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Docetaxel/cisplatin as first-line chemotherapy in patients with head and neck carcinoma : A Phase II trial

✍ Scribed by Martina Baur; Heinz-Roland Kienzer; Johannes Schweiger; Maria DeSantis; Erich Gerber; Jörg Pont; Marcus Hudec; Annemarie Ulrike Schratter-Sehn; Wolfram Wicke; Christian Dittrich

Publisher
John Wiley and Sons
Year
2002
Tongue
English
Weight
69 KB
Volume
94
Category
Article
ISSN
0008-543X

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✦ Synopsis

Abstract

BACKGROUND

The objective of this Phase II study was to assess the clinical activity and toxicity of docetaxel (D) and cisplatin (P) in patients with locally advanced unresectable, metastatic, or recurrent squamous cell carcinoma of the head and neck (SCCHN).

PATIENTS

Of 34 patients, 30 were eligible for treatment with D 80 mg/m^2^ on Day 1 and P 70 mg/m^2^ on Day 2. Therapy was repeated every 3 weeks. At the start of chemotherapy, the tumors had the following extensions: locoregional, n = 15; distant metastatic, n = 2; and relapse, n = 13.

RESULTS

Overall, the rate of objective responses in the population of all eligible patients based on an intention‐to‐treat analysis was 53%, with a 95% confidence interval (CI; 34.33–71.66%). Two patients had complete disease remission (pathologic), 4 patients had complete disease remission (clinical), 10 patients had partial disease remission, 3 patients had no change in disease status, and 7 patients had disease progression. The duration of objective response was median 5+ months (range 3–8+ months). Eleven patients (37%) had Grade 4 granulocytopenia and three patients (10%) had Grade 3 granulocytopenia (grades were based on the classification of the National Cancer Institute of Canada‐Common Toxicity Criteria). Six patients died of septicemia.

CONCLUSIONS

Overall, the combination of D and P represents a highly active chemotherapeutic regimen for the treatment of patients with SCCHN. However, because of the high toxicity of this regimen, prophylactic administration of antibiotics and hematopoietic growth factors is essential as is a three‐day corticosteroid premedication regimen. Above all, this combination of drugs is not recommended for treatment of patients with a World Health Organization performance status of >1. Cancer 2002;94:2953–8. © 2002 American Cancer Society.

DOI 10.1002/cncr.10574

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