雷替曲塞联合伊立替康2周方案对比FOLFIRI方案二线治疗晚期结直肠癌的疗效观察

目的 观察雷替曲塞联合伊立替康2周方案治疗转移性结直肠癌的有效性和安全性。方法 经病理组织学或细胞学确诊的50例晚期转移性结直肠癌患者分为试验组（n=25）和对照组（n=25）。试验组方案： 雷替曲塞 2.5mg／m² 静滴，d₁；伊立替康（CPT-11） 180mg／m² 静滴，d₁。对照组方案：CPT-11 180mg／m² 静滴90min，d₁；亚叶酸钙 400mg／m² 静滴，d₁；5-FU 400mg／m² 静滴，d₁；5-FU 2400mg／m² 持续静滴46～48 h，d₁、d₂。两方案均2周为1周期，每周期评价毒副反应，每3个周期评价疗效，直至疾病进展或毒性不能耐受，最多治疗12个周期。结果 试验组获CR 1例，PR 4例，SD 18例，PD 2例；对照组获PR 2例，SD 19例，PD 4例。两组有效率（RR）分别为20％和8％，疾病控制率（DCR）分别为92％和84％，差异均无统计学意义（P＞0.05）。试验组1、2级转氨酶升高的发生率为24％，高于对照组的4％（P＜0.05）；对照组1、2级中性粒细胞减少、口腔黏膜炎的发生率均高于试验组（48％ vs. 20％，32％ vs. 8％，P＜0.05）。结论 雷替曲塞联合伊立替康2周方案与FOLFIRI方案的近期疗效相当，但毒副反应更轻，可以作为转移性结直肠癌的有效姑息治疗方案。

Clinical observation of raltitrexed combination with irinotecan versus FOLFIRI regimen as second-line treatment for advanced colorectal cancer

Objective To compare the efficacy and safety between biweekly raltitrexed and irinotecan with FOLFIRI for pa- tients with metastatic colorectal cancer. Methods A total of 50 patients with metastatic colorectal carcinoma were included into the study. There were 25 patients for irinotecan plus raltitrexed regimen group （treatment group： rahitrexed 2. 5mg/m2 iv d1, irinotecan 180mg/m2 iv d1 ） and 25 patients for FOLFIRI group（ control group： irinotecan 180mg/m2 iv d1, leucovorin 400mg/m2 iv d1, fluorou- racil 40Omg/m2 iv dj , fluorouracil 2400mg/m2 iv 46-48 h）. Both two regimens were 14 days as a cycle,and a total of 12 cycles was applied unless there was evidence of disease progression or intolerance of treatment. The efficacy was evaluated every 3-cycle chemo- therapy and side effects were evaluated every cycle. Results Patients in treatment group received 1 CR, 4 PR, 18 SD, 2 PD; and in control group were 2 PR, 19 SD, 4 PD. No statistical difference was found between two groups in regard to response rate （20% vs. 8% ） and disease control rate（92% vs. 84% ）. Raltitrexed and irinotecan regimen had higher frequency of grade 1-2 transaminase in- crease（24% vs. 4% ,P 〈0. 05）, while FOLFIRIF regimen had higher frequency of grade 1-2 neutropenia（48% vs. 20%, P 〈0. 05） and mucositis （32% vs. 8%, P 〈 O. 05）. Conclusion Rahitrexed and irinotican regimen is effective for metastatic colorectal cancer. It has lower toxicity compared with FOLFIRI regimen.