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- Title
Bimonthly high dose leucovorin and 5-fluorouracil 48-hour infusion with interferon-alpha-2a in patients with advanced colorectal carcinoma. Groupe d'Etude et de Recherche sur les Cancers de l'Ovaire et Digestifs (GERCOD).
- Authors
Tournigand, Christophe; Louvet, Christophe; de Gramont, Aimery; Lucchi, Elisabeth; Seitz, Jean-François; Mal, Frédéric; Raymond, Eric; Cady, Jean; Carola, Elisabeth; Krulik, Marcel; Tournigand, C; Louvet, C; de Gramont, A; Lucchi, E; Seitz, J F; Mal, F; Raymond, E; Cady, J; Carola, E; Krulik, M
- Abstract
<bold>Unlabelled: </bold>BACKGROUND; The rationale for the modulation of 5-fluorouracil (5-FU) with interferon-alpha (IFN) is inhibition of 5-FU catabolism and 5-FU resistance. Clinical trials have shown debatable results when IFN is given in high doses with 5-FU used as a bolus alone or in combination with leucovorin (LV). A first-line Phase II study was performed in 50 patients with metastatic colorectal carcinoma who were given a bimonthly combination of high dose LV, a high dose 48-hour infusion of 5-FU, and a low dose of IFN.<bold>Methods: </bold>The regimen was comprised of a 2-hour infusion of LV, 500 mg/m2, on each of 2 consecutive days, and a 48-hour infusion of 5-FU, 1.5 to 2 g/m2/24 hours, starting after Day 1 of LV treatment every 2 weeks until there was evidence of disease progression. IFN was administered subcutaneously three times weekly at a dose of 3 MU (body surface area [BSA] < 1.75 m2) or 4.5 MU (BSA > OR = 1.75 m2).<bold>Results: </bold>World Health Organization toxicity Grade 3-4 occurred in 21 patients (42%): diarrhea in 6%, mucositis in 12%, neutropenia in 30%, and alopecia in 8%. The overall response rate was 44%; 1 patient had a complete response (2%), 21 had partial responses (42%), 23 had stable disease (46%), and 5 had disease progression (10%). The median progression free survival was 9 months, and median survival was 25 months.<bold>Conclusions: </bold>Bimonthly high dose LV, a high dose 48-hour infusion of 5-FU, and a low dose of IFN had good activity in patients with advanced colorectal carcinoma. However, as in other schedules of LV and 5-FU, IFN induces high grade toxicity.
- Subjects
ADENOCARCINOMA; ANTINEOPLASTIC agents; CLINICAL trials; COLON tumors; COMPARATIVE studies; DRUG administration; FLUOROURACIL; FOLINIC acid; INTRAVENOUS therapy; RESEARCH methodology; MEDICAL cooperation; PROTEINS; RECOMBINANT proteins; RECTUM tumors; RESEARCH; SURVIVAL analysis (Biometry); EVALUATION research
- Publication
Cancer (0008543X), 1997, Vol 79, Issue 6, p1094
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/(SICI)1097-0142(19970315)79:6<1094::AID-CNCR6>3.0.CO;2-G