Imatinib in gastrointestinal stromal tumour: Northern Cancer Network experience
Imatinib in gastrointestinal stromal tumour: Northern Cancer Network experience
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DOI：
10.3332/ecancer.2010.162
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发表时间：
2009-01-01
影响因子：
1.8
通讯作者：
Verrill, M.
中科院分区：
文献类型：
--
作者：
Azribi, F.;Razak, A. R. A.;Verrill, M.
伊马替尼治疗转移性或不能手术的胃肠道间质瘤（GIST）已经改变了这种疾病的治疗模式。伊马替尼的成功临床试验迅速获得了监管机构的批准，在英格兰和威尔士，国家健康与临床卓越研究所（NICE）发布了关于该技术使用的指南。NICE建议在临床实践中对其指南进行详细审核。该审核反映了该指南，旨在记录伊马替尼在常规临床实践中的使用。方法：我们对2002年2月1日至2007年3月31日接受伊马替尼治疗的GIST患者进行了回顾性审计。收集的信息包括患者人口统计、疾病特征和治疗细节、治疗反应、毒性和随访数据。主要目的是记录疾病控制率（DCR），定义为三个月时计算机断层扫描缺乏进展。该审计的次要终点是无进展和总生存期。这些结果与已发表的临床试验结果进行了比较。结果：36例连续接受伊马替尼治疗的GIST患者被确认。患者中位年龄为70.1岁。在分析时，患者的随访时间中位数为41.6个月。总的来说，患者的中位治疗时间为15.8个月。治疗通常耐受性良好，一小部分患者出现3/4级毒性。30例患者观察到疾病控制（DCR, 83.3%, 95% CI 67.2-93.6，意向治疗分析）。该队列的中位无进展生存期（PFS）为23.7个月（95% CI 12.9-34.4）；中位总生存期为39.7个月（95% CI 22.8-56.5）。结论：我们的数据表明，在NICE指导下，未选择的GIST患者的治疗优于先前发表的伊马替尼随机注册研究数据。值得注意的是，该队列的中位年龄比试验中报告的年龄大10岁左右。伊马替尼耐受性良好，治疗相关不良事件可接受。
Imatinib treatment in metastatic or inoperable gastrointestinal stromal tumours (GIST) has shifted the paradigm of treatment of this disease. Successful clinical trials of imatinib led to rapid regulatory approval and, in England and Wales, National Institute for Health and Clinical Excellence (NICE) guidance on use of this technology. NICE recommend detailed audit of their guidelines in clinical practice. This audit reflects that guidance and was designed to document the use of imatinib in routine clinical practice.Methods: We conducted a retrospective audit of patients with GIST treated with imatinib from 1 February 2002 to 31 March 2007. Information gathered included patient demographics, disease characteristics and details of treatment administered, treatment response, toxicities and follow-up data. The primary objective was to record disease control rate (DCR), defined as a lack of progression on computed tomography at three months. Secondary end points of this audit were progression-free and overall survival. These were compared with published clinical trial results.Results: Thirty-six consecutive patients with a diagnosis of GIST treated with imatinib were identified. Median age of patients was 70.1 years. At the time of analysis, patients have been followed up for a median of 41.6 months. In total, patients were treated for a median of 15.8 months. Treatment was generally well tolerated with a small percentage of patients experiencing grade 3/4 toxicities. Disease control was observed in 30 patients (DCR, 83.3%, 95% CI 67.2-93.6, intention to treat analysis). The median progression free survival (PFS) in this cohort was 23.7 months (95% CI 12.9-34.4); while the median overall survival was 39.7 months (95% CI 22.8-56.5).Conclusion: Our data demonstrated that the treatment of unselected GIST patients within the NICE guidance compares favourably to previously published data of randomized registration studies of imatinib. Of note, the median age of this cohort is some ten years older than that reported in the trials. Imatinib was well tolerated with acceptable treatment-related adverse events.