卡培他滨联合奥沙利铂 沙利度胺治疗晚期结直肠癌的疗效观察

Clinical Observation of Capecitabine Plus Oxaliplatin and Thalidomide in the Treatment of Advanced Colorectal Cancer

目的:观察卡培他滨(Capecitabine,希罗达)联合奥沙利铂(Oxaliplatin L-OHP)、沙利度胺(Thalidomide)治疗晚期结直肠癌的临床疗效和患者的耐受性,并与一线方案进行比较。方法:采用随机分组的方法将46例晚期结直肠癌患者分为Capecitabine+L-OHP+Thalidomide组(联合组)26例与奥沙利铂(L-OHP)+亚叶酸钙(CF)+5-氟尿嘧啶(5-Fu)组(化疗组)20例,观察两组的临床疗效和毒副反应。结果:46例病例中联合用药组2例因药物不良反应未服完1个疗程即中断治疗,44例可评价病例中,联合用药组有效率45.83%(11/24),化疗组有效率40.0%(8/20),联合用药有效率高于化疗组,但两组差异无统计学意义(P>0.05)。联合组的疾病控制率为79.2%(19/24),化疗组为55.0%(11/20),两组差异有统计学意义(P<0.05)。联合组KPS评分的改善率为79.2%,化疗组KPS改善率为40.0%,两组差异有统计学意义(P<0.05)。联合组的骨髓抑制、胃肠道反应和周围神经炎明显低于化疗组,差异有统计学意义(P<0.05);其余毒副反应均相似。结论:与经典化疗方案相比,希罗达联合奥沙利铂、沙利度胺治疗晚期结直肠癌提高了疾病的控制率,同时改善患者的生活质量,具有较轻的毒副反应,疗效评价有待于进一步扩大样本量进行临床随机对照研究。

Objective： This study was designed to investigate the clinical curative effects and tolerance of pa- tients with advanced eolorectal cancer of treatment with regimen of capecitabine plus oxaliplatin and thalido- mide. We compared this treatment with the regimen of oxaliplatin, leucovorin and 5 - fluorouracil. Methods： In a randomized manner, 46patients with advanced colorectal cancer were divided into combined treatment group （capecitabine plus oxaliplatin and thalidomide） and chemotherapy group（L- OHP ＋ CF ＋ 5 - FU）. We com- pared the clinical curative effects and tolerance between two groups. Results： The overall responses rate for the combined treatment group and chemotherapy group were 45.8 96 （11/24）and 40.0 % （8/20）, respectively. The overall responses to the combined treatment group were higher than that of the chemotherapy group, but there were no statistically significant difference between two groups （P ~ 0.05）. The disease control rate of combined treatment group and chemotherapy group were 79.2 % （19/24） and 55.0 % （11/20）, respectively. There were statistically significant difference between two group（ P 〈 0.05）. The improvement rate of KPS score for the combined treatment group and chemotherapy group were 79.2 % and 40.0 %, respectively. Obviously, the im- provement of life quality to the combined treatment group were higher than that of the chemotherapy group （P 〈 0.05 ）. Myelosuppression, peripheral neuritis nausea and vomiting were less pronounced in the combined treat- ment group. There were statistically significant difference between two group （P 〈 0.05） ; other toxicities were similar. Conclusion：Compared with traditional chemotherapy regimen, capecitabine plus oxaliplatin and thalido- mide regimen obviously increase clinically disease control rate and improve life quality of patients with advanced colorectal cancer, resulting in less toxicities. Although the efficacy was better, it should be confirmed by well- controlled randomized clinical trials with more patients.