Abstract | BACKGROUND: 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.
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Authors | Isabelle Baumgaertner, Emmanuel Quinaux, Ahmed Khalil, Christophe Louvet, Marc Buyse, Aimery de Gramont, Thierry André, GERCOR Group |
Journal | Clinical colorectal cancer
(Clin Colorectal Cancer)
Vol. 9
Issue 2
Pg. E5-10
(Apr 2010)
ISSN: 1938-0674 [Electronic] United States |
PMID | 20378497
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antimetabolites, Antineoplastic
- Vitamin B Complex
- Leucovorin
- Fluorouracil
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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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