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Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients.
Lung Cancer ( IF 5.3 ) Pub Date : 2019-12-16 , DOI: 10.1016/j.lungcan.2019.12.006
Maria Lucia Reale 1 , Rita Chiari 2 , Marcello Tiseo 3 , Fabiana Vitiello 4 , Fausto Barbieri 5 , Diego Cortinovis 6 , Giovanni Luca Ceresoli 7 , Giovanna Finocchiaro 8 , Gianpiero Diego Romano 9 , Pier Luigi Piovano 10 , Alessandro Del Conte 11 , Gloria Borra 12 , Francesco Verderame 13 , Vieri Scotti 14 , Daniela Nonnis 15 , Domenico Galetta 16 , Concetta Sergi 17 , Maria Rita Migliorino 18 , Giuseppe Tonini 19 , Fabiana Cecere 20 , Rossana Berardi 21 , Maria Simona Pino 22 , Olga Martelli 23 , Alain Gelibter 24 , Annamaria Carta 25 , Emanuela Vattemi 26 , Maria Pagano 27 , Alessandro Zullo 28 , Silvia Ferrari 29 , Antonio Rossi 30 , Silvia Novello 1
Affiliation  

OBJECTIVES Molecular diagnostics and care of non-small cell lung cancer (NSCLC) are continuously evolving. Few data document the current strategies to manage advanced NSCLC patients beyond progression in clinical practice. PATIENTS AND METHODS Be-TeaM is an Italian multi-center observational study conducted on consecutive EGFR-mutated stage IV NSCLC patients, progressed during/after a first-line EGFR-TKI. It consists of a retrospective phase, from first-line EGFR-TKI therapy start until study entry (i.e. beginning of the diagnostic process), and a prospective phase, until treatment choice or for 3 months if no therapy was prescribed. Primary objective was to describe the diagnostic and therapeutic approaches adopted after progression in a real-world setting. RESULTS Of 308 patients enrolled in 63 centers from July 2017 to June 2018, 289 were included in the analysis. In first line, 53.3 % received gefitinib, 32.5 % afatinib and 14.2 % erlotinib. The testing rate (i.e. rate of all patients undergone any biopsy -liquid and/or tissue- for the T790 M detection) was 90.7 %, with liquid biopsy being the most frequently executed. Of 262 biopsied patients, 64.5 % underwent only 1 liquid biopsy, 10.7 % only 1 tissue biopsy and 18.3 % >1 biopsy, both liquid and solid in 85.4 %. The T790M positivity rate was 45.3 %; of 166 patients undergone only a liquid biopsy and tested for the mutation, 39.8 % were T790M+ and 60.2 % T790M-/undetermined. By the observation end, 87.9 % patients had a post-progression treatment chosen, osimertinib being the most frequent among the T790M+. CONCLUSION Be-TeaM provides the first snapshot of current practices for the management of NSCLC patients beyond progression in Italy; in clinical practice, assessing the T790M status is not always feasible.

中文翻译:

Be-TeaM:一项针对EGFR突变的NSCLC患者的二线治疗的意大利真实观察研究。

目的非小细胞肺癌(NSCLC)的分子诊断和护理正在不断发展。很少有数据记录目前用于治疗晚期NSCLC患者的策略,这些策略超出了临床实践的进展。患者与方法Be-TeaM是一项意大利多中心观察性研究,针对一线EGFR-TKI期间/之后进行的连续EGFR突变的IV期NSCLC患者进行。它包括回顾性阶段,从一线EGFR-TKI治疗开始到研究进入(即诊断过程的开始),以及前瞻性阶段,直到选择治疗,或者如果没有处方治疗,则为3个月。主要目的是描述在现实环境中进展后所采用的诊断和治疗方法。结果2017年7月至2018年6月,在63个中心招募了308名患者,分析中包括289个。在第一行中,有53.3%的人接受了吉非替尼,32.5%的阿法替尼和14.2%的厄洛替尼。测试率(即,所有接受过T790 M检测的活检(液体和/或组织)的患者的比率)为90.7%,其中液体活检是最常执行的检查。在262例活检患者中,有64.5%的患者仅进行了1次液体活检,只有10.7%的患者进行了1次组织活检和18.3%的> 1次活检,液体和固体均占85.4%。T790M阳性率为45.3%。在166名仅进行了液体活检并测试了突变的患者中,有39.8%的T790M +和60.2%的T790M- /未定。到观察结束时,已选择87.9%的患者进行了治疗后治疗,其中Oimertinib是T790M +中最常见的治疗方法。结论Be-TeaM提供了目前在意大利以外的NSCLC患者管理实践的第一张快照。在临床实践中,评估T790M的状态并不总是可行的。
更新日期:2019-12-17
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