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一线表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)持续治疗对晚期EGFR突变非小细胞肺癌(NSCLC)患者在实体瘤疗效评价标准(RECIST)定义的疾病进展后的影响:GFPC 04-13回顾性研究

Impact of Continuing First-Line EGFR Tyrosine Kinase Inhibitor Therapy Beyond RECIST Disease Progression in Patients with Advanced EGFR-Mutated Non-Small-Cell Lung Cancer (NSCLC): Retrospective GFPC 04-13 Study.

作者信息

Auliac J B, Fournier C, Audigier Valette C, Perol M, Bizieux A, Vinas F, Decroisette Phan van Ho C, Bota Ouchlif S, Corre R, Le Garff G, Fournel P, Baize N, Lamy R, Vergnenegre A, Arpin D, Marin B, Chouaid C, Gervais R

机构信息

Service de Pneumologie et oncologie thoracique, Hôpital F Quesnay, 2 Boulevard de Sully, 78200, Mantes la Jolie, France.

, Marseille, France.

出版信息

Target Oncol. 2016 Apr;11(2):167-74. doi: 10.1007/s11523-015-0387-4.

DOI:10.1007/s11523-015-0387-4
PMID:26315967
Abstract

UNLABELLED

Retrospective studies suggested a benefit of first-line tyrosine kinase inhibitor (TKI) treatment continuation after response evaluation in solid tumors (RECIST) progression in epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) patients. The aim of this multicenter observational retrospective study was to assess the frequency of this practice and its impact on overall survival (OS). The analysis included advanced EGFR-mutated NSCLC patients treated with first-line TKI who experienced RECIST progression between June 2010 and July 2012. Among the 123 patients included (67 ± 12.7 years, women: 69 %, non smokers: 68 %, PS 0-1: 87 %), 40.6 % continued TKI therapy after RECIST progression. There was no difference between the patients who did and did not continue TKI therapy with respect to progression-free survival (PFS1: 10.5 versus 9.5 months, p = 0.4). Overall survival (OS) showed a non-significant trend in favor of continuing TKI therapy (33.0 vs. 21.2 months, p = 0.054). Progressions were significantly less symptomatic in the TKI continuation group than in the discontinuation group (18 % vs. 37 %, p < 0.01). Univariate analysis showed a higher risk of death among patients with PS >1 (HR 4.33, 95 %CI: 2.21-8.47, p = 0.001), >1 one metastatic site (HR 1.96, 95 %CI: 1.06-3.61, p = 0.02), brain metastasis (HR 1.75, 95 %CI: 1.08-2.84, p = 0.02) at diagnosis, and a trend towards a higher risk of death in cases of TKI discontinuation after progression (HR 1.62, 95 %CI: 0.98-2.67, p = 0.056 ). In multivariate analysis only PS >1 (HR 6.27, 95 %CI: 2.97-13.25, p = 0.00001) and >1 metastatic site (HR 2.54, 95 %CI: 1.24-5.21, p = 0.02) at diagnosis remained significant. This study suggests that under certain circumstances, first-line TKI treatment continuation after RECIST progression is an acceptable option in EGFR-mutated NSCLC patients.

CLINICAL TRIAL INFORMATION

NCT02293733.

摘要

未标注

回顾性研究表明,在表皮生长因子受体(EGFR)突变的非小细胞肺癌(NSCLC)患者中,根据实体瘤疗效评价标准(RECIST)评估疾病进展后继续一线酪氨酸激酶抑制剂(TKI)治疗有益。这项多中心观察性回顾性研究的目的是评估这种做法的频率及其对总生存期(OS)的影响。分析纳入了2010年6月至2012年7月期间接受一线TKI治疗且经历RECIST进展的晚期EGFR突变NSCLC患者。在纳入的123例患者中(67±12.7岁,女性:69%,非吸烟者:68%,体能状态0 - 1:87%),40.6%的患者在RECIST进展后继续TKI治疗。继续和未继续TKI治疗的患者在无进展生存期方面无差异(PFS1:10.5个月对9.5个月,p = 0.4)。总生存期显示出继续TKI治疗的非显著优势趋势(33.0个月对21.2个月,p = 0.054)。TKI继续治疗组的症状性进展明显少于停药组(18%对37%,p < 0.01)。单因素分析显示,体能状态>1(HR 4.33,95%CI:2.21 - 8.47,p = 0.001)、诊断时转移部位>1个(HR 1.96,95%CI:1.06 - 3.61,p = 0.02)、脑转移(HR 1.75,95%CI:1.08 - 2.84,p = 0.02)的患者死亡风险更高,并且进展后停用TKI的患者有死亡风险增加的趋势(HR 1.62,95%CI:0.98 - 2.67,p = 0.056)。多因素分析显示,仅诊断时体能状态>1(HR 6.27,95%CI:2.97 - 13.25,p = 0.00001)和转移部位>1个(HR 2.54,95%CI:1.24 - 5.21,p = 0.02)仍具有显著性。这项研究表明,在某些情况下,EGFR突变的NSCLC患者在RECIST进展后继续一线TKI治疗是一个可接受的选择。

临床试验信息

NCT02293733。

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