Background: Epidermal growth factor receptor (EGFR) is commonly overexpressed in lung squamous cell carcinoma and has been associated with impaired prognosis. The aim of this study was to observe the efficacy and safety of nimotuzumab, a anti-EGFR monoclonal antibody, combined with chemotherapy as second- or later-line in the treatment of advanced lung squamous cell carcinoma.
Methods: A retrospective analysis of clinical data was conducted in 13 patients with advanced lung squamous cell carcinoma, who were administered with nimotuzumab combined with chemotherapy as second-line or later-line treatment. The efficacy of therapy was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and safety by National Cancer Institute Common Toxicity Criteria (NCI-CTC) 4.0.
Results: Of the 13 advanced squamous-cell lung cancer patients, one patient had complete response (CR), 2 patients had partial response (PR), 4 cases had stable disease (SD), and 6 patients had progressive disease. The overall response rate (ORR) was 23.1% and clinical benefit rate (CBR) was 53.8%. EGFR expression were detected by immunohistochemistry in 6 patients and the results showed 5 patients were EGFR 3+ and the other was EGFR 2+. Of these 6 EGFR positive patients, 1 case had CR, 1 case had PR and 4 cases had SD; ORR was 33.3% and CBR was 100.0%. Grade 3/4 hematological toxicities were observed in 3 (23.1%) patients, and non-hametological toxicities were mild. Nimotuzumab-associated skin rash was found in 2 (15.4%) patients.
Conclusions: Nimotuzumab combined with chemotherapy as second- or later-line therapy for advanced squamous cell lung carcinoma was active and well-tolerated, especially for those patients with EGFR positive.
背景与目的 表皮生长因子受体（epidermal growth factor receptor, EGFR）过表达在肺鳞癌中常见，而与预后差相关。本研究旨在观察抗EGFR单克隆抗体尼妥珠单抗联合化疗二线及以上治疗晚期肺鳞癌的疗效及安全性。方法 回顾性分析13例尼妥珠单抗联合化疗二线及以上治疗的晚期肺鳞癌患者的临床资料，分别采用实体瘤疗效评价标准1.1版和美国国立癌症研究所通用毒性标准4.0版进行疗效和安全性评估。结果 13例晚期肺鳞癌患者中，1例完全缓解（complete response, CR），2例部分缓解（partial response, PR），4例稳定（stable disease, SD）和6例进展（progressive disease, PD），总有效率（overall response rate, ORR）为23.1%，临床获益率（clinical benefit rate, CBR）为53.8%。6例患者进行了EGFR免疫组化检测，5例EGFR 3+，1例EGFR 2+，这6例患者1例CR，1例PR，4例SD，ORR为33.3%，CBR为100.0%。23.1%的患者出现3度-4度血液学毒性，非血液学毒性轻微，2例（15.4%）出现尼妥珠单抗相关皮疹。结论 尼妥珠单抗联合化疗二线及以上治疗晚期肺鳞癌有效且不良反应容易耐受，尤其是EGFR表达阳性的患者。.