1. Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin.
- Author
-
Dierks J, Gaspersz MP, Belkouz A, van Vugt JLA, Coelen RJS, de Groot JWB, Ten Tije AJ, Meijer WG, Pruijt JFM, van Voorthuizen T, van Spronsen DJ, Rentinck M, Ten Oever D, Smit JM, Otten HM, van Gulik TM, Wilmink JW, Groot Koerkamp B, and Klümpen H
- Subjects
- Adult, Aged, Aged, 80 and over, Biliary Tract Neoplasms mortality, Cholangiocarcinoma mortality, Cisplatin administration & dosage, Cisplatin adverse effects, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Disease-Free Survival, Female, Gallbladder Neoplasms mortality, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Treatment Outcome, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biliary Tract Neoplasms drug therapy, Cholangiocarcinoma drug therapy, Gallbladder Neoplasms drug therapy, Palliative Care methods
- Abstract
Background: Biliary tract cancer (BTC) is an uncommon cancer with an unfavorable prognosis. Since 2010, the standard of care for patients with unresectable BTC is palliative treatment with gemcitabine plus cisplatin, based on the landmark phase III ABC-02 trial. This current study aims to evaluate the efficacy and safety of gemcitabine and cisplatin in patients with unresectable cholangiocarcinoma and gallbladder cancer in daily practice that meet the criteria for the ABC-02 trial in comparison to patients who did not., Methods: Patients diagnosed with unresectable BTC between 2010 and 2015 with an indication for gemcitabine and cisplatin were included. We divided these patients into three groups: (I) patients who received chemotherapy and met the criteria of the ABC-02 trial, (II) patients who received chemotherapy and did not meet these criteria and (III) patients who had an indication for chemotherapy, but received best supportive care without chemotherapy. Primary outcome was overall survival (OS) and secondary outcome was progression-free survival (PFS)., Results: We collected data of 208 patients, of which 138 (66.3%) patients received first line chemotherapy with gemcitabine and cisplatin. Median OS of 69 patients in group I, 63 patients in group II and 65 patients in group III was 9.6 months (95%CI = 6.7-12.5), 9.5 months (95%CI = 7.7-11.3) and 7.6 months (95%CI = 5.0-10.2), respectively. Median PFS was 6.0 months (95%CI = 4.4-7.6) in group I and 5.1 months (95%CI = 3.7-6.5) in group II. Toxicity and number of dose reductions (p = .974) were comparable between the two chemotherapy groups., Conclusion: First-line gemcitabine and cisplatin is an effective and safe treatment for patients with unresectable BTC who do not meet the eligibility criteria for the ABC-02 trial. Median OS, PFS and treatment side effects were comparable between the patients who received chemotherapy (group I vs. group II).
- Published
- 2018
- Full Text
- View/download PDF