摘要
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： This work aimed to study the efficacy and safety of cytoreductive surgery （CRS） plus hyperthermic in tra-peritoneal chemotherapy （HIPEC） on peritoneal carcinomatosis （PC） from gastric cancer. Methods： A total of 106 gastric cancer patients with PC were randomized into the CRS group （ n=45 ） and the CRS＋HIPEC group （n=61 ）. The former group received conventional radical surgery, and the latter group underwent maximal CRS and HIPEC therapy using hydroxycamptothecin 20mg plus mitomycin 30mg, or docetaxel 120 mg plus cisplatin 120 mg in12 ,000 mL of normal saline at 43 ±0.5℃for 60 min to 90 min. The primary endpoint was overall survival （OS）, and the secondary endpoint was severe adverse events （SAE）. Results：The major clinico-pathological characteristics were well-balanced between the CRS and CRS＋HIPEC groups. By the end of the follow-up （median, 30 mo）, the gastric cancer PC-related death rates were93 .3% （42 /45 ） in the CRS group and 77 .0% （47 /61 ） in CRS＋HIPEC group （P〈0.05 ）. The median OS were 7.0 mo （ 95 % CI 5.8 mo to8.2 mo） in the CRS group, but11 .1 mo （ 95 % CI8.3 mo to13 .9 mo） in the CRS＋HIPEC group （P=0.003）. SAE occurred in 6 patients in the CRS group and 8 in the CRS＋HIPEC group （P 〉0.05）. Multivariate analysis showed 5 independent factors for achieving survival improvement, including CRS＋HIPEC, gastric cancer with synchronous PC, complete cytoreduction, no SAE and systemic chemotherapy over 6 cycles. Conclusion：CRS＋HIPEC could improve the survival of gastric cancer patients with synchronous PC without significant increase of SAE.
出处
《中国肿瘤临床》
CAS
CSCD
北大核心
2012年第22期1734-1740,共7页
Chinese Journal of Clinical Oncology
基金
国家自然科学基金创新群体项目(编号:20621502)
国家大学生创新性实验计划项目(编号:081048646)
教育部博士点专项研究基金资助~~
关键词
胃癌腹膜转移癌
细胞减灭术腹腔热灌注化疗
Gastric cancer
Peritoneal carcinomatosis
Cytoreductive surgery
Hyperthermic intra-peritoneal chemotherapy
