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

Autor: Hwang IG; Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 224 Heukseok-dong, Dongjak-gu, Seoul, 156-755, Korea., Jang JS, Oh SY, Rho MH, Lee S, Park YS, Park JO, Nam EM, Lee HR, Jun HJ, Chi KC
Jazyk: angličtina
Zdroj: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2015 Apr; Vol. 75 (4), pp. 757-62. Date of Electronic Publication: 2015 Feb 13.
DOI: 10.1007/s00280-015-2691-1
Abstrakt: 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.
Databáze: MEDLINE
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