A Phase I/II Study of Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Squamous Cell Cancer of the Head and Neck

ABSTRACT

Nab-paclitaxel might impact efficacy of radiation for head and neck (H&N) cancer. Nab-paclitaxel, cisplatin, cetuximab, and radiation were evaluated in patients with locally advanced head and neck cancer in this phase I/II trial. Median follow-up was 24 months for 34 patients. The maximum tolerated dose of nab-paclitaxel was 20 mg/m² with 20 mg/m² cisplatin and 250 mg/m² cetuximab. The 2-year progression-free survival (PFS) was 60% (95% confidence interval (CI) 0.42, 0.78), local control 71% (95% CI 0.55, 0.87), and overall survival 68% (95% CI 0.50, 0.86). This is the first study evaluating these agents with radiation in humans, with similar 2-year PFS as historic control.

KEYWORDS:

• Abraxane
• head and neck cancer
• erbitux
• cisplatin
• radiation therapy

Acknowledgments

We express our gratitude to Dr. Daniel Von Hoff, MD, of the Translational Genomics Research Institute for assistance in the discussion of this trial.

Declaration of Interest

The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article.

This work was supported by a grant from Celgene.