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


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.


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.


CONCLUSIONS
Docetaxel with concurrent RT has acceptable toxicity. This approach warrants further investigation in a phase II trial.
Clark
Joseph I
JI
Department of Medicine, Division of Hematology-Oncology, Cardinal Bernardin Cancer Center, Loyola University Medical Center, 2160 S. First Avenue, Maywood, IL 60153, USA. jclark@lumc.edu
Eisner
Robert M
RM
Hofmeister
Craig
C
Norton
John
J
Thomas
Sachdev
S
Choudhury
Abdul
A
Petruzzelli
Guy
G
Lathers
Deanne
D
Young
M Rita I
MR
Lau
Ann
A
Emami
Bahman
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000556:secondary* / Q000628:therapy*; D003131:Combined Modality Therapy; D016001:Confidence Intervals; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008207:Lymphatic Metastasis; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D011336:Probability; D011379:Prognosis; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D018570:Risk Assessment; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel