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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Predictive factors of survival in patients with advanced colorectal cancer: an individual data analysis of 602 patients included in irinotecan phase III trials
Ann. Onc.,
July 1, 2004;
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1013 - 1017.
[Abstract]
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L. Cals, O. Rixe, E. Francois, R. Favre, L. Merad, G. Deplanque, A. Laadem, P. Juin, J. M. Bereder, D. Bernardini, et al.
Dose-finding study of weekly 24-h continuous infusion of 5-fluorouracil associated with alternating oxaliplatin or irinotecan in advanced colorectal cancer patients
Ann. Onc.,
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[Abstract]
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T. Andre, C. Boni, L. Mounedji-Boudiaf, M. Navarro, J. Tabernero, T. Hickish, C. Topham, M. Zaninelli, P. Clingan, J. Bridgewater, et al.
Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer
N. Engl. J. Med.,
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[Abstract]
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J. Cassidy, J. Tabernero, C. Twelves, R. Brunet, C. Butts, T. Conroy, F. Debraud, A. Figer, J. Grossmann, N. Sawada, et al.
XELOX (Capecitabine Plus Oxaliplatin): Active First-Line Therapy for Patients With Metastatic Colorectal Cancer
J. Clin. Oncol.,
June 1, 2004;
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2084 - 2091.
[Abstract]
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E. Diaz-Rubio
New Chemotherapeutic Advances in Pancreatic, Colorectal, and Gastric Cancers
Oncologist,
June 1, 2004;
9(3):
282 - 294.
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