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S-1 noninferior to UFT/LV for stage III colon cancer
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Adjuvant chemotherapy with the oral fluoropyrimidine derivative S-1 conferred similar DFS rates as tegafur-uracil plus leucovorin among patients with stage III colon cancer, according to results of a randomized phase 3 study.
The findings suggest S-1 could be a new treatment option in this setting, researchers wrote.
Prior studies have demonstrated the antitumor effects of S-1 as monotherapy or as part of combination chemotherapy for several gastrointestinal cancers, including metastatic colon cancer.
In the current study, researchers assessed the noninferiority of adjuvant chemotherapy with S-1 vs. tegafur-uracil plus leucovorin (UFT/LV) for patients with curatively resected stage III colon cancer.
The analysis included 1,518 patients aged 20 to 80 years.
Researchers assigned 758 patients to S-1. They received 80 mg to 120 mg daily on days 1 through 28 every 42 days for four courses. The 760 patients assigned UFT/LV received 300 mg to 600 mg UFT daily plus LV 75 mg daily on days 1 through 28 every 35 days for five courses.
DFS at 3 years served as the primary endpoint.
Researchers reported 3-year DFS rates of 75.5% in the S-1 group and 72.5% in the UFT/LV group (HR=0.85; 95% CI, 0.7-1.03), demonstrating the noninferiority of S-1 (P<.001). A subgroup analysis showed no significant interactions between major baseline characteristics and the treatment groups, researchers wrote.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
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