Survival Outcomes of Adjuvant Nivolumab after Neoadjuvant Chemotherapy in Esophageal Squamous Cell Carcinoma.
Given the limited Japanese real-world evidence, this study aimed to evaluate the survival and safety of adjuvant nivolumab after neoadjuvant chemotherapy in patients with an incomplete pathological response to esophageal squamous cell carcinoma (ESCC).
This single-center retrospective study included 105 of 259 patients with ESCC who had an incomplete pathological response after neoadjuvant chemotherapy and esophagectomy. Recurrence patterns and immune-related adverse events (irAEs) were analyzed, and disease-free survival (DFS) and overall survival (OS) were compared between the nivolumab and non-nivolumab groups before and after propensity score matching (PSM).
Among 105 patients, 17 received adjuvant nivolumab. Median follow-up was 26.8 months; recurrence occurred in 33 patients (31.4%), and irAEs occurred in 2 nivolumab-treated patients (11.8%). Before PSM, OS and DFS were not significantly different between 2 groups. After PSM, OS remained nonsignificant (P = 0.202), whereas DFS showed a favorable trend toward improvement in the nivolumab group, with 1-year DFS rates of 75.0% versus 68.8% and 3-year DFS rates of 68.2% versus 19.3%, respectively (P = 0.067). Nivolumab was not an independent prognostic factor, although exploratory high-risk subgroups showed favorable DFS trends.
Adjuvant nivolumab showed a nonsignificant favorable trend in DFS after PSM, with late curve separation favoring the nivolumab group and manageable irAEs.
This single-center retrospective study included 105 of 259 patients with ESCC who had an incomplete pathological response after neoadjuvant chemotherapy and esophagectomy. Recurrence patterns and immune-related adverse events (irAEs) were analyzed, and disease-free survival (DFS) and overall survival (OS) were compared between the nivolumab and non-nivolumab groups before and after propensity score matching (PSM).
Among 105 patients, 17 received adjuvant nivolumab. Median follow-up was 26.8 months; recurrence occurred in 33 patients (31.4%), and irAEs occurred in 2 nivolumab-treated patients (11.8%). Before PSM, OS and DFS were not significantly different between 2 groups. After PSM, OS remained nonsignificant (P = 0.202), whereas DFS showed a favorable trend toward improvement in the nivolumab group, with 1-year DFS rates of 75.0% versus 68.8% and 3-year DFS rates of 68.2% versus 19.3%, respectively (P = 0.067). Nivolumab was not an independent prognostic factor, although exploratory high-risk subgroups showed favorable DFS trends.
Adjuvant nivolumab showed a nonsignificant favorable trend in DFS after PSM, with late curve separation favoring the nivolumab group and manageable irAEs.
Authors
Zeng Zeng, Mine Mine, Nasu Nasu, Hashimoto Hashimoto, Makuuchi Makuuchi, Ozaki Ozaki, Yoshimoto Yoshimoto, Watanabe Watanabe, Takai Takai, Fukunaga Fukunaga
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