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Background <p>Olaparib is widely used as maintenance therapy in advanced ovarian cancer following response to platinum-based chemotherapy, but the magnitude of benefit across molecular subgroups and its safety profile remain uncertain. This updated meta-analysis evaluated the efficacy and safety of olaparib maintenance therapy across biomarker-defined subgroups and treatment settings.</p> Methods <p>PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials. Two reviewers independently screened studies evaluating olaparib as maintenance therapy in patients with advanced ovarian cancer who achieved a response to platinum-based chemotherapy in either first-line or recurrent disease settings.</p> Results <p>Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included time to first subsequent therapy (TFST), time to second subsequent therapy (TSST), and adverse events (AEs). Hazard ratios (HRs) and risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model. Eight randomized trials were included. Olaparib significantly improved PFS compared with control (HR 0.48; 95% CI 0.37–0.62; <i>p</i> &lt; 0.01). The benefit was greater in BRCA-mutated patients (HR 0.33; 95% CI 0.22–0.52) than in BRCA wild-type patients (HR 0.62; 95% CI 0.47–0.82; <i>p</i> for interaction = 0.001). The largest benefit was observed in HRD-positive tumors (HR 0.44; 95% CI 0.35–0.54), whereas evidence of benefit in HRD-negative patients remained limited. OS showed a trend toward improvement overall (HR 0.82; 95% CI 0.66–1.02; <i>p</i> = 0.07) and was significantly improved among BRCA-mutated patients (HR 0.66; 95% CI 0.56–0.78). Olaparib also prolonged TFST and TSST but was associated with a higher risk of grade ≥ 3 AEs, without a statistically significant increase in hematologic adverse events.</p> Conclusion <p>Olaparib maintenance therapy significantly delays disease progression in advanced ovarian cancer, with the greatest benefit observed in BRCA-mutated and HRD-positive tumors. These findings support the role of olaparib maintenance therapy in biomarker-selected patients across first-line and recurrent treatment settings, while highlighting ongoing uncertainties in specific biomarker-defined subgroups.</p>

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Olaparib maintenance versus placebo or standard of care in ovarian cancer: a biomarker-driven systematic review and meta-analysis of randomized trials

  • 期刊论文

  • 发表日期：

    2026年8月4日

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  • Farida Namozova,
  • Isadora Mamede,
  • Carolina Alves Felippe,
  • Ellen Rodrigues,
  • Carlos Stecca

摘要

Background

Olaparib is widely used as maintenance therapy in advanced ovarian cancer following response to platinum-based chemotherapy, but the magnitude of benefit across molecular subgroups and its safety profile remain uncertain. This updated meta-analysis evaluated the efficacy and safety of olaparib maintenance therapy across biomarker-defined subgroups and treatment settings.

Methods

PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials. Two reviewers independently screened studies evaluating olaparib as maintenance therapy in patients with advanced ovarian cancer who achieved a response to platinum-based chemotherapy in either first-line or recurrent disease settings.

Results

Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included time to first subsequent therapy (TFST), time to second subsequent therapy (TSST), and adverse events (AEs). Hazard ratios (HRs) and risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model. Eight randomized trials were included. Olaparib significantly improved PFS compared with control (HR 0.48; 95% CI 0.37–0.62; p < 0.01). The benefit was greater in BRCA-mutated patients (HR 0.33; 95% CI 0.22–0.52) than in BRCA wild-type patients (HR 0.62; 95% CI 0.47–0.82; p for interaction = 0.001). The largest benefit was observed in HRD-positive tumors (HR 0.44; 95% CI 0.35–0.54), whereas evidence of benefit in HRD-negative patients remained limited. OS showed a trend toward improvement overall (HR 0.82; 95% CI 0.66–1.02; p = 0.07) and was significantly improved among BRCA-mutated patients (HR 0.66; 95% CI 0.56–0.78). Olaparib also prolonged TFST and TSST but was associated with a higher risk of grade ≥ 3 AEs, without a statistically significant increase in hematologic adverse events.

Conclusion

Olaparib maintenance therapy significantly delays disease progression in advanced ovarian cancer, with the greatest benefit observed in BRCA-mutated and HRD-positive tumors. These findings support the role of olaparib maintenance therapy in biomarker-selected patients across first-line and recurrent treatment settings, while highlighting ongoing uncertainties in specific biomarker-defined subgroups.