伊立替康联合卡培他滨治疗转移性结直肠癌的临床研究

目的 探讨伊立替康（CPT-11）联合卡培他滨治疗转移性结直肠癌的近期疗效、毒性反应及生存状况.方法 135例病理学证实的转移性结直肠腺癌患者接受了伊立替康350 mg/m2,静脉滴注90 min,第1天；卡培他滨1000 mg/m2,第1～14天,2次/d,口服；每3周为一周期,至少6周期方案治疗.评价近期疗效、毒副反应,并进行随访观察生存情况.结果 全组135例患者疗效及毒副反应可评价.其中CR 0例,PR 63例（46.7％）,SD 42例（31.1％）,PD 30例（22.2％）,总有效率（CR＋ PR）46.7％,临床获益率（CR＋ PR＋ SD）77.8％.化疗中主要的毒副反应为骨髓抑制及消化道反应,可耐受.中位无进展生存期10个月（95％CI：6.8～13.1个月）,中位生存时间为18个月（95％ CI：16.5～19.5个月）.统计1年生存率57.8％ （78/135）,2年生存率31.1％（42/135）,3年生存率21.5％（29/135）.生存分析显示KPS评分、肿瘤转移部位多少及化疗后的近期疗效是生存的独立预后因素.结论 伊立替康联合卡培他滨治疗转移性结直肠癌疗效肯定,毒副反应能耐受,给药方便,能一定程度改善生存,值得进一步研究.

Study of Irinotecan plus Capecitabine combination in the treatment of patients with metastatic colorectal cancer

Objective To investigate the efficacy,the side effects and the survival of the combination of Irinotecan and Capecitabine in patients with metastatic colorectal cancer （MCRC）.Methods 135 patients （median age 57 years）with histologic or cytologic confirmnation of metastatic colorectal cancer received Irinotecan 350 mg/m2 intravenously on day 1 for 90 minutes and Capecitabine 1000 mg/m2 orally twice daily on days 1 to 14 in a 21-day treatment cycle as palliative chemotherapy.Each patient was received at least six cycles.Results The complete response rate（CR） was 0％ （0/135）.The partial response rate （PR） was 46.7％ （63/135）,stable disease （SD） rate was 31.1％ （42/135）,and disease progression （PD） rate was 22.2％ （30/135）.The overall rate （CR ＋ PR） was 46.7％ and the clinical benefit rate（RR ＋ SD） was 77.8％.The main toxicities were leukopenia（48.9％）,nausea and vomiting（44.4％）,diarrhea （64.4％）and hand-foot syndrome （28.9％）.No grade 4 events from the entire cohort was found.The median progression-free survival was 10 months （95％ CI 6.8-13.1 months）,and median overall survival was 18 months （95％ CI 16.5-19.5 months）.The 1-year,2-year and 3-year survival rates were 57.8％,31.1％ and 21.5％ respectively.High Karnofsky performance status,single metastatic lesion and response to the regimen indicated respectively good prognosis.Conclusion It was demonstrated that Irinotecan plus Capecitabine regimen was efficient and tolerable in MCRC.The regimen improve the survival moderately and merits further study.