尼妥珠单抗联合化疗治疗30例晚期非小细胞肺癌的临床观察

目的:回顾性分析尼妥珠单抗联合化疗治疗晚期非小细胞肺癌的临床疗效和安全性。方法:纳入中国医学科学院肿瘤医院2011年1月至2014年12月30例经病理组织学或细胞学确诊的晚期非小细胞肺癌患者,其中腺癌19例、鳞状细胞癌8例、未知型3例。所有患者均接受尼妥珠单抗联合化疗的治疗,其中19例采用含铂类方案,11例采用非含铂类方案。尼妥珠单抗给药剂量为200 mg,静脉给药,每周1次。尼妥珠单抗联合化疗作为一线方案患者5例,二线方案9例,三线及以上方案16例。每治疗2个周期后按照实体瘤疗效评价标准(RECIST)1.1进行疗效评价;采用NCI-CTCAE3.0标准评价不良反应。结果:30例患者均完成了至少一次疗效评价,其中无完全缓解(CR),部分缓解(PR)5例,疾病稳定(SD)12例,病情进展(PD)13例;客观缓解率(ORR)为16.7%(5/30),疾病控制率(DCR)为56.7%(17/30),中位无进展生存时间(PFS)为89 d(74~104 d),中位总生存时间(OS)为307d(197~417 d)。进一步分析显示,腺癌患者中位OS显著长于鳞癌患者(327 d vs 185 d,P=0.008)。药物安全性评价结果显示尼妥珠单抗联合化疗的安全性良好。结论:尼妥珠单抗联合化疗治疗非小细胞肺癌疗效确切,不良反应较轻,值得临床进一步研究。

Nimotuzumab in combination with chemotherapy in patients with advanced non-small cell lung cancer

Objective:To retrospectively analyze the efifcacy and safety of nimotuzumab combined with chemotherapy in advanced non-small cell lung cancer(NSCLC) patients.Methods: Thirty NSCLC patients were confirmed by histopathology or cytopathology, including 19 cases of adenocarcinoma, 8 cases of squamous cell carcinoma and 3 casesof unknown origin.Nineteen patients received platinum-based chemotherapy in combination with nimotuzumab and 11 patients received non-platinum-based chemotherapy in combination with nimotuzumab(nimotuzumab 200 mg, iv qw).Nimotuzumab was adopted as ifrst-line therapy in 8 patients,as second-line therapy in 12 patients and as third-line or other therapy in 10 patients.The efifcacy was evaluated according to Response Evaluation Criteria In Solid Tumors(RECIST1.1). National Cancer Institute’s Common Toxicity Criteria for Adverse Events (NCI-CTCAE 4.03) was applied to assess safety.Results:All patients accomplished efficacy evaluation at least once, with none reached complete remission(CR). Five patients achieved partial remission(PR), 12 patients maintained stable disease (SD), and 13 patients underwent disease progression.The objective response rate (ORS) was 16.7%(5/30) and disease control rate (DCR) was 56.7%(17/30).The median overall survival (OS)and median progression free survival (PFS) time was 307 (197~417) and 89 days (74~104) respectively. Prolonged OS was observed in adenocarcinoma patients compared with squamous cell carcinoma patients (P=0.008). Safety analysis showed that nimotuzumab in combination with chemotherapy was well tolerated.Conclusion:The regimen of nimotuzumab in combination with chemotherapy showed promising efifcacy and was well tolerated for patients with advanced NSCLC.