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September 10, 2025

The Retrospective Analysis of Nivolumab Plus Folfox Therapy as the First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma

Key Points

Nivolumab plus FOLFOX treatment led to a 61.5% objective response rate in advanced ESCC patients.
The median progression-free survival was 6.0 months, with some patients experiencing manageable adverse events.
This retrospective analysis included 13 patients, primarily older males with advanced ESCC, showing promising results.
Overall survival was not reached within the first 4.3 months of follow-up, highlighting the need for further research.

Abstract

Abstract Background Nivolumab plus platinum-based chemotherapy is the standard of care as the first-line treatment for advanced esophageal squamous cell carcinoma (ESCC) based on the results of the CheckMate 648 trial. However, patients with renal or cardiac dysfunction, elderly patients might be unfit for cisplatin-containing regimens because of its toxicities and hydration. Leucovorin, 5-FU, and oxaliplatin (FOLFOX) therapy has less renal toxicity than cisplatin-containing regimens and does not need hydration. Therefore, nivolumab plus FOLFOX therapy might be an alternative option for advanced ESCC patients who are unfit for cisplatin, but there is no data on efficacy and safety of this therapy. Methods This retrospective study included patients with histologically confirmed advanced ESCC treated with nivolumab (240 mg/body, day 1, every 2 weeks) plus FOLFOX (leucovorin 200 mg/m2, day 1, 5-FU 400 mg/m2, day 1 and 2400 mg/m2, over 46 hour, and oxaliplatin 85 mg/m2, day 1, every 2 weeks) in our hospital from January to November 2024 for the first-line treatment. Efficacy was evaluated by objective response rate (ORR) assessed by the RECIST ver.1.1, progression-free survival (PFS), and overall survival (OS). To evaluate safety, adverse events were assessed by CTCAE ver. 5.0. Results Thirteen patients were included (median age, 75 range: 65–82 years; male/female, 100/0%; performance status 0/1/≥2, 15/77/8%; tumor location Ce/Ut/Mt/Lt, 39/15/23/23%; status advanced/recurrent, 62/38%; PD-L1 TPS 1%/≥1%/not available, 62/30/8%). Median follow-up time was 4.3 (range: 1–11) months. The ORR was 61.5% (95%CI: 35.4–82.4), and median PFS was 6.0 (95%CI: 2.9–NA) months. The OS was not reached within the follow-up period. The most frequent adverse events included neutropenia (38%) and leukopenia (38%), anemia (23%) and thrombocytopenia (23%). The most common grade ≥ 3 adverse events were neutropenia observed in 4 patients (30%). Conclusion Nivolumab plus FOLFOX therapy showed manageable safety profiles and promising short-term efficacy in patients with advanced ESCC who were unfit for cisplatin-containing treatments.

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