TPF induction chemotherapy and pathologic response for patients with locally advanced and resectable oral squamous cell carcinoma.

Abstract

5593 Background: The role of induction chemotherapy in locally advanced and resectable oral squamous cell carcinoma has not been well issued. Methods: A prospective, open label, parallel, and interventional randomized control trail has been performed to evaluate the induction chemotherapy of TPF protocol in resectable oral squamous cell carcinoma (OSCC) patients at clinical stage III and IVA. The patients received two cycles of TPF induction chemotherapy (75 mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy with a dose from 54 to 66 Gy (the experimental group) or surgery and post-operative radiotherapy (the control group). Post-surgical pathologic examination was performed to determine a positive response or negative response. A positive response was defined as absence of any tumor cells (pathologic complete response) or presence of scattered foci of a few tumor cells (minimal residual disease with <10% viable tumor cells). The primary endpoint is the survival rate; the secondary endpoint is the local control and safety. This study has been approved by institutional ethics committee at Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University. Survival analysis was conducted with the Kaplan-Meier method. Results: 256 patients were enrolled in this trail and 224 patients (111 in experiment group and 113 in control group) finished the whole treatment protocol. After a median follow-up of 21 months (ranging 6-43 m). The pathologic positive response rate was 29.7% (33/111), and negative response rate was 70.3% (78/111). The patients with positive response had a better disease free survival (38.5±2.1m, 95%CI 34.4-42.6m, P=0.003) compared with those with negative response (24.6±2.1m, 95%CI 20.6-28.7m) and control group (31.0±1.6m, 95%CI 27.9-34.1m). The toxicity of induction chemotherapy could be tolerated. Conclusions: Pathologic positive response to TPF induction chemotherapy could benefit the patients with locally advanced and resectable OSCC. However, further long-term follow-up is needed to confirm the benefit on survival and local control.