1. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial
- Author
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Pujade-Lauraine, Eric, Ledermann, Jonathan A, Selle, Frédéric, Gebski, Val, Penson, Richard T, Oza, Amit M, Korach, Jacob, Huzarski, Tomasz, Poveda, André, Pignata, Sandro, Friedlander, Michael, Colombo, Nicoletta, Harter, Philipp, Fujiwara, Keiichi, Ray-Coquard, Isabelle, Banerjee, Susana, Liu, Joyce, Lowe, Elizabeth S, Bloomfield, Ralph, Pautier, Patricia, Byrski, Tomasz, Scambia, Giovanni, Nicoletto, Maria, Nussey, Fiona, Clamp, Andrew, Penson, Richard, Oza, Amit, Poveda Velasco, André, Rodrigues, Manuel, Lotz, Jean-Pierre, Provencher, Diane, Prat Aparicio, Aleix, Vidal Boixader, Laura, Scott, Clare, Tamura, Kenji, Yunokawa, Mayu, Lisyanskaya, Alla, Medioni, Jacque, Pécuchet, Nicola, Dubot, Coraline, de la Motte Rouge, Thibault, Kaminsky, Marie-Christine, Weber, Béatrice, Lortholary, Alain, Parkinson, Christine, Ledermann, Jonathan, Williams, Sarah, Cosin, Jonathan, Hoffman, Jame, Plante, Marie, Covens, Allan, Sonke, Gabe, Joly, Florence, Floquet, Anne, Hirte, Holger, Amit, Amnon, Park-Simon, Tjoung-Won, Matsumoto, Koji, Tjulandin, Sergei, Kim, Jae Hoon, Gladieff, Laurence, Sabbatini, Roberto, O'Malley, David, Timmins, Patrick, Kredentser, Daniel, Laínez Milagro, Nuria, Barretina Ginesta, Maria Pilar, Tibau Martorell, Ariadna, Gómez de Liaño Lista, Alfonso, Ojeda González, Belén, Mileshkin, Linda, Mandai, Masaki, Boere, Ingrid, Ottevanger, Petronella, Nam, Joo-Hyun, Filho, Elia, Hamizi, Salima, Cognetti, Francesco, Warshal, David, Dickson-Michelson, Elizabeth, Kamelle, Scott, Mckenzie, Nathalie, Rodriguez, Gustavo, Armstrong, Deborah, Chalas, Eva, Celano, Paul, Behbakht, Kian, Davidson, Susan, Welch, Stephen, Helpman, Limor, Fishman, Ami, Bruchim, Ilan, Sikorska, Magdalena, Słowińska, Anna, Rogowski, Wojciech, Bidziński, Mariusz, Śpiewankiewicz, Beata, Casado Herraez, Antonio, Mendiola Fernández, César, Gropp-Meier, Martina, Saito, Toshiaki, Takehara, Kazuhiro, Enomoto, Takayuki, Watari, Hidemichi, Choi, Chel Hun, Kim, Byoung-Gie, Kim, Jae Weon, Hegg, Roberto, Vergote, Ignace, Scambia, Giovanni (ORCID:0000-0003-2758-1063), Pujade-Lauraine, Eric, Ledermann, Jonathan A, Selle, Frédéric, Gebski, Val, Penson, Richard T, Oza, Amit M, Korach, Jacob, Huzarski, Tomasz, Poveda, André, Pignata, Sandro, Friedlander, Michael, Colombo, Nicoletta, Harter, Philipp, Fujiwara, Keiichi, Ray-Coquard, Isabelle, Banerjee, Susana, Liu, Joyce, Lowe, Elizabeth S, Bloomfield, Ralph, Pautier, Patricia, Byrski, Tomasz, Scambia, Giovanni, Nicoletto, Maria, Nussey, Fiona, Clamp, Andrew, Penson, Richard, Oza, Amit, Poveda Velasco, André, Rodrigues, Manuel, Lotz, Jean-Pierre, Provencher, Diane, Prat Aparicio, Aleix, Vidal Boixader, Laura, Scott, Clare, Tamura, Kenji, Yunokawa, Mayu, Lisyanskaya, Alla, Medioni, Jacque, Pécuchet, Nicola, Dubot, Coraline, de la Motte Rouge, Thibault, Kaminsky, Marie-Christine, Weber, Béatrice, Lortholary, Alain, Parkinson, Christine, Ledermann, Jonathan, Williams, Sarah, Cosin, Jonathan, Hoffman, Jame, Plante, Marie, Covens, Allan, Sonke, Gabe, Joly, Florence, Floquet, Anne, Hirte, Holger, Amit, Amnon, Park-Simon, Tjoung-Won, Matsumoto, Koji, Tjulandin, Sergei, Kim, Jae Hoon, Gladieff, Laurence, Sabbatini, Roberto, O'Malley, David, Timmins, Patrick, Kredentser, Daniel, Laínez Milagro, Nuria, Barretina Ginesta, Maria Pilar, Tibau Martorell, Ariadna, Gómez de Liaño Lista, Alfonso, Ojeda González, Belén, Mileshkin, Linda, Mandai, Masaki, Boere, Ingrid, Ottevanger, Petronella, Nam, Joo-Hyun, Filho, Elia, Hamizi, Salima, Cognetti, Francesco, Warshal, David, Dickson-Michelson, Elizabeth, Kamelle, Scott, Mckenzie, Nathalie, Rodriguez, Gustavo, Armstrong, Deborah, Chalas, Eva, Celano, Paul, Behbakht, Kian, Davidson, Susan, Welch, Stephen, Helpman, Limor, Fishman, Ami, Bruchim, Ilan, Sikorska, Magdalena, Słowińska, Anna, Rogowski, Wojciech, Bidziński, Mariusz, Śpiewankiewicz, Beata, Casado Herraez, Antonio, Mendiola Fernández, César, Gropp-Meier, Martina, Saito, Toshiaki, Takehara, Kazuhiro, Enomoto, Takayuki, Watari, Hidemichi, Choi, Chel Hun, Kim, Byoung-Gie, Kim, Jae Weon, Hegg, Roberto, Vergote, Ignace, and Scambia, Giovanni (ORCID:0000-0003-2758-1063)
- Abstract
Background Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib. Methods This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status at baseline of 0â1 and histologically confirmed, relapsed, high-grade serous ovarian cancer or high-grade endometrioid cancer, including primary peritoneal or fallopian tube cancer. Patients were randomly assigned 2:1 to olaparib (300 mg in two 150 mg tablets, twice daily) or matching placebo tablets using an interactive voice and web response system. Randomisation was stratified by response to previous platinum chemotherapy (complete vs partial) and length of platinum-free interval (6â12 months vs â¥12 months) and treatment assignment was masked for patients, those giving the interventions, data collectors, and data analysers. The primary endpoint was investigator-assessed progression-free survival and we report the primary analysis from this ongoing study. The efficacy analyses were done on 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 NCT01874353, and is ongoing and no longer recruiting patients. Findings Between Sept 3, 2013, and Nov 21, 2014, we enrolled 295 eligible patients who were randomly assigned to receive olaparib (n=196) or placebo (n=99). One patient in the ola
- Published
- 2017