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Background <p>The open-label, single-arm, multicentre ORZORA trial (NCT02476968) evaluated maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) with a germline (g) or somatic (s) <i>BRCA1</i> and/or <i>BRCA2</i> mutation (BRCAm) or a non-BRCA homologous recombination repair mutation (non-BRCA HRRm).</p> Methods <p>Patients were in response to platinum-based chemotherapy after ≥2 prior lines of treatment and underwent prospective central screening for tumour BRCA status, then central gBRCAm testing to determine sBRCAm or gBRCAm status. An exploratory cohort evaluated non-BRCA HRRm in 13 predefined genes. Patients received olaparib 400 mg (capsules) twice daily until investigator-assessed disease progression. Secondary endpoints included overall survival (OS) and safety.</p> Results <p>177 patients received olaparib. At the final data cutoff (25 June 2021), median OS from study enrolment was 46.8 (95% confidence interval [CI] 37.9–54.4), 43.2 (31.7–NC [not calculated]), 47.4 (37.9–NC) and 44.9 (28.9–NC) months in the BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts, respectively. No new safety signals were identified.</p> Conclusion <p>Maintenance olaparib showed consistent clinical activity in the BRCAm and sBRCAm cohorts; exploratory analysis suggested similar activity in the non-BRCA HRRm cohort. These findings highlight that patients with PSR OC, beyond those with gBRCAm, may benefit from maintenance olaparib.</p>

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Overall survival with maintenance olaparib in platinum-sensitive relapsed ovarian cancer by somatic or germline BRCA and homologous recombination repair mutation status

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月17日

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  • Sandro Pignata,
  • Amit Oza,
  • Geoff Hall,
  • Beatriz Pardo,
  • Radoslaw Madry,
  • David Cibula,
  • Jaroslav Klat,
  • Ana Montes,
  • Rosalind Glasspool,
  • Nicoletta Colombo,
  • Imre Pete,
  • Ana Herrero Ibáñez,
  • Margarita Romeo,
  • Rumyana Ilieva,
  • Constanta Timcheva,
  • Massimo Di Maio,
  • Zahid Bashir,
  • Rosie Taylor,
  • Alan Barnicle,
  • Andrew Clamp

摘要

Background

The open-label, single-arm, multicentre ORZORA trial (NCT02476968) evaluated maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) with a germline (g) or somatic (s) BRCA1 and/or BRCA2 mutation (BRCAm) or a non-BRCA homologous recombination repair mutation (non-BRCA HRRm).

Methods

Patients were in response to platinum-based chemotherapy after ≥2 prior lines of treatment and underwent prospective central screening for tumour BRCA status, then central gBRCAm testing to determine sBRCAm or gBRCAm status. An exploratory cohort evaluated non-BRCA HRRm in 13 predefined genes. Patients received olaparib 400 mg (capsules) twice daily until investigator-assessed disease progression. Secondary endpoints included overall survival (OS) and safety.

Results

177 patients received olaparib. At the final data cutoff (25 June 2021), median OS from study enrolment was 46.8 (95% confidence interval [CI] 37.9–54.4), 43.2 (31.7–NC [not calculated]), 47.4 (37.9–NC) and 44.9 (28.9–NC) months in the BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts, respectively. No new safety signals were identified.

Conclusion

Maintenance olaparib showed consistent clinical activity in the BRCAm and sBRCAm cohorts; exploratory analysis suggested similar activity in the non-BRCA HRRm cohort. These findings highlight that patients with PSR OC, beyond those with gBRCAm, may benefit from maintenance olaparib.