Capecitabine-Enhanced Brachytherapy in Locally Advanced Cervical Cancer: A Phase II Non-Randomized Trial on Safety and Efficacy

To evaluate the safety and efficacy of administering capecitabine concurrent with brachytherapy in advanced-stage cervical cancer. Eligible patients with FIGO stage IB2-IVA cervical cancer were enrolled in this phase II non-randomized trial. After external beam chemoradiotherapy (EBRT), patients received capecitabine alongside brachytherapy as radiosensitizer. The primary objective was to assess the tolerability of the combined regimen and its effect on one-year disease-free (DFS) and overall survival rates (OS). Of the 69 patients completed treatment, 18 were enrolled as intervention group and 51 served as controls. Both groups were matched in terms of comorbidities, stage, and response to EBRT. Overall, concurrent capecitabine administration during brachytherapy was safe. At one-year follow-up, one death was recorded in each group, with recurrence rates of 16.7% in the intervention group and 19.6% in the control group. One-year DFS was 82% (95% CI: 54%-98%) in the intervention group and 87% (95% CI: 72%-94%) in the control group, while one-year OS was 93% (95% CI: 53%-98%) and 97% (95% CI: 85%-99%), respectively (for both p < 0.05). In conclusion, while capecitabine-augmented brachytherapy was demonstrated to be safe in patients with advanced cervical cancer, its addition did not yield significant improvements in DFS or OS.