Hematologic and Non-hematologic Toxicity after Intravenous Adjuvant 5-Fluorouracil and Leucovorin Treatment of Colorectal Cancer: A Prospective Study

ABSTRACT

PURPOSE: Although large clinical trials have been performed attempting to find an optimal 5-fluorouracil (5-FU)-based regimen on the basis of activity and toxicity, there have been few data reporting the toxicity. We experienced a less severe toxicity than previous reports, so we undertook an analysis of the toxicity profiles of 5-FU-based chemotherapy on colorectal cancer patients. METHODS: Forty-two patients were consecutively enrolled in this study from Sep. 2002 to Sep. 2003. The primary endpoints were the incidences of anorexia, nausea, vomiting, diarrhea, constipation, headache, stomatitis, alopecia, and leukopenia, as recorded with the standard National Cancer Institute- Common Toxicity Criteria (NCI-CTC). The regimen used in this study was intravenous infusion of 5-FU, 500 mg/m2, plus leucovorin (LV), 20 mg, daily for 5 days every 4 weeks for 6 cycles. Information on toxic profiles was obtained by questionnaire and blood test data during each cycle of treatment. RESULTS: Of the patients, 73.8% experienced at least one type of toxicity. There were no clinical grade 3/4 toxicities. Toxicites (grade 1/2) were as follows anorexia (51.2%), nausea (50.4%), constipation (24.6%), headache (11.5%), vomiting (4.0%), diarrhea (2.4%), alopecia (2.0%), stomatitis (0.4%), and leukopenia (4.0%). The most common adverse event was gastrointestinal toxicity (16.6%). There were no deaths attributed to non-hematologic toxicity. There was no dose reduction during any cycle of treatment. In a comparison of the incidence of toxicity by age ( or =65), gender, and TNM stage, univariate analysis found no statistical differences. CONCLUSIONS: Our data would seem to confirm that Korean patients experienced less incidence and severity of toxicity than Western patients. We believe that the accumulated data provide sufficient evidence that colorectal patients in Korea actually experience a less severe toxicity of 5-FU-based chemotherapy when they are treated on this schedule. Considering this study, a race-specific dose determination for a colorectal cancer adjuvant chemotherapeutic setting is warranted.