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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02981-0

摘要内容如下：

铂敏感的复发性卵巢癌（PSROC）的手术被广泛应用，但在以前的研究中有矛盾的生存结果。在这项多中心、开放标签的3期试验中，患有PSROC且既往接受过一次治疗且未接受过6个月或更长时间的以铂为基础的化疗（无铂间期）的妇女被随机分配到手术组（182名患者）或非手术组（对照组）（175名患者）。根据国际模型（iModel），结合正电子发射断层扫描-计算机断层扫描成像，可切除疾病的患者符合条件。在分层检验中，总生存期（OS）和无进展生存期是共同的主要终点，并且先前报道了手术治疗的无进展生存期显著延长。计划在数据成熟度达到59%时对操作系统进行最终分析。在2012年7月19日至2019年6月3日期间，共招募了357名患者。中位随访时间82.5个月。手术组中位OS为58.1个月，对照组中位OS为52.1个月（风险比（HR）0.80，95%可信区间（CI）0.61-1.05，P=0.11）。未达到统计学显著性的预定阈值，但进行了预先指定的敏感性分析。总体而言，175例对照组患者中有61例（35%）在随后的复发后接受了手术治疗，与对照组相比，手术组死亡的校正HR为0.76，95%CI为0.58-0.99。在通过影像学对复发部位进行的亚组分析中，手术组的中位生存期无法估计，而对照组<20个部位的患者的中位生存期为69.5个月（HR 0.69，95%CI 0.46-1.03）。完全切除的患者预后最好，中位OS为73.0个月。手术组182例患者中有24例（13.2%）无复发且存活>60个月，而对照组175例患者中有5例（2.9%）无复发且存活>60个月。在PSROC患者中，手术没有增加意向治疗人群的OS，但在交叉调整后延长了生存期。ClinicalTrials.gov注册：NCT01611766。

英文原文如下：

Abstracts

Surgery for platinum-sensitive, relapsed ovarian cancer (PSROC) is widely practiced but had contradictory survival outcomes in previous studies. In this multicenter, open-label, phase 3 trial, women with PSROC, and having had one previous therapy and no platinum-based chemotherapy (platinum-free interval) of 6 months or more, were randomly assigned to either the surgery group (182 patients) or the no-surgery group (control) (175 patients). Patients with resectable diseases were eligible according to the international model (iMODEL), combined with a positron emission tomography-computed tomography imaging. Overall survival (OS) and progression-free survival were coprimary endpoints in hierarchical testing, and a significantly longer progression-free survival with surgery was previously reported. Final analysis of OS was planned at data maturity of 59%. Between 19 July 2012 and 3 June 2019, 357 patients were enrolled. Median follow-up was 82.5 months. Median OS was 58.1 months with surgery and 52.1 months for control (hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.61-1.05, P = 0.11). The predefined threshold for statistical significance was not met, but prespecified sensitivity analysis was performed. Overall, 61 of 175 (35%) patients in control had crossed over to surgery following subsequent relapse, and adjusted HR for death in the surgery group compared with control was 0.76, 95% CI 0.58-0.99. In subgroup analysis of relapse sites by imaging, median survival was not estimable in the surgery group and was 69.5 months in control in patients with <20 sites (HR 0.69, 95% CI 0.46-1.03). Patients with a complete resection had the most favorable outcome, with a median OS of 73.0 months. Twenty-four of 182 (13.2%) patients remained relapse free and alive >60 months in the surgery group as compared with five of 175 (2.9%) patients in the control group. In patients with PSROC, surgery did not increase OS in the intention-to-treat population but resulted in a prolongation of survival following adjustment of crossover.ClinicalTrials.gov registration: NCT01611766 .

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