Abstract

Objective: The purpose of this study was to explore the utility of the Choi Criteria in judging response to axitinib therapy in unresectable recurrent or distant metastatic head and neck squamous cell carcinoma.

Methods: Radiologic and clinical data was evaluated in a retrospective fashion from a single-arm phase II clinical trial of axitinib for the treatment of unresectable recurrent or metastatic head and neck squamous cell carcinoma. Twenty-nine patients had imaging to which the Choi Criteria were applied in an exploratory fashion. Responses rates by Choi Criteria were compared to those identified by RECIST v1.0 and statistical analyses were performed to evaluate significance. Association of best response to survival was also examined for each criteria (RECIST v1.0 and Choi).

Results: Application of the Choi Criteria demonstrated that 65.5% of patients achieved a partial response versus 6.9% by RECIST v1.0. Disease control rate was identical by Choi Criteria and RECIST v1.0 at 72.4%. Response to therapy based on Choi Criteria correlated to significantly improved estimated overall survival at 12 months (63% vs. 20%, p=0.03), whereas response to therapy based on RECIST was not a significant predictor of survival.

Conclusion: The Choi Criteria appear to better identify patients responding to therapy with the anti-angiogenic tyrosine kinase inhibitor axitinib versus RECIST v1.0 in this exploratory analysis. Use of the Choi Criteria to guide treatment decisions in further studies utilizing axitinib in this population may better identify patients benefiting from therapy.

Keywords: Head and neck neoplasm; Metastatic head and neck cancer; Axitinib; Vascular endothelial growth factor receptor; Choi Criteria; Imaging response criteria; Tyrosine kinase inhibitor