Zhong, Lai-ping, Zhang, Zhi-yuan, Zhang, Chen-ping, Ren, Guo-xin, Guo, Wei, Sun, Jian, Zhu, Han-guang, Tu, Wen-yong, Wang, Zhong-he, Hu, Yong-jie, Ji, Tong, Yang, Wen-jun, Ye, Wei-min, Li, Jun, He, Yue, Wang, Yan-an, and Xu, Li-qun
Purpose: To evaluate induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) followed by surgery and post-operative radiotherapy versus upfront surgery and post-operative radiotherapy in patients with locally advanced, resectable oral squamous cell carcinoma (OSCC). Patients and methods: A prospective, open label, phase III trial was conducted. Eligibility criteria included untreated, stage III or IVA locally advanced, resectable OSCC. Patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy (54–66Gy), versus upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Secondary endpoints included local control and safety. Results: 256 patients were enrolled in this trial and 222 patients completed the full treatment protocol. There were no unexpected toxicities and induction chemotherapy did not increase peri-operative morbidity. The clinical response rate to induction chemotherapy was 80.6%. After a median follow-up of 30months, there was no significant difference in overall survival (HR=0.977, 95% CI 0.634–1.507, p =0.918) and disease-free survival (HR=0.974, 95% CI 0.654–1.45, p =0.897) between the patients treated with and without TPF induction (Fig. 1). Patients in the induction chemotherapy arm with a clinical response or favorable pathologic response (10% or less viable tumor cells) had superior overall survival, locoregional and distant control (Fig. 2). Conclusion: Our study failed to demonstrate that TPF induction chemotherapy improves survival compared to surgery upfront in patients with resectable stage III and IVA OSCC. [Copyright &y& Elsevier]