SGO速递文章

Randomized phase II CLIO study on olaparib monotherapy versus chemotherapy in platinum-sensitive recurrent ovarian cancer. 

奥拉帕利单药VS化疗治疗BRCA野生型铂敏感复发性卵巢癌的随机Ⅱ期CLIO研究

L. Loverixa, A. Vanderstichelea,

The CLIO trial (NCT02822157) evaluated Olaparib single-agent therapy versus standard-of-care chemotherapy in platinum-sensitive recurrent epithelial ovarian cancer

目的：在铂敏感复发性卵巢癌治疗中，CLIO研究评估奥拉帕利单药对比标准化疗方案的疗效。

Method: Eligible patients with measurable germline BRCA wildtype PSOC disease and ≥1 prior line of chemotherapy were randomized 2:1 to olaparib (OLA) monotherapy (300-mg tablets, BID) or physician’s choice chemotherapy (CT; carboplatin AUC 5 pegylated liposomal doxorubicin 30 mg/m2 q4w or carboplatin AUC 4 d1 gemcitabine 1,000 mg/m2 d1 d8 q3w). Response was evaluated according to RECIST v1.1. Prior bevacizumab was allowed. Disease control rate (DCR) was defined as response or stable disease at 12 weeks

方法：BRCA胚系野生型的铂敏感复发患者，至少经过一线及以上化疗（允许既往接受贝伐珠单抗治疗），随机2：1入组奥拉帕利单药治疗组（OLA），或由医生选择的化疗方案组（CT，可选化疗方案为：卡铂AUC 5 聚乙二醇脂质体阿霉素 30 mg/m2 q4w；或者卡铂AUC 4 d1，吉西他滨 1,000 mg/m2 d1 d8 q3w）。研究依照RECIST v1.1评估；疾病控制率（DCR）定义为第12周时的缓解及稳定比率。

Results: A total of 60 patients were randomized 2:1 to OLA (n = 40) or CT (n = 20). Baseline characteristics, summarized in Table 1, were not significantly different between both arms. Objective response rate (ORR) was 40% (14/40) for OLA and 60% (12/20) for CT (P = 0.12). DCR was 80% (32/40) for OLA and 85% (17/20) for CT. Progression-free survival (PFS) was similar in both arms (median PFS 6.4 vs 8.5 months for OLA and CT, respectively, HR = 1.11, 95% CI 0.60–2.04, P = 0.7) as well as for overall survival (OS; median OS 23.9 vs 27.7, respectively, HR = 1.01, 95% CI 0.40–2.51). Adverse events in the OLA and CT arms did not reveal any unexpected events. Somatic BRCA testing is ongoing and will be presented at the meeting.

Conclusions: PFS and OS were similar between olaparib monotherapy and chemotherapy in recurrent germline BRCA wildtype platinum-sensitive epithelial ovarian cancer.

结果：共60位患者随机2:1入组OLA（n=40）及CT（n=40）。两组基线特征无显著差异（如表1）。客观缓解率（ORR）：OLA组40% vs CT组60%, (P = 0.12)；DCR：OLA组80% vs CT组85%；PFS：OLA组6.4m vs CT组8.5m (HR = 1.11, 95% CI 0.60–2.04, P = 0.7)；OS：OLA组23.9m vs CT组27.7m (HR = 1.01, 95% CI 0.40–2.51)。两组不良反应事件与既往研究相似，BRCA体系检测在进行中，将于稍后会议公布。

结论：对于BRCA胚系野生型的铂敏感复发患者的治疗，奥拉帕利单药组与医生选择的标准化疗组的PFS和OS均无统计学差异，两组疗效相似。