CAJ | 학술논문

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120 mg加顺铂120 mg,溶于生理盐水12 L,温度(43±0.5)℃,时间60~90 min.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.
목적:분석세포감멸술(Cytoreductive surgery,CRS)가복강열관주화료(Hyperthermic intraperitoneal chemotherapy, HIPEC)치료위암복막암(Peritoneal carcinomatosis,PC)적료효화안전성.방법:대106례위암 PC 환자수궤분위 CRS 조혹 CRS+HIPEC 조,전자행상규수술치료,후자행 CRS+HIPEC,약물위간기희소감(HTPC)20 mg 가사렬매소(MMC)30 mg,혹다서타새120 mg가순박120 mg,용우생리염수12 L,온도(43±0.5)℃,시간60~90 min.주요종점지표위총체생존기,차요종점지표위안전성.결과:입조환자106례,CRS조45례,CRS+HIPEC조61례,량조적주요림상병리지표평형.지환자적중위수방기30개월시,위암PC상관사망솔재CRS조위93.3%(42/45),CRS+HIPEC조위77.0%(47/61,P<0.05).량조환자적중위생존기재CRS조시7.0개월(95%CI:5.8~8.2개월),CRS+HIPEC조시11.1개월(95% CI:8.3~13.9개월,P=0.003).치료상관적엄중불량사건재CRS조위6례,CRS+HIPEC조위8례(P>0.05).다인소분석현시CRS+HIPEC치료、위암동시성PC환자、육안가견완전종류세포감멸、불발생엄중불량사건、계통성화료6개주기이상위영향예후적독립삼수.결론:대우위암동시성PC환자,CRS+HIPEC가연장생존기,병불명현증가엄중불량사건.
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 20 mg plus mitomycin 30 mg, or docetaxel 120 mg plus cisplatin 120 mg in 12,000 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 were 93.3% (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 to 8.2 mo) in the CRS group, but 11.1 mo (95% CI 8.3 mo to 13.9 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.