Abstract
Background/Objectives: Most patients with biliary tract cancer are diagnosed at an advanced or metastatic stage, making systemic chemotherapy the mainstay of treatment. Gemcitabine plus cisplatin is the current standard first-line regimen, while Gemcitabine plus S-1 has also demonstrated efficacy in several clinical trials. However, real-world evidence regarding the effectiveness and safety of this regimen in Vietnam remains limited. Therefore, this study aimed to evaluate treatment outcomes and safety of first-line gemcitabine plus S-1 in patients with advanced biliary tract cancer treated at Military Central Hospital 108.
Methods: This retrospective descriptive study included patients with advanced biliary tract cancer who received first-line treatment with gemcitabine plus S-1 at 108 Military Central Hospital. Statistical analyses were performed using SPSS version 27.0.
Results: A total of 26 patients were enrolled. After 3, 6, and 9 treatment cycles, the rates of partial response, stable disease, and progressive disease were 15.4%, 73.1%, 11.5%; 25.0%, 55.0%, 20.0%; and 38.4%, 38.4%, and 23.2%, respectively. The median progression-free survival was 6.54 months (95% CI, 4.86-8.22), and the median overall survival was 12.45 months (95% CI, 7.80-17.10). The most common hematologic toxicities were grade 1-2 anemia (34.6%) and grade 1-2 leukopenia (34.6%), while grade 3-4 leukopenia occurred in 26.9% of patients. The most frequent non-hematologic adverse events were anorexia (53.8%), nausea (23.1%), and grade 1-2 hepatotoxicity (23.1%). No renal toxicity was observed.
Conclusions: First-line Gemcitabine plus S-1 demonstrated promising efficacy and an acceptable safety profile in patients with advanced or metastatic biliary tract cancer.
Keywords: advanced biliary tract cancer, gemcitabine S-1, first-line chemotherapy.
References
Sung H, Filho AM, Laversanne M, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA: A Cancer Journal for Clinicians. 2026;76(4):e70090.
Zhang D, Dorman K, Westphalen CB, Haas M, Ormanns S, Neumann J, et al. Unresectable biliary tract cancer: Current and future systemic therapy. European Journal of Cancer. 2024;203:114046.
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. New England Journal of Medicine. 2010;362(14):1273-81.
Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, et al. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Annals of Oncology. 2019;30(12):1950-8.
Bộ Y tế. Hướng dẫn chẩn đoán và điều trị một số bệnh ung bướu. Nhà xuất bản Y học; 2020. p. 281-294.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-47.
Institute NC. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Bethesda (MD): National Cancer Institute; 2017.
Nịnh Thị Thảo, Vũ Hồng Thăng. Đánh giá kết quả bước đầu điều trị phác đồ Gemcitabine kết hợp Cisplatin trong ung thư đường mật giai đoạn muộn. Tạp chí Y học Việt Nam. 2021;506(2).
Nguyễn Thị Kim Anh, Trần Thắng. Kết quả hóa trị bước một ung thư đường mật không còn chỉ định phẫu thuật triệt căn bằng phác đồ Gemcitabine-Oxaliplatin tại bệnh viện K. 2022;519(số chuyên đề).
Chiang NJ, Chen MH, Yang SH, Hsu C, Yen CJ, Tsou HH, et al. Multicentre, phase II study of gemcitabine and S‐1 in patients with advanced biliary tract cancer: TG1308 study. Liver International. 2020;40(10):2535-43.
Trần Phương Thảo, Đỗ Anh Tú, Trần Thị Kim Phượng, Trần Khắc Hùng. Đánh giá kết quả điều trị bước đầu ung thư đường mật giai đoạn tiến triển bằng phác đồ Gemcitabine-Cisplatin tại bệnh viện K cơ sở Tam Hiệp. Tạp chí Y học Việt Nam. 2025;556(2).
| Published | 18-08-2026 | |
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| Issue | Vol. 18 No. 5 (2026) | |
| Section | Original article | |
| DOI | 10.38103/jcmhch.18.5.6 | |
| Keywords | ung thư đường mật tiến triển, di căn, Gemcitabine, S-1, hóa trị bước một advanced biliary tract cancer, gemcitabine S-1, first-line chemotherapy |
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