EFFICACY AND SAFETY OF DURVALUMAB PLUS CHEMOTHERAPY IN PATIENTS WITH ADVANCED BILIARY TRACT CANCER: A MULTICENTER REALWORD DATA FROM TURKISH ONCOLOGY GROUP


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Efil S. C., Şendur M. A. N., Kuş F., Bayram S., Köylü B., Araz M., ...Daha Fazla

14th International Gastrointestinal Cancers Conference (IGICC2024), İstanbul, Türkiye, 28 Kasım - 01 Aralık 2024, ss.25-26, (Tam Metin Bildiri)

  • Yayın Türü: Bildiri / Tam Metin Bildiri
  • Basıldığı Şehir: İstanbul
  • Basıldığı Ülke: Türkiye
  • Sayfa Sayıları: ss.25-26
  • İstanbul Üniversitesi-Cerrahpaşa Adresli: Evet

Özet

Background: Durvalumab in combination with gemcitabine and cisplatin was recently approved as a first-line treatment for patients with advanced biliary tract cancer (BTC), following results from the TOPAZ-1 trial. Objective: The main objective of this study was to assess the efficacy and safety of durvalumab combined with chemotherapy as a first-line treatment for advanced BTC. Methods: In total, 39 patients with advanced BTC from 13 institutions in Turkey, treated with durvalumab plus chemotherapy between March 2022 and August 2024, were retrospectively screened. Data on overall survival (OS), progression-free survival (PFS), response rate, and safety were analyzed. Kaplan–Meier survival analysis was conducted to assess OS and PFS. Results: Baseline demographic and clinicopathological characteristics of the patients are shown in Table 1. The median age was 60 years (20-80) and 59% of the patients (n=23) were female. The most common primary tumor location was intrahepatic (61%, n=24) and disease status was initially unresectable (77%, n=30). The liver was the most common site of metastases, occurring in 80% of patients (n=31), followed by the peritoneum and bones, each affected in 18% of patients (n=7 for both). After a median follow-up of 14 months (95%CI 9.7-18.3), 22 patients (56%) had died, and 31 patients (79%) experienced disease progression. The median PFS was 4.8 months (95% CI 2.2-7.4) and the median OS was 10.1 months (95% CI 5.5-14.7) (figure1). The results indicated that complete response (CR) was seen in 1 case (3%), partial response (PR) in 14 cases (36%), stable disease (SD) in 8 cases (20%), and progressive disease (PD) in 16 cases (41%). The incidences of >= grade 3 advers events and >= grade 3 immunotherapy-related adverse events (IRAE) were 49% and 5%, respectively. Conclusions: Durvalumab combined with chemotherapy is an effective and safe first-line treatment option for patients with advanced BTC.