Objectives This study aimed to evaluate the incidence and prognostic significance of imaging-detected immune-related adverse events (irAEs) in patients with unresectable biliary tract cancer (BTC) receiving durvalumab combined with gemcitabine and cisplatin. Materials and methods This retrospective cohort study included 66 patients (mean age ± standard deviation, 64.7 ± 9.4 years, 35 women) with histologically confirmed unresectable BTC who received a combination of durvalumab, gemcitabine, and cisplatin as the first-line systemic therapy. Clinical records and imaging studies were reviewed to identify irAEs. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), treatment response, and incidence of irAEs. Cox regression analyses were conducted to determine predictors of survival outcomes. Results Imaging-detected irAEs were observed in 21.2% (14/66) of patients, with the most frequent findings being bowel wall thickening and transient inflammatory lung nodules. The majority of these events (85.7%) manifested within 90 days of treatment initiation, and only 35.7% (5/14) had clinical symptoms related to irAE. In multivariate analysis, the presence of imaging-detected irAEs was a significant independent predictor of improved OS (hazard ratio (HR) = 0.42; p = 0.017) and PFS (HR = 0.43; p = 0.016). The median OS was significantly longer in patients with imaging-detected irAEs compared to those without (23.0 vs. 12.0 months; p = 0.009). Conclusion Imaging-detected irAEs are potent prognostic markers for superior survival in BTC patients receiving durvalumab-based chemotherapy. Given that these events are frequently subclinical and occur early in the treatment course, meticulous radiologic surveillance is essential to identify patients likely to achieve favorable clinical outcomes. Key Points <Emphasis Type="BoldItalic">Question</Emphasis> The relationship between immune-related adverse events (irAEs) on imaging and treatment outcome in biliary tract cancer patients undergoing durvalumab-based therapy has not been thoroughly investigated. <Emphasis Type="BoldItalic">Findings</Emphasis> The development of irAEs detected on imaging study was significantly associated with improved overall survival. <Emphasis Type="BoldItalic">Clinical relevance</Emphasis> Careful imaging evaluation during follow-up to detect early irAE-related change is important, since the occurrence of irAEs may indicate better clinical outcomes. Graphical Abstract

Prognostic value of imaging-detected immune-related adverse events in biliary tract cancer patients receiving durvalumab-based chemotherapy

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2026年5月28日

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Jeongin Yoo,
Dong Ho Lee,
Do-Youn Oh,
Jeesun Yoon,
Sang Hyub Lee,
In Rae Cho,
Woo Hyun Paik

摘要

Objectives

This study aimed to evaluate the incidence and prognostic significance of imaging-detected immune-related adverse events (irAEs) in patients with unresectable biliary tract cancer (BTC) receiving durvalumab combined with gemcitabine and cisplatin.

Materials and methods

This retrospective cohort study included 66 patients (mean age ± standard deviation, 64.7 ± 9.4 years, 35 women) with histologically confirmed unresectable BTC who received a combination of durvalumab, gemcitabine, and cisplatin as the first-line systemic therapy. Clinical records and imaging studies were reviewed to identify irAEs. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), treatment response, and incidence of irAEs. Cox regression analyses were conducted to determine predictors of survival outcomes.

Results

Imaging-detected irAEs were observed in 21.2% (14/66) of patients, with the most frequent findings being bowel wall thickening and transient inflammatory lung nodules. The majority of these events (85.7%) manifested within 90 days of treatment initiation, and only 35.7% (5/14) had clinical symptoms related to irAE. In multivariate analysis, the presence of imaging-detected irAEs was a significant independent predictor of improved OS (hazard ratio (HR) = 0.42; p = 0.017) and PFS (HR = 0.43; p = 0.016). The median OS was significantly longer in patients with imaging-detected irAEs compared to those without (23.0 vs. 12.0 months; p = 0.009).

Conclusion

Imaging-detected irAEs are potent prognostic markers for superior survival in BTC patients receiving durvalumab-based chemotherapy. Given that these events are frequently subclinical and occur early in the treatment course, meticulous radiologic surveillance is essential to identify patients likely to achieve favorable clinical outcomes.

Key Points

Question The relationship between immune-related adverse events (irAEs) on imaging and treatment outcome in biliary tract cancer patients undergoing durvalumab-based therapy has not been thoroughly investigated.

Findings The development of irAEs detected on imaging study was significantly associated with improved overall survival.

Clinical relevance Careful imaging evaluation during follow-up to detect early irAE-related change is important, since the occurrence of irAEs may indicate better clinical outcomes.

Graphical Abstract