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克唑替尼治疗ALK阳性非小细胞肺癌患者的真实世界疗效

Real-world outcomes in patients with ALK-positive non-small cell lung cancer treated with crizotinib.

作者信息

Davis K L, Kaye J A, Masters E T, Iyer S

机构信息

RTI Health Solutions, Research Triangle Park, NC, USA.

RTI Health Solutions, Waltham, MA, USA.

出版信息

Curr Oncol. 2018 Feb;25(1):e40-e49. doi: 10.3747/co.25.3723. Epub 2018 Feb 28.

Abstract

BACKGROUND

Crizotinib has shown greater efficacy in clinical trials than chemotherapy in patients with anaplastic lymphoma kinase-positive (alk+) non-small cell lung cancer (nsclc), but little information is available on its use and outcomes in real-world settings. We therefore assessed treatment patterns and outcomes in alk+ nsclc patients treated with crizotinib in regular clinical practice.

METHODS

A retrospective medical record review was conducted in North America for adults with alk+ nsclc treated with crizotinib as first- or later-line therapy for metastatic disease between 1 August 2011 and 31 March 2013 (for the United States) or 1 May 2012 and 31 March 2013 (for Canada). Crizotinib-related trial enrollees were excluded. Descriptive analyses were conducted to assess treatment patterns and objective response rate (orr). Progression-free survival (pfs) and overall survival (os) were descriptively analyzed using Kaplan-Meier methods.

RESULTS

Data were extracted for 212 patients in the United States ( = 147) and Canada ( = 65). Mean (standard deviation [sd]) age was 58.9 (9.5) years, and 69% were male. Seventy-nine patients (37%) were deceased at record abstraction. Sixty-five percent ( = 137) initiated crizotinib as first-line therapy. Mean (sd) duration of crizotinib treatment was 8.7 (4.9) months. Objective response rate was 66% (69% for first-line recipients, 60% for second-/later-line). Median (95% ci) pfs and os from crizotinib initiation were 9.5 (8.7, 10.1) and 23.4 (19.5, -) months, respectively. One- and two-year survival probabilities were 82% and 49%, respectively.

CONCLUSIONS

Outcomes for crizotinib recipients in this study align with previous trials, with orr appearing more favourable in first-line recipients. Our findings indicate that crizotinib outcomes in clinical studies may translate to regular clinical practice.

摘要

背景

在间变性淋巴瘤激酶阳性(ALK+)非小细胞肺癌(NSCLC)患者中,克唑替尼在临床试验中显示出比化疗更高的疗效,但关于其在实际临床环境中的使用情况和治疗结果的信息却很少。因此,我们评估了在常规临床实践中接受克唑替尼治疗的ALK+ NSCLC患者的治疗模式和治疗结果。

方法

在北美对2011年8月1日至2013年3月31日(美国)或2012年5月1日至2013年3月31日(加拿大)期间接受克唑替尼作为转移性疾病一线或后续治疗的ALK+ NSCLC成年患者进行了回顾性病历审查。排除与克唑替尼相关的试验参与者。进行描述性分析以评估治疗模式和客观缓解率(ORR)。采用Kaplan-Meier方法对无进展生存期(PFS)和总生存期(OS)进行描述性分析。

结果

提取了美国147例和加拿大65例患者的数据。平均(标准差[SD])年龄为58.9(9.5)岁,69%为男性。在病历摘要时,79例患者(37%)已死亡。65%(137例)患者开始使用克唑替尼作为一线治疗。克唑替尼治疗的平均(SD)持续时间为8.7(4.9)个月。客观缓解率为66%(一线治疗患者为69%,二线/后续治疗患者为60%)。从开始使用克唑替尼起,中位(95%CI)PFS和OS分别为9.5(8.7,10.1)个月和23.4(19.5,-)个月。1年和2年生存率分别为82%和49%。

结论

本研究中接受克唑替尼治疗的患者的治疗结果与先前试验一致,一线治疗患者的ORR似乎更有利。我们的研究结果表明,临床研究中克唑替尼的治疗结果可能适用于常规临床实践。

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