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A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

✍ Scribed by Roy B. Tishler; Charles M. Norris Jr.; A. Dimitrios Colevas; Carolyn C. Lamb; Daniel Karp; Paul M. Busse; Asa Nixon; Robert Frankenthaler; Bernadette Lake-Willcutt; Rosemary Costello; Maryann Case; Marshall R. Posner

Publisher
John Wiley and Sons
Year
2002
Tongue
English
Weight
95 KB
Volume
95
Category
Article
ISSN
0008-543X

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✦ Synopsis

Abstract

BACKGROUND

The authors conducted a Phase I/II study in patients with a poor prognosis who had locally advanced squamous cell carcinoma of the head and neck (SCCHN) and who were treated initially with induction chemotherapy. Patients were treated with weekly docetaxel and concurrent daily fractionated radiation therapy to determine the maximum tolerated dose (MTD) of docetaxel and the efficacy of the regimen.

METHODS

Twenty‐two patients were enrolled, and 21 patients were treated. Eight patients had Stage III SCCHN, and 13 patients had Stage IV SCCHN without distant metastases and were treated first with 2‐3 cycles of induction chemotherapy, which consisted of cisplatin plus 5‐fluorouracil with or without leucovorin. Patients with a poor prognosis were identified as those who achieved a partial response to induction treatment, achieved a complete response with a positive biopsy, or were at high risk for developing recurrent disease. Patients were treated subsequently with concurrent, escalating doses of docetaxel (given weekly × 6) and once daily 200‐centigray radiation fractions.

RESULTS

Three patients were treated with a weekly docetaxel dose of 20 mg/m^2^ without dose‐limiting toxicity (DLT). Both patients who were treated at the next dose level of 30 mg/m^2^ experienced DLT. A dose of 25 mg/m^2^ was studied without DLT in the 16 patients who were treated, establishing this as the MTD. Sixty‐seven percent of the patients are alive without disease at a median follow‐up of 35 months (range, 12–59 months) after the initiation of chemoradiotherapy.

CONCLUSIONS

The MTD of weekly docetaxel with concurrent daily radiation therapy in the postinduction setting was 25 mg/m^2^. Disease free survival data from this study were good and indicated that this regimen was effective in the treatment of patients with SCCHN who had a poor prognosis. Cancer 2002;95:1472–81. © 2002 American Cancer Society.

DOI 10.1002/cncr.10873

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