DOCETAXEL (TAXOTERE) IN ADVANCED MALIGNANT-MELANOMA - A PHASE-II STUDY OF THE EORTC EARLY CLINICAL-TRIALS GROUP
DOCETAXEL (TAXOTERE) IN ADVANCED MALIGNANT-MELANOMA - A PHASE-II STUDY OF THE EORTC EARLY CLINICAL-TRIALS GROUP
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DOI：
10.1016/0959-8049(94)90456-1
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发表时间：
1994-01-01
影响因子：
8.4
通讯作者：
VERWEIJ, J
中科院分区：
文献类型：
--
作者：
AAMDAL, S;WOLFF, I;VERWEIJ, J
研究了多西紫杉醇对晚期恶性黑色素瘤患者的抗肿瘤活性。多西紫杉醇，100 mg/m(2)，静脉滴注，超过60min，每3周一次。两个周期后进行疗效评估。没有给予类固醇或抗组胺药物的预防性治疗。纳入38例患者，36例合格并可评价毒性，30例可评价反应。主要血液学毒性为中性粒细胞减少[17例CTC分级为4级，11例CTC分级为3级]，服药5~8d后出现低谷，且恢复快。最常见的非血液学毒性是泛发性脱发(83%的患者)。58%的人还出现虚弱、不适和疲劳。皮肤中毒也很常见。42%的患者出现过敏反应(红斑疹、荨麻疹、血压变化和心动过速)，为轻度至中度。五分之一的患者出现水肿症，并在四个或更多的治疗周期后出现。可评估患者的总有效率为17%(5名部分应答者)。我们得出结论，多西紫杉醇对晚期恶性黑色素瘤有活性。
The antitumour activity of docetaxel was investigated in patients with advanced malignant melanoma. Docetaxel, 100 mg/m(2), intravenous, over 60 min, was administered every 3 weeks. Response evaluation was performed after two cycles. No prophylactic treatment with steroids or antihistamines was given. 38 patients were included, 36 were eligible and evaluable for toxicity and 30 patients were evaluable for response. The main haematological toxicity was neutropenia [17 patients with common toxicity criteria (CTC) grade 4 and 11 CTC grade 3] with nadir after 5-8 days and rapid recovery. The most frequent non-haematological toxicity was generalised alopecia (83% of the patients). Asthenia, malaise and fatigue were also seen in 58%. Skin toxicity was also frequent. Hypersensitivity reactions (erythematous rash, urticaria, blood pressure changes and tachycardia), seen in 42% of the patients, were mild to moderate. Oedema was registered in one fifth of the patients and developed after four or more treatment cycles. The overall response rate in the evaluable patients was 17% (five partial responders). We conclude that docetaxel has activity in advanced malignant melanoma.