O-Mel-Inib：一项由法国西北部癌症中心开展的多中心II期试验，关于高剂量甲磺酸伊马替尼治疗转移性葡萄膜黑色素瘤。
O-Mel-Inib: a Cancéro-pôle Nord-Ouest multicenter phase II trial of high-dose imatinib mesylate in metastatic uveal melanoma.
作者信息
Penel Nicolas, Delcambre Corinne, Durando Xavier, Clisant Stéphanie, Hebbar Mohamed, Negrier Sylvie, Fournier Charles, Isambert Nicolas, Mascarelli Frédéric, Mouriaux Frédéric
机构信息
Département de Cancérologie Générale, Centre Oscar Lambret, 59020, Lille, France.
出版信息
Invest New Drugs. 2008 Dec;26(6):561-5. doi: 10.1007/s10637-008-9143-2. Epub 2008 Jun 13.
BACKGROUND
Nowadays, there is no consensual and effective treatment in metastatic uveal melanoma (MUM). Numerous preclinical data (for example, 75% of MUM express c-kit) suggest that imatinib mesylate (IM) may be a potential treatment of UMM.
METHODS
The primary objective of this phase II trial was to determine the non-progression rate at 3 months for patients receiving IM at dose of 400 mg twice per day orally. The study was based on a Simon's optimal design, which allows entry a total of 29 patients, if at least two non-progressions among ten first patients were observed.
RESULT
Thirteen patients including ten assessable patients were enrolled in 12 months. No objective response and only one stable disease with duration of 5 months were noted. Five and one out of 13 enrolled patients experienced grade 3 and grade 4 toxicities, respectively. The most common severe adverse events were abdominal pain. The overall survival was 10.8 months.
CONCLUSIONS
Despite promising preclinical data, IM is an inactive single agent in MUM. This phase II clinical trial has been stopped at the first step.
背景
目前，转移性葡萄膜黑色素瘤（MUM）尚无公认的有效治疗方法。大量临床前数据（例如，75%的MUM表达c-kit）表明甲磺酸伊马替尼（IM）可能是葡萄膜黑色素瘤（UMM）的一种潜在治疗方法。
方法
这项II期试验的主要目的是确定每天口服两次400mg IM的患者3个月时的无进展率。该研究基于西蒙最优设计，如果在前10名患者中至少观察到2例无进展，则总共允许纳入29例患者。
结果
12个月内共纳入13例患者，其中10例可评估。未观察到客观缓解，仅1例疾病稳定，持续时间为5个月。13例纳入患者中分别有5例和1例出现3级和4级毒性反应。最常见的严重不良事件是腹痛。总生存期为10.8个月。
结论
尽管临床前数据很有前景，但IM作为单一药物治疗MUM无效。这项II期临床试验已在第一步停止。
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