@article {SCHINZARI5193, author = {GIOVANNI SCHINZARI and ERNESTO ROSSI and GIUSEPPINA MAMBELLA and ANTONIA STRIPPOLI and RODOLFO CANGIANO and MASSIMILIANO MUTIGNANI and MICHELE BASSO and ALESSANDRA CASSANO and CARLO BARONE}, title = {First-line Treatment of Advanced Biliary Ducts Carcinoma: A Randomized Phase II Study Evaluating 5-FU/LV Plus Oxaliplatin (Folfox 4) Versus 5-FU/LV (de Gramont Regimen)}, volume = {37}, number = {9}, pages = {5193--5197}, year = {2017}, publisher = {International Institute of Anticancer Research}, abstract = {Background/Aim: Few clinical trials are available for advanced biliary tract carcinoma (BTC). We conducted this randomized phase II clinical trial to explore efficacy and safety of 5-fluorouracil/leucovorin (5-FU/LV - de Gramont) or the same regimen plus oxaliplatin (Folfox 4) as first-line treatment of advanced BTC. Patients and Methods: Primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), response and toxicity. Results: A total of 48 patients were enrolled, 23 in de Gramont arm and 25 in the Folfox arm. Disease control rate was 56.5\% for de Gramont vs. 72\% for Folfox. RR was 21.7\% for de Gramont arm and 28\% for Folfox arm (p=0.12). PFS was in favor of Folfox (5.2 vs. 2.8 months; p=0.031). OS was 7.5 and 13.0 months for de Gramont and Folfox arm respectively (p=0.0010). Toxicity was generally mild in both arms. Conclusion: Folfox 4 could be considered a valid option as first-line treatment of BTC due to its efficacy and tolerability.}, issn = {0250-7005}, URL = {https://ar.iiarjournals.org/content/37/9/5193}, eprint = {https://ar.iiarjournals.org/content/37/9/5193.full.pdf}, journal = {Anticancer Research} }