BACKGROUND Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).

中文翻译：

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复发性卵巢癌的二次手术细胞减灭术。

背景 对铂敏感、复发性上皮性卵巢癌、原发性腹膜癌或输卵管（“卵巢”）癌的女性进行二次手术细胞减灭术得到广泛应用，但尚未在 3 期研究中进行评估。方肉眼可见的残留病灶）进行二次手术细胞减灭术，然后接受铂类化疗或仅接受铂类化疗。辅助化疗（紫杉醇-卡铂或吉西他滨-卡铂）和贝伐珠单抗的使用由研究者决定。主要终点是总生存期。结果 共有 485 名患者接受了随机分组，其中 240 名接受了化疗前的二次细胞减灭术，245 名接受了单纯化疗。中位随访时间为 48.1 个月。67% 接受手术的手术患者实现了完全切除。总体上 84% 的患者接受了贝伐珠单抗铂类化疗，随后进行了贝伐珠单抗维持治疗，并且在两组之间平均分配。死亡风险比（手术与非手术）为 1.29（95% 置信区间 [CI]，0.97 至 1.72；P = 0.08），这分别对应于 50.6 个月和 64.7 个月的中位总生存期。对无铂间期和化疗选择的调整并未改变效果。疾病进展或死亡（手术与不手术）的风险比为 0.82（95% CI，0.66 至 1.01；中位无进展生存期，分别为 18.9 个月和 16.2 个月）。30 天的手术并发症发生率为 9%；1 例患者 (0.4%) 死于术后并发症。患者报告的生活质量在手术后显着下降，但在康复后两组之间没有显着差异。结论 在这项涉及铂类敏感的复发性卵巢癌患者的试验中，二次手术细胞减灭术继以化疗并没有比单纯化疗延长总生存期。（由国家癌症研究所和其他机构资助；GOG-0213 ClinicalTrials.gov 编号，NCT00565851。）分别为 9 个月和 16.2 个月）。30 天的手术并发症发生率为 9%；1 例患者 (0.4%) 死于术后并发症。患者报告的生活质量在手术后显着下降，但在康复后两组之间没有显着差异。结论 在这项涉及铂类敏感的复发性卵巢癌患者的试验中，二次手术细胞减灭术继以化疗并没有比单纯化疗延长总生存期。（由国家癌症研究所和其他机构资助；GOG-0213 ClinicalTrials.gov 编号，NCT00565851。）分别为 9 个月和 16.2 个月）。30 天的手术并发症发生率为 9%；1 例患者 (0.4%) 死于术后并发症。患者报告的生活质量在手术后显着下降，但在康复后两组之间没有显着差异。结论 在这项涉及铂类敏感的复发性卵巢癌患者的试验中，二次手术细胞减灭术继以化疗并没有比单纯化疗延长总生存期。（由国家癌症研究所和其他机构资助；GOG-0213 ClinicalTrials.gov 编号，NCT00565851。）患者报告的生活质量在手术后显着下降，但在康复后两组之间没有显着差异。结论 在这项涉及铂类敏感的复发性卵巢癌患者的试验中，二次手术细胞减灭术继以化疗并没有比单纯化疗延长总生存期。（由国家癌症研究所和其他机构资助；GOG-0213 ClinicalTrials.gov 编号，NCT00565851。）患者报告的生活质量在手术后显着下降，但在康复后两组之间没有显着差异。结论 在这项涉及铂类敏感的复发性卵巢癌患者的试验中，二次手术细胞减灭术继以化疗并没有比单纯化疗延长总生存期。（由国家癌症研究所和其他机构资助；GOG-0213 ClinicalTrials.gov 编号，NCT00565851。）