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

In Gyu Hwang, Joung Soon Jang, Sung Yong Oh, Myung Hwan Rho, Suee Lee, Young Suk Park, Joon Oh Park, Eun Mi Nam, Hyo Rak Lee, Hyun Jung Jun, Kyong Choun Chi

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6 Scopus citations

Abstract

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/m2 (day 1) and leucovorin 30 mg (days 1, 2) followed by 5-fluorouracil 1,500 mg/m2 (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.

Original languageEnglish
Pages (from-to)757-762
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume75
Issue number4
DOIs
StatePublished - Apr 2015

Keywords

  • Biliary tract cancer
  • Fluorouracil
  • Oxaliplatin
  • Second line

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