Phase II study of mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) as second-line treatment after gemcitabine failure in patients with unresectable/metastatic biliary tract cancer

• Published in: Cancer chemotherapy and pharmacology 2015-04, Vol.75 (4), p.757-762
• Main Authors: Hwang, In Gyu, Jang, Joung-Soon, Oh, Sung Yong, Rho, Myung Hwan, Lee, Suee, Park, Young Suk, Park, Joon Oh, Nam, Eun Mi, Lee, Hyo Rak, Jun, Hyun Jung, Chi, Kyong-Choun
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biliary Tract Neoplasms - drug therapy; Biliary Tract Neoplasms - pathology; Cancer Research; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Humans; Kaplan-Meier Estimate; Leucovorin - administration & dosage; Leucovorin - adverse effects; Leucovorin - therapeutic use; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Metastasis; Oncology; Organoplatinum Compounds - administration & dosage; Organoplatinum Compounds - adverse effects; Organoplatinum Compounds - therapeutic use; Original Article; Pharmacology/Toxicology; Prospective Studies; Treatment Failure
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-015-2691-1

Purpose We conducted a phase II trial of 5-fluorouracil and oxaliplatin combination chemotherapy as a second-line treatment in unresectable/metastatic biliary tract cancer patients who had failed gemcitabine-based chemotherapy. Methods Patients treated with gemcitabine-based palliative treatment were enrolled in this study. Patients were received modified FOLFOX3 (mFOLFOX3) consists of oxaliplatin 85 mg/m 2 (day 1) and leucovorin 30 mg (days 1, 2) followed by 5-fluorouracil 1,500 mg/m 2 (days 1, 2) every 2 weeks. Results Between March 2010 and June 2012, a total of 30 patients were enrolled in this study. Twenty-eight patients were measurable for treatment response. One achieved complete response, and one a partial response was observed. Overall response rate was 7.1 % (95 % confidence interval 0.9–23.5 %). The median progression-free survival was 1.6 months, and the median overall survival was 4.4 months. Grade 3–4 hematologic toxicities included neutropenia (6.7 %) and thrombocytopenia (3.4 %). The most common non-hematologic toxicity was neuropathy (22.2 %). However, the most common grade 3–4 non-hematologic toxicity was hyperbilirubinemia (5.0 %). There was one treatment-related death due to neutropenic infection. Conclusion mFOLFOX3 as a second-line regimen has modest effect and tolerable toxicity in unresectable/metastatic biliary tract cancer patients who have been treated previously via gemcitabine-based chemotherapy.