Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial
Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial
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DOI：
10.1200/jco.20.00799
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发表时间：
2020-10-20
影响因子：
45.3
通讯作者：
Moore, Kathleen N.
中科院分区：
文献类型：
--
作者：
DiSilvestro, Paul;Colombo, Nicoletta;Moore, Kathleen N.
目的：在SOLO1中，与安慰剂相比，维持性奥拉帕尼（300 mg，每日2次）显著提高了新诊断的BRCA1和/或brca2突变的晚期卵巢癌患者的无进展生存期（PFS）（风险比[HR]， 0.30; 95% CI， 0.23至0.41；中位数未达到v 13.8个月）。我们根据预先选择的基线因素调查了SOLO1患者亚组的PFS。患者和方法研究人员评估的SOLO1的PFS亚组分析包括铂类化疗后的临床反应（完全[CR]或部分缓解[PR]）、手术类型（术前或间歇手术）、手术后疾病状态（残留或无明显残留疾病）和BRCA突变状态（BRCA1或BRCA2）。此外，我们评估了III期疾病患者的PFS，这些患者接受了前期手术，没有明显的残留疾病。我们还报告客观反应率。结果：与安慰剂相比，接受前期或间歇手术的患者，奥拉帕尼的疾病进展或死亡风险分别降低了69% （HR, 0.31; 95% CI， 0.21至0.46）和63% (HR, 0.37, 95% CI， 0.24至0.58)；术后残留或无残留病变的患者分别为56% （HR, 0.44, 95% CI, 0.25 ~ 0.77）和67% (HR, 0.33, 95% CI, 0.23 ~ 0.46)；66% （HR, 0.34; 95% CI, 0.24 - 0.47）和69% (HR, 0.31; 95% CI, 0.18 - 0.52)；BRCA1或BRCA2突变患者分别为59% （HR, 0.41; 95% CI， 0.30至0.56）和80% （HR 0.20, 95% CI， 0.10至0.37）。结论：不论基线手术结果、化疗反应或BRCA突变类型如何，新诊断的晚期卵巢癌患者从维持奥拉帕尼治疗中获益显著。
PURPOSEIn SOLO1, maintenance olaparib (300 mg twice daily) significantly improved progression-free survival (PFS) for patients with newly diagnosed BRCA1- and/or BRCA2-mutated advanced ovarian cancer compared with placebo (hazard ratio [HR], 0.30; 95% CI, 0.23 to 0.41; median not reached v 13.8 months). We investigated PFS in SOLO1 for subgroups of patients based on preselected baseline factors.PATIENTS AND METHODSInvestigator-assessed PFS subgroup analyses of SOLO1 included clinical response after platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery), disease status after surgery (residual or no gross residual disease), and BRCA mutation status (BRCA1 or BRCA2). Additionally, we evaluated PFS in patients with stage III disease who underwent upfront surgery and had no gross residual disease. We also report objective response rate.RESULTSThe risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1 or BRCA2 mutation, respectively.CONCLUSIONPatients with newly diagnosed advanced ovarian cancer achieve substantial benefit from maintenance olaparib treatment regardless of baseline surgery outcome, response to chemotherapy, or BRCA mutation type.