西妥昔单抗单周和双周方案治疗晚期大肠癌的对比研究

A comparision study between one-week and two-week schedule of cetuximab plus chemotherapy for metastatic colorectal cancer

目的比较西妥昔单抗250mg／m^2单周方案和500mg／m^2双周方案分别联合化疗治疗晚期大肠癌的近期疗效及安全性。方法56例晚期大肠癌患者，ECOG行为状态评分0～2分，均有可评价病灶（RECIST2000标准）。西妥昔单抗单周方案联合化疗组30例，给药方法为400mg／m^2第1周，以后250mg／m^2每周重复应用；双周方案联合化疗组26例，给药方法为500mg／m^2第1周，以后每两周重复应用。两组均以完成8周治疗或出现疾病进展为治疗终点。结果西妥昔单抗单周方案联合化疗组28例可评价疗效：完全缓解（CR）1例，部分缓解（PR）7例，疾病稳定（SD）11例，疾病进展（PD）9例，有效率28．6％，疾病控制率67．9％；双周方案联合化疗组26例可评价疗效：CR0例，PR8例，SD9例，PD9例，有效率30．8％，疾病控制率65．4％，两组比较差异无统计学意义（P〉0．05）。两组Ⅲ～Ⅳ度不良反应主要表现为皮疹、恶心、中性粒细胞减少及白细胞减少，两组比较差异也无统计学意义（P〉0．05）。结论西妥昔单抗单周和双周方案分别联合化疗治疗晚期大肠癌疗效相近，不良反应均可耐受。

Objective To compare the short-term efficacy and main side effects between one-week and two-week schedule of cetuximab plus chemotherapy for metastatic colorectal cancer. Methods 56 patients with metastatic colorectal cancer were enrolled, ECOG physical status 0-2, good liver and renal function, using the RECIST published in 2000 to evaluate the measurable lesions. 30 patients received oneweek schedule of cetuximab plus chemotherapy, cetuximab was administered at an initial dose of 400 mg/m^2 followed by weekly doses of 250 mg/m^2; 26 patients received two-week schedule of cetuximab plus chemotheraphy, cetuximab was administered at an initial dose of 500 mg/m^2 and the same dose was given every two weeks. The termination of the study was patients finishing 8 weeks treatment or disease progress. Results 28 patients were evaluable in one-week schedule group： CR 1, PR 7, SD 11, PD 9, RR was 28.6 %, DCR was 67.9 %. 26 patients were evaluable in two-week schedule： none of CR, PR 8, SD 9, PD 9, RR was 30.8 %, DCR was 65.4 %, and no significant difference was found（P 〉0.05）. Grade Ⅲ-Ⅳ toxicity were rash, nausea, vomiting, neutropenia and reduction of leukemia, no siginificant difference was found in the two groups （P 〉0.05）. Conclusion The therapeutic effect and safety for metastatic colorectal cancer are similar between one-week and two-week schedule of cetuximab plus chemotherapy.