This study aimed to evaluate treatment outcomes and safety of afatinib in patients with squamous cell carcinoma of the lung (LSCC) who progressed after chemotherapy and immunotherapy. We recruited patients both retrospectively and prospectively and collected the outcomes and safety data. Additionally, we performed next-generation sequencing using tumor tissue and/or plasma to explore potential molecular biomarkers. Altogether, 42 patients were included in the final analysis. The median number of prior treatments was three (range 1–8), and the median TTF was 2.1 months. Objective response rate and disease control rate were 16.2% and 59.5%, respectively, and median duration of response was 4.0 months among response evaluable patients (n= 37). Treatment-related adverse events (TRAEs, including diarrhea, stomatitis, and paronychia) occurred in 22 (52.3%) patients; however, most were grade 2 or lower, and only 5 cases were grade 3. TRAEs led to dose modification in 17 (40.5%) and discontinuation in 4 (9.5%) patients. The TTF in patients withERBB2mutations was significantly longer than that in patients without (6.8 vs. 2.1 months,p= 0.045). Our results highlight that afatinib is a reasonable treatment option in terms of effectiveness and safety, andERBB2mutation can be used as a predictive biomarker in clinical settings.
本研究旨在评估阿法替尼在化疗及免疫治疗后进展的肺鳞状细胞癌(LSCC)患者中的疗效与安全性。我们通过回顾性与前瞻性相结合的方式纳入患者,系统收集疗效及安全性数据。同时,采用肿瘤组织和/或血浆样本进行二代测序,以探索潜在的分子生物标志物。最终共42例患者纳入分析。患者既往中位治疗线数为3线(范围1-8线),中位治疗失败时间(TTF)为2.1个月。在可评估疗效的患者(n=37)中,客观缓解率与疾病控制率分别为16.2%和59.5%,中位缓解持续时间为4.0个月。共22例(52.3%)患者发生治疗相关不良事件(包括腹泻、口腔炎、甲沟炎等),其中多数为2级或以下,仅5例为3级。因治疗相关不良事件导致剂量调整和停药的患者分别为17例(40.5%)和4例(9.5%)。携带ERBB2基因突变患者的TTF显著长于未突变患者(6.8个月 vs. 2.1个月,p=0.045)。本研究结果表明,阿法替尼在疗效与安全性方面是合理的治疗选择,且ERBB2突变可作为临床实践中潜在的预测性生物标志物。