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A controlled evaluation of recent approaches to biochemical modulation or enhancement of 5-fluorouracil therapy in colorectal carcinoma.
J Clin Oncol ; 3(12): 1624-31, 1985 Dec.
Article en En | MEDLINE | ID: mdl-2933492
Three hundred thirty-five previously untreated patients with advanced colorectal carcinoma were randomly assigned to treatment with 5-fluorouracil (5-FU) alone, 5-FU plus N-(phosphonacetyl)-L-aspartic acid (PALA), 5-FU plus high-dose thymidine, 5-FU plus levamisole, or 5-FU plus methyl CCNU, vincristine, and streptozotocin (MOF-Strept). Dosages were designed to produce definite toxicity in the majority of patients, although the nature of dose-limiting reactions varied considerably among regimens. 5-FU alone and 5-FU plus levamisole produced mucocutaneous reactions, diarrhea, and leukopenia; 5-FU plus PALA produced primarily mucocutaneous reactions and diarrhea; 5-FU plus thymidine produced leukopenia with occasional neurotoxicity and hypotension; and MOF-Strept produced substantial nausea and vomiting with both thrombocytopenia and leukopenia. Objective response rates among patients with measurable disease varied from 12% (5-FU plus PALA) to 34% (MOF-Strept), but none of the regimens were significantly superior to 5-FU alone. Both interval to progression and survival were comparable among the five regimens with no reasonable chance that any combination regimen could produce as much as a 50% improvement when compared with 5-FU alone. Whereas we observed definite modulation of 5-FU dose--toxicity relationships, particularly with the thymidine and PALA combinations, this did not result in a detectable improvement in therapeutic effect. None of the combination regimens, administered in the dosages and schedules we used, can be recommended as standard therapy of advanced colorectal carcinoma.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias del Colon / Fluorouracilo Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Año: 1985 Tipo del documento: Article Pais de publicación: Estados Unidos
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias del Colon / Fluorouracilo Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Año: 1985 Tipo del documento: Article Pais de publicación: Estados Unidos