西妥昔单抗联合化疗对53例晚期结直肠癌的疗效  

Efficacy of cetuximab combined with chemotherapy on advanced colorectal cancer:a report of 53 cases

作　　者：郭桂芳[1,2] 夏良平[1,2] 张蓓[1,2] 姜文奇[1,3] 刘茂珍[1,2] 胡丕丽[1,2] 陈徐贤[1,2] 丘惠娟[1,2] 周菲菲[1,2] 

机构地区：[1]华南肿瘤学国家重点实验室,广东广州510060 [2]中山大学肿瘤防治中心综合科,广东广州510060 [3]中山大学肿瘤防治中心内科,广东广州510060

出　　处：《癌症》2009年第12期1317-1323,共7页Chinese Journal of Cancer

基　　金："重大新药创新"科技重大专项基金(No.2008ZXO9312-002)~~

摘　　要：背景与目的:西妥昔单抗联合化疗治疗晚期结直肠癌(advanced colorectal cancer,ACRC)是近几年来肿瘤治疗领域的重大进展,国内缺乏较大病例数的研究报道。本研究对53例应用西妥昔单抗联合化疗的ACRC患者的临床资料进行回顾分析,以期对西妥昔单抗在ACRC的应用提供临床经验。方法:收集自2005年3月至2008年4月中山大学肿瘤防治中心记录完整的西妥昔单抗联合化疗的ACRC资料,对联合用药的疗效和安全性进行分析。卡方检验比较一线与非一线应用西妥昔单抗联合化疗的近期疗效的差异;Cox模型进行多因素分析,评估一线应用西妥昔单抗联合化疗对ACRC预后的影响。结果:53例病例入选,男性40例,女性13例;中位年龄55岁;均为腺癌。共完成了572周的西妥昔单抗治疗,中位周期数为8周。西妥昔单抗与化疗联合的有效率为39.6%,疾病控制率为66.0%,一线应用的疾病控制率高于非一线应用者(80.0%vs.60.5%),但差异无统计学意义(P=0.177)。姑息治疗中曾用西妥昔单抗的ACRC患者,临床分期是独立的预后因素(P=0.002,OR>1),分期越高,预后越差。应用西妥昔单抗与否不是影响预后的因素(P=0.940)。常见的Ⅲ～Ⅳ级不良反应有痤疮样皮疹(7.5%),中性粒细胞下降(18.9%)和腹泻(5.6%)。未出现超敏反应,未出现治疗相关死亡,仅1例患者因严重腹泻和Ⅳ度骨髓抑制而停药,其余患者均未出现无法耐受的不良反应。结论:西妥昔单抗不良反应少且大多可耐受,与化疗联合应用对ACRC有较高的疾病控制率,西妥昔单抗作一线用药是否较作为非一线用药更好,有待进一步研究。Background and Objective： Studies showed that cetuximab combined with chemotherapy was effective on advanced colorectal cancer （ACRC） in recent years, however, few reports based on large case cohort are available in China. This study was to analyze the efficacy of cetuximab combined with chemotherapy for 53 chinese patients with ACRC. Methods. Clinical data of 53 patients with ACRC, treated with cetuximab combined with chemotherapy in Sun Yat-sen Cancer Center from March 2005 to April 2008, were analyzed for short-term efficacy and safety. The efficacy of the regimen used as first-line and non-first-line treatment was compared by Chi-square test; the effect of the regimen on prognosis was analyzed by multivariate Cox proportional hazards model. Results： Of the 53 patients with colorectal adenocarcinoma, 40 were men and 13 were women, with a median age of 55 years. A total of 572 weeks （median, 8 weeks） of cetuximab treatment were completed. The overall response rate （RR） of the regimen was 39.6% and the disease control rate 66.0%. The disease control rates were similar when the regimen was used as first-line and non-first-line treatment （80.3% vs. 60.5%, P=0.177）. For all 53 patients, clinical stage was an independent prognostic factor （P=0.002, OR〉l）. The most common Grade 3 to 4 adverse events included acne-like rash （7.5%）, neutropenia （18.9%）, and diarrhea （5.6%）. No hypersensitive reaction or treatmentrelated death was observed. Only one patient discontinued treatment because of Grade 4 diarrhea and neutopenia. Conclusions： Cetuximab combined with chemotherapy can achieve relatively high disease control rate for ACRC patients, with less adverse events. Whether cetuximab has better effect in first-line treatment than in non-first-line treatment needs further study.

关 键 词：西妥昔单抗 晚期结直肠肿瘤 近期疗效 预后 安全性 

分 类 号：R735.3[医药卫生—肿瘤] R735.53[医药卫生—临床医学]