Cancers · 2025
Durvalumab-Based First-Line Chemoimmunotherapy in Advanced Biliary Tract Cancer: Real-World Outcomes and Prognostic Factors-A Turkish Oncology Group Study.
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Efil Safa Can, Kus Fatih, Koylu Bahadir, Durukan Bekir Mert, Bayram Selami, Guzel Halil Goksel, Ozturk Banu, Muglu Harun, Bilici Ahmet, Kose Fatih, Alan Ozkan, Karapelit Agitoglu Eda, Guner Gurkan, Besen Ali Ayberk, Helvaci Kaan, Araz Murat, Kacan Turgut, Arslan Cagatay, Unal Ahmet, Eniseler Emine Bihter, Biter Sedat, Ekinci Ferhat, Aslan Ferit, Unek Ilkay Tugba, Tas Semra, Acar Omer, Ates Ozturk, Sakalar Teoman, Akbas Sinem, Karakas Hilal, Akinci Muhammed Bulent, Yalcin Bulent, Yalcin Suayip, Sendur Mehmet Ali Nahit
Аннотация
BACKGROUND: Durvalumab combined with gemcitabine-cisplatin (GC) has become the standard first-line treatment for advanced biliary tract cancer (BTC) following the TOPAZ-1 trial. However, real-world effectiveness, safety, and prognostic determinants, particularly in underrepresented populations, remain insufficiently defined. The aim of this study was to evaluate the real-world outcomes of first-line durvalumab plus chemotherapy and identify independent prognostic factors in patients with advanced BTC.
METHODS: This multicenter retrospective cohort study included patients with unresectable or metastatic BTC treated with first-line durvalumab plus chemotherapy across 21 tertiary oncology centers in Türkiye. Clinical characteristics, laboratory parameters, biomarker data, and treatment details were collected. The primary endpoint was overall survival (OS), while secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Survival outcomes were analyzed using the Kaplan-Meier method and Cox proportional hazards regression models.
RESULTS: A total of 78 patients were analyzed; 53.8% were male, and the median age was 62 years. Primary tumor sites were intrahepatic (55.1%), extrahepatic (30.8%), and gallbladder (14.1%). After a median follow-up of 12.58 months, median OS was 11.59 months and median PFS was 6.80 months. The ORR was 50.6%, including complete and partial responses in 2.7% and 47.9% of patients, respectively. Treatment-related adverse events occurred in 97.4% of patients, with grade 3-4 events in 37.2%. Immune-related adverse events were observed in 19.2%, including one case of grade 3 pneumonitis. No patient permanently discontinued durvalumab due to toxicity, and no durvalumab-related mortality occurred. In multivariable analysis, ECOG performance status 2 (HR 3.43; 95% CI 1.33-8.80) and ALBI grade 2-3 (HR 2.54; 95% CI 1.24-5.19) independently predicted worse OS, while ECOG performance status 2 also predicted shorter PFS (HR 5.91; 95% CI 2.30-15.17).
CONCLUSIONS: In this multicenter real-world Turkish cohort, first-line durvalumab plus chemotherapy showed effectiveness and tolerability comparable to clinical trial data. Baseline ECOG performance status and ALBI grade were independent prognostic factors, supporting their use for risk stratification in advanced biliary tract cancer.
METHODS: This multicenter retrospective cohort study included patients with unresectable or metastatic BTC treated with first-line durvalumab plus chemotherapy across 21 tertiary oncology centers in Türkiye. Clinical characteristics, laboratory parameters, biomarker data, and treatment details were collected. The primary endpoint was overall survival (OS), while secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Survival outcomes were analyzed using the Kaplan-Meier method and Cox proportional hazards regression models.
RESULTS: A total of 78 patients were analyzed; 53.8% were male, and the median age was 62 years. Primary tumor sites were intrahepatic (55.1%), extrahepatic (30.8%), and gallbladder (14.1%). After a median follow-up of 12.58 months, median OS was 11.59 months and median PFS was 6.80 months. The ORR was 50.6%, including complete and partial responses in 2.7% and 47.9% of patients, respectively. Treatment-related adverse events occurred in 97.4% of patients, with grade 3-4 events in 37.2%. Immune-related adverse events were observed in 19.2%, including one case of grade 3 pneumonitis. No patient permanently discontinued durvalumab due to toxicity, and no durvalumab-related mortality occurred. In multivariable analysis, ECOG performance status 2 (HR 3.43; 95% CI 1.33-8.80) and ALBI grade 2-3 (HR 2.54; 95% CI 1.24-5.19) independently predicted worse OS, while ECOG performance status 2 also predicted shorter PFS (HR 5.91; 95% CI 2.30-15.17).
CONCLUSIONS: In this multicenter real-world Turkish cohort, first-line durvalumab plus chemotherapy showed effectiveness and tolerability comparable to clinical trial data. Baseline ECOG performance status and ALBI grade were independent prognostic factors, supporting their use for risk stratification in advanced biliary tract cancer.