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一项关于卡莫司汀单独使用或与肿瘤坏死因子联合用于晚期黑色素瘤患者的随机II期研究。

A randomised phase II study of carmustine alone or in combination with tumour necrosis factor in patients with advanced melanoma.

作者信息

Jones A L, O'Brien M E, Lorentzos A, Viner C, Hanrahan A, Moore J, Millar J L, Gore M E

机构信息

Department of Medicine, Royal Marsden Hospital, London, U.K.

出版信息

Cancer Chemother Pharmacol. 1992;30(1):73-6. doi: 10.1007/BF00686489.

Abstract

Laboratory data suggest a synergistic interaction between carmustine (BCNU) and tumour necrosis factor (TNF) in melanoma. We therefore studied the activity of 200 mg/m2 BCNU given alone or in combination with 88 micrograms/m2 recombinant human TNF-alpha (rhTNF alpha) as a daily i.v. infusion for 5 days at 48-day intervals to patients with metastatic melanoma. In this randomised phase II trial, the rate of response to BCNU alone was 20% [95% confidence interval (CI), 2%-38%], and this was not improved by the addition of TNF (response rate, 10.5%; 95% CI, 1.3%-33%). Toxicity was higher in the combination arm, and there was no difference in survival.

摘要

实验室数据表明,卡莫司汀(BCNU)与肿瘤坏死因子(TNF)在黑色素瘤中存在协同相互作用。因此,我们对转移性黑色素瘤患者进行了研究,以200mg/m²的BCNU单独给药,或与88μg/m²重组人TNF-α(rhTNFα)联合给药,每天静脉输注,持续5天,间隔48天。在这项随机II期试验中,单独使用BCNU的缓解率为20%[95%置信区间(CI),2%-38%],添加TNF后缓解率并未提高(缓解率为10.5%;95%CI,1.3%-33%)。联合治疗组的毒性更高,生存率无差异。

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