替吉奥维持治疗晚期结直肠癌的临床效果

Clinical efficacy of S-1 maintenance therapy of metastatic colorectal cancer

目的评价替吉奥维持治疗晚期结直肠癌效果及安全性。方法回顾性分析大连市第三人民医院2010年5月~2013年12月收治的晚期结直肠癌病例73例,一线化疗获得临床缓解后,42例接受临床观察,31例接受替吉奥单药维持治疗,体表面积〈1.25 m2者,给予替吉奥40 mg,日二次,口服;1.25 m2〈体表面积〈1.5 m2者,给予替吉奥50 mg,日二次,口服;体表面积〉1.5 m2者,给予替吉奥60 mg,日二次,口服。所有患者均连续口服替吉奥14 d,21 d为一周期,直至出现病情进展或不可耐受的不良反应。每2个周期进行临床疗效评价,并观察其不良反应,记录其无进展生存期（PFS）、随访总生存（OS）。结果维持治疗组与观察组中位PFS分别为8.0、6.5个月,两组间比较差异有统计学意义（P=0.039）;中位OS分别为19、16个月,两组间比较差异有统计学意义（P=0.004）;分层分析显示维持治疗组中癌胚抗原（CEA）〈100 ng/m L更能从维持治疗中得到生存获益（P=0.001）;替吉奥维持治疗组未观察到严重不良反应。结论转移性结直肠癌一线化疗后替吉奥维持治疗可延长PFS及OS。

Objective To evaluate the efficacy and toxicity of S-1 maintenance therapy in metastatic colorectal cancer（m CRC） patients. Methods 73 m CRC cases in the Third Hospital of Dalian from May 2010 to December 2013 were analyzed retrospectively and assigned into two treatment strategies after they had achieved disease control from first-line chemotherapy. Forty-two patients in non-maintenance group did not receive any further chemotherapy. Thirty-one patients in maintenance group were treated with S-1. The S-1 was given according to the body surface area（BSA）： 40 mg,bid（BSA1.25 m2）, 50 mg, bid（1.25 m2BSA1.5 m2） and 60 mg, bid（BSA1.5 m2） orally for 14 days with 21 days per-cycle. The administration was stopped until disease progression or unbearable toxicities. Clinical and imaging evaluation was performed after every two cycles of S-1 maintenance therapy. S-1 related toxicity, PFS and OS of these73 patients were recorded accordingly. Results The median PFS and OS were 8.0 months and 19 months in the maintenance group, as compared with 6.5 months（P=0.039） and 16 months（P=0.004） in the non-maintenance group. In the maintenance group, patients with CEA100 ng/m L had longer OS（P=0.001）. No severe adverse event was observed in the S-1 maintenance group. Conclusion m CRC patients can benefit from S-1 maintenance therapy by prolonging progression free survival and survival time.