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1. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Korach, Jacob, Huzarski, Tomasz, Byrski, Tomasz, Pautier, Patricia, Friedlander, Michael, Harter, Philipp, Colombo, Nicoletta, Pignata, Sandro, Scambia, Giovanni, Nicoletto, Maria, Nussey, Fiona, Clamp, Andrew, Penson, Richard, Oza, Amit, Poveda Velasco, Andrés, Rodrigues, Manuel, Lotz, Jean-Pierre, Selle, Frédéric, Ray-Coquard, Isabelle, Provencher, Diane, Prat Aparicio, Aleix, Vidal Boixader, Laura, Scott, Clare, Tamura, Kenji, Yunokawa, Mayu, Lisyanskaya, Alla, Medioni, Jacques, Pécuchet, Nicolas, Dubot, Coraline, De La Motte Rouge, Thibault, Kaminsky, Marie-Christine, Weber, Béatrice, Lortholary, Alain, Parkinson, Christine, Ledermann, Jonathan, Williams, Sarah, Banerjee, Susana, Cosin, Jonathan, Hoffman, James, Plante, Marie, Covens, Allan, Sonke, Gabe, Joly, Florence, Floquet, Anne, Hirte, Holger, Amit, Amnon, Park-Simon, Tjoung-Won, Matsumoto, Koji, Tjulandin, Sergei, Hoon Kim, Jae, 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, Elias, 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, Weon Kim, Jae, Hegg, Roberto, Vergote, Ignace, Poveda, Andrés, Ledermann, Jonathan A, Asher, Rebecca, Penson, Richard T, Oza, Amit M, Baldoni, Alessandra, Sonke, Gabe S, Kim, Jae-Hoon, Filho, Elias Abdo, Milenkova, Tsveta, Lowe, Elizabeth S, Rowe, Phil, and Pujade-Lauraine, Eric

Published
2021
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2. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial

Author

Friedlander, Michael, Gebski, Val, Gibbs, Emma, Davies, Lucy, Bloomfield, Ralph, Hilpert, Felix, Wenzel, Lari B, Eek, Daniel, Rodrigues, Manuel, Clamp, Andrew, Penson, Richard T, Provencher, Diane, Korach, Jacob, Huzarski, Tomasz, Vidal, Laura, Salutari, Vanda, Scott, Clare, Nicoletto, Maria Ornella, Tamura, Kenji, Espinoza, David, Joly, Florence, and Pujade-Lauraine, Eric

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Research, Clinical Trials and Supportive Activities, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Development of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Good Health and Well Being, Adult, Aged, Antineoplastic Agents, BRCA1 Protein, BRCA2 Protein, Carcinoma, Ovarian Epithelial, Female, Humans, Maintenance Chemotherapy, Middle Aged, Mutation, Neoplasm Recurrence, Local, Phthalazines, Piperazines, Progression-Free Survival, Quality of Life, Surveys and Questionnaires, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundIn the phase 3 SOLO2 trial (ENGOT Ov-21), maintenance therapy with olaparib tablets significantly prolonged progression-free survival (primary endpoint) compared with placebo in patients with a germline BRCA1 or BRCA2 (BRCA1/2) mutation and platinum-sensitive, relapsed ovarian cancer who had received two or more lines of previous chemotherapy. The most common subjective adverse effects included fatigue, nausea, and vomiting, which were typically low grade and self-limiting. Our a-priori hypothesis was that maintenance olaparib would not negatively affect health-related quality of life (HRQOL) and additionally that the prolongation of progression-free survival with olaparib would be underpinned by additional patient-centred benefits.MethodsIn SOLO2, 196 patients were randomly assigned to olaparib tablets (300 mg twice daily) and 99 to placebo. Randomisation was stratified by response to previous chemotherapy (complete vs partial) and length of platinum-free interval (>6-12 vs >12 months). The prespecified primary HRQOL analysis evaluated the change from baseline in the Trial Outcome Index (TOI) score during the first 12 months of the study. To be assessable, patients had to have an evaluable score at baseline and at least one evaluable follow-up form. Secondary planned quality-of-life (QOL) analyses included the duration of good quality of life (defined as time without significant symptoms of toxicity [TWiST] and quality-adjusted progression-free survival [QAPFS]). Efficacy and QOL outcomes were analysed in all randomly assigned patients (the full analysis set), and safety outcomes were analysed in all randomly assigned patients who received at least one dose of study drug. This ongoing study is registered with ClinicalTrials.gov, number NCT01874353, and is closed to new participants.FindingsThe adjusted average mean change from baseline over the first 12 months in TOI was -2·90 (95% CI -4·13 to -1·67) with olaparib and -2·87 (-4·64 to -1·10) with placebo (estimated difference -0·03; 95% CI -2·19 to 2·13; p=0·98). Mean QAPFS (13·96 [SD 10·96] vs 7·28 [5·22] months; difference 6·68, 95% CI 4·98-8·54) and mean duration of TWiST (15·03 [SD 12·79] vs 7·70 [6·42] months; difference 7·33, 95% CI 4·70-8·96) were significantly longer with olaparib than with placebo.InterpretationOlaparib maintenance therapy did not have a significant detrimental effect on HRQOL compared with placebo. There were clinically meaningful patient-centred benefits in both TWiST and QAPFS despite the adverse effects associated with olaparib. These patient-centred endpoints support the improvement in progression-free survival, the primary endpoint in SOLO2, and should be included in future trials of maintenance therapies.FundingAstraZeneca.

Published
2018

3. Berzosertib plus gemcitabine versus gemcitabine alone in platinum-resistant high-grade serous ovarian cancer: a multicentre, open-label, randomised, phase 2 trial

Author

Konstantinopoulos, Panagiotis A, Cheng, Su-Chun, Wahner Hendrickson, Andrea E, Penson, Richard T, Schumer, Susan T, Doyle, L Austin, Lee, Elizabeth K, Kohn, Elise C, Duska, Linda R, Crispens, Marta A, Olawaiye, Alexander B, Winer, Ira S, Barroilhet, Lisa M, Fu, Siqing, McHale, Michael T, Schilder, Russell J, Färkkilä, Anniina, Chowdhury, Dipanjan, Curtis, Jennifer, Quinn, Roxanne S, Bowes, Brittany, D'Andrea, Alan D, Shapiro, Geoffrey I, and Matulonis, Ursula A

Published
2020
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5. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Poveda, Andrés, primary, Floquet, Anne, additional, Ledermann, Jonathan A, additional, Asher, Rebecca, additional, Penson, Richard T, additional, Oza, Amit M, additional, Korach, Jacob, additional, Huzarski, Tomasz, additional, Pignata, Sandro, additional, Friedlander, Michael, additional, Baldoni, Alessandra, additional, Park-Simon, Tjoung-Won, additional, Tamura, Kenji, additional, Sonke, Gabe S, additional, Lisyanskaya, Alla, additional, Kim, Jae-Hoon, additional, Filho, Elias Abdo, additional, Milenkova, Tsveta, additional, Lowe, Elizabeth S, additional, Rowe, Phil, additional, Vergote, Ignace, additional, Pujade-Lauraine, Eric, additional, Byrski, Tomasz, additional, Pautier, Patricia, additional, Harter, Philipp, additional, Colombo, Nicoletta, additional, Scambia, Giovanni, additional, Nicoletto, Maria, additional, Nussey, Fiona, additional, Clamp, Andrew, additional, Penson, Richard, additional, Oza, Amit, additional, Poveda Velasco, Andrés, additional, Rodrigues, Manuel, additional, Lotz, Jean-Pierre, additional, Selle, Frédéric, additional, Ray-Coquard, Isabelle, additional, Provencher, Diane, additional, Prat Aparicio, Aleix, additional, Vidal Boixader, Laura, additional, Scott, Clare, additional, Yunokawa, Mayu, additional, Medioni, Jacques, additional, Pécuchet, Nicolas, additional, Dubot, Coraline, additional, De La Motte Rouge, Thibault, additional, Kaminsky, Marie-Christine, additional, Weber, Béatrice, additional, Lortholary, Alain, additional, Parkinson, Christine, additional, Ledermann, Jonathan, additional, Williams, Sarah, additional, Banerjee, Susana, additional, Cosin, Jonathan, additional, Hoffman, James, additional, Plante, Marie, additional, Covens, Allan, additional, Sonke, Gabe, additional, Joly, Florence, additional, Hirte, Holger, additional, Amit, Amnon, additional, Matsumoto, Koji, additional, Tjulandin, Sergei, additional, Hoon Kim, Jae, additional, Gladieff, Laurence, additional, Sabbatini, Roberto, additional, O'Malley, David, additional, Timmins, Patrick, additional, Kredentser, Daniel, additional, Laínez Milagro, Nuria, additional, Barretina Ginesta, Maria Pilar, additional, Tibau Martorell, Ariadna, additional, Gómez De Liaño Lista, Alfonso, additional, Ojeda González, Belén, additional, Mileshkin, Linda, additional, Mandai, Masaki, additional, Boere, Ingrid, additional, Ottevanger, Petronella, additional, Nam, Joo-Hyun, additional, Filho, Elias, additional, Hamizi, Salima, additional, Cognetti, Francesco, additional, Warshal, David, additional, Dickson-Michelson, Elizabeth, additional, Kamelle, Scott, additional, McKenzie, Nathalie, additional, Rodriguez, Gustavo, additional, Armstrong, Deborah, additional, Chalas, Eva, additional, Celano, Paul, additional, Behbakht, Kian, additional, Davidson, Susan, additional, Welch, Stephen, additional, Helpman, Limor, additional, Fishman, Ami, additional, Bruchim, Ilan, additional, Sikorska, Magdalena, additional, Słowińska, Anna, additional, Rogowski, Wojciech, additional, Bidziński, Mariusz, additional, Śpiewankiewicz, Beata, additional, Casado Herraez, Antonio, additional, Mendiola Fernández, César, additional, Gropp-Meier, Martina, additional, Saito, Toshiaki, additional, Takehara, Kazuhiro, additional, Enomoto, Takayuki, additional, Watari, Hidemichi, additional, Choi, Chel Hun, additional, Kim, Byoung-Gie, additional, Weon Kim, Jae, additional, and Hegg, Roberto, additional

Published
2021
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7. 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

Pujade-Lauraine, Eric, primary, Ledermann, Jonathan A, additional, Selle, Frédéric, additional, Gebski, Val, additional, Penson, Richard T, additional, Oza, Amit M, additional, Korach, Jacob, additional, Huzarski, Tomasz, additional, Poveda, Andrés, additional, Pignata, Sandro, additional, Friedlander, Michael, additional, Colombo, Nicoletta, additional, Harter, Philipp, additional, Fujiwara, Keiichi, additional, Ray-Coquard, Isabelle, additional, Banerjee, Susana, additional, Liu, Joyce, additional, Lowe, Elizabeth S, additional, Bloomfield, Ralph, additional, Pautier, Patricia, additional, Byrski, Tomasz, additional, Scambia, Giovanni, additional, Nicoletto, Maria, additional, Nussey, Fiona, additional, Clamp, Andrew, additional, Penson, Richard, additional, Oza, Amit, additional, Poveda Velasco, Andrés, additional, Rodrigues, Manuel, additional, Lotz, Jean-Pierre, additional, Provencher, Diane, additional, Prat Aparicio, Aleix, additional, Vidal Boixader, Laura, additional, Scott, Clare, additional, Tamura, Kenji, additional, Yunokawa, Mayu, additional, Lisyanskaya, Alla, additional, Medioni, Jacques, additional, Pécuchet, Nicolas, additional, Dubot, Coraline, additional, de la Motte Rouge, Thibault, additional, Kaminsky, Marie-Christine, additional, Weber, Béatrice, additional, Lortholary, Alain, additional, Parkinson, Christine, additional, Ledermann, Jonathan, additional, Williams, Sarah, additional, Cosin, Jonathan, additional, Hoffman, James, additional, Plante, Marie, additional, Covens, Allan, additional, Sonke, Gabe, additional, Joly, Florence, additional, Floquet, Anne, additional, Hirte, Holger, additional, Amit, Amnon, additional, Park-Simon, Tjoung-Won, additional, Matsumoto, Koji, additional, Tjulandin, Sergei, additional, Kim, Jae Hoon, additional, Gladieff, Laurence, additional, Sabbatini, Roberto, additional, O'Malley, David, additional, Timmins, Patrick, additional, Kredentser, Daniel, additional, Laínez Milagro, Nuria, additional, Barretina Ginesta, Maria Pilar, additional, Tibau Martorell, Ariadna, additional, Gómez de Liaño Lista, Alfonso, additional, Ojeda González, Belén, additional, Mileshkin, Linda, additional, Mandai, Masaki, additional, Boere, Ingrid, additional, Ottevanger, Petronella, additional, Nam, Joo-Hyun, additional, Filho, Elias, additional, Hamizi, Salima, additional, Cognetti, Francesco, additional, Warshal, David, additional, Dickson-Michelson, Elizabeth, additional, Kamelle, Scott, additional, McKenzie, Nathalie, additional, Rodriguez, Gustavo, additional, Armstrong, Deborah, additional, Chalas, Eva, additional, Celano, Paul, additional, Behbakht, Kian, additional, Davidson, Susan, additional, Welch, Stephen, additional, Helpman, Limor, additional, Fishman, Ami, additional, Bruchim, Ilan, additional, Sikorska, Magdalena, additional, Słowińska, Anna, additional, Rogowski, Wojciech, additional, Bidziński, Mariusz, additional, Śpiewankiewicz, Beata, additional, Casado Herraez, Antonio, additional, Mendiola Fernández, César, additional, Gropp-Meier, Martina, additional, Saito, Toshiaki, additional, Takehara, Kazuhiro, additional, Enomoto, Takayuki, additional, Watari, Hidemichi, additional, Choi, Chel Hun, additional, Kim, Byoung-Gie, additional, Kim, Jae Weon, additional, Hegg, Roberto, additional, and Vergote, Ignace, additional

Published
2017
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