Neoadjuvant dose-modified docetaxel in squamous cell carcinoma of the head and neck: A phase 3 study

Abstract

Objective To evaluate the efficacy and safety of dose-modified docetaxel plus cisplatin and 5-fluorouracil (TPF) in Chinese patients with squamous cell carcinoma of the head and neck (SCCHN). Materials and methods This Phase III, open-label, multi-center study included Chinese adults with previously untreated TNM Stage III or IV SCCHN (NCT00995293). Patients were randomized (1:1) to induction chemotherapy with TPF (docetaxel 60 mg/m(2) and cisplatin 60 mg/m(2) on day 1 and 5-FU 750 mg/m(2) per day continuous IV infusion on days 1-5) or PF (cisplatin 75 mg/m(2) on day 1 and 5-FU 750 mg/m(2) per day on days 1-5) every 3 weeks for 3-4 cycles. The primary endpoint was progression-free survival (PFS). Results Median PFS in the TPF (n = 108) and PF (n = 111) groups was 400 days and 342 days (HR = 0.75; 95% CI, 0.531.06; p = .227), respectively. Overall response rate was higher for TPF versus PF (76.3% vs. 52.9%; p = .001), although this equalized following radiotherapy (75.0% vs. 73.9%). In the TPF and PF groups, >= 1 treatment-emergent adverse event was experienced by 104 (94.5%) and 110 (93.2%) patients, respectively. Conclusion Adding dose-modified docetaxel to PF did not significantly improve PFS but may increase anti-tumor activity in Chinese patients with locally advanced SCCHN.