Phase 2 trial of induction chemoimmunotherapy followed by concurrent chemoradiotherapy plus immunotherapy for locally advanced ESCC

A phase 2 trial at Nanjing Medical University (China) evaluated the efficacy and safety of induction chemoimmunotherapy followed by concurrent chemoradiotherapy plus immunotherapy for patients with locally advanced esophageal squamous cell carcinoma (LA ESCC) who were ineligible for surgery. Forty-four patients received two cycles of induction therapy (paclitaxel plus carboplatin combined with a PD-1 inhibitor), followed by concurrent radiotherapy with two additional cycles of chemoimmunotherapy and subsequent immunotherapy maintenance for up to one year. At the data cutoff point (median follow-up 25.5 months) , both the objective response rate and the disease control rate were 95.5%. The median progression-free survival (primary endpoint) was 26 months (95% CI 14.8-37.2) and the median overall survival was 29 months (23.0-35.0). Distant metastasis was the main failure mechanism (64%). Treatment-related adverse events were generally mild; 17 patients (38%) experienced grade ≥ 3 events. Quality of life assessment in 21 surviving patients indicated favorable overall functioning and well-being. The authors conclude that this regimen of induction chemoimmunotherapy followed by concurrent chemoradiotherapy and maintenance immunotherapy demonstrated promising outcomes, thereby offering a viable nonsurgical alternative for patients with LA ESCC.