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1. 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

Bachelot, T., Bouzid, K., Campone, M., Desmoulins, I., Coudert, B., Bondarenko, I., Nowecki, Z., Glogowska, I., Ciruelos Gil, E., Errihani, H., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Paluch-Shimon, S., Wardley, A., Schneeweiss, A., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Puglisi, F., 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., Miles, D., 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., Juhász, 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-Vásques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M.J., Illarramendi Mañas, J., Martinez De Dueñas, 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., Alarcón 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-Böess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferraù, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., López, 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., Müller, 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., Cedeño, 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., García Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M.H., Martínez Jañez, N., Mele Olive, M., McAdam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Grève, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kütner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Lück, H.-J., Zahm, D.-M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C.H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Viñas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kühn, T., Ober, A., Repp, R., Schröder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Pérez Martínez, M., van de Wouw, A.J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Antón Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florián Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Björneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodríguez, R., Ciruelos, E., Peretz-Yablonski, T., Merot, J.-L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., and Klingbiel, D.

Published
2021
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2. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Cerana, S, Dictar, MO, Bonvehi, P, Tregnaghi, JP, Fein, L, Ashley, D, Singh, M, Hayes, T, Playford, G, Morrissey, O, Thaler, J, Kuehr, T, Greil, R, Pecherstorfer, M, Duck, L, Van Eygen, K, Aoun, M, De Prijck, B, Franke, FA, Barrios, CHE, Mendes, AVA, Serrano, SV, Garcia, RF, Moore, F, Camargo, JFC, Pires, LA, Alves, RS, Radinov, A, Oreshkov, K, Minchev, V, Hubenova, AI, Koynova, T, Ivanov, I, Rabotilova, B, Petrov, PA, Chilingirov, P, Karanikolov, S, Raynov, J, Grimard, D, McNeil, S, Kumar, D, Larratt, LM, Weiss, K, Delage, R, Diaz-Mitoma, FJ, Cano, PO, Couture, F, Carvajal, P, Yepes, A, Torres Ulloa, R, Fardella, P, Caglevic, C, Rojas, C, Orellana, E, Gonzalez, P, Acevedo, A, Galvez, KM, Gonzalez, ME, Franco, S, Restrepo, JG, Rojas, CA, Bonilla, C, Florez, LE, Ospina, AV, Manneh, R, Zorica, R, Vrdoljak, DV, Samarzija, M, Petruzelka, L, Vydra, J, Mayer, J, Cibula, D, Prausova, J, Paulson, G, Ontaneda, M, Palk, K, Vahlberg, A, Rooneem, R, Galtier, F, Postil, D, Lucht, F, Laine, F, Launay, O, Laurichesse, H, Duval, X, Cornely, OA, Camerer, B, Panse, J, Zaiss, M, Derigs, H-G, Menzel, H, Verbeek, M, Georgoulias, V, Mavroudis, D, Anagnostopoulos, A, Terpos, E, Cortes, D, Umanzor, J, Bejarano, S, Galeano, RW, Wong, RSM, Hui, P, Pedrazzoli, P, Ruggeri, L, Aversa, F, Bosi, A, Gentile, G, Rambaldi, A, Contu, A, Marei, L, Abbadi, A, Hayajneh, W, Kattan, J, Farhat, F, Chahine, G, Rutkauskiene, J, Marfil Rivera, LJ, Lopez Chuken, YA, Franco Villarreal, H, Lopez Hernandez, J, Blacklock, H, Lopez, RI, Alvarez, R, Gomez, AM, Quintana, TS, Moreno Larrea, MDC, Zorrilla, SJ, Alarcon, E, Samanez, FCA, Caguioa, PB, Tiangco, BJ, Mora, EM, Betancourt-Garcia, RD, Hallman-Navarro, D, Feliciano-Lopez, LJ, Velez-Cortes, HA, Cabanillas, F, Ganea, DE, Ciuleanu, TE, Ghizdavescu, DG, Miron, L, Cebotaru, CL, Cainap, CI, Anghel, R, Dvorkin, MV, Gladkov, OA, Fadeeva, NV, Kuzmin, AA, Lipatov, ON, Zbarskaya, II, Akhmetzyanov, FS, Litvinov, IV, Afanasyev, BV, Cherenkova, M, Lioznov, D, Lisukov, IA, Smirnova, YA, Kolomietz, S, Halawani, H, Goh, YT, Drgona, L, Chudej, J, Matejkova, M, Reckova, M, Rapoport, BL, Szpak, WM, Malan, DR, Jonas, N, Jung, CW, Lee, DG, Yoon, SS, Lopez Jimenez, J, Duran Martinez, I, Rodriguez Moreno, JF, Solano Vercet, C, de la Camara, R, Batlle Massana, M, Yeh, S-P, Chen, C-Y, Chou, H-H, Tsai, C-M, Chiu, C-H, Siritanaratkul, N, Norasetthada, L, Sriuranpong, V, Seetalarom, K, Akan, H, Dane, F, Ozcan, MA, Ozsan, GH, Kalayoglu Besisik, SF, Cagatay, A, Yalcin, S, Peniket, A, Mullan, SR, Dakhil, KM, Sivarajan, K, Suh, JJ-G, Sehgal, A, Marquez, F, Gomez, EG, Mullane, MR, Skinner, WL, Behrens, RJ, Trevarthe, DR, Mazurczak, MA, Lambiase, EA, Vidal, CA, Anac, SY, Rodrigues, GA, Baltz, B, Boccia, R, Wertheim, MS, Holladay, CS, Zenk, D, Fusselman, W, Wade III, JL, Jaslowsk, AJ, Keegan, J, Robinson, MO, Go, RS, Farnen, J, Amin, B, Jurgens, D, Risi, GF, Jr, Beatty, PG, Naqvi, T, Parshad, S, Hansen, VL, Ahmed, M, Steen, PD, Badarinath, S, Dekker, A, Scouros, MA, Young, DE, Graydon Harker, W, Kendall, SD, Citron, ML, Chedid, S, Posada, JG, Jr, Gupta, MK, Rafiyath, S, Buechler-Price, J, Sreenivasappa, S, Chay, CH, Burke, JM, Young, SE, Mahmood, A, Kugler, JW, Gerstner, G, Fuloria, J, Belman, ND, Geller, R, Nieva, J, Whittenberger, BP, Wong, BMY, Cescon, TP, Abesada-Terk, G, Jr, Guarino, MJ, Zweibach, A, Ibrahim, EN, Takahashi, G, Garrison, MA, Mowat, RB, Choi, BS, Oliff, IA, Singh, J, Guter, KA, Ayrons, K, Rowland, KM, Noga, SJ, Rao, SB, Columbie, A, Nualart, MT, Cecchi, GR, Campos, LT, Mohebtash, M, Flores, MR, Rothstein-Rubin, R, O'Connor, BM, Soori, G, Knapp, M, Miranda, FG, Goodgame, BW, Kassem, M, Belani, R, Sharma, S, Ortiz, T, Sonneborn, HL, Markowitz, AB, Wilbur, D, Meiri, E, Koo, VS, Jhangiani, HS, Wong, L, Sanani, S, Lawrence, SJ, Jones, CM, Murray, C, Papageorgiou, C, Gurtler, JS, Ascensao, JL, Venigalla, ML, D'Andrea, M, De Las Casas, C, Haile, DJ, Qazi, FU, Santander, JL, Thomas, MR, Rao, VP, Craig, M, Garg, RJ, Robles, R, Lyons, RM, Stegemoller, RK, Goel, S, Garg, S, Lowry, P, Lynch, C, Lash, B, Repka, T, Baker, J, Goueli, BS, Campbell, TC, Van Echo, DA, Lee, YJ, Reyes, EA, Senecal, FM, Donnelly, G, Byeff, P, Weiss, R, Reid, T, Roeland, E, Goel, A, Prow, DM, Brandt, DS, Kaplan, HG, Payne, JE, Boeckh, MG, Rosen, PJ, Mena, RR, Khan, R, Betts, RF, Sharp, SA, Morrison, VA, Fitz-Patrick, D, Congdon, J, Erickson, N, Abbasi, R, Henderson, S, Mehdi, A, Wos, EJ, Rehmus, E, Beltzer, L, Tamayo, RA, Mahmood, T, Reboli, AC, Moore, A, Brown, JM, Cruz, J, Quick, DP, Potz, JL, Kotz, KW, Hutchins, M, Chowhan, NM, Devabhaktuni, YD, Braly, P, Berenguer, RA, Shambaugh, SC, O'Rourke, TJ, Conkright, WA, Winkler, CF, Addo, FEK, Duic, JP, High, KP, Kutner, ME, Collins, R, Carrizosa, DR, Perry, DJ, Kailath, E, Rosen, N, Sotolongo, R, Shoham, S, Chen, T, Mullane, Kathleen M, Morrison, Vicki A, Camacho, Luis H, Arvin, Ann, McNeil, Shelly A, Durrand, Jessie, Campbell, Bernadette, Su, Shu-Chih, Chan, Ivan S F, Parrino, Janie, Kaplan, Susan S, Popmihajlov, Zoran, and Annunziato, Paula W

Published
2019
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3. The use of breast imaging for predicting response to neoadjuvant lapatinib, trastuzumab and their combination in HER2-positive breast cancer: Results from Neo-ALTTO

Author

Di Cosimo, S., Campbell, C., Azim, H.A., Jr., Galli, G., Bregni, G., Curigliano, G., Criscitiello, C., Izquierdo, M., de la Pena, L., Fumagalli, D., Fein, L., Vinholes, J., Ng, W.M.J., Colleoni, M., Ferro, A., Naume, B.J., Patel, A., Huober, J., Piccart-Gebhart, M.J., Baselga, J., and de Azambuja, E.

Published
2018
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4. 11 Flabra, frontline approach for BRCA testing in ovarian cancer (OC) treatment naïve population. A latin america (LA) epidemiologic study

Author

Goncalves, S, Gomez Abuin, G, Gallardo, D, Estevez Diz, P, Caceres, V, De la Vega, M, Palazzo, F, Lerzo, G, Kaen, D, Gerson, R, Lim, M, Philco, M, Moreira Costa Zorzzeto, M, De Melo, AC, Hegg, R, de Oliveira Santana, R, Medeiros Milhomen Beato, P, Trujillo, L, Plata, M, Yepes, A, Cock, A, Bonifacino, MM, Cortes, M, Fein, L, Castillo, C, Pacheco, C, Ticona, M, Hoyoa, E, Jaramillo, R, Soare Nunes, J, Menezes Morelle, A, Freire de Carvalho Calabrich, A, Cronemberger Costa e Silva, EH, Mora, P, Damian, F, Diaz Perez, I, Sganga, L, Pereira, MH, Ramirez, H, Nogueira, A, Guindalini, R, Miranda, V, and Giornelli, G

Published
2019
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6. EP03.01-003 Clinical Features and Molecular Profile of Advanced Non-small Cell Lung Cancer in Latin America: LATINO Lung (LACOG 0116)

Author

Werutsky, G., primary, Arrieta, O., additional, Zukin, M., additional, Mathias, C., additional, Gelatti, A.C.Z., additional, Kaen, D.L., additional, Cardona, A.F., additional, Cronemberg, E., additional, Campos, C., additional, Araújo, L.H., additional, de Andrade, H., additional, Reichow, S.L., additional, de Lima, V.C., additional, Pacheco, P., additional, Coelho, J.C., additional, Borges, G., additional, Silva, A., additional, Mascarenhas, E., additional, Quiroga, A., additional, Fein, L., additional, de Oliveira, F.N.G., additional, Pastorello, J., additional, Dutra, C., additional, Morbeck, I., additional, Cruz, F.S.M., additional, Rebelatto, T.F., additional, Gomes, R., additional, and Barrios, C.H., additional

Published
2022
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7. Overall survival in the OlympiA phase Ill trial of adjuvant olaparib in patients with germime pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Author

Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., Johannsson, O. Th, Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., and Johannsson, O. Th

Abstract

Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. Patients and methods: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. Results: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Delta 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Delta 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Delta 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. Conclusion: With 35 years of median follow-up, OlympiA demonstrates statistical

Published
2022

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

Miles, D., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Campone, M., additional, Bondarenko, I., additional, Nowecki, Z., additional, Errihani, H., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, Trask, P., additional, du Toit, Y., additional, Pena-Murillo, C., additional, Revelant, V., additional, Klingbiel, D., additional, Bachelot, T., additional, Bouzid, K., additional, Desmoulins, I., additional, Coudert, B., additional, Glogowska, I., additional, Ciruelos Gil, E., additional, Dalenc, F., additional, Ricci, F., additional, Dieras, V., additional, Kaufman, B., additional, Ferreira, A., additional, Mano, M., additional, Kalofonos, H., additional, Andreetta, C., additional, Montemurro, F., additional, Barrett, S., additional, Zhang, Q., additional, Mavroudis, D., additional, Matus, J., additional, Villarreal Garza, C., additional, Beato, C., additional, Ismael, G., additional, Hu, X., additional, Abdel Azeem, H., additional, Gaafar, R., additional, Perrin, C., additional, Kerbrat, P., additional, Ettl, J., additional, Paepke, S., additional, Hitre, E., additional, Lang, I., additional, Trudeau, M., additional, Verma, S., additional, Li, H., additional, Hoffmann, O., additional, Aktas, B., additional, Cariello, A., additional, Cruciani, G., additional, Tienghi, A., additional, Tondini, C., additional, Al-Twegieri, T., additional, Loman, N., additional, Laing, R., additional, Miles, D., additional, Brain, E., additional, Fasching, P., additional, Lux, M., additional, Frassoldati, A., additional, Aziz, Z., additional, Salas, J., additional, Streb, J., additional, Krzemieniecki, K., additional, Wronski, A., additional, Garcia Garcia, J., additional, Menjon Beltran, S., additional, Cicin, I., additional, Schmid, P., additional, Gallagher, C., additional, Turner, N., additional, Tong, Z., additional, Boer, K., additional, Juhász, B., additional, Horvath, Z., additional, Bianchini, G., additional, Gianni, L., additional, Curigliano, G., additional, Juarez Ramiro, A., additional, Susnjar, S., additional, Matos, E., additional, Sevillano, E., additional, Garcia Estevez, L., additional, Gokmen, E., additional, Uslu, R., additional, Wildiers, H., additional, Schutz, F., additional, Cruz, M., additional, Bourgeois, H., additional, von Schumann, R., additional, Stemmer, S., additional, Dominguez, A., additional, Morales-Vásques, F., additional, Wojtukiewicz, M., additional, Trifunovic, J., additional, Echarri Gonzalez, M.J., additional, Illarramendi Mañas, J., additional, Martinez De Dueñas, E., additional, Voitko, N., additional, Hicks, J., additional, Waters, S., additional, Barrett-Lee, P., additional, Wheatley, D., additional, De Boer, R., additional, Cocquyt, V., additional, Jerusalem, G., additional, Barrios, C., additional, Panasci, L., additional, Mattson, J., additional, Tanner, M., additional, Gozy, M., additional, 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additional, Garcia Saenz, J., additional, López, R., additional, Del Val Munoz, O., additional, Ozyilkan, O., additional, Azribi, F., additional, Jaafar, H., additional, Baird, R., additional, Verrill, M., additional, Beith, J., additional, Petzer, A., additional, Moreira de Andrade, J., additional, Bernstein, V., additional, Macpherson, N., additional, Rayson, D., additional, Saad Eldin, I., additional, Achille, M., additional, Augereau, P., additional, Müller, V., additional, Rasco, A., additional, Evron, E., additional, Katz, D., additional, Berardi, R., additional, Cascinu, S., additional, De Censi, A., additional, Gennari, A., additional, El-Saghir, N., additional, Ghosn, M., additional, Oosterkamp, H.M., additional, Van den Bosch, J., additional, Kukulska, M., additional, Kalinka, E., additional, Alonso, J., additional, Dalmau Portulas, E., additional, Del Mar Gordon Santiago, M., additional, Pelaez Fernandez, I., additional, Aksoy, S., additional, Altundag, K., additional, Senol Coskun, H., additional, Bozcuk, H., additional, Shparyk, Y., additional, Barraclough, L., additional, Levitt, N., additional, Panwar, U., additional, Kelly, S., additional, Rigg, A., additional, Varughese, M., additional, Castillo, C., additional, Fein, L., additional, Malik, L., additional, Stuart-Harris, R., additional, Singer, C., additional, Stoeger, H., additional, Samonigg, H., additional, Feng, J., additional, Cedeño, M., additional, Ruohola, J., additional, Berdah, J.-F., additional, Goncalves, A., additional, Orfeuvre, H., additional, Grischke, E.-M., additional, Simon, E., additional, Wagner, S., additional, Koumakis, G., additional, Papazisis, K., additional, Ben Baruch, N., additional, Fried, G., additional, Geffen, D., additional, Karminsky, N., additional, Peretz, T., additional, Cavanna, L., additional, Pedrazzioli, P., additional, Grasso, D., additional, Ruggeri, E., additional, D’Auria, G., additional, Moscetti, L., additional, Juozaityte, E., additional, Rodriguez Cid, J., additional, Roerdink, H., additional, Siddiqi, N., additional, Passos Coelho, J., additional, Arcediano Del Amo, A., additional, Garcia Garre, E., additional, García Gonzalez, M., additional, Garcia-Palomo Perez, A., additional, Herenandez Perez, C., additional, Lopez Alvarez, P., additional, Lopez De Ceballos, M.H., additional, Martínez Jañez, N., additional, Mele Olive, M., additional, McAdam, K., additional, Perren, T., additional, Dunn, G., additional, Humphreys, A., additional, Taylor, W., additional, Vera, R., additional, Kaen, L., additional, Andel, J., additional, Steger, G., additional, De Grève, J., additional, Huizing, M., additional, Hegg, R., additional, Joy, A., additional, Kuruvilla, P., additional, Sehdev, S., additional, Smiljanic, S., additional, Kütner, R., additional, Alexandre, J., additional, Grosjean, J., additional, Laplaige, P., additional, Largillier, R., additional, Maes, P., additional, Martin, P., additional, Pottier, V., additional, Christensen, 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S., additional, Robidoux, A., additional, Li, E., additional, Li, N., additional, Jiang, J., additional, Soria, T., additional, Padrik, P., additional, Lahdenpera, O., additional, Barletta, H., additional, Dohollou, N., additional, Genet, D., additional, Prulhiere, K., additional, Coeffic, D., additional, Facchini, T., additional, Vieillot, S., additional, Catala, S., additional, Teixeira, L., additional, Hesse, T., additional, Kühn, T., additional, Ober, A., additional, Repp, R., additional, Schröder, W., additional, Pectasides, D., additional, Bodoky, G., additional, Kahan, Z., additional, Jiveliouk, I., additional, Rosengarten, O., additional, Rossi, V., additional, Alabiso, O., additional, Pérez Martínez, M., additional, van de Wouw, A.J., additional, Smok-Kalwat, J., additional, Damasecno, M., additional, Augusto, I., additional, Sousa, G., additional, Saadein, A., additional, Abdelhafiez, N., additional, Abulkhair, O., additional, Antón Torres, A., additional, Corbellas Aparicio, M., additional, Llorente Domenech, R., additional, Florián Jerico, J., additional, Garcia Mata, J., additional, Gil Raga, M., additional, Galan Brotons, A., additional, Llombart Cussac, A., additional, Llorca Ferrandiz, C., additional, Martinez Del Prado, P., additional, Olier Garate, C., additional, Rodriguez Sanchez, C., additional, Sanchez Gomez, R., additional, Santisteban Eslava, M., additional, Soberino, J., additional, Vidal Losada Garcia, M., additional, Soto de Prado, D., additional, Torrego Garcia, J., additional, Vicente Rubio, E., additional, Garcia, M., additional, Murias Rosales, A., additional, Granstam Björneklett, H., additional, Narbe, U., additional, Jafri, M., additional, Rea, D., additional, Newby, J., additional, Jones, A., additional, Westwell, S., additional, Ring, A., additional, Alonso, I., additional, and Rodríguez, R., additional

Published
2021
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9. Abstract PS13-06: Lower rates of neuropathy with oral paclitaxel and encequidar (oPac+E) compared to IV paclitaxel (IVPac) in treatment of metastatic breast cancer (mBC): Study KX-ORAX-001

Author

Rugo, H S, primary, Umanzor, G, additional, Barrios, F J, additional, Vasallo, R H, additional, Chivalan, M A, additional, Bejarano, S, additional, Ramirez, J R, additional, Fein, L, additional, Kowalyszyn, R D, additional, Cutler, D L, additional, Kramer, D, additional, Goldfinch, J, additional, Wang, H, additional, Moore, T, additional, and Kwan, R MF, additional

Published
2021
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10. Abstract PD1-08: Oral paclitaxel and encequidar (oPac+E) versus IV paclitaxel (IVPac) in the treatment of metastatic breast cancer (mBC) patients (study KX-ORAX-001): Progression free survival (PFS) and overall survival (OS) updates

Author

Umanzor, G, primary, Rugo, H S, additional, Barrios, F J, additional, Vasallo, R H, additional, Chivalan, M A, additional, Bejarano, S, additional, Ramirez, J R, additional, Fein, L, additional, Kowalyszyn, R D, additional, Cutler, D L, additional, Kramer, D, additional, Goldfinch, J, additional, Wang, H, additional, Moore, T, additional, and Kwan, R MF, additional

Published
2021
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11. Abstract PS13-11: Oral paclitaxel and encequidar (oPac+E) in the treatment of metastatic breast cancer (mBC): Management of gastrointestinal adverse events (GI AE). Study KX-ORAX-001

Author

Rugo, H S, primary, Umanzor, G, additional, Barrios, F J, additional, Vasallo, R H, additional, Chivalan, M A, additional, Bejarano, S, additional, Ramirez, J R, additional, Fein, L, additional, Kowalyszyn, R D, additional, Cutler, D L, additional, Kramer, D, additional, Goldfinch, J, additional, Wang, H, additional, Moore, T, additional, and Kwan, R MF, additional

Published
2021
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13. Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

Author

Schmidinger, M. Bamias, A. Procopio, G. Hawkins, R. Sanchez, A.R. Vázquez, S. Srihari, N. Kalofonos, H. Bono, P. Pisal, C.B. Hirschberg, Y. Dezzani, L. Ahmad, Q. Jonasch, E. Gimeno, R.A. Herranz, U.A. Ardavanis, A. Ashraf, S.A. Bamias, A. Barone, C. Bella, S.R. Belz, H. Companario, E.B. Bolling, C. Bono, P. Bothe, K. Carteni, G. Espinosa, J.C. Clausse, M. Confente, C. Coskun, H. Herrero, G.C. Demey, W. D'hondt, R. Santasusana, M.D. Doshi, G. Elkiran, E. Facchini, G. Fein, L. Calvo, O.F. Flaherty, A. Fountzilas, G. Fruehauf, J. Díaz, E.G. Garcia, R. Domínguez, R.G. Ghosn, M. Glorieux, P. Goebell, P.J. Gutierrez, L.G.-A. Gonzalez, M. Green, N.B. Arnau, M.G. Harich, H.-D. Hawkins, R. Hegele, A. Pérez, C.H. Herrmann, E. Horniniger, W.J. Hutson, T.E. Janetschek, G. Kalantari, H. Kalofonos, H. Klausmann, M. Kolin, M. Krause, S. Kroening, H. Sorrosal, J.J.L. Lázaro, M. Lema, M. Lema, M.L. Lin, J. Lueck, A. Lybaert, W. Magi, A. Marina, V.A. Rey, J.P.M. Matus, G. Melear, J. Gonzalez, B.M. Milella, M. Montalar, J. Ferrandis, J.M. Nathan, P. Nechushtan, H. Nusch, A. Ojamaa, K. Oksuzoglu, B. Ozkan, M. Papazisis, K. Passalacqua, R. Pe'er, A. Gracia, J.L.P. Pichler, A. Pokker, H. Porta, C. Rauchenwald, M. Richardet, M.E. Richey, S.L. Garcia, J.M.R. Sánchez, A.R. Rudolph, R. Sabbatini, R. Salmon, J.-P. Lobera, C.S. Sarid, D.L. Saylors, G.B. Schmidinger, M. Schrijvers, D. Schulze, M. Sevilay, A. Shumaker, G.G. Siemer, S. de Prado y Otero, D.S. Srihari, N. Stoiber, F. Rodriguez, C.S. Varela, M.S. Vasanthan, S. Estevez, S.V. Vehling-Kaiser, U. Vogelzang, N. Weiss, H. Whenham, N. Wyendaele, W. Yildiz, R. Yucel, I. Zarba, J.J. Zarkar, A. Zhong, W. Ziem, P. the PRINCIPAL Study Group

Abstract

Background: Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC). Subjects, Materials, and Methods: Patients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups. Results: Six hundred fifty-seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2–12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups. Conclusion: PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting. Implications for Practice: PRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced/metastatic renal cell carcinoma, to the authors’ knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real-world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first-line pazopanib generally do not show disease progression for approximately 10 months and generally survive for nearly 30 months. © AlphaMed Press 2019

Published
2019

14. EP1.16-39 Prospective Epidemiological Study of Metastatic Non-Small Cell Lung Cancer (NSCLC) in Latin America – LATINO Lung (LACOG 0116)

Author

Werutsky, G., primary, Cardona, A.F., additional, Kaen, D., additional, Arrieta, O.G., additional, Gelatti, A., additional, Mathias, C., additional, Zukin, M., additional, Cronemberger, E., additional, Mascarenhas, E., additional, Campos, C., additional, De Lima, V. Cordeiro, additional, Borges, G., additional, Coelho, J., additional, Oliveira, F., additional, Silva, A., additional, Araújo, L.H., additional, Quiroba, A., additional, Andrade, H., additional, Morbeck, I., additional, Lobaton, J., additional, Dias, J., additional, Zarba, J., additional, Fein, L., additional, Salman, P., additional, Trejo, R., additional, and Barrios, C., additional

Published
2019
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15. 11 Flabra, frontline approach for BRCA testing in ovarian cancer (OC) treatment naïve population. A latin america (LA) epidemiologic study

Author

Goncalves, S, primary, Gomez Abuin, G, additional, Gallardo, D, additional, Estevez Diz, P, additional, Caceres, V, additional, De la Vega, M, additional, Palazzo, F, additional, Lerzo, G, additional, Kaen, D, additional, Gerson, R, additional, Lim, M, additional, Philco, M, additional, Moreira Costa Zorzzeto, M, additional, De Melo, AC, additional, Hegg, R, additional, de Oliveira Santana, R, additional, Medeiros Milhomen Beato, P, additional, Trujillo, L, additional, Plata, M, additional, Yepes, A, additional, Cock, A, additional, Bonifacino, MM, additional, Cortes, M, additional, Fein, L, additional, Castillo, C, additional, Pacheco, C, additional, Ticona, M, additional, Hoyoa, E, additional, Jaramillo, R, additional, Soare Nunes, J, additional, Menezes Morelle, A, additional, Freire de Carvalho Calabrich, A, additional, Cronemberger Costa e Silva, EH, additional, Mora, P, additional, Damian, F, additional, Diaz Perez, I, additional, Sganga, L, additional, Pereira, MH, additional, Ramirez, H, additional, Nogueira, A, additional, Guindalini, R, additional, Miranda, V, additional, and Giornelli, G, additional

Published
2019
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16. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Mullane, Kathleen M, primary, Morrison, Vicki A, additional, Camacho, Luis H, additional, Arvin, Ann, additional, McNeil, Shelly A, additional, Durrand, Jessie, additional, Campbell, Bernadette, additional, Su, Shu-Chih, additional, Chan, Ivan S F, additional, Parrino, Janie, additional, Kaplan, Susan S, additional, Popmihajlov, Zoran, additional, Annunziato, Paula W, additional, Cerana, S, additional, Dictar, MO, additional, Bonvehi, P, additional, Tregnaghi, JP, additional, Fein, L, additional, Ashley, D, additional, Singh, M, additional, Hayes, T, additional, Playford, G, additional, Morrissey, O, additional, Thaler, J, additional, Kuehr, T, additional, Greil, R, additional, Pecherstorfer, M, additional, Duck, L, additional, Van Eygen, K, additional, Aoun, M, additional, De Prijck, B, additional, Franke, FA, additional, Barrios, CHE, additional, Mendes, AVA, additional, Serrano, SV, additional, Garcia, RF, additional, Moore, F, additional, Camargo, JFC, additional, Pires, LA, additional, Alves, RS, additional, Radinov, A, additional, Oreshkov, K, additional, Minchev, V, additional, Hubenova, AI, additional, Koynova, T, additional, Ivanov, I, additional, Rabotilova, B, additional, Petrov, PA, additional, Chilingirov, P, additional, Karanikolov, S, additional, Raynov, J, additional, Grimard, D, additional, McNeil, S, additional, Kumar, D, additional, Larratt, LM, additional, Weiss, K, additional, Delage, R, additional, Diaz-Mitoma, FJ, additional, Cano, PO, additional, Couture, F, additional, Carvajal, P, additional, Yepes, A, additional, Torres Ulloa, R, additional, Fardella, P, additional, Caglevic, C, additional, Rojas, C, additional, Orellana, E, additional, Gonzalez, P, additional, Acevedo, A, additional, Galvez, KM, additional, Gonzalez, ME, additional, Franco, S, additional, Restrepo, JG, additional, Rojas, CA, additional, Bonilla, C, additional, Florez, LE, additional, Ospina, AV, additional, Manneh, R, additional, Zorica, R, additional, Vrdoljak, DV, additional, Samarzija, M, additional, Petruzelka, L, additional, Vydra, J, additional, Mayer, J, additional, Cibula, D, additional, Prausova, J, additional, Paulson, G, additional, Ontaneda, M, additional, Palk, K, additional, Vahlberg, A, additional, Rooneem, R, additional, Galtier, F, additional, Postil, D, additional, Lucht, F, additional, Laine, F, additional, Launay, O, additional, Laurichesse, H, additional, Duval, X, additional, Cornely, OA, additional, Camerer, B, additional, Panse, J, additional, Zaiss, M, additional, Derigs, H-G, additional, Menzel, H, additional, Verbeek, M, additional, Georgoulias, V, additional, Mavroudis, D, additional, Anagnostopoulos, A, additional, Terpos, E, additional, Cortes, D, additional, Umanzor, J, additional, Bejarano, S, additional, Galeano, RW, additional, Wong, RSM, additional, Hui, P, additional, Pedrazzoli, P, additional, Ruggeri, L, additional, Aversa, F, additional, Bosi, A, additional, Gentile, G, additional, Rambaldi, A, additional, Contu, A, additional, Marei, L, additional, Abbadi, A, additional, Hayajneh, W, additional, Kattan, J, additional, Farhat, F, additional, Chahine, G, additional, Rutkauskiene, J, additional, Marfil Rivera, LJ, additional, Lopez Chuken, YA, additional, Franco Villarreal, H, additional, Lopez Hernandez, J, additional, Blacklock, H, additional, Lopez, RI, additional, Alvarez, R, additional, Gomez, AM, additional, Quintana, TS, additional, Moreno Larrea, MDC, additional, Zorrilla, SJ, additional, Alarcon, E, additional, Samanez, FCA, additional, Caguioa, PB, additional, Tiangco, BJ, additional, Mora, EM, additional, Betancourt-Garcia, RD, additional, Hallman-Navarro, D, additional, Feliciano-Lopez, LJ, additional, Velez-Cortes, HA, additional, Cabanillas, F, additional, Ganea, DE, additional, Ciuleanu, TE, additional, Ghizdavescu, DG, additional, Miron, L, additional, Cebotaru, CL, additional, Cainap, CI, additional, Anghel, R, additional, Dvorkin, MV, additional, Gladkov, OA, additional, Fadeeva, NV, additional, Kuzmin, AA, additional, Lipatov, ON, additional, Zbarskaya, II, additional, Akhmetzyanov, FS, additional, Litvinov, IV, additional, Afanasyev, BV, additional, Cherenkova, M, additional, Lioznov, D, additional, Lisukov, IA, additional, Smirnova, YA, additional, Kolomietz, S, additional, Halawani, H, additional, Goh, YT, additional, Drgona, L, additional, Chudej, J, additional, Matejkova, M, additional, Reckova, M, additional, Rapoport, BL, additional, Szpak, WM, additional, Malan, DR, additional, Jonas, N, additional, Jung, CW, additional, Lee, DG, additional, Yoon, SS, additional, Lopez Jimenez, J, additional, Duran Martinez, I, additional, Rodriguez Moreno, JF, additional, Solano Vercet, C, additional, de la Camara, R, additional, Batlle Massana, M, additional, Yeh, S-P, additional, Chen, C-Y, additional, Chou, H-H, additional, Tsai, C-M, additional, Chiu, C-H, additional, Siritanaratkul, N, additional, Norasetthada, L, additional, Sriuranpong, V, additional, Seetalarom, K, additional, Akan, H, additional, Dane, F, additional, Ozcan, MA, additional, Ozsan, GH, additional, Kalayoglu Besisik, SF, additional, Cagatay, A, additional, Yalcin, S, additional, Peniket, A, additional, Mullan, SR, additional, Dakhil, KM, additional, Sivarajan, K, additional, Suh, JJ-G, additional, Sehgal, A, additional, Marquez, F, additional, Gomez, EG, additional, Mullane, MR, additional, Skinner, WL, additional, Behrens, RJ, additional, Trevarthe, DR, additional, Mazurczak, MA, additional, Lambiase, EA, additional, Vidal, CA, additional, Anac, SY, additional, Rodrigues, GA, additional, Baltz, B, additional, Boccia, R, additional, Wertheim, MS, additional, Holladay, CS, additional, Zenk, D, additional, Fusselman, W, additional, Wade III, JL, additional, Jaslowsk, AJ, additional, Keegan, J, additional, Robinson, MO, additional, Go, RS, additional, Farnen, J, additional, Amin, B, additional, Jurgens, D, additional, Risi, GF, additional, Beatty, PG, additional, Naqvi, T, additional, Parshad, S, additional, Hansen, VL, additional, Ahmed, M, additional, Steen, PD, additional, Badarinath, S, additional, Dekker, A, additional, Scouros, MA, additional, Young, DE, additional, Graydon Harker, W, additional, Kendall, SD, additional, Citron, ML, additional, Chedid, S, additional, Posada, JG, additional, Gupta, MK, additional, Rafiyath, S, additional, Buechler-Price, J, additional, Sreenivasappa, S, additional, Chay, CH, additional, Burke, JM, additional, Young, SE, additional, Mahmood, A, additional, Kugler, JW, additional, Gerstner, G, additional, Fuloria, J, additional, Belman, ND, additional, Geller, R, additional, Nieva, J, additional, Whittenberger, BP, additional, Wong, BMY, additional, Cescon, TP, additional, Abesada-Terk, G, additional, Guarino, MJ, additional, Zweibach, A, additional, Ibrahim, EN, additional, Takahashi, G, additional, Garrison, MA, additional, Mowat, RB, additional, Choi, BS, additional, Oliff, IA, additional, Singh, J, additional, Guter, KA, additional, Ayrons, K, additional, Rowland, KM, additional, Noga, SJ, additional, Rao, SB, additional, Columbie, A, additional, Nualart, MT, additional, Cecchi, GR, additional, Campos, LT, additional, Mohebtash, M, additional, Flores, MR, additional, Rothstein-Rubin, R, additional, O'Connor, BM, additional, Soori, G, additional, Knapp, M, additional, Miranda, FG, additional, Goodgame, BW, additional, Kassem, M, additional, Belani, R, additional, Sharma, S, additional, Ortiz, T, additional, Sonneborn, HL, additional, Markowitz, AB, additional, Wilbur, D, additional, Meiri, E, additional, Koo, VS, additional, Jhangiani, HS, additional, Wong, L, additional, Sanani, S, additional, Lawrence, SJ, additional, Jones, CM, additional, Murray, C, additional, Papageorgiou, C, additional, Gurtler, JS, additional, Ascensao, JL, additional, Venigalla, ML, additional, D'Andrea, M, additional, De Las Casas, C, additional, Haile, DJ, additional, Qazi, FU, additional, Santander, JL, additional, Thomas, MR, additional, Rao, VP, additional, Craig, M, additional, Garg, RJ, additional, Robles, R, additional, Lyons, RM, additional, Stegemoller, RK, additional, Goel, S, additional, Garg, S, additional, Lowry, P, additional, Lynch, C, additional, Lash, B, additional, Repka, T, additional, Baker, J, additional, Goueli, BS, additional, Campbell, TC, additional, Van Echo, DA, additional, Lee, YJ, additional, Reyes, EA, additional, Senecal, FM, additional, Donnelly, G, additional, Byeff, P, additional, Weiss, R, additional, Reid, T, additional, Roeland, E, additional, Goel, A, additional, Prow, DM, additional, Brandt, DS, additional, Kaplan, HG, additional, Payne, JE, additional, Boeckh, MG, additional, Rosen, PJ, additional, Mena, RR, additional, Khan, R, additional, Betts, RF, additional, Sharp, SA, additional, Morrison, VA, additional, Fitz-Patrick, D, additional, Congdon, J, additional, Erickson, N, additional, Abbasi, R, additional, Henderson, S, additional, Mehdi, A, additional, Wos, EJ, additional, Rehmus, E, additional, Beltzer, L, additional, Tamayo, RA, additional, Mahmood, T, additional, Reboli, AC, additional, Moore, A, additional, Brown, JM, additional, Cruz, J, additional, Quick, DP, additional, Potz, JL, additional, Kotz, KW, additional, Hutchins, M, additional, Chowhan, NM, additional, Devabhaktuni, YD, additional, Braly, P, additional, Berenguer, RA, additional, Shambaugh, SC, additional, O'Rourke, TJ, additional, Conkright, WA, additional, Winkler, CF, additional, Addo, FEK, additional, Duic, JP, additional, High, KP, additional, Kutner, ME, additional, Collins, R, additional, Carrizosa, DR, additional, Perry, DJ, additional, Kailath, E, additional, Rosen, N, additional, Sotolongo, R, additional, Shoham, S, additional, and Chen, T, additional

Published
2019
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18. LATITUDE study: PSA response characteristics and correlation with overall survival (OS) and radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving ADT+abiraterone acetate and prednisone (AAP) or placebo (PBO)

Author

Matsubara, N., primary, Chi, K.N., additional, Ozguroglu, M., additional, Rodriguez Antolin, A., additional, Feyerabend, S., additional, Fein, L., additional, Alekseev, B.Y., additional, Sulur, G., additional, Protheroe, A., additional, Li, S., additional, Mundle, S.D., additional, De Porre, P., additional, Tran, N., additional, and Fazazi, K., additional

Published
2018
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19. 797PD - LATITUDE study: PSA response characteristics and correlation with overall survival (OS) and radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving ADT+abiraterone acetate and prednisone (AAP) or placebo (PBO)

Author

Matsubara, N., Chi, K.N., Ozguroglu, M., Rodriguez Antolin, A., Feyerabend, S., Fein, L., Alekseev, B.Y., Sulur, G., Protheroe, A., Li, S., Mundle, S.D., De Porre, P., Tran, N., and Fazazi, K.

Published
2018
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20. Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study

Author

Mieog, Js, Morden, Jp, Bliss, Jm, Coombes, Rc, van de Velde CJ, IES Steering Committee: Delozier, T, Veronesi, A, Vrdoljak, E, Monnier, A, Coombes, C, Nagykalnai, T, Roumen, Rm, Utracka Hutka, B, Pluzanska, A, Porpiglia, M, Genta, F, Benedetto, Chiara, Sozzani, P, Steiner, M, Rubinov, R, Leviov, M, Semiglazov, V, Fox, J, Mayordomo, Ji, Cervek, J, Sleeboom, Hp, Jassem, J, Hinton, Cp, Paulsen, Th, Guleng, Rj, Fein, L, Gutulescu, N, Florián, J, Rosso, R, Rutgers, Ej, Krzakowski, M, Pienkowski, T, Krajina, Z, Siffnerova, H, Pawlicki, M, Drosik, K, Wagnerowa, M, Brunt, M, Vukelja, S, Mitrowic, L, Cataliotti, L, Karnicka Mlodkowska, H, Bonnefoi, H, Tilch, G, Chollet, P, Patel, A, Kamby, C, Giustini, L, Acito, L, Mouridsen, H, Roche, H, De Lafontan, B, Tomczak, P, Petruzelka, L, Lortholary, A, Pacquola, Mg, Skene, A, Rici, S, Michelotti, A, Ghilezan, N, Stewart, A, Beauduin, M, Andersen, J, Vassilaros, S, Celio, L, Bajetta, E, Bastús, R, Marsland, T, Paridaens, R, Tzekova, V, Lichtenegger, W, Piersma, H, Jones, S, Holmberg, S, Verhoeven, D, Hill, A, Porcile, G, Bruno, Mf, Chernozemski, I, Coleman, R, Jadeja, J, Cohn, A, Merlano, M, Perroni, D, Di Costanzo, F, Van Bochove, A, Gerrits, Ma, Malec, V, Balil, A, Mendiola, C, Dodwell, D, Knox, R, Horgan, K, Joannides, T, Leonard, Rc, Cawthorn, Sj, Ghosh, C, Cantrell, J, Campos, D, Orti, R, Diedrich, K, Aas, H, Barnadas, A, Vila, Mm, Makris, A, Anderson, T, Chittor, S, Michel, J, Philip, P, Redmond, P, Mastboom, Wj, Nordenskjöld, B, Simmonds, P, Grieve, Rj, Tomova, A, Piot, G, Borea, G, Ucci, G, Einarsson, E, Nicholson, S, Gardiol, Ea, Kerger, J, Schlosser, J, Namer, M, Pinotti, G, Rutten, Ht, Iversen, T, Nejim, A, Dudov, A, Grundtvig, P, Lang, I, Massidda, B, Van De Velde CH, Gervasio, Mh, Tengrup, I, Tennvall, L, Goodman, S, Modgill, Vk, Vorobiof, Da, Mickiewicz, E, Chirgwin, J, Focan, C, Albin, N, Contu, Aa, Svensson, Jh, Borghede, G, Källström, Ac, Forbes, Jf, Hurtz, Hj, Tubiana Hulin, M, Viens, P, Scanni, A, Arnoldi, E, Nastasi, G, Bottini, A, Alquati, P, Muscat, V, Brincat, S, Holmen, K, Amaral, N, Moreno, I, Trask, C, Robinson, A, Mcintyre, K, Otsuka, A, Hohaus, B, Hoefig, G, Georgoulias, V, Salvagni, S, Bidin, L, Artioli, F, Engan, T, Benedikstsson, Kp, Campbell, I, Harvey, V, Zimbler, H, Mrsic Krmpotic, Z, Canon, Jl, Tchilingirov, Pv, Buser, K, Bolanca, A, Reztke, U, Rhein, U, Jouve, M, Mullins, G, Vesentini, L, Gallo, L, Merlini, L, Decensi, A, Carreca, I, Van Tienhoven, G, Börjesson, B, Hansen, J, Koza, I, Arcusa, A, Inoriza, A, Pelegri, A, Eremin, O, Modiano, Mr, Anthony, S, Donat, D, Richardet, E, Kochli, O, Zeißig, P, Gauch, G, Aabo, K, Fumoleau, P, Erdkamp, Fl, Lovén, L, Jönsson, Pe, Perren, T, Stuart, N, Galindo, E, Marek, Bj, Salmon, Jp, Dohollou, N, Thompson, R, Folco, U, Rosa, A, Tonato, M, Heijmans, Gj, Koralewski, P, Bång, H, Lescure, Ar, Carrato, A, Martin, M, Neave, F, Howell, T, Savin, M, Loesch, D, Hannois, A, Mohr, A, Laube, T, Omar, S, Bonneterre, J, Servent, V, Danese, S, Sertoli, Mr, Butzelaar, Rm, Steller, Ep, Gomez, H, Skoog, P, Alvarez, I, Aguilar, Ea, Giner, Jl, Yosef, Hm, Barrett Lee, P, Buzdar, Au, George, T, Olivaires, J, Vsianska, M, Köhler, U, Lindeløv, B, Toftdahl, Db, Nielsen, Eb, Veyret, C, Castera, D, Kerbrat, P, Vassilaros, P, Yeo, W, Boni, C, Aitini, E, Luporini, G, Herben, Mg, Espelid, H, Dahl, S, Ingvar, C, Meana, A, Pico, C, Garcia, Am, Agrawal, Rk, Gruenberg, D, Nunez de Pierro, A, Gill, G, Nogaret, Jm, Honhon, B, Wassenaar, H, Nielander, R, Warnier, P, Sessa, C, Padrik, P, Guastalla, Jp, Serin, D, Jaubert, D, Dank, M, Given, Fh, Mascia, V, De Fraia, E, Silingardi, V, Conte, Pf, Labianca, R, Tondini, C, Bagnulo, A, Gardani, G, Wils, J, Liem, G, Nuytinck, Jk, Formoe, E, Ambré, T, Alés, J, Aramburo, P, Mansi, J, Graham, J, Joffe, J, Sainsbury, J, Stone, J, Good, Rh, Cartwright, T, Werner, Id, Murray, E, Beith, J, Tigges, Fj, Bojko, P, Sandberg, E, Jensen, B, Lotz, Jp, Carney, D, Shapira, J, Neumann, A, Goldhirsch, A, Dicato, M, de Graaf, H, Maartense, E, Burghouts, J, Cassinello, J, Jones, A, Gaffney, C, Blum, R, Abdi, E, Becquart, D, Dirix, L, Janssens, J, Nmarschner, N, Blaska Jaulerry, B, Prevot, G, Mirah Lev, L, Shani, A, Baruch, Nb, Peretz, T, Gips, M, Cognetti, F, Carlini, P, Nortier, Jw, Huinink D, ten B., Roussel, Jg, Unneberg, K, Kylberg, F, Hovind, H, Nestvold, T, Fogelkvist, R, Due, J, Muller, S, Gilligan, D, Russel, S, Mcaleer, J, Yiangou, C, Foote, L, Schottstaedt, M, Holmes, Fa, Wainstein, R, Contreras, O, Martinez, J, Della Fiorentina, S, Beslija, S, Vermorken, Jb, Thirion, M, Fraikin, J, Castiglione, M, Jäger, W, Fasching, P, Fabriz, H, Neis, K, Kirschbaum, M, Labat, Jp, Dupuis, O, Bernard, J, Datchary, J, Provencal, J, Allain, P, Clerico, M, Lopez, M, Nalli, G, Aspevik, R, Fràguas, A, Curescu, S, Cuevas, Jm, Oltra, A, Bradley, C, Kapoor, R, Akbain, S, Croghan, Mk, Modiano, M, Taetle, R, Beale, P, Gobert, P, Bondue, H, Böhm, R, Møller, Ka, Brettes, Jp, Netter, G, Grogan, L, Klein, B, Botta, M, Barni, S, Van Meerwijk, I, Kåresen, R, Godes, J, Aramburo, A, Jara, C, Zanger, B, Fleagle, Jt, Greenspan, A, Marschke, R, Medgyesy, Dc, Garbo, L., CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, Population, Breast Neoplasms, Disease-Free Survival, chemistry.chemical_compound, Breast cancer, Exemestane, Internal medicine, Surveys and Questionnaires, medicine, Clinical endpoint, Humans, Carpal tunnel syndrome, education, Aged, Retrospective Studies, Aged, 80 and over, education.field_of_study, business.industry, Aromatase Inhibitors, Hazard ratio, Middle Aged, medicine.disease, Carpal Tunnel Syndrome, Surgery, Musculoskeletal Abnormalities, Androstadienes, Postmenopause, Tamoxifen, Treatment Outcome, Oncology, chemistry, Hormonal therapy, Female, business, medicine.drug
Abstract

BACKGROUND: Aromatase inhibitors are more effective than is tamoxifen in prevention of breast-cancer recurrence, but at the expense of increased musculoskeletal side-effects, such as carpal tunnel syndrome. The aim of this study was to assess risk factors and the prognostic value of musculoskeletal symptoms during treatment with the steroidal aromatase inhibitor exemestane or with tamoxifen after 2-3 years of tamoxifen. METHODS: In the Intergroup Exemestane Study, postmenopausal women treated for early invasive breast cancer who remained disease free and on treatment after 2-3 years of tamoxifen were randomised to switch to exemestane or to continue tamoxifen for the remainder of the 5-year period of endocrine treatment. The primary endpoint for this retrospective analysis was occurrence of carpal tunnel syndrome and any musculoskeletal events, analysed in the safety population, which consisted of all patients who had received any trial treatment. As well as case-report forms, questionnaires were distributed retrospectively to gain more details of cases of carpal tunnel syndrome. The relation between musculoskeletal symptoms reported by 6 months from randomisation and survival from 9 months onwards was assessed by Cox proportional hazards models. The trial is registered, number ISRCTN11883920. It has completed accrual and follow-up is continuing for enrolled participants. FINDINGS: After a median follow-up of 91·0 months (IQR 83·0-99·2), carpal tunnel syndrome had been reported for 66 (2·8%) of 2319 patients in the exemestane group compared with 13 (0·6%) of 2338 in the tamoxifen group (odds ratio [OR] 5·23, 99% CI 2·39-11·49; p

Published
2012

21. Randomised Phase Ii Study Evaluating, As First-Line Chemotherapy, Weekly Oral Vinorelbine As a Single-Agent Versus Weekly Paclitaxel As a Single-Agent in Estrogen Receptor Positive, Her2-Negative Patients with Advanced Breast Cancer (Norbreast-231 Trial)

Author

Aapro, M., primary, Staroslawska, E., additional, Morales, S., additional, Borrego, M. Ruiz, additional, Cinieri, S., additional, Szombara, E., additional, Estevez, L. Garcia, additional, Tubiana-Mathieu, N., additional, Levy, C., additional, Wojtukiewicz, M., additional, Passalacqua, R., additional, Ardizzoia, A., additional, Hegg, R., additional, Fein, L., additional, Simon, H., additional, Richardet, E., additional, Egreteau, J., additional, Garrone, O., additional, Morand, M., additional, and Villanova, G.R., additional

Published
2014
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22. Abstract P4-12-26: A phase II randomized study of lapatinib in combination with capecitabine, vinorelbine or gemcitabine as first or second line-therapy in patients with HER2 positive metastatic breast cancer progressing after taxane (LACOG 0801)

Author

Gomez, H, primary, Neciosup, S, additional, Tosello, C, additional, Mano, M, additional, Bines, J, additional, Ismael, G, additional, Santi, PX, additional, Pinczowsky, H, additional, Neron, Y, additional, Fanelli, M, additional, Fein, L, additional, Sampaio, C, additional, Lerzo, G, additional, Capo, A, additional, Zarba, JJ, additional, Blajman, C, additional, Varela, MS, additional, Martínez-Mesa, J, additional, Werutsky, G, additional, and Barrios, CH, additional

Published
2013
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23. Abstract P3-15-03: Safety analysis of BOLERO-3: A phase 3 trial of daily everolimus (EVE) vs placebo (PBO), both with weekly trastuzumab (TRAS) and vinorelbine in trastuzumab-resistant, advanced breast cancer

Author

Jerusalem, G, primary, Masuda, N, additional, André, F, additional, Fein, L, additional, Fasolo, A, additional, O'Regan, R, additional, Wilks, S, additional, Isaacs, C, additional, Zhang, Y, additional, Taran, T, additional, and Toi, M, additional

Published
2013
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24. Abstract P2-16-23: The ENCHANT-1 trial (NCT01677455): An open label multicenter phase 2 proof of concept study evaluating first line ganetespib monotherapy in women with metastatic HER2 positive or triple negative breast cancer (TNBC)

Author

Awada, A, primary, Spector, N, additional, El-Hariry, I, additional, Rodriguez, AA, additional, Erban, JK, additional, Cortes, J, additional, Gomez, H, additional, Kong, A, additional, Hickish, T, additional, Fein, L, additional, Vahdat, L, additional, MacPherson, I, additional, Canon, J-L, additional, Mansoor, S, additional, Giovanne, A, additional, McAdam, K, additional, Vukovic, VM, additional, Yalcin, I, additional, Bradley, R, additional, Proia, D, additional, Mano, MS, additional, Perez, EA, additional, and Cameron, DA, additional

Published
2013
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38. 413TiP - Randomised Phase Ii Study Evaluating, As First-Line Chemotherapy, Weekly Oral Vinorelbine As a Single-Agent Versus Weekly Paclitaxel As a Single-Agent in Estrogen Receptor Positive, Her2-Negative Patients with Advanced Breast Cancer (Norbreast-231 Trial)

Author

Aapro, M., Staroslawska, E., Morales, S., Borrego, M. Ruiz, Cinieri, S., Szombara, E., Estevez, L. Garcia, Tubiana-Mathieu, N., Levy, C., Wojtukiewicz, M., Passalacqua, R., Ardizzoia, A., Hegg, R., Fein, L., Simon, H., Richardet, E., Egreteau, J., Garrone, O., Morand, M., and Villanova, G.R.

Published
2014
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39. Paclitaxel (P) plus carboplatin (C) in advanced non-small cell lung cancer (NSCLC)

Author

Richardet, E, primary, Cóppola, F, additional, Jovtis, S, additional, Fein, L, additional, Uranga, G, additional, Lewi, D, additional, Ventriglia, M, additional, Alasino, C, additional, Delfino, C, additional, Mickiewicz, E, additional, Pascón, G, additional, Cuevas, M, additional, Breier, S, additional, Pilnik, N, additional, Abraham, M, additional, Callejas, M, additional, Trigo, M, additional, De Cristófaro, O, additional, and Suárez, L.A, additional

Published
2000
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41. 358 Navelbine (NVB) plus mitomycin (MMC) or mitoxantrone (MTZ): A randomized trial in anthracycline breast cancer resistant (ABCR) patients. Preliminary report

Author

Bonicato, S., primary, Polera, F., additional, Martinez, F., additional, Brown Arnold, M., additional, Arrieta, F., additional, Arboit, L., additional, Ferro, A., additional, Marantz, A., additional, Litoska, S., additional, Triguhoff, E., additional, Uranga, G., additional, Fein, L., additional, Muro, H., additional, Trigo, M., additional, and Reale, M., additional

Published
1995
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42. Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT.

Author

Chia S, Gradishar W, Mauriac L, Bines J, Amant F, Federico M, Fein L, Romieu G, Buzdar A, Robertson JF, Brufsky A, Possinger K, Rennie P, Sapunar F, Lowe E, Piccart M, Chia, Stephen, Gradishar, William, Mauriac, Louis, and Bines, Jose

Published
2008
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46. MICROWAVE TECHNIQUES FOR COMPUTER APPLICATION

Author

GENERAL ELECTRIC CO PALO ALTO CA TRAVELING WAVE TUBE PRODUCT SECTION, FORRER, M.P., FEIN, L., GENERAL ELECTRIC CO PALO ALTO CA TRAVELING WAVE TUBE PRODUCT SECTION, FORRER, M.P., and FEIN, L.

Published
1956

49. Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma.

Author

Choueiri, T. K., Powles, T., Albiges, L., Burotto, M., Szczylik, C., Zurawski, B., Ruiz, E. Yanez, Maruzzo, M., Zaizar, A. Suarez, Fein, L. E., Schutz, F. A., Heng, D. Y. C., Wang, F., Mataveli, F., Chang, Y.-L., van Kooten Losio, M., Suarez, C., and Motzer, R. J.

Subjects
*NIVOLUMAB, *IPILIMUMAB, *PROGRESSION-free survival, *EXPERIMENTAL groups, *CARCINOMA, *RENAL cell carcinoma
Abstract

BACKGROUND The efficacy and safety of treatment with cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced renal-cell carcinoma are unknown. METHODS In this phase 3, double-blind trial, we enrolled patients with advanced clear-cell renal-cell carcinoma who had not previously received treatment and had intermediate or poor prognostic risk according to the International Metastatic Renal-Cell Carcinoma Database Consortium categories. Patients were randomly assigned to receive 40 mg of cabozantinib daily in addition to nivolumab and ipilimumab (experimental group) or matched placebo in addition to nivolumab and ipilimumab (control group). Nivolumab (3 mg per kilogram of body weight) and ipilimumab (1 mg per kilogram) were administered once every 3 weeks for four cycles. Patients then received nivolumab maintenance therapy (480 mg once every 4 weeks) for up to 2 years. The primary end point was progression-free survival, as determined by blinded independent review according to Response Evaluation Criteria in Solid Tumors, version 1.1, and was assessed in the first 550 patients who had undergone randomization. The secondary end point was overall survival, assessed in all patients who had undergone randomization. RESULTS Overall, 855 patients underwent randomization: 428 were assigned to the experimental group and 427 to the control group. Among the first 550 patients who had undergone randomization (276 in the experimental group and 274 in the control group), the probability of progression-free survival at 12 months was 0.57 in the experimental group and 0.49 in the control group (hazard ratio for disease progression or death, 0.73; 95% confidence interval, 0.57 to 0.94; P=0.01); 43% of the patients in the experimental group and 36% in the control group had a response. Grade 3 or 4 adverse events occurred in 79% of the patients in the experimental group and in 56% in the control group. Follow-up for overall survival is ongoing. CONCLUSIONS Among patients with previously untreated, advanced renal-cell carcinoma who had intermediate or poor prognostic risk, treatment with cabozantinib plus nivolumab and ipilimumab resulted in significantly longer progression-free survival than treatment with nivolumab and ipilimumab alone. Grade 3 or 4 adverse events were more common in the experimental group than in the control group. (Funded by Exelixis; COSMIC-313 ClinicalTrials.gov number, NCT03937219.). [ABSTRACT FROM AUTHOR]

Published
2023
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50. 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. H., Martinez Janez, N., Mele Olive, M., Mcadam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Greve, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kutner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Luck, H. -J., Zahm, D. -M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C. H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Vinas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kuhn, T., Ober, A., Repp, R., Schroder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Perez Martinez, M., van de Wouw, A. J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Anton Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florian Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Bjorneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodriguez, R., Apollo - University of Cambridge Repository, Medical Genetics, Clinical sciences, and Laboratory for Medical and Molecular Oncology

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

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