Clinical phase II evaluation of paclitaxel in combination with cisplatin in metastatic or recurrent squamous cell carcinoma of the head and neck
| Autor: | B. Heinrich, F. Theiss, S. Quasthoff, K. Diergarten, M. Herzog, Axel Hanauske, M. Kemmerich, R. Kau, R. Thodtmann, C. Laubenbacher |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
Adult
Male medicine.medical_specialty Paclitaxel medicine.medical_treatment Phases of clinical research Neutropenia Gastroenterology Drug Administration Schedule Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans Infusions Intravenous Survival rate Aged Chemotherapy Leukopenia business.industry Hematology Middle Aged medicine.disease Antineoplastic Agents Phytogenic Hematologic Diseases Surgery Survival Rate Regimen Treatment Outcome Oncology Epidermoid carcinoma Head and Neck Neoplasms Carcinoma Squamous Cell Female Cisplatin Neoplasm Recurrence Local medicine.symptom business |
| Zdroj: | Annals of Oncology. 9:335-337 |
| ISSN: | 0923-7534 |
| DOI: | 10.1023/a:1008298915121 |
| Popis: | Summary Background Paclitaxel as single agent has shown marked activity in several malignancies. The aim of the present phase II trial was to determine the activity of paclitaxel/cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. Patients and methods 200 mg/m2 paclitaxel was administered over three hours followed by cisplatin (100 mg/m2), repeated every 22 days. Twenty-eight patients were entered and received a total of 99 cycles (median 2, range 1–6). All patients were evaluable for toxicity, and 25 for response. Results Hematologic toxicities included leukopenia CTC grade 3 in 13 patients, and grade 4 in five patients, neutropenia grade 3 in nine patients, and grade 4 in eigth patients, grade 3 anemia and grade 2 thrombocytopenia in one patient each. Non-hematologic toxicities included hypotension grade 2 (six patients), grade 3 (four patients), and grade 4 (two patients). A decline in renal function was observed in 15 courses and 10 patients, leading to a median delay of 2.5 days. Neurosensory and neuromotor toxicity grade 1 were observed in 13 patients (grade 2: 12 patients; grade 3: one patient), myalgia grade 3 in one patient, asthenia grade 3 in two and grade 4 in one patient. Partial responses were observed in 12 patients for an overall response rate of 48% (95% CI: 28%–68%) with a median response duration of 6.5 months (range 1-10 months). Stable disease was observed in seven patients, of who two also had clinical benefit. Conclusions Paclitaxel 200 mg/m2 administered over three hours combined with cisplatin 100 mg/m2 is an active regimen warranting further evaluation. |
| Databáze: | OpenAIRE |
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