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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
  • 211
    Citations
  • 0
    Usage
  • 221
    Captures
  • 15
    Mentions
  • 17
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    211
  • Captures
    221
  • Mentions
    15
    • News Mentions
      15
      • News
        15
  • Social Media
    17
    • Shares, Likes & Comments
      17
      • Facebook
        17

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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

DiSilvestro, Paul; Banerjee, Susana; Colombo, Nicoletta; Scambia, Giovanni; Kim, Byoung-Gie; Oaknin, Ana; Friedlander, Michael; Lisyanskaya, Alla; Floquet, Anne; Leary, Alexandra; Sonke, Gabe S; Gourley, Charlie; Oza, Amit; González-Martín, Antonio; Aghajanian, Carol; Bradley, William; Mathews, Cara; Liu, Joyce; McNamara, John; Lowe, Elizabeth S; Ah-See, Mei-Lin; Moore, Kathleen N; SOLO1 Investigators

American Society of Clinical Oncology (ASCO)

Medicine; Biochemistry, Genetics and Molecular Biology

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