A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer

• DOI: 10.1038/sj.bjc.6605374
• Publication Date: 2009-10-13T20:10:14Z
• Authors: C Yoo; J Y Hwang; J-E Kim; T W Kim; J S Lee; D H Park; S S Lee; D W Seo; S K Lee; M-H Kim; D J Han; S C Kim; J-L Lee
• Keywords: Folinic acid; Regimen; FOLFIRI; FOLFOX

Only a few clinical trials have been conducted in patients with advanced pancreatic cancer after failure of first-line gemcitabine-based chemotherapy. Therefore, there is no current consensus on the treatment these patients. We randomised phase II study modified FOLFIRI.3 (mFOLFIRI.3; regimen combining 5-fluorouracil (5-FU), folinic acid, and irinotecan) FOLFOX (mFOLFOX; 5-FU, oxaliplatin) regimens as second-line treatments gemcitabine-refractory cancer.The primary end point was 6-month overall survival rate. The mFOlFIRI.3 consisted irinotecan (70 mg m(-2); days 1 3), leucovorin (400 day 1), 5-FU (2000 2) every 2 weeks. mFOLFOX composed oxaliplatin (85 weeks.Sixty-one were to mFOLFIRI.3 (n=31) or (n=30) regimen. six-month rates 27% (95% confidence interval (CI)=13-46%) 30% CI=15-49%), respectively. median periods 16.6 14.9 weeks, Disease control achieved 23% CI=10-42%) 17% CI=6-35%), number at least one grade 3/4 toxicity identical (11 patients, 38%) both groups: neutropenia (7 under vs 6 regimen), asthaenia (1 4), vomiting (3 both), diarrhoea (2 0), mucositis 2).Both tolerated manageable toxicity, offering modest activities for cancer, previously treated gemcitabine.