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3. Unilateral inguinofemoral lymphadenectomy in patients with early-stage vulvar squamous cell carcinoma and a unilateral metastatic sentinel lymph node is safe

Author

Van der Kolk, W.L., primary, Van der Zee, A.G.J., additional, Slomovitz, B.M., additional, Baldwin, P.J.W., additional, Van Doorn, H.C., additional, De Hullu, J.A., additional, Van der Velden, J., additional, Gaarenstroom, K.N., additional, Slangen, B.F.M., additional, Kjolhede, P., additional, Brännström, M., additional, Vergote, I., additional, Holland, C.M., additional, Coleman, R., additional, Van Dorst, E.B.L., additional, Van Driel, W.J., additional, Nunns, D., additional, Widschwendter, M., additional, Nugent, D., additional, DiSilvestro, P.A., additional, Mannel, R.S., additional, Tjiong, M.Y., additional, Boll, D., additional, Cibula, D., additional, Covens, A., additional, Provencher, D., additional, Runnebaum, I.B., additional, Monk, B.J., additional, Zanagnolo, V., additional, Tamussino, K., additional, Oonk, M.H.M., additional, Levenback, C.F., additional, Hermans, R.H., additional, Bouda, J., additional, Sharma, A., additional, Luesley, D., additional, Ellis, P., additional, Cruickshank, D.J., additional, Duncan, T.J., additional, Kieser, K., additional, Palle, C., additional, Spirtos, N.M., additional, O'Malley, D.M., additional, Leitao, M.M., additional, Geller, M., additional, Dhar, K., additional, Asher, V., additional, Tobias, D.H., additional, Borgfeldt, C., additional, Lea, J.S., additional, Lood, M., additional, Bailey, J., additional, Eyjolfsdottir, B., additional, Attard-Montalto, S., additional, Tewari, K.S., additional, Persson, P., additional, Manchanda, R., additional, Jensen, P., additional, and Van Le, L., additional

Published
2022
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4. 17 Safety and patient-reported outcomes in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Freyer, G, primary, Pothuri, B, additional, Han, S, additional, Chase, D, additional, Monk, B, additional, Heitz, F, additional, Burger, R, additional, Gaba, L, additional, Van Le, L, additional, Guerra, E, additional, Bender, D, additional, Korach, J, additional, Cloven, N, additional, Churruca, C, additional, Follana, P, additional, DiSilvestro, P, additional, Baurain, JF, additional, Jardon, K, additional, Pisano, C, additional, Peen, U, additional, Maenpaa, J, additional, Hoskins, P, additional, Bacque, E, additional, Li, Y, additional, Eliason, L, additional, and González-Martín, A, additional

Published
2020
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7. Patient-reported outcomes (PRO) in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Heitz, F, additional, Pothuri, B, additional, Han, S, additional, Chase, D, additional, Burger, R, additional, Gaba, L, additional, Van Le, L, additional, Guerra, E, additional, Bender, D, additional, Korach, J, additional, Cloven, N, additional, Follana, P, additional, Baurain, JF, additional, Pisano, C, additional, Peen, U, additional, Maenpaa, J, additional, Bacque, E, additional, Li, Y, additional, González-Martin, A, additional, and Monk, BJ, additional

Published
2020
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10. 810MO Patient-reported outcomes (PROs) in patients (pts) receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Pothuri, B., primary, Han, S., additional, Chase, D., additional, Heitz, F., additional, Burger, R., additional, Gaba, L., additional, Van Le, L., additional, Guerra, E., additional, Bender, D., additional, Korach, J., additional, Cloven, N.G., additional, Follana, P., additional, Baurain, J-F., additional, Pisano, C., additional, Peen, U., additional, Maenpaa, J., additional, Bacqué, E., additional, Li, Y., additional, Martín, A. González, additional, and Monk, B.J., additional

Published
2020
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11. 818P Veliparib with carboplatin and paclitaxel in frontline high-grade serous ovarian cancer (HGSOC): Efficacy and safety of paclitaxel weekly and every 3 weeks in the VELIA study

Author

Okamoto, A., primary, Fleming, G., additional, Bookman, M., additional, Brady, M.F., additional, Swisher, E.M., additional, Steffensen, K.D., additional, Cloven, N.G., additional, Enomoto, T., additional, O'Malley, D.M., additional, Van Le, L., additional, Tewari, K.S., additional, Barlin, J.N., additional, Bradley, W., additional, Moore, K.N., additional, Chan, J., additional, Wu, M., additional, Hashiba, H., additional, Dinh, M.H., additional, Coleman, R.L., additional, and Aghajanian, C., additional

Published
2020
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12. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial

Author

Vergote, I. Scambia, G. O'Malley, D.M. Van Calster, B. Park, S.-Y. del Campo, J.M. Meier, W. Bamias, A. Colombo, N. Wenham, R.M. Covens, A. Marth, C. Raza Mirza, M. Kroep, J.R. Ma, H. Pickett, C.A. Monk, B.J. Park, S.Y. Song, Y.S. Makarova, Y. Trinidad, J. Ngan, H.Y.S. Aravantinos, G. Nam, J.-H. Gorbunova, V. Krikunova, L. Bae, D.-S. Arija, J.A.A. Mirza, M.R. Zamagni, C. Papandreou, C. Raspagliesi, F. Lisyanskaya, A. Benzaquen, A.O. Tognon, G. Ortega, E. Herraez, A.C. Buscema, J. Green, A. Burger, R. Sakaeva, D. Sanchez, A.R. Ghamande, S. King, L. Petru, E. Peen, U. Takeuchi, S. Ushijima, K. Martin, A.G. Kamelle, S. Carney, M. Forget, F. Bentley, J. Sehouli, J. Zola, P. Kato, H. Fadeeva, N. Gotovkin, E. Vladimirov, V. Marin, M.R. Alia, E.G. Shahin, M. Bhoola, S. Tewari, K. Anderson, D. Honhon, B. Pelgrims, J.G. Oza, A. Jimenez, J.G.-D. Hansen, V. Benjamin, I. Renard, V. Van den Bulck, H. Haenle, C. Koumakis, G. Yokota, H. Popov, V. Bradley, W. Wenham, R. Reid, R. McNamara, D. Friedman, R. Barlin, J. Spirtos, N. Chapman, J. Sevelda, P. Huizing, M. Lamot, C. Goffin, F. Hondt, L.D. Covens, A. Spadafora, S. Rautenberg, B. Reimer, T. Möbus, V. Hilpert, F. Gropp-Meier, M. Savarese, A. Pignata, S. Verderame, F. Mizuno, M. Takano, H. Ottevanger, P. Velasco, A.P. Palacio-Vazquez, I. Law, A. McIntyre, K. Teneriello, M. Fields, A. Lentz, S. Street, D. Schwartz, B. Mannel, R. Lim, P. Pulaski, H. Janni, W. Zorr, A. Karck, U. Cheng, A.C.K. Sorio, R. Gridelli, C. Aoki, D. Oishi, T. Hirashima, Y. Boere, I. Ferrer, E.F. Braly, P. Wilks, S. Lee, C. Schilder, J. Veljovich, D. Secord, A. Davis, K. Rojas-Espaillat, L. Lele, S. DePasquale, S. Squatrito, R. Schauer, C. Dirix, L. Vuylsteke, P. Joosens, E. Provencher, D. Lueck, H.-J. Hein, A. Burges, A. Canzler, U. Park-Simon, T.-W. Griesinger, F. Gadducci, A. Alabiso, O. Okamoto, A. Sawasaki, T. Saito, T. Ibañez, A.H. Calomeni, C. Spillman, M. Choksi, J. Taylor, N. Muller, C. Moore, D. DiSilvestro, P. Cunningham, M. Rose, P. Oppelt, P. Verhoeven, D. Graas, M.-P. Ghatage, P. Tonkin, K. Kurzeder, C. Schnappauf, B. Müller, V. Schmalzrie, H. Kalofonos, H. Bruzzone, M. Kroep, J. Diaz, C.C. Garcia, J.M. Polo, S.H. Garrison, M. Rocconi, R. Andrews, S. Bristow, R. McHale, M. Basil, J. Houck III, W. Bell, M. Cosin, J. Modesitt, S. Kendrick, J. Wade III, J. Wong, C. Evans, A. Buekers, T. Vanderkwaak, T. Ferriss, J. Darus, C. DAndre, S. Higgins, R. Monk, B. Bakkum-Gamez, J. DeMars, L. Van Le, L. Puls, L. Trehan, S. LaPolla, J. Michelson, E.D. Merchant, J. Peterson, C. Reid, G. Seago, D. Zweizig, S. Gajewski, W. Panwalkar, A. Leikermoser, R. Bogner, G. Debruyne, P. D'hondt, R. Berteloot, P. Kerger, J. Biagi, J. Castonguay, V. Welch, S. Muhic, A. Heubner, M. Grischke, E.-M. Rack, B. Fleisch, M. Lordick, F. Pectasides, D. Ho, W.M. Selvaggi, L. Vasquez, F.M. Villanueva, W.O.B. Alavez, A.M. Kessels, L. Bertran, A.S. Fernandez, C.M. Fabregat, M.B. Del Prete, S. Elkas, J. Cecchi, G. Kumar, P. Huh, W. Messing, M. Karimi, M. Kelley, A. Edraki, B. Mutch, D. Leiserowitz, G. Anderson, J. Lentz, S. Chambers, S. Morris, R. Waggoner, S. Gordon, A. Method, M. Johnson, P. Lord, R. Drake, J. Sivarajan, K. Midathada, M. Rice, K. Wadsworth, T. Pavelka, J. Edwards, R. Miller, D.S. Ford, P.L. Hurteau, J. Bender, D. Schimp, V. Creasman, W. Lerner, R. Chamberlain, D. Kueck, A. McDonald, J. Malad, S. Robinson-Bennett, B. Davidson, S. Krivak, T. Lestingi, T. Arango, H. Berard, P. Finkelstein, K. Gaur, R. Krasner, C. Ueland, F. Talmage, L. Yamada, S. Sutton, G. Potkul, R. Prasad-Hayes, M. Osborne, J. Celano, P. Thigpen, J. Sharma, S. Schilder, R. Tammela, J. Kemeny, M. Brown, A. Eisenhauer, E. Williams, J. Rowland, K. Nahum, K. Burke, J. Dar, Z. Fleming, N. Gibb, R. Guirguis, A. Herzog, T. John, V. Kumar, S. Kamat, A. Kassar, M. Leitao, M. Levine, L. Mendez, L. Patel, D. Berry, E. Warshal, D. Wolf, J. Zarwan, C. Collins, Y. Spitzer, G. Miller, B. Einstein, M. TRINOVA-3/ENGOT-ov2/GOG-3001 investigators

Abstract

Background: Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2, improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial. Methods: TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres)in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO)stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned (2:1)using a permuted block method (block size of six patients)to receive six cycles of paclitaxel (175 mg/m2)and carboplatin (area under the serum concentration-time curve 5 or 6)every 3 weeks, plus weekly intravenous trebananib 15 mg/kg or placebo. Maintenance therapy with trebananib or placebo continued for up to 18 additional months. The primary endpoint was progression-free survival, as assessed by the investigators, in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01493505, and is complete. Findings: Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients were randomly allocated to treatment (678 to trebananib and 337 to placebo). After a median follow-up of 27·4 months (IQR 17·7–34·2), 626 patients had progression-free survival events (405 [60%]of 678 in the trebananib group and 221 [66%]of 337 in the placebo group). Median progression-free survival did not differ between the trebananib group (15·9 months [15·0–17·6])and the placebo group (15·0 months [12·6–16·1])groups (hazard ratio 0·93 [95% CI 0·79–1·09]; p=0·36). 512 (76%)of 675 patients in the trebananib group and 237 (71%)of 336 in the placebo group had grade 3 or worse treatment-emergent adverse events; of which the most common events were neutropenia (trebananib 238 [35%]vs placebo 126 [38%])anaemia (76 [11%]vs 40 [12%]), and leucopenia (81 [12%]vs 35 [10%]). 269 (40%)patients in the trebananib group and 104 (31%)in the placebo group had serious adverse events. Two fatal adverse events in the trebananib group were considered related to trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis); two were considered to be related to paclitaxel and carboplatin (general physical health deterioration and platelet count decreased). No treatment-related fatal adverse events occurred in the placebo group. Interpretation: Trebananib plus carboplatin and paclitaxel did not improve progression-free survival as first-line treatment for advanced ovarian cancer. The combination of trebananib plus carboplatin and paclitaxel did not produce new safety signals. These results show that trebananib in combination with carboplatin and paclitaxel is minimally effective in this patient population. Funding: Amgen. © 2019 Elsevier Ltd

Published
2019

16. Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer

Author

Colombo, N, Huang, G, Scambia, G, Chalas, E, Pignata, S, Fiorica, J, Van Le, L, Ghamande, S, González-Santiago, S, Bover, I, Graña Suárez, B, Green, A, Huot-Marchand, P, Bourhis, Y, Karve, S, Blakeley, C, Colombo, Nicoletta, Huang, Gloria, Scambia, Giovanni, Chalas, Eva, Pignata, Sandro, Fiorica, James, Van Le, Linda, Ghamande, Sharad, González-Santiago, Santiago, Bover, Isabel, Graña Suárez, Begoña, Green, Andrew, Huot-Marchand, Philippe, Bourhis, Yann, Karve, Sudeep, Blakeley, Christopher, Colombo, N, Huang, G, Scambia, G, Chalas, E, Pignata, S, Fiorica, J, Van Le, L, Ghamande, S, González-Santiago, S, Bover, I, Graña Suárez, B, Green, A, Huot-Marchand, P, Bourhis, Y, Karve, S, Blakeley, C, Colombo, Nicoletta, Huang, Gloria, Scambia, Giovanni, Chalas, Eva, Pignata, Sandro, Fiorica, James, Van Le, Linda, Ghamande, Sharad, González-Santiago, Santiago, Bover, Isabel, Graña Suárez, Begoña, Green, Andrew, Huot-Marchand, Philippe, Bourhis, Yann, Karve, Sudeep, and Blakeley, Christopher

Abstract

Purpose There is a growing demand for BRCA1/2 mutation (BRCAm) testing in patients with ovarian cancer; however, the limited number of genetic counselors presents a potential barrier. To facilitate more widespread BRCAm testing in ovarian cancer, pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors. Patients and Methods The prospective, observational Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) study evaluated a streamlined, oncologist-led BRCAm testing pathway. The analysis population comprised 700 patients with ovarian cancer at 26 sites in the United States, Italy, and Spain. The primary objectives were to assess turnaround time and, using questionnaires, to evaluate stakeholder satisfaction (patients, oncologists, and geneticists or genetic counselors) with the oncologist-led BRCAm testing pathway. Results The median overall turnaround time was 9.1 weeks (range, 0.9 to 37.1 weeks), with median turnaround times in the United States, Italy, and Spain of 4.1 weeks (range, 0.9 to 37.1 weeks), 20.4 weeks (range, 2.9 to 35.4 weeks), and 12.0 weeks (range, 2.0 to 36.7 weeks), respectively. Patient satisfaction with the oncologist-led BRCAm testing pathway was high, with . 99% of patients expressing satisfaction with pre- and post-BRCAm test counseling. Oncologist satisfaction with the BRCAm testing pathway was also high, with . 80% agreeing that the process for performing BRCAm testing worked well and that counseling patients on BRCAm testing was an efficient use of their time. Oncologists expressed higher levels of satisfaction with the BRCAm testing pathway than did geneticists or genetic counselors. Conclusion The results of the ENGAGE study demonstrate that an oncologist-led BRCAm testing process is feasible in ovarian cancer. Development of local BRCAm testing guidelines similar to the one used in this study could allow faste

Published
2018

18. Rationale and study protocol for the Patient-Centered Outcome Aid (PCOA) randomized controlled trial: A personalized decision tool for newly diagnosed ovarian cancer patients

Author

Wenzel, L, primary, Mukamel, D, additional, Osann, K, additional, Havrilesky, L, additional, Sparks, L, additional, Lipscomb, J, additional, Wright, AA, additional, Walker, J, additional, Alvarez, R, additional, Van Le, L, additional, Robison, K, additional, Bristow, R, additional, Morgan, R, additional, Rimel, BJ, additional, Ladd, H, additional, Hsieh, S, additional, Wahi, A, additional, and Cohn, D, additional

Published
2017
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21. A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study

Author

Walker, J., primary, Brady, M.F., additional, DiSilvestro, P.A., additional, Fujiwara, K., additional, Alberts, D., additional, Zheng, W., additional, Tewari, K., additional, Cohn, D.E., additional, Powell, M., additional, Van Le, L., additional, Rubin, S., additional, Davidson, S.A., additional, Gray, H.J., additional, Waggoner, S., additional, Myers, T., additional, Aghajanian, C., additional, Secord, A.A., additional, and Mannel, R.S., additional

Published
2016
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22. An original phylogenetic approach identified mitochondrial haplogroup T1a1 as inversely associated with breast cancer risk in BRCA2 mutation carriers

Author

Blein, S, Bardel, C, Danjean, V, McGuffog, L, Healey, S, Barrowdale, D, Lee, A, Dennis, J, Kuchenbaecker, KB, Soucy, P, Terry, MB, Chung, WK, Goldgar, DE, Buys, SS, Janavicius, R, Tihomirova, L, Tung, N, Dorfling, CM, van Rensburg, EJ, Neuhausen, SL, Ding, YC, Gerdes, A-M, Ejlertsen, B, Nielsen, FC, Hansen, TVO, Osorio, A, Benitez, J, Andres Conejero, R, Segota, E, Weitzel, JN, Thelander, M, Peterlongo, P, Radice, P, Pensotti, V, Dolcetti, R, Bonanni, B, Peissel, B, Zaffaroni, D, Scuvera, G, Manoukian, S, Varesco, L, Capone, GL, Papi, L, Ottini, L, Yannoukakos, D, Konstantopoulou, I, Garber, J, Hamann, U, Donaldson, A, Brady, A, Brewer, C, Foo, C, Evans, DG, Frost, D, Eccles, D, Douglas, F, Cook, J, Adlard, J, Barwell, J, Walker, L, Izatt, L, Side, LE, Kennedy, MJ, Tischkowitz, M, Rogers, MT, Porteous, ME, Morrison, PJ, Platte, R, Eeles, R, Davidson, R, Hodgson, S, Cole, T, Godwin, AK, Isaacs, C, Claes, K, De Leeneer, K, Meindl, A, Gehrig, A, Wappenschmidt, B, Sutter, C, Engel, C, Niederacher, D, Steinemann, D, Plendl, H, Kast, K, Rhiem, K, Ditsch, N, Arnold, N, Varon-Mateeva, R, Schmutzler, RK, Preisler-Adams, S, Markov, NB, Wang-Gohrke, S, de Pauw, A, Lefol, C, Lasset, C, Leroux, D, Rouleau, E, Damiola, F, Dreyfus, H, Barjhoux, L, Golmard, L, Uhrhammer, N, Bonadona, V, Sornin, V, Bignon, Y-J, Carter, J, Van Le, L, Piedmonte, M, DiSilvestro, PA, de la Hoya, M, Caldes, T, Nevanlinna, H, Aittomaki, K, Jager, A, van den Ouweland, AMW, Kets, CM, Aalfs, CM, van Leeuwen, FE, Hogervorst, FBL, Meijers-Heijboer, HEJ, Oosterwijk, JC, van Roozendaal, KEP, Rookus, MA, Devilee, P, van der Luijt, RB, Olah, E, Diez, O, Teule, A, Lazaro, C, Blanco, I, Del Valle, J, Jakubowska, A, Sukiennicki, G, Gronwald, J, Lubinski, J, Durda, K, Jaworska-Bieniek, K, Agnarsson, BA, Maugard, C, Amadori, A, Montagna, M, Teixeira, MR, Spurdle, AB, Foulkes, W, Olswold, C, Lindor, NM, Pankratz, VS, Szabo, CI, Lincoln, A, Jacobs, L, Corines, M, Robson, M, Vijai, J, Berger, A, Fink-Retter, A, Singer, CF, Rappaport, C, Kaulich, DG, Pfeiler, G, Tea, M-K, Greene, MH, Mai, PL, Rennert, G, Imyanitov, EN, Mulligan, AM, Glendon, G, Andrulis, IL, Tchatchou, S, Toland, AE, Pedersen, IS, Thomassen, M, Kruse, TA, Jensen, UB, Caligo, MA, Friedman, E, Zidan, J, Laitman, Y, Lindblom, A, Melin, B, Arver, B, Loman, N, Rosenquist, R, Olopade, OI, Nussbaum, RL, Ramus, SJ, Nathanson, KL, Domchek, SM, Rebbeck, TR, Arun, BK, Mitchell, G, Karlan, BY, Lester, J, Orsulic, S, Stoppa-Lyonnet, D, Thomas, G, Simard, J, Couch, FJ, Offit, K, Easton, DF, Chenevix-Trench, G, Antoniou, AC, Mazoyer, S, Phelan, CM, Sinilnikova, OM, Cox, DG, Blein, S, Bardel, C, Danjean, V, McGuffog, L, Healey, S, Barrowdale, D, Lee, A, Dennis, J, Kuchenbaecker, KB, Soucy, P, Terry, MB, Chung, WK, Goldgar, DE, Buys, SS, Janavicius, R, Tihomirova, L, Tung, N, Dorfling, CM, van Rensburg, EJ, Neuhausen, SL, Ding, YC, Gerdes, A-M, Ejlertsen, B, Nielsen, FC, Hansen, TVO, Osorio, A, Benitez, J, Andres Conejero, R, Segota, E, Weitzel, JN, Thelander, M, Peterlongo, P, Radice, P, Pensotti, V, Dolcetti, R, Bonanni, B, Peissel, B, Zaffaroni, D, Scuvera, G, Manoukian, S, Varesco, L, Capone, GL, Papi, L, Ottini, L, Yannoukakos, D, Konstantopoulou, I, Garber, J, Hamann, U, Donaldson, A, Brady, A, Brewer, C, Foo, C, Evans, DG, Frost, D, Eccles, D, Douglas, F, Cook, J, Adlard, J, Barwell, J, Walker, L, Izatt, L, Side, LE, Kennedy, MJ, Tischkowitz, M, Rogers, MT, Porteous, ME, Morrison, PJ, Platte, R, Eeles, R, Davidson, R, Hodgson, S, Cole, T, Godwin, AK, Isaacs, C, Claes, K, De Leeneer, K, Meindl, A, Gehrig, A, Wappenschmidt, B, Sutter, C, Engel, C, Niederacher, D, Steinemann, D, Plendl, H, Kast, K, Rhiem, K, Ditsch, N, Arnold, N, Varon-Mateeva, R, Schmutzler, RK, Preisler-Adams, S, Markov, NB, Wang-Gohrke, S, de Pauw, A, Lefol, C, Lasset, C, Leroux, D, Rouleau, E, Damiola, F, Dreyfus, H, Barjhoux, L, Golmard, L, Uhrhammer, N, Bonadona, V, Sornin, V, Bignon, Y-J, Carter, J, Van Le, L, Piedmonte, M, DiSilvestro, PA, de la Hoya, M, Caldes, T, Nevanlinna, H, Aittomaki, K, Jager, A, van den Ouweland, AMW, Kets, CM, Aalfs, CM, van Leeuwen, FE, Hogervorst, FBL, Meijers-Heijboer, HEJ, Oosterwijk, JC, van Roozendaal, KEP, Rookus, MA, Devilee, P, van der Luijt, RB, Olah, E, Diez, O, Teule, A, Lazaro, C, Blanco, I, Del Valle, J, Jakubowska, A, Sukiennicki, G, Gronwald, J, Lubinski, J, Durda, K, Jaworska-Bieniek, K, Agnarsson, BA, Maugard, C, Amadori, A, Montagna, M, Teixeira, MR, Spurdle, AB, Foulkes, W, Olswold, C, Lindor, NM, Pankratz, VS, Szabo, CI, Lincoln, A, Jacobs, L, Corines, M, Robson, M, Vijai, J, Berger, A, Fink-Retter, A, Singer, CF, Rappaport, C, Kaulich, DG, Pfeiler, G, Tea, M-K, Greene, MH, Mai, PL, Rennert, G, Imyanitov, EN, Mulligan, AM, Glendon, G, Andrulis, IL, Tchatchou, S, Toland, AE, Pedersen, IS, Thomassen, M, Kruse, TA, Jensen, UB, Caligo, MA, Friedman, E, Zidan, J, Laitman, Y, Lindblom, A, Melin, B, Arver, B, Loman, N, Rosenquist, R, Olopade, OI, Nussbaum, RL, Ramus, SJ, Nathanson, KL, Domchek, SM, Rebbeck, TR, Arun, BK, Mitchell, G, Karlan, BY, Lester, J, Orsulic, S, Stoppa-Lyonnet, D, Thomas, G, Simard, J, Couch, FJ, Offit, K, Easton, DF, Chenevix-Trench, G, Antoniou, AC, Mazoyer, S, Phelan, CM, Sinilnikova, OM, and Cox, DG

Abstract

INTRODUCTION: Individuals carrying pathogenic mutations in the BRCA1 and BRCA2 genes have a high lifetime risk of breast cancer. BRCA1 and BRCA2 are involved in DNA double-strand break repair, DNA alterations that can be caused by exposure to reactive oxygen species, a main source of which are mitochondria. Mitochondrial genome variations affect electron transport chain efficiency and reactive oxygen species production. Individuals with different mitochondrial haplogroups differ in their metabolism and sensitivity to oxidative stress. Variability in mitochondrial genetic background can alter reactive oxygen species production, leading to cancer risk. In the present study, we tested the hypothesis that mitochondrial haplogroups modify breast cancer risk in BRCA1/2 mutation carriers. METHODS: We genotyped 22,214 (11,421 affected, 10,793 unaffected) mutation carriers belonging to the Consortium of Investigators of Modifiers of BRCA1/2 for 129 mitochondrial polymorphisms using the iCOGS array. Haplogroup inference and association detection were performed using a phylogenetic approach. ALTree was applied to explore the reference mitochondrial evolutionary tree and detect subclades enriched in affected or unaffected individuals. RESULTS: We discovered that subclade T1a1 was depleted in affected BRCA2 mutation carriers compared with the rest of clade T (hazard ratio (HR) = 0.55; 95% confidence interval (CI), 0.34 to 0.88; P = 0.01). Compared with the most frequent haplogroup in the general population (that is, H and T clades), the T1a1 haplogroup has a HR of 0.62 (95% CI, 0.40 to 0.95; P = 0.03). We also identified three potential susceptibility loci, including G13708A/rs28359178, which has demonstrated an inverse association with familial breast cancer risk. CONCLUSIONS: This study illustrates how original approaches such as the phylogeny-based method we used can empower classical molecular epidemiological studies aimed at identifying association or risk modification effe

Published
2015

23. Translational studies of phenotypic probes for the mononuclear phagocyte system and liposomal pharmacologys

Author

Clarke-Pearson, D. L., La-Beck, N. M., Newman, S. E., Van Le, L., Lay, J. C., Zamboni, W. C., Gehrig, P. A., Monaco, J. H., Kumar, P., Brewster, W. R., Caron, W. P., Bae-Jump, V. L., Zhou, H., and Fong, A. M.

Abstract

As nanoparticles (NPs) are cleared via phagocytes of the mononuclear phagocyte system (MPS), we hypothesized that the function of circulating monocytes and dendritic cells (MO/DC) in blood can predict NP clearance (CL). We measured MO/DC phagocytosis and reactive oxygen species (ROS) production in mice, rats, dogs, and patients with refractory solid tumors. Pharmacokinetic studies of polyethylene glycol (PEG)-encapsulated liposomal doxorubicin (PEGylated liposomal doxirubicin [PLD]), CKD-602 (S-CKD602), and cisplatin (SPI-077) were performed at the maximum tolerated dose. MO/DC function was also evaluated in patients with recurrent epithelial ovarian cancer (EOC) administered PLD. Across species, a positive association was observed between cell function and CL of PEGylated liposomes. In patients with EOC, associations were observed between PLD CL and phagocytosis (R2 = 0.43, P = 0.04) and ROS production (R2 = 0.61, P = 0.008) in blood MO/DC. These findings suggest that probes of MPS function may help predict PEGylated liposome CL across species and PLD CL in patients with EOC.

Published
2013
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24. Impact of circulating tumor cells (CTCs) on overall survival among patients treated with chemotherapy plus bevacizumab for advanced cervical cancer: An NRG Oncology/Gynecologic Oncology Group study

Author

Tewari, K.S., primary, Sill, M., additional, Monk, B.J., additional, Penson, R.T., additional, Lankes, H., additional, Leitao, M.M., additional, Ramondetta, L.M., additional, Van Le, L., additional, Richardson, D.L., additional, Landrum, L.M., additional, DiSilvestro, P.A., additional, Behbakht, K., additional, Ueland, F.R., additional, Michael, H., additional, and Birrer, M.J., additional

Published
2015
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28. 1A randomized phase III trial of pelvic radiation therapy (PXRT) versus vaginal cuff brachytherapy followed by paclitaxel/carboplatin chemotherapy (VCB/C) in patients with high risk (HR), early stage endometrial cancer (EC): A Gynecologic Oncology Group trial

Author

McMeekin, D.S., primary, Filiaci, V.L., additional, Aghajanian, C., additional, Cho, J., additional, Kim, J.W., additional, DiSilvestro, P.A., additional, O'Malley, D., additional, Rutherford, T.J., additional, Van Le, L., additional, and Randall, M.E., additional

Published
2014
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34. Patient and physician factors associated with participation in Gynecologic Oncology Group (GOG) trials in cervical and uterine cancer

Author

Brooks, S.E., primary, Carter, R.L., additional, Plaxe, S.C., additional, Basen-Engquist, K.M., additional, Rodriguez, M., additional, Walker, J.L., additional, Myers, T.K.N., additional, Drake, J.G., additional, Havrilesky, L.J., additional, Brown, C.L., additional, Van Le, L., additional, and Landrum, L.M., additional

Published
2014
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36. Common Genetic Variants and Modification of Penetrance of BRCA2-Associated Breast Cancer

Author

Gaudet, MM, Kirchhoff, T, Green, T, Vijai, J, Korn, JM, Guiducci, C, Segre, AV, McGee, K, McGuffog, L, Kartsonaki, C, Morrison, J, Healey, S, Sinilnikova, OM, Stoppa-Lyonnet, D, Mazoyer, S, Gauthier-Villars, M, Sobol, H, Longy, M, Frenay, M, Hogervorst, FBL, Rookus, MA, Collee, Margriet, Hoogerbrugge, N, van Roozendaal, KEP, Piedmonte, M, Rubinstein, W, Nerenstone, S, Van Le, L, Blank, SV, Caldes, T, de la Hoya, M, Nevanlinna, H, Aittomaki, K, Lazaro, C (Conxi), Blanco, I, Arason, A, Johannsson, OT, Barkardottir, RB, Devilee, P, Olopade, OI, Neuhausen, SL, Wang, XS, Fredericksen, ZS, Peterlongo, P, Manoukian, S, Barile, M, Viel, A, Radice, P, Phelan, CM, Narod, S, Rennert, G, Lejbkowicz, F, Flugelman, A, Andrulis, IL, Glendon, G, Ozcelik, H, Toland, AE, Montagna, M, D'Andrea, E, Friedman, E, Laitman, Y, Borg, A, Beattie, M, Ramus, SJ, Domchek, SM, Nathanson, KL, Rebbeck, T, Spurdle, AB, Chen, XQ, Holland, H, John, EM, Hopper, JL, Buys, SS, Daly, MB, Southey, MC, Terry, MB, Tung, N, Hansen, TVO, Nielsen, FC, Greene, MI, Mai, PL, Osorio, A, Duran, M (Mercedes), Andres, R, Benitez, J, Weitzel, JN, Garber, J, Hamann, U, Peock, S, Cook, M, Oliver, C, Frost, D, Platte, R, Evans, DG, Lalloo, F, Eeles, R, Izatt, L, Walker, L, Eason, J, Barwell, J, Godwin, AK, Schmutzler, RK, Wappenschmidt, B, Engert, S, Arnold, N, Gadzicki, D, Dean, M, Gold, B, Klein, RJ, Couch, FJ, Chenevix-Trench, G, Easton, DF, Daly, MJ, Antoniou, AC, Altshuler, DM, Offit, K, Gaudet, MM, Kirchhoff, T, Green, T, Vijai, J, Korn, JM, Guiducci, C, Segre, AV, McGee, K, McGuffog, L, Kartsonaki, C, Morrison, J, Healey, S, Sinilnikova, OM, Stoppa-Lyonnet, D, Mazoyer, S, Gauthier-Villars, M, Sobol, H, Longy, M, Frenay, M, Hogervorst, FBL, Rookus, MA, Collee, Margriet, Hoogerbrugge, N, van Roozendaal, KEP, Piedmonte, M, Rubinstein, W, Nerenstone, S, Van Le, L, Blank, SV, Caldes, T, de la Hoya, M, Nevanlinna, H, Aittomaki, K, Lazaro, C (Conxi), Blanco, I, Arason, A, Johannsson, OT, Barkardottir, RB, Devilee, P, Olopade, OI, Neuhausen, SL, Wang, XS, Fredericksen, ZS, Peterlongo, P, Manoukian, S, Barile, M, Viel, A, Radice, P, Phelan, CM, Narod, S, Rennert, G, Lejbkowicz, F, Flugelman, A, Andrulis, IL, Glendon, G, Ozcelik, H, Toland, AE, Montagna, M, D'Andrea, E, Friedman, E, Laitman, Y, Borg, A, Beattie, M, Ramus, SJ, Domchek, SM, Nathanson, KL, Rebbeck, T, Spurdle, AB, Chen, XQ, Holland, H, John, EM, Hopper, JL, Buys, SS, Daly, MB, Southey, MC, Terry, MB, Tung, N, Hansen, TVO, Nielsen, FC, Greene, MI, Mai, PL, Osorio, A, Duran, M (Mercedes), Andres, R, Benitez, J, Weitzel, JN, Garber, J, Hamann, U, Peock, S, Cook, M, Oliver, C, Frost, D, Platte, R, Evans, DG, Lalloo, F, Eeles, R, Izatt, L, Walker, L, Eason, J, Barwell, J, Godwin, AK, Schmutzler, RK, Wappenschmidt, B, Engert, S, Arnold, N, Gadzicki, D, Dean, M, Gold, B, Klein, RJ, Couch, FJ, Chenevix-Trench, G, Easton, DF, Daly, MJ, Antoniou, AC, Altshuler, DM, and Offit, K

Abstract

The considerable uncertainty regarding cancer risks associated with inherited mutations of BRCA2 is due to unknown factors. To investigate whether common genetic variants modify penetrance for BRCA2 mutation carriers, we undertook a two-staged genome-wide association study in BRCA2 mutation carriers. In stage 1 using the Affymetrix 6.0 platform, 592,163 filtered SNPs genotyped were available on 899 young (, 40 years) affected and 804 unaffected carriers of European ancestry. Associations were evaluated using a survival-based score test adjusted for familial correlations and stratified by country of the study and BRCA2*6174delT mutation status. The genomic inflation factor (lambda) was 1.011. The stage 1 association analysis revealed multiple variants associated with breast cancer risk: 3 SNPs had p-values, 10 25 and 39 SNPs had p-values<10(-4). These variants included several previously associated with sporadic breast cancer risk and two novel loci on chromosome 20 (rs311499) and chromosome 10 (rs16917302). The chromosome 10 locus was in ZNF365, which contains another variant that has recently been associated with breast cancer in an independent study of unselected cases. In stage 2, the top 85 loci from stage 1 were genotyped in 1,264 cases and 1,222 controls. Hazard ratios (HR) and 95% confidence intervals (CI) for stage 1 and 2 were combined and estimated using a retrospective likelihood approach, stratified by country of residence and the most common mutation, BRCA2*6174delT. The combined per allele HR of the minor allele for the novel loci rs16917302 was 0.75 (95% CI 0.66-0.86, p = 3: 8 x 10(-5)) and for rs311499 was 0.72 (95% CI 0.61-0.85, p = 6: 6 x 10(-5)). FGFR2 rs2981575 had the strongest association with breast cancer risk (per allele HR = 1.28, 95% CI 1.18-1.39, p = 1: 2 x 10(-8)). These results indicate that SNPs that modify BRCA2 penetrance identified by an agnostic approach thus far are limited to variants that also modify risk of sporadic BRCA2 wi

Published
2010

43. Technetium-99m sulfur colloid (TSC) as a phenotypic probe for the pharmacokinetics (PK) and pharmacodynamics (PD) of pegylated liposomal doxorubicin (PLD) in patients (pts) with recurrent epithelial ovarian cancer (EOC).

Author

Walsh, M. D., primary, Giovinazzo, H., additional, Sheikh, A., additional, Ivanovic, M., additional, Whitlow, A. B., additional, Newman, S. E., additional, La-Beck, N. M., additional, Kowalsky, R. J., additional, Zamboni, B. A., additional, Clarke-Pearson, D. L., additional, Brewster, W. R., additional, Van Le, L., additional, Bae-Jump, V. L., additional, Gehrig, P. A., additional, and Zamboni, W., additional

Published
2011
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45. Cellular function of the mononuclear phagocyte system (MPS) as a phenotypic probe for pegylated liposomal doxorubicin (PLD) pharmacokinetics (PK) in patients with recurrent ovarian cancer.

Author

Caron, W. P., primary, Lay, J. C., additional, Fong, A. M., additional, La-Beck, N. M., additional, Newman, S. E., additional, Clarke-Pearson, D. L., additional, Brewster, W. R., additional, Van Le, L., additional, Bae-Jump, V. L., additional, Gehrig, P. A., additional, and Zamboni, W., additional

Published
2011
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46. Relationship between relative dose intensity and mortality in women receiving combination chemotherapy for stage III-IV epithelial ovarian cancer.

Author

Havrilesky, L. J., primary, Hanna, R. K., additional, Poniewierski, M. S., additional, Laskey, R., additional, Secord, A. A., additional, Gehrig, P. A., additional, Lopez, M. A., additional, Shafer, A., additional, Van Le, L., additional, Dale, D. C., additional, Crawford, J., additional, and Lyman, G. H., additional

Published
2011
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