Journal of Clinical Oncology, Vol 15, 808-815, Copyright © 1997 by American Society of Clinical Oncology
Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study
A de Gramont, JF Bosset, C Milan, P Rougier, O Bouche, PL Etienne, F Morvan, C Louvet, T Guillot, E Francois and L Bedenne
Groupe d'Etude et de Recherche sur les Cancers de l'Ovaire et Digestifs (GERCOD), Hopital Saint-Antoine, Paris, France.
PURPOSE: This multicenter study compared the therapeutic ratio of a monthly
schedule of low-dose leucovorin (LV) and fluorouracil (5-FU) bolus with a
bimonthly schedule of high-dose LV and 5-FU bolus plus continuous infusion
in patients with advanced colorectal cancer. PATIENTS AND METHODS: Of the
448 patients randomly assigned to treatment, 433 were assessable. Treatment
A was a monthly regimen of intravenous (IV) LV 20 mg/m2 plus bolus 5-FU 425
mg/m2 for 5 days every 4 weeks. Treatment B was a bimonthly regimen of IV
LV 200 mg/m2 as a 2- hour infusion followed by bolus 5-FU 400 mg/m2 and
22-hour infusion 5- FU 600 mg/m2 for 2 consecutive days every 2 weeks.
Therapy was continued until disease progression. Second-line chemotherapy,
which included 5-FU continuous infusion, was allowed in both arms. RESULTS:
The response rates in 348 patients with measurable lesions were 14.4%
(monthly regimen) and 32.6% (bimonthly regimen) (P = .0004). The median
progression-free survival times were 22 weeks (monthly regimen) and 27.6
weeks (bimonthly regimen) (P = .0012). The median survival times were 56.8
weeks (monthly regimen) and 62 weeks (bimonthly regimen) (P = .067). Grade
3-4 toxicities occurred in 23.9% of patients in the monthly arm compared
with 11.1% of those in the bimonthly arm (P = .0004). Patients in arm A
more frequently experienced severe granulocytopenia (7.3% v 1.9%), diarrhea
(7.3% v 2.9%), and mucositis (7.3% v 1.9%) than patients in arm B.
CONCLUSION: The bimonthly regimen was more effective and less toxic than
the monthly regimen and definitely increased the therapeutic ratio.
However, there was no evidence of increased survival.

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