DOCETAXEL (TAXOTERE) IN ADVANCED MALIGNANT-MELANOMA - A PHASE-II STUDY OF THE EORTC EARLY CLINICAL-TRIALS GROUP

The antitumour activity of docetaxel was investigated in patients with advanced malignant melanoma. Docetaxel, 100 mg/m(2), intravenous, ove r 60 min, was administered every 3 weeks. Response evaluation was perf ormed after two cycles. No prophylactic treatment with steroids or ant ihistamines was given. 38 patients were included, 36 were eligible and evaluable for toxicity and 30 patients were evaluable for response. T he main haematological toxicity was neutropenia [17 patients with comm on toxicity criteria (CTC) grade 4 and 11 CTC grade 3] with nadir afte r 5-8 days and rapid recovery. The most frequent non-haematological to xicity was generalised alopecia (83% of the patients). Asthenia, malai se and fatigue were also seen in 58%. Skin toxicity was also frequent. Hypersensitivity reactions (erythematous rash, urticaria, blood press ure changes and tachycardia), seen in 42% of the patients, were mild t o moderate. Oedema was registered in one fifth of the patients and dev eloped after four or more treatment cycles. The overall response rate in the evaluable patients was 17% (five partial responders). We conclu de that docetaxel has activity in advanced malignant melanoma.