From February 1995 through October 1996, 25 patients with metastatic colorectal cancer showing a clinical resistance to 5-fluorouracil (5-FU) entered this study. Thirteen received oxaliplatin alone and 12 received it in combination with 5-FU. Oxaliplatin was administered at 130 mg/m(2) over a 2-hour infusion every 3 weeks, alone or added either to 5-FU as a continuous infusion at 200 mg/m(2) to 300 mg/m(2) (six patients) or to a 5-FU bolus, 375 mg/m(2), plus leucovorin, 100 mg/m(2) daily for 5 days every 3 weeks (6 patients). Eighty-six of 98 administered cycles were evaluable for toxicity (47 for oxaliplatin plus 5-FU and 39 for oxaliplatin alone). Hematologic toxicity was mild, occurring as grade 2 leukopenia in 23% of the cycles of 5-FU and oxaliplatin and in 5% of the cycles of oxaliplatin alone. The most common toxicity was neurologic (grade 1 to 2 in 60%-6% of the cycles of the combination, respectively, and 68%-10% of oxaliplatin given alone) as hand-foot paresthesia or hypersensitivity to cold. No grade 4 toxicity was reported and only three patients in the 5-FU group developed grade 3 diarrhea. Grade 2 nausea and vomiting occurred in 33% of the cycles when both drugs were given and in 15% when oxaliplatin was administered alone. The combination of oxaliplatin and 5-FU induced four partial remissions (33%; 95% confidence interval, 6%-60%), whereas eight patients of the whole group had stable disease. No response occurred when oxaliplatin was administered as a single agent. The results of this study confirm the antitumor activity of oxaliplatin when added to 5-FU in patients who have metastatic colorectal cancer previously refractory to 5-FU. The possible therapeutic synergy with 5-FU was not accompanied by increased toxicity.
Synergistic activity of oxaliplatin and 5-fluorouracil in patients with metastatic colorectal cancer with progressive disease while on or after 5-fluorouracil / F. de Braud, E. Munzone, F. Nole, T. De Pas, R. Biffi, S. Brienza, M. Aapro. - In: AMERICAN JOURNAL OF CLINICAL ONCOLOGY: CANCER CLINICAL TRIALS. - ISSN 0277-3732. - 21:3(1998 Jun), pp. 279-283.
|Titolo:||Synergistic activity of oxaliplatin and 5-fluorouracil in patients with metastatic colorectal cancer with progressive disease while on or after 5-fluorouracil|
DE BRAUD, FILIPPO GUGLIELMO MARIA (Primo) (Corresponding)
|Parole Chiave:||metastatic colorectal cancer; oxaliplatin; synergistic activity|
|Settore Scientifico Disciplinare:||Settore MED/06 - Oncologia Medica|
|Data di pubblicazione:||giu-1998|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1097/00000421-199806000-00015|
|Appare nelle tipologie:||01 - Articolo su periodico|
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