Department of Respiratory Diseases, Peking Union Medical College Hospital, Beijing, China.
Department of Pathology, Peking Union Medical College Hospital, Beijing, China.
Thorac Cancer. 2018 Aug;9(8):1056-1061. doi: 10.1111/1759-7714.12789. Epub 2018 Jun 19.
This study was conducted to evaluate the efficacy and safety of nimotuzumab combined with chemotherapy as first-line therapy in advanced lung squamous cell carcinoma (LSCC), and to explore predictive biomarkers of the efficacy of nimotuzumab.
A retrospective study was conducted of patients with advanced LSCC administered nimotuzumab combined with chemotherapy as first-line therapy from June 2012 to December 2016 at the Department of Respiratory Medicine, Peking Union Medical College Hospital. The associations between EGFR expression, EGFR gene copy numbers, and clinical efficacy were detected by immunohistochemistry and fluorescence in situ hybridization (FISH).
Twenty-six patients were enrolled, including 22 men and 4 women. The objective response rate was 50% and the disease control rate was 100%. The median progression-free survival (PFS) and overall survival were 6.7 and 16.3 months, respectively. Patients whose samples were tested via FISH and showed positive EGFR expression had a trend of longer median PFS (10.0 months; P = 0.10). Adverse effects included 15 cases (57.7%) of bone marrow suppression, 15 (57.7%) of sensory neuropathy, 14 (53.8%) of alopecia, nine (34.6%) of nausea/vomiting and one case (3.8%) of elevated creatinine level. All adverse effects were attributed to chemotherapy.
Nimotuzumab combined with chemotherapy might be a possible option as first-line therapy in patients with advanced LSCC. EGFR gene copy number examined by FISH might be a possible predictive biomarker.
本研究旨在评估尼妥珠单抗联合化疗作为晚期肺鳞癌(LSCC)一线治疗的疗效和安全性,并探索尼妥珠单抗疗效的预测生物标志物。
回顾性分析 2012 年 6 月至 2016 年 12 月北京协和医院呼吸内科收治的 26 例接受尼妥珠单抗联合化疗作为一线治疗的晚期 LSCC 患者的临床资料。采用免疫组化和荧光原位杂交(FISH)检测 EGFR 表达、EGFR 基因拷贝数与临床疗效的关系。
26 例患者中,男 22 例,女 4 例。客观缓解率为 50%,疾病控制率为 100%。中位无进展生存期(PFS)和总生存期(OS)分别为 6.7 和 16.3 个月。FISH 检测 EGFR 表达阳性的患者中位 PFS 有延长趋势(10.0 个月;P=0.10)。不良反应包括骨髓抑制 15 例(57.7%)、感觉神经毒性 15 例(57.7%)、脱发 14 例(53.8%)、恶心/呕吐 9 例(34.6%)和血肌酐升高 1 例(3.8%)。所有不良反应均归因于化疗。
尼妥珠单抗联合化疗可能是晚期 LSCC 患者的一种潜在一线治疗选择。FISH 检测 EGFR 基因拷贝数可能是一种潜在的预测生物标志物。