Tegafur-Uracil Maintenance Did Not Improve Survival for Patients With Locally Advanced Cervical Cancer
According to results from the phase 3 GOTIC-002 trial, low-dose tegafur-uracil maintenance therapy did not improve survival among patients with locally advanced cervical cancer.
“Concurrent chemoradiotherapy is the standard treatment for locally advanced cervical cancer, but recurrence rates remain high,” stated Kosei Hasegawa, MD, PhD, Saitama Medical University International Medical Center, Yamani, Saitama, Japan, and coauthors.
In this multicenter study, 351 patients with stage Ib2-IVa cervical cancer who achieved complete or partial remission after concurrent chemoradiotherapy were randomized on a 1-to-1 basis to receive 300 to 400 mg of daily tegafur-uracil based on body surface area (n = 173) or observation for up to 2 years or until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Key secondary end points included overall survival (OS) and safety.
At a median follow-up of 3 years, median PFS was not reached in either treatment arm. The 5-year PFS rate was 62% in the tegafur-uracil arm and 61.3% in the observation arm (hazard ratio [HR], 0.92; P = .634). The 5-year OS rate was 76.1% in the tegafur-uracil arm and 77.6% in the observation arm (HR, 1.04; P = .869). Mild or moderate adverse events were observed in 73.9% and 93.5% of patients, respectively.
“These findings suggest the need to reconsider maintenance therapy strategies after [concurrent chemoradiotherapy] for potentially shifting away from cytotoxic chemotherapy towards alternative methods to enhance survival outcomes in patients with [locally advanced cervical cancer],” concluded Dr Hasegawa et al.
Source:
Hasegawa K, Nishio S, Yamamoto K, et al. Tegafur-uracil maintenance chemotherapy post-chemoradiotherapy for cervical cancer: Randomized trial. Eur J Cancer. Published online: February 15, 2025. doi: 10.1016/j.ejca.2025.115304
