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Peer-reviewedCC BY 4.0Esophagus

FOLFOX plus nivolumab combination therapy for cisplatin-unfit patients with untreated advanced esophageal squamous cell carcinoma

  • Nozomu Ogura1
  • Shun Yamamoto1
  • Ryuichi Morita1
  • Hiroshi Imazeki1
  • Hideaki Takahashi1
  • Yoshitaka Honma1
  • Tairo Kashihara2
  • Daisuke Kurita3
  • Koshiro Ishiyama3
  • Hiroyuki Daiko3
  • Yasuyuki Seto3
  • Ken Kato1
  1. 1Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 1040045 Japan
  2. 2Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan
  3. 3Department of Esophageal Surgery, National Cancer Center Hospital, Tokyo, Japan
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Abstract

Background: Combination chemotherapy with cisplatin and fluorouracil plus an immune checkpoint inhibitor (ICI) is a standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). However, cisplatin is unsuitable for patients with renal or cardiac dysfunction and older patients because of nephrotoxicity and the need for hydration. Oxaliplatin-based regimens (e.g., FOLFOX) have demonstrated clinically meaningful efficacy and are well tolerated in cisplatin-unfit patients with untreated advanced ESCC. This study investigated the effectiveness and safety of FOLFOX combined with an ICI in these patients.

Methods: Cisplatin-unfit patients with untreated advanced ESCC who received FOLFOX plus nivolumab at our institution between January 2024 and July 2025 were retrospectively identified. Progression-free survival, overall survival, and the response rate were evaluated as efficacy endpoints and adverse events as safety endpoints.

Results: Seventeen patients with a median age of 75 years (range, 62–82) were included. ECOG performance status was 0 in 3 cases (17.6%), 1 in 11 (64.7%), and 2 in 3 (17.6%). The main reasons for cisplatin ineligibility were older age (88.2%) and poor condition (58.8%). The response rate was 57.1% in patients with measurable lesions during a median follow-up of 9.9 months. Median progression-free survival was 6.5 months (95% confidence interval 3.6–not reached [NR]) and median overall survival was 15.6 months (4.5–NR). Common adverse events were neutropenia (41.2%) and leukopenia (35.3%). No treatment-related deaths occurred.

Conclusions: FOLFOX plus nivolumab might have effectiveness and safety comparable with that of cisplatin and fluorouracil plus nivolumab in cisplatin-unfit patients with untreated advanced ESCC.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10388-026-01227-x.

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Cite

BibTeXRIS
BibTeX
@article{ogura2026folfox,
  title = {{FOLFOX plus nivolumab combination therapy for cisplatin-unfit patients with untreated advanced esophageal squamous cell carcinoma}},
  author = {Nozomu Ogura and Shun Yamamoto and Ryuichi Morita and Hiroshi Imazeki and Hideaki Takahashi and Yoshitaka Honma and Tairo Kashihara and Daisuke Kurita and Koshiro Ishiyama and Hiroyuki Daiko and Yasuyuki Seto and Ken Kato},
  journal = {Esophagus},
  year = {2026},
  month = jun,
  doi = {10.1007/s10388-026-01227-x},
  url = {https://doi.org/10.1007/s10388-026-01227-x},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - FOLFOX plus nivolumab combination therapy for cisplatin-unfit patients with untreated advanced esophageal squamous cell carcinoma
AU  - Nozomu Ogura
AU  - Shun Yamamoto
AU  - Ryuichi Morita
AU  - Hiroshi Imazeki
AU  - Hideaki Takahashi
AU  - Yoshitaka Honma
AU  - Tairo Kashihara
AU  - Daisuke Kurita
AU  - Koshiro Ishiyama
AU  - Hiroyuki Daiko
AU  - Yasuyuki Seto
AU  - Ken Kato
PY  - 2026
DA  - 2026/06/10
JO  - Esophagus
DO  - 10.1007/s10388-026-01227-x
UR  - https://doi.org/10.1007/s10388-026-01227-x
AB  - Background: Combination chemotherapy with cisplatin and fluorouracil plus an immune checkpoint inhibitor (ICI) is a standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). However, cisplatin is unsuitable for patients with renal or cardiac dysfunction and older patients because of nephrotoxicity and the need for hydration. Oxaliplatin-based regimens (e.g., FOLFOX) have demonstrated clinically meaningful efficacy and are well tolerated in cisplatin-unfit patients with untreated advanced ESCC. This study investigated the effectiveness and safety of FOLFOX combined with an ICI in these patients.  Methods: Cisplatin-unfit patients with untreated advanced ESCC who received FOLFOX plus nivolumab at our institution between January 2024 and July 2025 were retrospectively identified. Progression-free survival, overall survival, and the response rate were evaluated as efficacy endpoints and adverse events as safety endpoints.  Results: Seventeen patients with a median age of 75 years (range, 62–82) were included. ECOG performance status was 0 in 3 cases (17.6%), 1 in 11 (64.7%), and 2 in 3 (17.6%). The main reasons for cisplatin ineligibility were older age (88.2%) and poor condition (58.8%). The response rate was 57.1% in patients with measurable lesions during a median follow-up of 9.9 months. Median progression-free survival was 6.5 months (95% confidence interval 3.6–not reached [NR]) and median overall survival was 15.6 months (4.5–NR). Common adverse events were neutropenia (41.2%) and leukopenia (35.3%). No treatment-related deaths occurred.  Conclusions: FOLFOX plus nivolumab might have effectiveness and safety comparable with that of cisplatin and fluorouracil plus nivolumab in cisplatin-unfit patients with untreated advanced ESCC.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10388-026-01227-x.
SN  - 1612-9059
SN  - 1612-9067
ER  -