Background: Advanced biliary cancer (ABC) is still regarded as an incurable condition. However, the improved depth and duration of response enabled by chemo-immunotherapy may foster intensified strategies, including surgical procedures, radiotherapy and intra-arterial techniques. Objectives: The prevalence, clinical features and treatment outcomes of ABC receiving multimodality treatment in the immunotherapy era are unknown. Design: Newly diagnosed ABC treated with chemo-immunotherapy and loco-regional procedures from February 2022 to December 2024 were retrospectively identified at 10 tertiary referral cancer centres in Italy. Methods: Categorical variables were compared using the chi-squared test, and the inverse probability of treatment weighting analysis was performed to reduce selection biases. Results: Of 241 ABC receiving first-line treatment, 12 (4.9%) fulfilled the inclusion criteria. The median age was 69 (range 36–80), and 9 patients (75%) had intrahepatic cholangiocarcinoma (iCCA). Ten (83.3%) presented with de novo unresectable ABC: 3 (25%) had locally advanced, and 7 (50.3%) had metastatic disease. The median number of metastatic sites was one, with lymph nodes being the most commonly involved location (41.6%, n = 5). Patients treated with intensified therapy were more likely to have low tumour burden (p = 0.03) and iCCA (p = 0.06). Overall, four patients underwent surgery, three transarterial radioembolization, three stereotactic body radiotherapy and two liver transplants. As of data cut-off, 11 patients were alive (91.6%), and five patients were disease-free (41.6%). After adjusting for age, gender, Eastern Cooperative Group Performance Status (ECOG PS), primary site, disease status and number of metastases, the overall survival for the multimodality strategy versus systemic treatment alone was not reached versus 14.1 months (p < 0.001). Conclusion: This study, the first on multimodality treatment of ABC in the immunotherapy era, suggests that a highly selected subset of patients may achieve long-term disease control with an intensified approach. Oligometastatic patients and those affected by iCCA appear as the best candidates. Future studies are needed to confirm these preliminary findings.
Preliminary report on advanced biliary cancer patients receiving multimodality treatment in the immunotherapy era: a real-world multicentre experience
Ghidini M.
2026-01-01
Abstract
Background: Advanced biliary cancer (ABC) is still regarded as an incurable condition. However, the improved depth and duration of response enabled by chemo-immunotherapy may foster intensified strategies, including surgical procedures, radiotherapy and intra-arterial techniques. Objectives: The prevalence, clinical features and treatment outcomes of ABC receiving multimodality treatment in the immunotherapy era are unknown. Design: Newly diagnosed ABC treated with chemo-immunotherapy and loco-regional procedures from February 2022 to December 2024 were retrospectively identified at 10 tertiary referral cancer centres in Italy. Methods: Categorical variables were compared using the chi-squared test, and the inverse probability of treatment weighting analysis was performed to reduce selection biases. Results: Of 241 ABC receiving first-line treatment, 12 (4.9%) fulfilled the inclusion criteria. The median age was 69 (range 36–80), and 9 patients (75%) had intrahepatic cholangiocarcinoma (iCCA). Ten (83.3%) presented with de novo unresectable ABC: 3 (25%) had locally advanced, and 7 (50.3%) had metastatic disease. The median number of metastatic sites was one, with lymph nodes being the most commonly involved location (41.6%, n = 5). Patients treated with intensified therapy were more likely to have low tumour burden (p = 0.03) and iCCA (p = 0.06). Overall, four patients underwent surgery, three transarterial radioembolization, three stereotactic body radiotherapy and two liver transplants. As of data cut-off, 11 patients were alive (91.6%), and five patients were disease-free (41.6%). After adjusting for age, gender, Eastern Cooperative Group Performance Status (ECOG PS), primary site, disease status and number of metastases, the overall survival for the multimodality strategy versus systemic treatment alone was not reached versus 14.1 months (p < 0.001). Conclusion: This study, the first on multimodality treatment of ABC in the immunotherapy era, suggests that a highly selected subset of patients may achieve long-term disease control with an intensified approach. Oligometastatic patients and those affected by iCCA appear as the best candidates. Future studies are needed to confirm these preliminary findings.
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