西妥昔单抗联合化疗治疗晚期非小细胞肺癌的临床疗效分析

Efficacy of Cetuximab in Combination with Chemotherapy in Advanced Non-small Cell Lung Cancer

背景与目的西妥昔单抗是作用于表皮生长因子受体的单克隆抗体。已有的研究表明在化疗基础上加用西妥昔单抗,可以提高晚期非小细胞肺癌患者的疗效,但来自东方人群的数据有限。本研究旨在分析西妥昔单抗联合化疗治疗中国晚期非小细胞肺癌患者的疗效。方法纳入接受西妥昔单抗联合化疗的晚期非小细胞肺癌患者,回顾性分析其临床数据,包括患者的临床特征、疗效和不良反应。结果共纳入40例患者,其中29例为男性,36例为腺癌,23例既往接受过姑息性化疗(中位2个化疗方案),上一个化疗方案的中位无进展生存期(progression-free survival,PFS)为2.3个月。采用西妥昔单抗联合化疗后,全组患者的缓解率为32.5%(13/40)。既往未接受过化疗和接受过化疗的患者缓解率分别为52.9%(9/17)和17.4%(4/23)(P=0.018)。全组患者的中位PFS为4.8个月。既往未接受过化疗的患者中位PFS为8.4个月,而接受过化疗者的PFS为4.1个月(P=0.062)。全组患者的中位总生存期为17.1个月。不良反应可处理,未发生治疗相关死亡。结论西妥昔单抗联合化疗有望提高中国晚期非小细胞肺癌患者的疗效,并且不良反应可耐受。

Background and objective Cetuximab is a monoclonal antibody directed against epidermal growth fac-tor receptor. Emerging evidence showed improved efficacy with the addition of cetuximab to chemotherapy in advanced nonsmall cell lung cancer （NSCLC）, but the data in oriental population are limited. The aim of this study is to investigate the effi- cacy of cetuximab in combination with chemotherapy in Chinese patients with advanced NSCLC. Methods NSCLC patients receiving cetuximab in combination with chemotherapy in Cancer Hospital, Chinese Academy of Medical Sciences ＆ Peking Union Medical College were enrolled and retrospectively analyzed. Clinical characteristic, efficacy, outcome and toxicity data were analyzed. Results A total of 40 patients were enrolled into this study in which 29 were male, 36 with adenocarcinoma. In the 23 patients who had received palliative chemotherapy previously （with a median of 2 prior chemotherapy regimens）, the median progression-free survival （PFS） after the last prior chemotherapy regimen was 2.3 months. For the overall population, 13 （32.5%） patients achieved partial response after cetuximab in combination with chemotherapy. Response rate were 52.9% （9/17） and 17.4% （4/23） in chemotherapy-naive patients and chemotherapy-treated patients, respectively （P=0.018）. The median PFS was 4.8 months for the overall population. In chemotherapy-naive patients and chemotherapy-treated patients, the median PFS was 8.4 months and 4.1 months, respectively （P=0.062）. The estimated median overall survival was 17.1 months. Toxicities were generally manageable and no treatment-related deaths occurred. Conclusion Cetuximab in addition to chemotherapy appears to be associated with promising efficacy and acceptable toxicity profile in Chinese patients with advanced NSCLC. Further validation is needed.