434 A phase II study of cisplatin (CDDP) and 96 hours continuous infusion (CI) of navelbine® (NVB) in patients (PTS) with advanced squamous cell carcinoma of the head and neck (HNT)

Autor: R. Gourmet, G. Catimel, A. Dumortier, X. Montbarbon, C. Terret, B. Gignoux, Jean-Pierre Droz, J. Leval, R. Caliandro
Rok vydání: 1995
Předmět:
Zdroj: European Journal of Cancer. 31:S94
ISSN: 0959-8049
DOI: 10.1016/0959-8049(95)95687-2
Popis: Significant antitumor activity of weekly NVB administration has been previously reported in HNT. As NVB has a cycle specific activity, a CI schedule may increase its therapeutic index. We initiated a trial of CDDP (75 mg/m 2 on d. l) and NVB (5 mg iv bolus on d.1 immediately followed by 96 hrs CI of 4 mg/m 2 /d) q. 3 weeks. 14 pts (median age 59 y) were included in a first part of the study testing tolerability and efficacy of this association. 12 pts had been previously treated with CT. The median number of courses per pt was 2 (range l–6). Treatment was generally well tolerated. Hematologic toxicity consisted of neutropenia (gr 1–2: 5 pts, gr 3–4: 2 pts), anemia (gr 1–2: 6 pts, gr 3: 1 pt). No thrombopenia was observed. Non hematological toxicity consisted of nausea/vomiting (gr 1–2: 9 pts, gr 3–4: 1 pt), alopecia (gr 1–2: 3 pts), asthenia (gr 12: 2 pts), neuropathy (gr 1: 1 pt), creatinine increase (gr 1–2: 3 pts). One pt developed angina pectoris during the 4th cycle. Antitumor activity was documented in 4 pts (1 CR, 3 PRJ, giving a 29% response rate. Tumor progression was observed in 9 pts, and disease stabilisation in I pt. Present data suggest that COOP-NVB combination has significant activity in pts with recurrent and/or metastatic HNT. Since toxicity was limited, the study is ongoing with a higher NVB dose (6 mg iv bolus on d. 1 immediately followed by 96 hours CI of NVB 6 mg/m 2 /day).
Databáze: OpenAIRE
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