PD05.06. Predictive Factors of Early Progressive Disease and Acquired Resistance With Ipilimumab Plus Nivolumab in Esophageal Squamous Cell Carcinoma

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ID: 326130
2026
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Abstract
Abstract Topic Esophageal Cancer: Non-Surgical Treatment of Esophageal Cancer Background Ipilimumab plus nivolumab (Ipi+Nivo) is a first-line treatment for unresectable advanced or recurrent esophageal cancer. However, high rate of early progressive disease (PD) and frequent immune-related adverse events (irAE) limit its clinical use. Despite these limitations, durable responses can be achieved with Ipi+Nivo, although some patients eventually develop acquired resistance. Methods We retrospectively analyzed patients with unresectable advanced or recurrent esophageal squamous cell carcinoma who received ipilimumab plus nivolumab at our institution between April 2022 and September 2025. Early PD rate, acquired resistance rate, overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and irAEs incidence were retrospectively evaluated. Clinical and laboratory factors associated with early PD and acquired resistance, including Eastern Cooperative Oncology Group performance status (ECOG PS), age, PD-L1 expression, neutrophil-to-lymphocyte ratio (NLR), liver or multiple organ metastases, and prior chemoradiotherapy (CRT) or immune checkpoint inhibitor (ICI) therapy, were assessed using multivariate logistic regression models. Early PD was defined as progression within 3 months of treatment initiation, and acquired resistance was defined as disease progression after achieving stable disease or better for at least 6 months during treatment. Results Fifty-nine patients were included (median age 70 years, range 46–84; 49 males). PS was 0–1 in 52 and 2–3 in 7. PD-L1 was negative in 33, positive in 17, and unknown in 9. NLR was <3.3 in 28 and ≥3.3 in 31. Liver metastasis was present in 12 and multiple organ metastases in 31. Prior CRT and ICI therapy were administered in 27 and 12. The early PD rate was 20.3%, and the acquired resistance rate was 8.5%. Median OS was 24.0 months (95% CI, 15.0–NR), and median PFS was 8.7 months (95% CI, 5.4–20.8); ORR was 28.8%. Logistic regression showed that NLR <3.3, negative PD-L1 expression, PS 2–3, liver metastasis, and prior CRT or ICI therapy were independently associated with early PD. No factors were associated with acquired resistance. Any-grade irAEs occurred in 50.8%, grade ≥3 in 10.3%, and discontinuation in 23.7%. Conclusion Low NLR, negative PD-L1 expression, poor PS, liver metastasis, and prior CRT or ICI therapy were associated with early PD following Ipi+Nivo therapy. No significant factors were identified for acquired resistance. Treatment efficacy and the incidence of irAEs were generally consistent with previous reports. Careful patient selection based on these factors may help avoid early progression.
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Authors Go Ikeda, Eriko Mura, Risako Suzuki, Toshiaki Tsurui, Nana Iriguchi, Tomoyuki Ishiguro, Yuya Hirasawa, Takahiro Yoshizawa, Ryotaro Ohkuma, Masahiro Shimokawa, Hirotsugu Ariizumi, Masahiro Kohmoto, Akira Saito, Kentaro Motegi, Takeshi Yamashita, Tomotake Ariyoshi, Yutaro Kubota, Satoshi Wada, Kiyoshi Yoshimura, Satoru Goto, Takuya Tsunoda, Atsushi Horiike
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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/doag077.109
URL
https://doi.org/10.1093/dote/doag077.109
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