A randomized phase III study of two cisplatin based chemoradiation (CCRT) regimens in locally advanced head and neck squamous cell carcinoma (LAHNSCC): The impact of changing disease epidemiology on contemporary trial design.

Publication Type:

Journal Article

Source:

Head & neck (2014)

Keywords:

2014, Clinical Research Division, July 2014

Abstract:

Background: CCRT results in excellent outcomes in LAHNSCC. This trial compared two CCRT regimens. Methods: Patients with LAHNSCC were treated with radiation(70-74.4 Gy), and randomized to Arm A: cisplatin 100mg/m(2) on RT d1, 22 and 43, or Arm B: cisplatin(20mg/m(2) /day) and 5-FU(1000mg/m(2) /day) continuous 96-hr infusions on RT wks 1 and 4. The primary endpoint was relapse free survival (RFS). Results: Between 2/2008 and 10/2011, 69 patients were enrolled. The study prematurely closed when a scheduled interim analysis showed superior outcomes in both arms and futility of continuation. 83% of patients had oropharynx cancer, of these 86% were HPV/p16+. The 3-yr KM outcome estimates (median follow-up 41 mos) for arms A and B were: RFS 87% vs. 80%(p= 0.24), overall survival 97% vs. 85%(p=0.013), locoregional control 96% vs. 94%(p=0.52), and distant metastatic control 91% vs. 87%(p=0.9). Conclusions: Multiagent was not superior to single agent CCRT. Overrepresentation of HPV/p16+ patients resulted in better than expected outcomes. Head Neck, 2014.