Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy
Università Cattolica del Sacro Cuore Sede di Roma, Roma, Italy.
Int J Gynecol Cancer. 2020 Nov;30(11):1657-1664. doi: 10.1136/ijgc-2020-001640. Epub 2020 Oct 7.
To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.
Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.
171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.
研究对于肿瘤负荷高的晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者，新辅助化疗后间隔减瘤术是否在围手术期并发症和无进展生存期方面优于初次减瘤术。
接受腹腔镜检查的晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌（IIIC-IV 期）患者。根据标准化腹腔镜预测指数评估肿瘤负荷高的患者按 1:1 比例随机分配（1:1 比例）接受初次减瘤术加辅助化疗（A 组）或新辅助化疗后间隔减瘤术加辅助化疗（B 组）。主要研究终点为无进展生存期和术后并发症；次要终点为总生存期和生活质量。生存分析采用意向治疗人群。
171 例患者随机分配至初次减瘤术（n=84）与新辅助化疗（n=87）。两组完全切除率（R0）不同（A 组 47.6%，B 组 77.0%；p=0.001）。共登记 53 例重大术后并发症，主要分布在 A 组，而不是 B 组（25.9%比 7.6%；p=0.0001）。所有患者均纳入意向治疗分析。总体中位随访 59 个月（95%CI 53 至 64），83.0%（142/171）的患者发生疾病进展/复发，60.2%（103/171）的患者死亡。初次减瘤术组患者的中位无进展生存期和总生存期分别为 15 个月和 41 个月，新辅助化疗组患者分别为 14 个月和 43 个月（HR 1.05，95%CI 0.77 至 1.44，p=0.73；HR 1.12，95%CI 0.76 至 1.65，p=0.56）。
新辅助化疗和初次减瘤术在最大限度发挥作用时具有相同的疗效，但毒性谱不同。
