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Comparison of the levogyre and dextro-levogyre forms of leucovorin in a phase III trial of bimonthly LV5FU2 versus monthly 5-fluorouracil and high-dose leucovorin for patients with stage II and III colon cancer (GERCOR C96.1).

AbstractBACKGROUND:
These analyses compare the safety and efficacy of 2 forms (levogyre [L] and dextro-levogyre [DL]) of leucovorin (LV) when used with 5-fluorouracil (5-FU) for the adjuvant treatment of patients with stage II and III colon cancer.
MATERIALS AND METHODS:
The analysis used primary efficacy and safety data of a phase III trial comparing monthly 5-FU/LV or bimonthly LV5FU2 (LV 200 mg/m2 intravenously over 2 hours followed by 5-FU 400 mg/m2 bolus and then 600 mg/m2 continuous intravenous infusion over 22 hours, days 1 and 2, every 2 weeks). In both regimens, depending on the choice made by each center, patients received either DL-LV (200 mg/m2) or L-LV (100 mg/m2).
RESULTS:
L-LV and DL-LV were administered respectively to 60% (n = 519) and 40% (n = 357) of the patients. Important prognostic characteristics were well balanced between the 2 groups. The proportion of any grade 3/4 toxicity was 20% in the L-LV group and 17% in the DL-LV group. There was no statistical difference in terms of toxicity between the 2 groups. The median follow-up time was 6.1 years. There were no statistically significant differences between L-LV and DL-LV in terms of either disease-free survival (66.7% vs. 67.2%; hazard ratio [HR], 1.03; 95% CI, 0.82-1.31; P = .78) or overall survival (78.2% vs. 74.5%; HR, 1.28; 95% CI, 0.97-1.69; P = .078).
CONCLUSION:
This study supports the use of either DL (200 mg/m2) or L (100 mg/m2) LV in association with 5-FU as adjuvant treatment of patients with colon cancer.
AuthorsIsabelle Baumgaertner, Emmanuel Quinaux, Ahmed Khalil, Christophe Louvet, Marc Buyse, Aimery de Gramont, Thierry André,
JournalClinical colorectal cancer (Clin Colorectal Cancer) Vol. 9 Issue 2 Pg. E5-10 (Apr 2010) ISSN: 1938-0674 [Electronic] United States
PMID20378497 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
Chemical References
  • Antimetabolites, Antineoplastic
  • Vitamin B Complex
  • Leucovorin
  • Fluorouracil
Topics
  • Adult
  • Aged
  • Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Chemotherapy, Adjuvant
  • Colorectal Neoplasms (drug therapy, mortality, pathology)
  • Confidence Intervals
  • Female
  • Fluorouracil (administration & dosage, adverse effects, therapeutic use)
  • Humans
  • Infusions, Intravenous
  • Leucovorin (adverse effects, chemistry, therapeutic use)
  • Male
  • Middle Aged
  • Vitamin B Complex (administration & dosage, adverse effects, therapeutic use)
  • Young Adult

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