OP042: A randomized of induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by surgery versus surgery upfront in locally advanced and resectable oral squamous cell carcinoma

Abstract

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 (75 mg/m2 docetaxel d1, 75 mg/m2 cisplatin d1, and 750 mg/m2 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy (54–66 Gy), 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 30 months, 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.