Paclitaxel and cisplatin with or without cetuximab in metastatic esophageal squamous cell carcinoma: a randomized, multicenter phase II trial
Zhihao Lü, Yanqiao Zhang, Qingxia Fan, Yueyin Pan, Da Jiang, Ping Lu, Jingdong Zhang, Xianglin Yuan, Jifeng Feng, Shujun Yang, Wenbin Yue, Lin Zhao, Yunhua Xu, Jinhua Luo, Lin Shen
Abstract
weekly), respectively. Targeted next-generation sequencing (NGS) was performed on 89 tumor samples for biomarker exploration. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. With a median follow-up of 22.6 months, median PFS was 5.7 months (95% confidence interval [CI]: 4.8-7.0) in patients administered CTP versus 4.2 months (95% CI: 3.0-5.3) in the TP group (hazard ratio [HR] = 0.61; 95% CI: 0.40-0.93; p = 0.02). Median overall survival was 11.5 months (95% CI: 7.9-13.1) in the CTP group and 10.5 months (95% CI: 9.0-13.2) in the TP arm (HR = 0.98; 95% CI: 0.67-1.44; p = 0.91). The most common reported greater than or equal to grade 3 adverse events were neutropenia (35.2% versus 22.4%) and leukopenia (25.4% versus 13.2%). In patients with epidermal growth factor receptor (EGFR) amplification tumors (15.7%), PFS was improved with CTP compared with TP treatment (HR = 0.11; 95% CI: 0.01-0.98; p = 0.018). First-line CTP significantly improves PFS, with a manageable safety profile in patients with metastatic ESCC.