Phase I adjuvant radiation with docetaxel in high-risk head and neck cancer.

Authors :: Clark JI
Eisner RM
Hofmeister C
Norton J
Thomas S
Choudhury A
Petruzzelli G
Lathers D
Young MR
Lau A
Emami B
Source :: American journal of clinical oncology [Am J Clin Oncol] 2009 Aug; Vol. 32 (4), pp. 396-400.
Publication Year :: 2009
Abstract: Background: This phase I study was designed to determine the maximum tolerated dose (MTD) and preliminary efficacy of docetaxel with concurrent radiotherapy (RT), in high-risk squamous cell carcinoma of the head and neck.<br />Patients and Methods: Eligible patients had resected squamous cell carcinoma of the head and neck, histologically involved lymph nodes, and/or extranodal disease, and/or involved surgical margins and performance status 0 to 1. Treatment included weekly docetaxel with concurrent RT in a dose-finding study; a subsequent small cohort of patients was treated using the MTD of docetaxel.<br />Results: Twenty patients were enrolled. Planned accrual was 25, but the study was closed prematurely because of slow accrual. The MTD was 15 mg/m2. Dose-limiting toxicity was oral stomatitis. Therapy was well tolerated. Five patients experienced locoregional relapse at a median follow-up of 32 months.<br />Conclusion: Docetaxel with concurrent RT has acceptable toxicity. This approach warrants further investigation in a phase II trial.