Update of phase I study of imatinib (ST1571) in advanced soft tissue sarcomas and gastrointestinal stromal tumors: a report of the EORTC Soft Tissue and Bone Sarcoma Group
Update of phase I study of imatinib (ST1571) in advanced soft tissue sarcomas and gastrointestinal stromal tumors: a report of the EORTC Soft Tissue and Bone Sarcoma Group
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DOI：
10.1016/s0959-8049(02)80608-6
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发表时间：
2002-09-01
影响因子：
8.4
通讯作者：
Nielsen, OS
中科院分区：
文献类型：
--
作者：
van Oosterom, AT;Judson, IR;Nielsen, OS
在EORTC软组织和骨肉瘤小组进行的一项I期研究中，40名患有晚期软组织肉瘤的患者接受了伊马替尼的治疗，剂量分别为400 mg q.d、300 mg bi.d、400 mg bi.d或500 mg bi.d，其中大多数患者患有胃肠道间质瘤(GIST)。剂量限制毒性，包括严重恶心、呕吐、浮肿和皮疹，出现在最高剂量水平；因此，最大耐受剂量为400毫克，每天两次。伊马替尼在35例GIST患者中有效，19例(54%)患者部分缓解，13例(37%)病情稳定。有反应的患者现在已经接受了至少10个月的跟踪调查。在继续接受治疗的患者中，最常见的副作用是。眶周浮肿(40%)、周围浮肿(37.5%)、乏力(30%)、皮疹(30%)、恶心呕吐(25%)。偶尔也会出现严重的晚期骨髓抑制。18例(51%)GIST患者继续有部分反应，11例(31%)继续病情稳定。因此，82%的胃肠道间质瘤患者继续接受伊马替尼治疗后仍能获得重要的临床益处。一些患者在开始使用伊马替尼后不久就表现出加速进展性疾病。另一方面，在停药后，2名患者在没有药物治疗的情况下肿瘤负担减轻并存活。综上所述，伊马替尼一般耐受性良好，在晚期GIST患者的长期治疗中具有显著的活性。(C)2002爱思唯尔科学有限公司。保留所有权利。
In a phase I study conducted by the EORTC Soft Tissue and Bone Sarcoma Group, 40 patients with advanced soft tissue sarcomas, most of whom had gastrointestinal stromal tumors (GISTs), received imatinib at doses of 400 mg q.d., 300 mg b.i.d., 400 mg b.i.d., or 500 mg b.i.d. Dose-limiting toxicities, including severe nausea, vomiting, edema and rash, were seen at the highest dose level; the maximum tolerated dose was therefore 400 mg b.i.d. Imatinib was active in the group of 35 patients with GISTs, producing partial responses in 19 (54%) patients and stable disease in 13 patients (37%). Responding patients have now been followed for a minimum of 10 months. The most common side effects seen in patients continuing on therapy have been. periorbital edema (40%), peripheral edema (37.5%), fatigue (30%), skin rash (30%) and nausea/vomiting (25%). Severe late myelosuppression has also been seen occasionally. Eighteen (51%) GIST patients continue to have partial responses and 11 (31%) continue with stable disease. Thus, 82% of patients with GISTs are still obtaining clinically important benefits with continued imatinib therapy. Some patients showed accelerated progressive disease shortly after starting imatinib. On the other hand, following drug withdrawal, 2 patients had reductions in tumor burden and remain alive without drug therapy. In summary, imatinib is generally well tolerated and has significant activity during long-term treatment of patients with advanced GISTs. (C) 2002 Elsevier Science Ltd. All rights reserved.