Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer
Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer
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DOI：
10.1056/nejmoa0908806
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发表时间：
2010-09-02
影响因子：
158.5
通讯作者：
Reed, Nick S.
中科院分区：
文献类型：
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作者：
Vergote, Ignace;Trope, Claes G.;Reed, Nick S.
基础化疗开始前的原发性减瘤手术一直是晚期卵巢癌患者的标准治疗方法，我们将IIIC或IV期上皮性卵巢癌，输卵管癌，或原发性腹膜癌行原发性减瘤手术，然后进行铂类化疗，或行新辅助铂类化疗，然后进行减瘤手术在随机分配到研究治疗的670名患者中，632名（94.3%）合格并开始治疗。这些患者中的大多数在初次减瘤手术时患有广泛的IIIC或IV期疾病（74.5%的患者转移性病灶直径大于5 cm，61.6%的患者转移性病灶直径大于10 cm）。41.6%的原发性肿瘤减积术后患者和80.6%的间歇性肿瘤减积术后患者的最大残留肿瘤直径小于或等于1 cm。术后不良反应率和死亡率在初次减积后往往高于间隔减积后。死亡风险比（意向性治疗分析），在新辅助化疗后间隔减积组中，与原发性减积手术后化疗组相比，（90%置信区间[CI]，0.84 - 1.13;非劣效性P = 0.01），疾病进展的风险比为1.01（90% CI，0.89 - 1.15）。完全切除所有宏观疾病（在主要或间隔手术）是最强的独立变量，在预测总survival. CONCLUSIONSNoadjuvant化疗，然后间隔减积手术并不劣于主要减积手术，然后化疗作为一种治疗方案，在这项研究中，巨大的IIIC或IV期卵巢癌患者。无论是作为主要治疗还是在新辅助化疗后进行，所有肉眼可见的疾病的完全切除仍然是进行细胞减灭术的目标。
BACKGROUNDPrimary debulking surgery before initiation of chemotherapy has been the standard of care for patients with advanced ovarian cancer.METHODSWe randomly assigned patients with stage IIIC or IV epithelial ovarian carcinoma, fallopian-tube carcinoma, or primary peritoneal carcinoma to primary debulking surgery followed by platinum-based chemotherapy or to neoadjuvant platinum-based chemotherapy followed by debulking surgery (so-called interval debulking surgery).RESULTSOf the 670 patients randomly assigned to a study treatment, 632 (94.3%) were eligible and started the treatment. The majority of these patients had extensive stage IIIC or IV disease at primary debulking surgery (metastatic lesions that were larger than 5 cm in diameter in 74.5% of patients and larger than 10 cm in 61.6%). The largest residual tumor was 1 cm or less in diameter in 41.6% of patients after primary debulking and in 80.6% of patients after interval debulking. Postoperative rates of adverse effects and mortality tended to be higher after primary debulking than after interval debulking. The hazard ratio for death (intention-to-treat analysis) in the group assigned to neoadjuvant chemotherapy followed by interval debulking, as compared with the group assigned to primary debulking surgery followed by chemotherapy, was 0.98 (90% confidence interval [CI], 0.84 to 1.13; P = 0.01 for non-inferiority), and the hazard ratio for progressive disease was 1.01 (90% CI, 0.89 to 1.15). Complete resection of all macroscopic disease (at primary or interval surgery) was the strongest independent variable in predicting overall survival.CONCLUSIONSNeoadjuvant chemotherapy followed by interval debulking surgery was not inferior to primary debulking surgery followed by chemotherapy as a treatment option for patients with bulky stage IIIC or IV ovarian carcinoma in this study. Complete resection of all macroscopic disease, whether performed as primary treatment or after neoadjuvant chemotherapy, remains the objective whenever cytoreductive surgery is performed.