CPT-11或草酸铂联合5-氟脲嘧啶/亚叶酸钙治疗晚期结直肠癌的临床研究

目的比较CPT-11联合5-氟脲嘧啶/亚叶酸钙(FOLFIRI方案)和草酸铂联合5-氟脲嘧啶/亚叶酸钙(FOLFOX4方案)对晚期结直肠癌患者的疗效和安全性。方法经细胞学或病理学证实、并有客观病灶的晚期大肠癌患者随机分为两组,24例应用FOLFIRI方案治疗,23例应用FOLFOX4方案治疗。以上两种方案均2周重复,每4周为一完整周期,每个受试者均接受两个及以上周期的治疗。对两组近期疗效和不良反应进行对比观察。结果FOLFIRI组22例可评价疗效,有效率为40.9%;FOLFOX4组23例可评价疗效,有效率为47.8%;两组之间比较无统计学意义(p>0.05)。中位疾病进展时间:FOLFIRI组7.2个月,FOL-FOX4组8.9个月(p>0.05),FOLFIRI组的腹泻发生率(45.8%)比FOLFOX4组(17.4%)明显(p<0.05),FOLFOX4组的神经毒性发生率(52.2%)明显高于FOLFIRI组(8.3%)(p<0.01),其它副作用包括白细胞减少、贫血、血小板减少、肝功能损害、恶心呕吐、静脉炎等,两组的不良反应均以Ⅰ、Ⅱ度为主,两组之间差异无统计学意义。结论对于晚期结直肠癌,FOLFOX4和FOLFIRI方案获得相似的近期疗效,两种方案均有较好的耐受性。

CLINICAL STUDY ON THE TREATMENT OF ADVANCED COLORECTAL CANCER WITH IRINOTECAN OR OXALIPLATIN COMBINED WITH 5-FLUOROURACIL AND LEUCOVOLIN

Objective To observe the difference of immediate efficacy and side effect in advanced colorectal cancer between two different chemotherapeutic regimens consisted of 5 -fluorouracil,leucovorin and Irinotecan （FOL- FIRI） or Oxaliplatin （FOLFOX4）. Methods 47 patients of advanced colorectal cancer pathologically confirmed were enrolled and randomly assigned into two groups. Twenty - four patients were treated with FOLFIRI and Twenty - three patients were treated with FOLFOX4. The chemotherapy was repeated every two weeks and every four weeks was a cycle. All enrolled patients received two cycles of treatment at least. Results Twenty - two patients in FOLFIRI group were evaluated and the response rate was 40. 9%. Twenty - three patients in FOLFOX4 group were evaluated and the response rate was 47. 8%. There was no significant difference in the response rate of the two groups,and a median time to progression was 7.2 months vs 8. 9 months between the two regimens, respectively （p 〉 0.05 ）. The incidence of diarrhea in FOLFIRI group was higher than in FOLFOX4 group （45. 8% vs 17.4% p 〈 0.05 ）. The incidence of peripheral neuropathy toxicities of FOLFOX4 group was higher than FOLFIRI group（52. 2% vs 8. 3% p 〈 0. 01 ）. The major other toxicities were bone marrow depression, gastro - intestinal toxicities,liver function damage and phlebitis, most of which were Ⅰ - 17Ⅱ grade. There was no significant difference in the two groups. Conclusion The two regimens showed similar immediate efficacy and acceptable toxicities for the advanced colorectal cancer patients.