A randomized, controlled study of different chemotherapy regimens combined with postoperative radiotherapy for patients with high-risk early stage cervical cancer

Objective: To investigate whether docetaxel plus cisplatin combined with radiotherapy(TP-R) compared with cisplatin-only combined radiotherapy(C-R) could increase overall survival and recurrence-free survival on patients with high-risk early stage cervical cancer. Methods: Eligible high-risk patients with stage Ⅰ_b and Ⅱ_a cervical cancer were randomly assigned to C-R and TP-R group. The external irradiation dose was 46-54 Gy, following 12-24 Gy of intracavitary brachytherapy. In C-R group, chemotherapy regimens consisted of cisplatin 30 mg/m² (weekly, with 5 cycles). In TP-R group, chemotherapy regimens consisted of cisplatin 25 mg/m² and of docetaxel 25 mg/m² (weekly, with 5 cycles). Results: A total of 285 patients entered final analysis. There were 140 cases in C-R group and 145 in TP-C group, respectively. The 5-year overall survival rate was 74.3% in C-R group and 82.8% in TP-R group(P > 0.05). The hazard ratio for death on TP-R group was 0.65(95%CI: 0.39-1.09). The 5-year recurrence survival rates were 69.3% in C-R group and 79.3% in TP-R group(P > 0.05), respectively. And the hazard ratio for death on TP-R group was 0.64(95%CI: 0.40-1.03). Recurrence rates were similar in two groups(P > 0.05). Rate of ≥ grade 3 adverse events was higher in TP-R group(χ² = 6.88, P < 0.05). Conclusions: Docetaxel plus cisplatin combined with radiotherapy fails to increase overall survival rates compared with cisplatin-only combined with radiotherapy for patients with high-risk stage Ⅰ_b and Ⅱ_a cervical cancer, though there is a trend to increase recurrence-free survival rates. (authors)