FIRST-LINE GEMCITABINE–CISPLATIN FOR ADVANCED, RECURRENT, OR METASTATIC BILIARY TRACT CANCER: TREATMENT OUTCOMES AT HANOI ONCOLOGY HOSPITAL
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Tóm tắt
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Abstract
Objective: To evaluate the efficacy and adverse effects of the Gemcitabine–Cisplatin regimen in patients with advanced, recurrent or metastatic biliary tract cancer at Hanoi Oncology Hospital.
Subjects and methods: A retrospective and prospective research on patients with advanced, recurrent or metastatic biliary tract cancer (including intrahepatic, extrahepatic, and gallbladder cancer) with ECOG PS 0–1, treated with at least 3 cycles of the Gemcitabine-Cisplatin regimen. The efficacy was evaluated according to RECIST 1.1 and toxicity according to CTCAE version 5.0. Survival analysis using Kaplan–Meier and Log-rank verification.
Results: Sixty-five patients were enrolled with a mean age of 56.8 ± 10.1; men accounted for 66.2%. The most common tumor site is the intrahepatic biliary tract (66.2%). The majority of patients were in the recurrent or metastasis stage (64.6%). After 3 cycles, the disease control rate reached 83.1% with an objective response rate of 29.2%. After 6 cycles, the complete response rate was 2.6%, partial response accounted for 15.8%, stable disease for 57.9% and progressed disease for 23.7%. The disease control rate reached 76.3%. The median progression-free survival was 8.1 months (95% CI: 5.4–10.7), and the median overall survival was 13.1 months (95% CI: 8.2–18.0). Performance status (ECOG, PS) and response after 3 cycles were statistically significant prognostic factors for both progression-free survival and overall survival. Common grade 3–4 adverse effects were neutropenia (38.5%), elevated liver enzymes (15.4%), and anemia (10.8%).
Conclusion: Gemcitabine - Cisplatin is an effective and acceptable safety regimen. Response and performance status after 3 cycles (ECOG PS) are important prognostic factors, which are valuable to guide treatment decisions. This regimen could be the first-line chemotherapy option in patients with advanced biliary tract cancer.
Từ khóa
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Keywords
Biliary tract cancer; Gemcitabine; Cisplatin; chemotherapy; survival; toxicity.
Tài liệu tham khảo (References)
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- Ninh Thi Thao (2021). Master's thesis in medicine. Hanoi Medical University.
