A randomized phase III clinical trial of weekly versus tri-weekly cisplatin-based chemoradiotherapy for locally advanced cervical cancer: results of the TACO (GCIG/KGOG 1027/THAI 2012) study.

BACKGROUND: The standard treatment for locally advanced cervical cancer is cisplatin-based chemoradiotherapy; however, the optimal dose and dosing schedule of cisplatin remain debated. The aim of this study was to compare the clinical outcomes of weekly cisplatin at 40 mg/m2 versus those of tri-weekly cisplatin at 75 mg/m2 during radiation in patients with locally advanced cervical cancer. PATIENTS AND METHODS: In this prospective, randomized clinical trial, we enrolled 314 patients with stage IIB-IVA cervical cancer, randomly assigning them in a 1 : 1 ratio into two arms. The weekly arm received a weekly dose of 40 mg/m2 cisplatin for six cycles, whereas the tri-weekly arm received a tri-weekly dose of 75 mg/m2 cisplatin for three cycles, both concurrently with radiotherapy. The primary endpoints included 3-year recurrence-free survival according to a superiority design, with P < 0.05 indicative of statistical significance. Overall survival, toxicity profiles, and quality of life (QOL) were also analyzed. RESULTS: Chemotherapy delay was more frequent in the weekly arm than in the tri-weekly arm (P = 0.008). However, the 3-year recurrence-free survival rate between the two arms did not significantly differ (78.7% in the weekly arm, 84.1% in the tri-weekly arm; hazard ratio 0.71, 95% confidence interval 0.39-1.32, P = 0.28). The pattern of recurrence did not differ significantly between the two arms. Grade 3 and 4 hematological toxicities occurred less frequently in the tri-weekly arm (P < 0.001). Furthermore, the tri-weekly arm had better QOL scores across several domains compared with the weekly arm. CONCLUSION: In this study, tri-weekly cisplatin-based chemoradiotherapy was not statistically superior to a weekly schedule in terms of survival outcomes for patients with locally advanced cervical cancer. However, the tri-weekly regimen exhibited a more favorable toxicity profile and improved QOL compared with the weekly regimen. These results suggest tri-weekly cisplatin administration as a feasible alternative for chemoradiotherapy in cervical cancer.