医学
拓扑替康
卡铂
奥拉帕尼
吉西他滨
卵巢癌
内科学
化疗
紫杉醇
肿瘤科
阿霉素
随机对照试验
危险系数
胃肠病学
妇科
癌症
泌尿科
顺铂
置信区间
化学
聚ADP核糖聚合酶
基因
聚合酶
生物化学
作者
Adriaan Vanderstichele,Liselore Loverix,Pieter Busschaert,Els Van Nieuwenhuysen,Sileny Han,Nicole Concin,Tiene Callewaert,Siel Olbrecht,Rawand Salihi,Patrick Berteloot,P. Neven,Diether Lambrechts,Toon Van Gorp,Ignace Vergote
标识
DOI:10.1016/j.ygyno.2022.01.034
摘要
Objective Comparison of olaparib (OLA) monotherapy versus chemotherapy in patients with platinum-sensitive (PSOC) or platinum-resistant ovarian cancer (PROC). Methods Patients with measurable disease and ≥ 1 prior line of chemotherapy (CT) were randomized 2:1 to OLA (300 mg tablets, BID) or physician's choice CT.: for PSOC: Carboplatin-Pegylated-Liposomal-Doxorubicin (PLD) or Carboplatin-Gemcitabine; for PROC: PLD, Topotecan, Paclitaxel or Gemcitabine. Results 160 patients (60 with PSOC and 100 with PROC) were randomized 2:1 to OLA (n = 107) or CT (n = 53). Baseline characteristics were similar between both arms. Overall objective response rate (ORR) for OLA and CT were similar (24.3% (26/107) and 28.3% (15/53), respectively). Clinical benefit rate (≥ 12 weeks) was similar with 54.2% (58/107) and 56.6% (30/53), respectively. In PSOC, ORR was 35.0% (14/40) and 65.0% (13/20) for OLA and CT (p = 0.053); in PROC, ORR was 17.9% (12/67) and 6.1% (2/33) for OLA and CT (p = 0.134). ORR in heavily pretreated PROC (>4 prior lines) was 22.9% (8/35) with OLA versus 0% (0/14) for CT. ORR of 35.7% (5/14) and 13.2% (7/53) was observed in BRCA-mutated and -wildtype PROC cases, respectively. Median PFS in PROC was not significantly different with 2.9 months (95% CI 2.8–5.1 in the OLA group versus 3.8 months (95% CI 3.0–6.4) in the CT group (hazard ratio [HR] 1.11 [95% CI 0.72–1.78]; log-rank p = 0.600). Conclusion OLA monotherapy showed overall an equal response rate in relapsed ovarian cancer compared with CT. In PROC, ORR and TFST tended to be higher with OLA than with CT. In heavily pretreated patients (four lines or more) with PROC disease, OLA treatment seemed to be more effective than CT.
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