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ASCO 2013:研究者推荐在亚裔晚期非小细胞肺癌患者中应用60mg/m2多烯紫杉醇治疗

2013-05-21 ASCO2013 dxy

对于西方国家晚期非小细胞肺癌患者而言,75mg/m2剂量的多烯紫杉醇治疗是一线治疗和维持治疗方案。但是在亚洲的非小细胞肺癌患者人群中,目前多烯紫杉醇的剂量与西方国家并不相同——为60mg/m2。由于在不同的种族人群中紫杉烷类的分布不同,从而造成药物基因组学的不同,这或能解释在不同人群中药物剂量不同。TFINE研究旨在评价多烯紫杉醇作为维持治疗对亚裔非小细胞肺癌患者的有效性和安全性,以及患者对治疗的

对于西方国家晚期非小细胞肺癌患者而言,75mg/m2剂量的多烯紫杉醇治疗是一线治疗和维持治疗方案。但是在亚洲的非小细胞肺癌患者人群中,目前多烯紫杉醇的剂量与西方国家并不相同——为60mg/m2。由于在不同的种族人群中紫杉烷类的分布不同,从而造成药物基因组学的不同,这或能解释在不同人群中药物剂量不同。TFINE研究旨在评价多烯紫杉醇作为维持治疗对亚裔非小细胞肺癌患者的有效性和安全性,以及患者对治疗的耐受情况,同时确定在亚裔人群中多烯紫杉醇治疗的适宜剂量。
本研究所纳入的受试者为既往没有接受过治疗、年龄范围介于18岁至75岁之间、经组织学或细胞学证实为晚期非小细胞肺癌的患者,并且他们的一般状态评分在0-1之间。本研究分为两个阶段,在R1阶段,研究者将符合上述标准的受试者按照1:1比例分为2组,一组按照75mg/m2的剂量接受顺铂治疗,同时联合75mg/m2或60mg/m2的多烯紫杉醇治疗,一共四个疗程。在初始治疗后病情得到控制的患者随即进入第二阶段(R2)的研究,在该阶段的研究中,研究者将其按照1:2的比例随机分为两组,一组接受最佳的支持治疗,另一组则按照60mg/m2的剂量继续接受多烯紫杉醇维持治疗,一共六个疗程。对所有纳入本研究的受试者,研究者前瞻性的进行基因组DNA采集。本研究的主要终点事件是在R2后的无进展生存期情况,次要终点则包括受试者对治疗的客观反应率、总体生存期和治疗所存在的毒性反应。本研究在ClinicalTrials.gov注册,注册号为NCT01038661。
本随机对照研究在中国的15个中心内进行。在研究的第一阶段共纳入了378名受试者,其中有184名(48.7%)受试者进入了第二阶段的研究,最佳支持治疗组和多烯紫杉醇维持治疗组分别有61人和123人。与仅接受支持治疗的受试者相比,支持治疗联合多烯紫杉醇维持治疗能显著延长受试者的无进展生存期,前者为2.8月(95%可信区间1.8-3.1),后者为5.4月(95%可信区间2.8-7.0),两组差异具有显著统计学意义。在初始化疗阶段,多烯紫杉醇不同剂量对治疗的客观反应率并未造成显著影响,其中60mg组为32.4%,而75mg组为33.7%。在本次会议上,研究者将进一步报道与总体生存率、治疗所带来的毒性反应,以及与药物基因组学变化相关的信息。
本研究结果指出,晚期非小细胞肺癌患者能够很好的耐受多烯紫杉醇进行维持治疗,并且该治疗也能改善他们的无进展生存期。研究者也证实了与75mg/m2的治疗剂量相比,60mg/m2剂量的多烯紫杉醇的治疗所带来的疗效相似,患者也能更好的耐受该治疗剂量的方案,因此推荐在亚洲人群中应用60mg/m2多烯紫杉醇治疗方案。临床研究信息:NCT01038661。
即进入第二阶段(R2)的研究,在该阶段的研究中,研究者将其按照1:2的比例随机分为两组,一组接受最佳的支持治疗,另一组则按照60mg/m2的剂量继续接受多烯紫杉醇维持治疗,一共六个疗程。对所有纳入本研究的受试者,研究者前瞻性的进行基因组DNA采集。本研究的主要终点事件是在R2后的无进展生存期情况,次要终点则包括受试者对治疗的客观反应率、总体生存期和治疗所存在的毒性反应。本研究在ClinicalTrials.gov注册,注册号为NCT01038661。
本随机对照研究在中国的15个中心内进行。在研究的第一阶段共纳入了378名受试者,其中有184名(48.7%)受试者进入了第二阶段的研究,最佳支持治疗组和多烯紫杉醇维持治疗组分别有61人和123人。与仅接受支持治疗的受试者相比,支持治疗联合多烯紫杉醇维持治疗能显著延长受试者的无进展生存期,前者为2.8月(95%可信区间1.8-3.1),后者为5.4月(95%可信区间2.8-7.0),两组差异具有显著统计学意义。在初始化疗阶段,多烯紫杉醇不同剂量对治疗的客观反应率并未造成显著影响,其中60mg组为32.4%,而75mg组为33.7%。在本次会议上,研究者将进一步报道与总体生存率、治疗所带来的毒性反应,以及与药物基因组学变化相关的信息。
本研究结果指出,晚期非小细胞肺癌患者能够很好的耐受多烯紫杉醇进行维持治疗,并且该治疗也能改善他们的无进展生存期。研究者也证实了与75mg/m2的治疗剂量相比,60mg/m2剂量的多烯紫杉醇的治疗所带来的疗效相似,患者也能更好的耐受该治疗剂量的方案,因此推荐在亚洲人群中应用60mg/m2多烯紫杉醇治疗方案。临床研究信息:NCT01038661。


Different-dose docetaxel plus cisplatin as first-line chemotherapy and then maintenance therapy with single-agent docetaxel for advanced non-small cell lung cancer (TFINE study, C-TONG 0904).
Abstract:
Background: Docetaxel (75 mg/m2) has been reported as first-line and maintenance treatment for Western population with advanced NSCLC. Different doses of docetaxel (60 mg/m2) are currently delivered in Asian population. Pharmacogenomics alterations in taxanes disposition in different ethnic groups may explain this difference. TFINE study was to evaluate the efficacy, safety, and tolerability of docetaxel in the maintenance setting, and to identify the preferable dose of docetaxel in Asian population. Methods: Previously untreated patients, aged between 18 and 75 years, histologically or cytologically confirmed advanced NSCLC with PS of 0-1 were included. Patients were initially randomized (R1, 1:1) to receive cisplatin (75 mg/m2) plus docetaxel of 75 mg/m2 or 60 mg/m2 for 4 cycles. Patients with disease control after the initial treatment were subsequently randomized (R2, 1:2) to best supportive care (BSC) or maintenance docetaxel of 60 mg/m2 for up to 6 cycles...

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    2013-08-04 quxin068
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    2014-03-26 stfoxst
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