Efficacy and safety of olaparib according to age in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer: Analysis of the phase III SOLO2/ENGOT-Ov21 study
Penson, R. T.
Sonke, G. S.
Lowe, E. S.
Lee, C. K.
AffiliationDepartment of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany. Electronic address: Fabian.Trillsch@med.uni-muenchen.de. Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany. Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany; Ev. Kliniken Essen Mitte, Essen, Germany. University of Sydney, Camperdown, Sydney, Australia. Institut Curie, Hôpital René Huguenin, Saint Cloud and GINECO, France. The Christie NHS Foundation Trust, Manchester, UK. Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. Princess Margaret Cancer Centre, Toronto, Canada. Rambam Health Care Campus, affiliated with Rappaport Faculty of Medicine, Technion, Haifa, Israel. Pomeranian Medical University, Szczecin, Poland. Hospital Clínico San Carlos, Instituto de Investigación Sanitaria (IdISSC) and CIBERONC, Madrid, Spain. Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica, Rome, Italy. University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, Australia. University of Milan-Bicocca and IEO, European Institute of Oncology IRCCS, Milan, Italy. Saitama Medical University International Medical Center, Saitama and Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Japan. The Netherlands Cancer Institute, Amsterdam, the Netherlands. Ghent University Hospital, Ghent, Belgium. AstraZeneca, Gaithersburg, MD, USA. ARCAGY-GINECO Université Paris Descartes, AP-HP, Paris, France.
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AbstractBackground Olaparib has significantly improved outcome and patient-centered endpoints in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer (PSOC). Specific information on efficacy and safety of olaparib for older patients appears of special interest. Methods 295 patients from the SOLO2 trial randomly assigned to olaparib or placebo were categorized according to age-cutoff at 65 years. Efficacy, tolerability, and quality of life (QoL) of olaparib relative to placebo within in each age group was analyzed. Results Baseline characteristics were similar in patients ≥65 years (N = 62;21.0%) compared to patients <65 years (N = 233;78.9%). No significant difference in the magnitude of progression-free survival (PFS) benefit from olaparib for older patients (N = 40, hazard ratio [HR]≥65 0.43, 95%-confidence interval [CI] 0.24–0.81) as compared with younger patients (N = 155, HR<65 0.31 (95%-CI 0.22–0.43) was seen (interaction P = 0.33). The overall survival (OS)benefit seen in younger patients in the olaparib arm was not observed in older patients. Older and younger patients had comparable safety profiles and QoL scores although higher discontinuation rates for toxicity, and higher frequency of AML/MDS were noted in the older subset. TWiST analysis revealed clinically meaningful duration of good QoL on olaparib for both age groups (≥65: 13.5 vs <65: 18.4 months, P = 0.05). Conclusions Results of this large phase III cohort of BRCA1/2-mutated PSOC patients treated with olaparib underline impressive efficacy of olaparib maintenance irrespective of age. Although toxicity and tolerability did not raise significant concerns, some caution, close monitoring, and follow-up needs to be exercised for older patients given higher discontinuation rates, frequency of AML/MDS, and no clear effects on OS.
CitationTrillsch F, Mahner S, Ataseven B, Asher R, Aryal N, Dubot C, et al. Efficacy and safety of olaparib according to age in BRCA1/2-mutated patients with recurrent platinum-sensitive ovarian cancer: Analysis of the phase III SOLO2/ENGOT-Ov21 study. Gynecologic Oncology. Elsevier BV; 2022.
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