A Controlled Clinical Trial Including Folinic Acid at Two Distinct Dose Levels in Combination with 5-Fluorouracil (5FU) for the Treatment of Advanced Colorectal Cancer: Experience of the Mayo Clinic and North Central Cancer Treatment Group
A prospectively randomized clinical trial was conducted to determine the therapeutic effect of five individual combination chemotherapy regimens compared to single agent FUra for the treatment of advanced colorectal cancer. For the purposes of this symposium, the detailed results of therapy will be presented only for PTS treated with FUra alone or FUra + LV* in a high dose (200 mg/m2) or a low dose (20 mg/m2) daily for five days. Two hundred twelve PTS were randomized to one these three regimens, and 208 PTS (98%) were available for analysis. Median time from randomization is 18 months and anproximately 70% of PTS have died. Both LV* + FUra regimens are associated with significantly improved survival compared to single agent FUra (p ≤ 0.03). In addition, interval-to-tumor-progression, measurable tumor response rates, and measures of quality of life (performance status, weight gain, symptomatic relief) were also significantly improved with the addition of LV*. The most favorable regimen in the trial is low dose LV* + FUra based on considerations of both therapeutic results and cost. A national intergroup trial will examine the efficacy of the low dose LV* + FUra regimen in the surgical adjuvant setting.
KeywordsAdvanced Colorectal Cancer Tumor Response Rate Nonhematologic Toxicity Objective Tumor Response North Central Cancer Treatment Group
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