细胞减灭术加腹腔热灌注化疗治疗卵巢癌腹膜转移癌的临床研究

Clinical Investigation on Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy on Patients with Peritoneal Carcinomatosis from Epithelial Ovarian Cancer

目的研究细胞减灭术（CRS）加腹腔热灌注化疗（HIPEC）治疗卵巢癌腹膜转移癌的疗效及安全性。方法 46例晚期卵巢癌腹膜癌（A组FIGOⅢc/Ⅳ期16例,B组复发性30例）患者接受了CRS＋HIPEC治疗,分析其临床资料,主要终点指标为总生存期,次要指标为安全性。结果 A、B两组患者的中位总生存期（OS）分别为74.0月和57.5月（P=0.68）。腹膜癌指数（PCI）≤20（n=24）和〉20（n=22）的中位OS分别为76.6和38.5月（P=0.01）。CC 0~1分和CC 2~3分的中位OS分别为79.5和24.3月（P=0.00）。对复发性卵巢癌腹膜癌患者来说,铂类敏感型和耐药型患者的中位OS分别为65.3和20.0月（P=0.05）。无围手术期死亡病例,5例患者出现术后并发症。多因素分析显示,CC 0~1分、术后化疗≥6周期为改善生存的独立预后因素。结论 CRS＋HIPEC可延长卵巢癌腹膜癌患者的总生存期,安全可行。

Objective To evaluate the efficacy and safety of cytoreductive surgery（CRS） plus hyperthermic intraperitoneal chemotherapy（HIPEC） on patients with peritoneal carcinomatosis（PC） from advanced/recurrent epithelial ovarian cancer（EOC）. Methods We included 46 patients with advanced EOC（FIGO stage Ⅲc/Ⅳ, n=16, Group A） and recurrent EOC with PC（n=30, Group B） treated by CRS＋HIPEC procedures. The primary endpoint was overall survival（OS） from the first treatment to disease-related death. The secondary endpoints were safety profiles. Results The median OS was 74.0 months（95%CI： 8.5-139.5） in Group A vs. 57.5 months（95%CI： 29.8-85.2） in Group B（P=0.68）. The median OS for patients with PCI≤20 vs. PCI〉20 were 76.6 months（95%CI： 56.5-96.7） vs. 38.5 months（95%CI： 24.2-52.8）（P=0.01）. The median OS for patients with CC0-1 vs. CC2-3 were 79.5 months（95%CI： 64.8-94.2） vs. 24.3 months（95%CI： 13.9-34.7）（P=0.00）. In the recurrent group, the median OS were 65.3 months（95%CI： 42.6-88.9） for platinum-sensitive patients vs. 20.0 months（95%CI： 14.5-23.5） for platinum resistant patients（P=0.05）. There was no perioperative death. Postoperative adverse events occurred in five patients. Multivariate analysis revealed that CC0-1 and chemotherapy ≥ six cycles were the independent factors for OS improvement. Conclusion For patients with PC from advanced/recurrent EOC, CRS plus HIPEC could improve the OS with acceptable safety profiles, particularly for advanced EOC PC patients.