论文部分内容阅读
目的:分析细胞减灭术(Cytoreductive surgery,CRS)加腹腔热灌注化疗(Hyperthermic intraperitoneal chemotherapy,HIPEC)治疗胃癌腹膜癌(Peritoneal carcinomatosis,PC)的疗效和安全性。方法:对106例胃癌PC患者随机分为CRS组或CRS+HIPEC组,前者行常规手术治疗,后者行CRS+HIPEC,药物为羟基喜素碱(HTPC)20 mg加丝裂霉素(MMC)30 mg,或多西他赛120mg加顺铂120mg,溶于生理盐水12 L,温度(43±0.5)℃,时间60～90min。主要终点指标为总体生存期,次要终点指标为安全性。结果:入组患者106例,CRS组45例,CRS+HIPEC组61例,两组的主要临床病理指标平衡。至患者的中位随访期30个月时,胃癌PC相关死亡率在CRS组为93.3%(42/45),CRS+HIPEC组为77.0%(47/61,P<0.05)。两组患者的中位生存期在CRS组是7.0个月(95%CI:5.8～8.2个月),CRS+HIPEC组是11.1个月(95%CI:8.3～13.9个月,P=0.003)。治疗相关的严重不良事件在CRS组为6例,CRS+HIPEC组为8例(P>0.05)。多因素分析显示CRS+HIPEC治疗、胃癌同时性PC患者、肉眼可见完全肿瘤细胞减灭、不发生严重不良事件、系统性化疗6个周期以上为影响预后的独立参数。结论:对于胃癌同时性PC患者,CRS+HIPEC可延长生存期,并不明显增加严重不良事件。
Objective: To evaluate the efficacy and safety of Cytoreductive surgery (CRS) and Hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of Peritoneal carcinomatosis (PC). Methods: One hundred and six patients with gastric cancer were randomly divided into CRS group or CRS + HIPEC group. The former underwent routine surgery and the latter received CRS + HIPEC. The drugs were HTPC 20 mg plus MMC (MMC ) 30 mg, or docetaxel 120 mg plus cisplatin 120 mg, dissolved in saline 12 L, temperature (43 ± 0.5) ℃, time 60 ~ 90min. The primary endpoint was overall survival and the secondary endpoint was safety. Results: There were 106 patients in the CRS group, 45 patients in the CRS group and 61 patients in the CRS + HIPEC group. The main clinical and pathological indexes of the two groups were balanced. At the median follow-up of 30 months, PC-related mortality in gastric cancer was 93.3% (42/45) in the CRS group and 77.0% (47/61, P <0.05) in the CRS + HIPEC group. Median survival was 7.0 months (95% CI: 5.8 to 8.2 months) in the CRS group and 11.1 months in the CRS + HIPEC group (95% CI: 8.3 to 13.9 months, P = .003) . Treatment-related serious adverse events were 6 in the CRS group and 8 in the CRS + HIPEC group (P> 0.05). Multivariate analysis showed that the CRS + HIPEC treatment, gastric cancer patients with PC simultaneously, the complete destruction of tumor cells can be seen with the naked eye, no serious adverse events, more than 6 cycles systemic chemotherapy prognostic independent parameters. Conclusions: CRS + HIPEC prolongs survival in patients with concurrent gastric cancer and does not significantly increase the severity of adverse events.