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. Copyright 2002 American Cancer Society.
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. Copyright 2002 American Cancer Society.