Overall Survival with Maintenance Olaparib at a 7-Year Follow-Up in Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial
Journal of Clinical Oncology, ISSN: 1527-7755, Vol: 41, Issue: 3, Page: 609-617
2023
- 211Citations
- 221Captures
- 15Mentions
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Metrics Details
- Citations211
- Citation Indexes208
- 208
- CrossRef12
- Policy Citations3
- Policy Citation3
- Captures221
- Readers221
- 220
- Mentions15
- News Mentions15
- News15
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Article Description
PURPOSEIn SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting.METHODSThis double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up.RESULTSThe median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P =.0004 [P <.0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups.CONCLUSIONResults indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.
Bibliographic Details
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85146484599&origin=inward; http://dx.doi.org/10.1200/jco.22.01549; https://clinicaltrials.gov/ct2/show/NCT01844986; http://www.ncbi.nlm.nih.gov/pubmed/36082969; https://ascopubs.org/doi/10.1200/JCO.22.01549; https://dx.doi.org/10.1200/jco.22.01549
American Society of Clinical Oncology (ASCO)
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