Administration Method of Adjuvant Tegafur-Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study
Mené sur 386 patients atteints d'un cancer colorectal ayant été réséqué, cet essai de phase III compare l'efficacité, du point de vue de la survie sans maladie à 3 ans, et la toxicité de deux protocoles d'administration quotidienne (2 ou 3 fois par jour) d'un traitement adjuvant combinant tégafur/uracile et leucovorine calcique
Background : Tegafur‐uracil (UFT)/leucovorin calcium (LV) is an adjuvant chemotherapy treatment for colorectal cancer. We conducted a multicenter randomized trial to assess the noninferiority of a twice‐daily compared with a three‐times‐daily UFT/LV regimen for stage II/III colorectal cancer in an adjuvant setting. Methods : Patients were randomly assigned to group A (three doses of UFT [300 mg/m2 per day]/LV [75 mg per day]) or B (two doses of UFT [300 mg/m2 per day]/LV [50 mg per day]). The primary endpoint was 3‐year disease‐free survival. Results : In total, 386 patients were enrolled between July 28, 2011, and September 27, 2013. The 3‐year disease‐free survival rates of group A (n = 194) and B (n = 192) were 79.4% and 81.4% (95% confidence interval, 72.6–84.4–74.5–85.9), respectively. The most common grade 3/4 adverse events in group A and B were diarrhea (3.9% vs. 7.3%), neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue (1.1% vs. 2.3%). Conclusion : Group B outcomes were not inferior to group A outcomes, and adverse events did not increase.
The Oncologist 2021