Open AccessAdministration Method of Adjuvant Tegafur‐Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study
Author(s) -
Hata Taishi,
Hagihara Kiyotaka,
Tsutsui Anna,
Akamatsu Hiroki,
Ohue Masayuki,
Shingai Tatsushi,
Tei Mitsuyoshi,
Ikenaga Masakazu,
Kim Ho Min,
Osawa Hideki,
Takemoto Hiroyoshi,
Konishi Ken,
Uemura Mamoru,
Matsuda Chu,
Mizushima Tsunekazu,
Murata Kohei,
Ohno Yuko,
Doki Yuichiro,
Eguchi Hidetoshi
Publication year - 2021
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1002/onco.13724
Subject(s) - medicine , regimen , tegafur , adverse effect , neutropenia , gastroenterology , clinical endpoint , colorectal cancer , adjuvant therapy , surgery , randomized controlled trial , cancer , chemotherapy
Lessons Learned The 3‐year disease‐free survival rate of the twice‐daily regimen was not inferior to that of the conventional three‐times‐daily regimen, and the twice‐daily regimen did not lead to an increase in adverse events. The effectiveness of the twice‐daily regimen highlights an increased number of treatment options for patients. This will facilitate personalized medicine, particularly for elderly or frail patients who may experience more severe side effects from the combination therapy.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/m 2 per day]/LV [75 mg per day]) or B (two doses of UFT [300 mg/m 2 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.