Neoadjuvant immunochemoradiotherapy with nivolumab, paclitaxel, and cisplatin followed by esophagectomy for locally advanced esophageal squamous cell carcinoma.
Journal
British journal of cancer
Start Page
PubMed ID 41862680 41862680
ISSN
1532-1827
Date Issued
2026-03-20
Author(s)
Huang, Ta-Chen
Guo, Jhe-Cyuan
Lin, Chia-Chi
Kuo, Hung-Yang
Liang, Cher-Wei
Hsu, Feng-Ming
Cheng, Jason Chia-Hsien
Lee, Jang-Ming
Huang, Pei-Ming
Li, Yu-I
Hsu, Chih-Hung
Abstract
Nivolumab is effective in treating patients with esophageal squamous cell carcinoma (ESCC). The efficacy of nivolumab in combination with neoadjuvant chemoradiotherapy (CRT) remains unclear.
In this phase II trial with Simon's 2-stage design, neoadjuvant nivolumab, paclitaxel, and cisplatin were administered with radiotherapy followed by esophagectomy to patients with locally advanced ESCC. The primary endpoint was pathological complete response (pCR). The secondary endpoints were feasibility, safety, recurrence-free survival (RFS), progression-free survival (PFS), and overall survival (OS).
A total of 17 patients were enrolled in stage I. Fourteen patients received esophagectomy, with pCR achieved in 4, below the criterion for continuing to stage II. All grade and ≥grade 3 treatment emergent adverse events (TEAEs) occurred in 15 and 4 patients, respectively. Immune-related TEAEs occurred in 7; none were ≥ grade 3. The median durations of RFS, PFS, and OS were 8, 12, and 25 months, respectively. Patients with high expression of PD-L1 had higher pCR rate (100% vs 18%, P = 0.019).
Nivolumab in combination with neoadjuvant CRT is safe for patients with locally advanced ESCC, and may be beneficial in those with high PD-L1 expression.
NCT05130684.
Type
journal article