P1.122. Feasibility and Efficacy of Immunochemotherapy in Patients With Advanced Esophageal Cancer Ineligible for Pivotal Trials

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ID: 326080
2026
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Abstract
Abstract Topic Esophageal Cancer: Oncology/Radiation Therapy Background Immunochemotherapy combining immune checkpoint inhibitors (ICIs) with cytotoxic chemotherapy is a standard first-line treatment for unresectable advanced or recurrent esophageal cancer. However, pivotal trials such as KEYNOTE-590, CheckMate 648, and RATIONALE-306 enrolled highly selected patients, and the safety and efficacy of immunochemotherapy in trial-ineligible patients remain unclear. Methods We retrospectively analyzed patients with unresectable advanced or recurrent esophageal cancer or Siewert type I esophagogastric junction cancer who initiated first-line immunochemotherapy at Shizuoka Cancer Center between December 2021 and December 2025. Patients were classified as trial-eligible and trial-ineligible. Trial-ineligible criteria included ECOG performance status ≥2, invasion of major adjacent structures (aorta or trachea; T4b), organ dysfunction, severe malnutrition requiring continuous nutritional support, or concomitant active malignancies requiring treatment. Safety endpoint included adverse events occurring during treatment and from treatment discontinuation to the initiation of subsequent therapy or death, assessed using CTCAE version 5.0. Efficacy endpoints included progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), response rate (RR), and duration of response (DoR). Tumor responses were evaluated according to RECIST version 1.1. Results A total of 55 patients were included: 20 trial-eligible and 35 trial-ineligible. The main reasons for trial-ineligible were T4b (40.0%), severe malnutrition (37.1%), and renal dysfunction (34.3%). Initial dose reduction was performed in 20.0% of trial-eligible group vs 34.3% of trial-ineligible group. Grade ≥3 treatment-related adverse events occurred in 35.0% vs 34.3% (P=1.00). The most common grade ≥3 adverse event was neutropenia (20.0% vs 14.3%), followed by immune-related adverse events, including enterocolitis (10.0% vs 0%), pneumonitis (5.0% vs 2.9%), and hepatitis (5.0% vs 2.9%). One treatment-related death due to pneumonitis occurred in the trial-ineligible group. The reasons for treatment discontinuation were disease progression (55.6% vs 56.2%), adverse events (22.2% vs 18.8%), and patient decision (11.1% vs 12.5%). Median TTF was 5.0 vs 5.5 months (P=0.72), and median PFS was 9.8 vs 7.3 months (P=0.58). Median overall survival was significantly longer in trial-eligible patients (28.3 vs 14.2 months; P=0.043). Conclusion Immunochemotherapy may be feasible and effective as first-line treatment for unresectable advanced or recurrent esophageal cancer, even in trial-ineligible patients with major adjacent structure invasion, renal dysfunction, or severe malnutrition, when appropriate monitoring and dose adjustment are applied. These findings suggest the potential to expand the indication for immunochemotherapy in real-world clinical practice.
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Authors Daisuke Oshikawa, Takahiro Tsushima, Kunihiro Fushiki, Akihiro Ohba, Kotoe Oshima, Takeshi Kawakami, Satoshi Hamauchi, Tomoya Yokota, Yusuke Onozawa, Kentaro Yamazaki, Hirofumi Yasui
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Journal diseases of the esophagus : official journal of the international society for diseases of the esophagus
Year 2026
DOI
10.1093/dote/doag077.270
URL
https://academic.oup.com/dote/article-pdf/39/Supplement_1/doag077.270/70760411/doag077.270.pdf
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