不同剂量密度伊立替康联合LD-FP持续灌注治疗晚期大肠癌的临床研究

Clinical study of two different dose-density irinotecan combined with low dose FP in treatment of patients with advanced colorectal cancer

目的 观察不同剂量密度伊立替康（CPT-11）联合LD-FP持续灌注治疗晚期大肠癌的近期疗效、生存期和毒副作用。方法采用两种方法对38例患者进行研究。每周剂量（A组）21例,3周剂量（B组）17例。A组：CPT-1160 mg/m^2,iv,d1、8、15;B组：CPT-11 150 mg/m^2iv,d1。两组分别联合5-Fu 300 mg/（m^2.d）,d1-14,微量泵持续静脉给药;DDP5 mg/d,d1-5,d8-14,iv;CF100 mg/（m^2 .d）,d1-14,iv。28 d为1周期。结果 A、B两组总有效率分别为20.0%和23.5%,中位肿瘤进展期（mTTP）均为5个月,中位生存期（MST）分别为15和14.5个月,临床获益率分别为75.0%和76.4%。胆碱能症状、黏膜炎均表现轻微。Ⅲ/Ⅳ度迟发性腹泻发生率分别为9.5%和23.5%,Ⅲ/Ⅳ度粒细胞减少发生率分别为14.3%和35.2%。结论 两种方案治疗晚期大肠癌疗效无差别,每周方案毒性反应更低,均可作为晚期大肠癌的一线、二线化疗方案。

Objective To evaluate the efficacy, the survival duration and the adverse effects of two different dose-densities of irinotecan（ CPT-11 ） combined with LD-FP regimen in treatment of advanced colorectal cancer. Methods Group A including 21 patients was treated with CPT-11 60 mg/m^2 iv on clays 1,8 and 15. Group B including 17 patients was treated with CPT-11 150 mg/m^2 iv on day 1. The two groups received intravenous infusion of CPT-11 in conjunction with 5-Fu 300 mg/（m^2 · d） continuous infusion for 14 days,cisplatin 5 mg/d iv for 5 days every week for 2 weeks and CF 100 mg/（ m^2 · d）for 14 days respectively. All the regimens were repeated every 3 weeks. Results The ORR were 20.0% and 23.5%, respectively, mTYP of both groups was 5 months. MST were 15 and 14.5 months respectively. The clinical benefit rates were 75.0% and 76.4%, respectively. Acute cholinergic syndrome and mucositis in both groups were mild. The incidences of grade Ⅲ/Ⅳ delayed diarrhea were 9.5% and 23.5% and incidences of grade Ⅲ/Ⅳ neutropenia were 14.3% and 35.2%, respectively. Conclusions There was no difference in the therapeutic effect between the two regimens. The weekly regimen was less toxic. Both regimens can be the therapeutic choice for advanced colorectal cancer.