BACKGROUND Regarding the comparison between primary debulking surgery (PDS) and neoadjuvant chemotherapy (NACT) for stage III/IV ovarian, tubal and peritoneal cancers, EORTC55971 and CHORUS studies demonstrated noninferiority of NACT. Previously, we reported reduced invasiveness of NACT in JCOG0602. This is a final analysis including the primary endpoint of overall survival (OS). METHODS Patients were randomised to PDS (PDS followed by 8x paclitaxel and carboplatin, i.e. TC regimen) or NACT (4x TC, interval debulking surgery [IDS], 4x TC). The primary endpoint was OS. The noninferiority hazard ratio (HR) margin for NACT compared with PDS was 1·161. The planned sample size was 300. FINDINGS Between 2006 and 2011, 301 patients were randomised, 149 to PDS and 152 to NACT. The median OS was 49·0 and 44·3 months in the PDS and NACT. HR for NACT was 1·052 [90·8% confidence interval (CI) 0·835-1·326], and one-sided noninferiority p-value was 0·24. Median progression-free survival was 15·1 and 16·4 months in the PDS and NACT (HR: 0·96 [95%CI 0·75-1·23]). In the PDS arm, 147/149 underwent PDS and 49/147 underwent IDS. In the NACT arm 130/152 underwent IDS. Complete resection was achieved in 12% (17/147) of PDS and 31% (45/147) of PDS ± IDS in the PDS arm and in 64% (83/130) of IDS in the NACT arm. Optimal surgery (residual tumour <1 cm) was achieved in 37% (55/147), 63% (92/147), and 82% (107/130 respectively. In the NACT, PS 2/3, serum albumin ≤2·5, CA125 > 2000 an institution with low study activity was advantageous, whereas clear/mucinous histology was disadvantageous for OS. INTERPRETATION The noninferiority of NACT was not confirmed. NACT may not always be a substitute for PDS. However, as our study had smaller numbers, the noninferiority of the previous studies cannot be denied. FUNDING Ministry of Health, Labour and Welfare, Japan and the National Cancer Center, Japan. CLINICAL TRIAL INFORMATION UMIN000000523.

中文翻译：

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在III期随机试验中，比较了针对III / IV期卵巢癌，输卵管癌和腹膜癌的初次实体化手术与新辅助化疗之间的生存期。

背景技术关于III / IV期卵巢癌，输卵管癌和腹膜癌的初级减脂手术（PDS）与新辅助化疗（NACT）的比较，EORTC55971和CHORUS研究表明NACT具有非劣效性。以前，我们报道了JCOG0602中NACT的侵袭性降低。这是最终分析，包括总体生存（OS）的主要终点。方法患者被随机分为PDS（PDS，然后8x紫杉醇和卡铂，即TC方案）或NACT（4x TC，间歇性减量手术[IDS]，4x TC）。主要终点是操作系统。与PDS相比，NACT的非劣效风险比（HR）余量为1·161。计划的样本量为300。结果在2006年至2011年之间，随机分配了301名患者，其中149例患者接受PDS，152例患者接受NACT。在PDS和NACT中，中位OS​​分别为49·0和44·3个月。NACT的HR为1·052 [90·8％置信区间（CI）0·835-1·326]，单侧非劣效性p值为0·24。PDS和NACT的中位无进展生存期分别为15·1和16·4个月（HR：0·96 [95％CI 0·75-1·23]）。在PDS部门中，147/149接受了PDS，49/147接受了IDS。在NACT臂130/152中进行了IDS。在PDS臂中，有12％（17/147）的PDS和31％（45/147）的PDS±IDS和在NACT臂中的IDS达到了完全切除的64％（83/130）。最佳手术（残留肿瘤<1 cm）分别达到37％（55/147），63％（92/147）和82％（107/130）。在NACT中，PS 2/3，血清白蛋白≤2 ·5，CA125> 2000，研究活动低的机构是有利的，而清晰/粘液的组织学对OS不利。解释未确认NACT的非劣效性。NACT并不总是可以替代PDS。但是，由于我们的研究数量较少，因此不能否认先前研究的非劣效性。资金日本厚生劳动省和日本国家癌症中心。临床试验信息UMIN000000523。