Therapeutic advances in medical oncology · 2025
Real-world effectiveness of durvalumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced gallbladder cancer: a study using the TriNetX global network.
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Lin Hsin-Chen, Tseng Kuan-Yu, Shih Yu-Hsuan
Аннотация
BACKGROUND: Gallbladder cancer (GBC) represents a rare but aggressive malignancy, often diagnosed at an advanced stage. Although immune checkpoint inhibitors have improved outcomes in biliary tract cancers, GBC-specific evidence remains limited due to underrepresentation in pivotal clinical trials.
OBJECTIVES: To evaluate the real-world effectiveness and safety of durvalumab combined with gemcitabine and cisplatin (Durva + gemcitabine and cisplatin (GemCis)) compared to GemCis alone in patients with advanced GBC.
DESIGN: Retrospective, multi-institutional cohort study.
METHODS: Data were collected from the TriNetX Global Collaborative Network. Adults diagnosed with advanced GBC between January 2020 and January 2025 who received Durva + GemCis or GemCis as first-line therapy were included. Propensity score matching (1:1) was performed based on age, sex, race, metastatic sites, and tumor marker levels. The primary outcome was overall survival (OS), whereas secondary outcomes included adverse events (AEs).
RESULTS: Among 2458 patients with advanced GBC, 130 received Durva + GemCis and 201 received GemCis. After matching, 111 patients per group were analyzed. Median OS was significantly longer in the Durva + GemCis group compared to the GemCis group (13.1 vs 8.5 months; log-rank p = 0.028). Most AEs were comparable between groups; however, malaise and fatigue were more frequently reported in the Durva group (28.8% vs 16.2%; hazard ratio: 1.98, 95% confidence interval: 1.11-3.53).
CONCLUSION: In this real-world study, the addition of durvalumab to GemCis was associated with improved OS in patients with advanced GBC, with a manageable safety profile. These exploratory findings should be interpreted with caution, underscoring the need for dedicated GBC-specific prospective trials.
OBJECTIVES: To evaluate the real-world effectiveness and safety of durvalumab combined with gemcitabine and cisplatin (Durva + gemcitabine and cisplatin (GemCis)) compared to GemCis alone in patients with advanced GBC.
DESIGN: Retrospective, multi-institutional cohort study.
METHODS: Data were collected from the TriNetX Global Collaborative Network. Adults diagnosed with advanced GBC between January 2020 and January 2025 who received Durva + GemCis or GemCis as first-line therapy were included. Propensity score matching (1:1) was performed based on age, sex, race, metastatic sites, and tumor marker levels. The primary outcome was overall survival (OS), whereas secondary outcomes included adverse events (AEs).
RESULTS: Among 2458 patients with advanced GBC, 130 received Durva + GemCis and 201 received GemCis. After matching, 111 patients per group were analyzed. Median OS was significantly longer in the Durva + GemCis group compared to the GemCis group (13.1 vs 8.5 months; log-rank p = 0.028). Most AEs were comparable between groups; however, malaise and fatigue were more frequently reported in the Durva group (28.8% vs 16.2%; hazard ratio: 1.98, 95% confidence interval: 1.11-3.53).
CONCLUSION: In this real-world study, the addition of durvalumab to GemCis was associated with improved OS in patients with advanced GBC, with a manageable safety profile. These exploratory findings should be interpreted with caution, underscoring the need for dedicated GBC-specific prospective trials.