarzugaza Peron, L. Klint, A. Kovalev, N. McCarthy, B. Yeo, D. Kee, J. Thomson, S. White, R. Greil, S. Wang, X. Artignan, I. Juhasz-Böess, A. Rody, R. Ngan, F. Dourleshter, H. Goldberg, L. Doni, F. Di Costanzo, F. Ferraù, M. Drobniene, E. Aleknavicius, K. Rashid, L. Costa, L. de la Cruz Merino, J. Garcia Saenz, R. López, O. Del Val Munoz, O. Ozyilkan, F. Azribi, H. Jaafar, R. Baird, M. Verrill, J. Beith, A. Petzer, J. Moreira de Andrade, V. Bernstein, N. Macpherson, D. Rayson, I. Saad Eldin, M. Achille, P. Augereau, V. Müller, A. Rasco, E. Evron, D. Katz, R. Berardi, S. Cascinu, A. De Censi, A. Gennari, N. El-Saghir, M. Ghosn, H.M. Oosterkamp, J. Van den Bosch, M. Kukulska, E. Kalinka, J. Alonso, E. Dalmau Portulas, M. Del Mar Gordon Santiago, I. Pelaez Fernandez, S. Aksoy, K. Altundag, H. Senol Coskun, H. Bozcuk, Y. Shparyk, L. Barraclough, N. Levitt, U. Panwar, S. Kelly, A. Rigg, M. Varughese, C. Castillo, L. Fein, L. Malik, R. Stuart-Harris, C. Singer, H. Stoeger, H. Samonigg, J. Feng, M. Cedeño, J. Ruohola, J.-F. Berdah, A. Goncalves, H. Orfeuvre, E.-M. Grischke, E. Simon, S. Wagner, G. Koumakis, K. Papazisis, N. Ben Baruch, G. Fried, D. Geffen, N. Karminsky, T. Peretz, L. Cavanna, P. Pedrazzioli, D. Grasso, E. Ruggeri, G. D’Auria, L. Moscetti, E. Juozaityte, J. Rodriguez Cid, H. Roerdink, N. Siddiqi, J. Passos Coelho, A. Arcediano Del Amo, E. Garcia Garre, M. García Gonzalez, A. Garcia-Palomo Perez, C. Herenandez Perez, P. Lopez Alvarez, M.H. Lopez De Ceballos, N. Martínez Jañez, M. Mele Olive, K. McAdam, T. Perren, G. Dunn, A. Humphreys, W. Taylor, R. Vera, L. Kaen, J. Andel, G. Steger, J. De Grève, M. Huizing, R. Hegg, A. Joy, P. Kuruvilla, S. Sehdev, S. Smiljanic, R. Kütner, J. Alexandre, J. Grosjean, P. Laplaige, R. Largillier, P. Maes, P. Martin, V. Pottier, B. Christensen, F. Khandan, H.-J. Lück, D.-M. Zahm, G. Fountzilas, V. Karavasilis, T. Safra, M. Inbar, L. Ryvo, A. Bonetti, E. Seles, A. Giacobino, Y. Chavarri Guerra, F. de Jongh, A. van der Velden, L. van Warmerdam, S. Vrijaldenhoven, C.H. Smorenburg, M. Cavero, R. Andres Conejero, A. Oltra Ferrando, A. Redondo Sanchez, N. Ribelles Entrena, S. Saura Grau, G. Viñas Vilaro, K. Bachmeier, M. Beresford, M. Butt, J. Joffe, C. Poole, P. Woodings, P. Chakraborti, G. Yordi, N. Woodward, A. Nobre, G. Luiz Amorim, N. Califaretti, S. Fox, A. Robidoux, E. Li, N. Li, J. Jiang, T. Soria, P. Padrik, O. Lahdenpera, H. Barletta, N. Dohollou, D. Genet, K. Prulhiere, D. Coeffic, T. Facchini, S. Vieillot, S. Catala, L. Teixeira, T. Hesse, T. Kühn, A. Ober, R. Repp, W. Schröder, D. Pectasides, G. Bodoky, Z. Kahan, I. Jiveliouk, O. Rosengarten, V. Rossi, O. Alabiso, M. Pérez Martínez, A.J. van de Wouw, J. Smok-Kalwat, M. Damasecno, I. Augusto, G. Sousa, A. Saadein, N. Abdelhafiez, O. Abulkhair, A. Antón Torres, M. Corbellas Aparicio, R. Llorente Domenech, J. Florián Jerico, J. Garcia Mata, M. Gil Raga, A. Galan Brotons, A. Llombart Cussac, C. Llorca Ferrandiz, P. Martinez Del Prado, C. Olier Garate, C. Rodriguez Sanchez, R. Sanchez Gomez, M. Santisteban Eslava, J. Soberino, M. Vidal Losada Garcia, D. Soto de Prado, J. Torrego Garcia, E. Vicente Rubio, M. Garcia, A. Murias Rosales, H. Granstam Björneklett, U. Narbe, M. Jafri, D. Rea, J. Newby, A. Jones, S. Westwell, A. Ring, I. Alonso, R. Rodríguez, Miles, D., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Campone, M., Bondarenko, I., Nowecki, Z., Errihani, H., Paluch-Shimon, S., Wardley, A., Merot, J. -L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., Klingbiel, D., Bachelot, T., Bouzid, K., Desmoulins, I., Coudert, B., Glogowska, I., Ciruelos Gil, E., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhasz, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vasques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M. J., Illarramendi Manas, J., Martinez De Duenas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcon Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., Mccarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Boess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferrau, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., Lopez, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Muller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H. M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeno, M., Ruohola, J., Berdah, J. -F., Goncalves, A., Orfeuvre, H., Grischke, E. -M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D'Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., Garcia Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M. 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Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, medicine.medical_treatment, chemistry.chemical_compound, paclitaxel, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, skin and connective tissue diseases, HER2 positive, hormone receptor, metastatic breast cancer, overall survival, pertuzumab, Hematology, Metastatic breast cancer, Receptor, ErbB-2/genetics, Neoplasm Recurrence, Local/drug therapy, Treatment Outcome, Docetaxel, Paclitaxel, 030220 oncology & carcinogenesis, Female, Taxoids, Pertuzumab, medicine.drug, medicine.medical_specialty, Taxoids/therapeutic use, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast Neoplasms/drug therapy, Internal medicine, medicine, Humans, Trastuzumab/adverse effects, neoplasms, Chemotherapy, Taxane, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, medicine.disease, 030104 developmental biology, chemistry, Neoplasm Recurrence, Local, business
Abstract

Background The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Published
2021

9. Social Acceptance of High-Ability Youth: Multiple Perspectives and Contextual Influences

Author

Alicia Ramos, Bieke De Fraine, Karine Verschueren, Tessa Weyns, Jeroen Lavrijsen, Subotnik, RF, Assouline, SG, OlszewskiKubilius, P, Stoeger, H, and Ziegler, A

Subjects
Social Psychology, Intelligence quotient, Context effect, media_common.quotation_subject, 05 social sciences, Self-concept, 050301 education, Peer group, Context (language use), Cognition, Developmental psychology, Friendship, Developmental stage theories, Developmental and Educational Psychology, 0501 psychology and cognitive sciences, Psychology, 0503 education, 050104 developmental & child psychology, media_common
Abstract

Peer relationships form a key developmental context. The current study investigated differences in peer acceptance between high-ability and average-ability youth, from the perspectives of teachers, peers, and students. Relying on the person-group similarity model, we also tested whether high-ability students’ acceptance would depend on the peer group’s mean ability level. A sample of 2,736 sixth-grade students from 188 classes in 117 schools participated. Students scoring in the top 10% of a cognitive ability measure were considered high-ability students (N = 274). Results showed that high-ability students were better accepted than average-ability students according to teachers and peers. However, the students did not show more positive self-perceptions of acceptance. Moreover, they nominated less peers as their friends. Gifted students felt more accepted in classes with higher mean ability levels. The authors call for a stronger integration of developmental theory and research into the study of giftedness. © 2019 Wiley Periodicals, Inc. Special Issue: The Future of Research in Talent Development: Promising Trends, Evidence, and Implications of Innovative Scholarship for Policy and Practice ispartof: New Directions For Child And Adolescent Development vol:168 issue:168 pages:27-46 ispartof: location:United States status: published

Published
2019

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