A four-arm, randomized, multicenter phase II trial of oxaliplatin combined with varying schedules of 5-fluorouracil as first-line therapy in previously untreated advanced colorectal cancer

Ramesh K. Ramanathan, Georg A. Bjarnason, Stephen Alan Bernard, Philip Desimone, Theodore Braich, Joseph P. Evers, William J. Hrushesky, Jacques Jolivet

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Background: Oxaliplatin combined with 5-fluorouracil (5-FU), with or without leucovorin (LV), is effective and well tolerated for first-line therapy of advanced colorectal cancer (CRC). However, there is no consensus as to which oxaliplatin/5-FU-containing regimen is superior in the first-line setting.This randomized, multicenter phase II trial was designed to evaluate and compare the efficacy of 4 different oxaliplatin/5-FU regimens. Patients and Methods: Patients with previously untreated metastatic CRC (mCRC; n = 129) were randomized to 1 of 4 treatment regimens: (1) continuous 5-FU infusion plus oxaliplatin (n = 23); (2) weekly 5-FU bolus with LV plus oxaliplatin (n = 40); (3) oxaliplatin with 2-day infusion 5-FU/LV (FOLFOX4, n = 41); and (4) chronomodulated 5-FU plus oxaliplatin (n = 25). Results: Overall response rates, after expert assessment, ranged from 24% to 34%, and median progression-free survival (PFS) ranged from 6 months to 8 months. Although no significant differences in efficacy were detected in pair-wise comparisons of the 4 different regimens, patients randomized to FOLFOX4 had the highest response rate and longest PFS. The FOLFOX4 regimen was also associated with the lowest incidence of severe (grade 3/4) toxicity, with the exception of cumulative peripheral neurotoxicity. Conclusion: This randomized phase II trial provides evidence that oxaliplatin/5-FU regimens are effective and well tolerated for first-line therapy of previously untreated mCRC. The FOLFOX regimens are now an established standard for CRC.

Original languageEnglish (US)
Pages (from-to)134-139
Number of pages6
JournalClinical colorectal cancer
Volume7
Issue number2
DOIs
StatePublished - Mar 2008

Keywords

  • Chronomodulated regimens
  • Continuous infusion
  • FOLFOX
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

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