综合基因组图谱分析对晚期非小细胞肺癌治疗的影响:FPG500计划肺癌队列的初步结果。

IF 5.3 2区 医学 Q1 ONCOLOGY JCO precision oncology Pub Date : 2024-10-01 Epub Date: 2024-10-07 DOI:10.1200/PO.24.00297
Antonio Vitale, Luca Mastrantoni, Jacopo Russo, Flavia Giacomini, Diana Giannarelli, Simona Duranti, Emanuele Vita, Camilla Nero, Ettore D'Argento, Tina Pasciuto, Luciano Giacò, Mariantonietta Di Salvatore, Arianna Panfili, Alessio Stefani, Alessandra Cancellieri, Filippo Lococo, Elisa De Paolis, Vanina Livi, Gennaro Daniele, Rocco Trisolini, Angelo Minucci, Stefano Margaritora, Domenica Lorusso, Nicola Normanno, Giovanni Scambia, Giampaolo Tortora, Emilio Bria
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引用次数: 0

摘要

目的:Fondazione Policlinico Universitario Agostino Gemelli IRCCS目前正在开展临床和研究FPG500计划(ClinicalTrials.gov标识符:NCT06020625),根据综合基因组图谱(CGP)确定的预测反应的生物标志物定制匹配的靶向疗法(MTT):概述了FPG500计划的非小细胞肺癌(NSCLC)队列结果。根据肿瘤细胞含量和DNA/RNA数量,采用TruSight Oncology 500高通量(TSO500HT)测定或Oncomine Focus测定加Archer's FusionPlex Lung Panel进行CGP分析。肿瘤分子委员会(MTB)评估的相关问题包括:不常见的基因组发现、标签外疗法评估、不确定的结果确认以及需要遗传咨询的可疑种系变异。采用 Kaplan-Meier 分析法评估了入组患者的无进展生存期(PFS)和总生存期(OS):2022年,283名NSCLC患者被考虑进行测序,其中93%符合资格标准。76%的患者进行了TSO500HT测序。获得了187名患者的随访数据,其中81%的患者接受了治疗。59%的患者确定了潜在的驱动基因改变,41%的患者接受了MTT治疗:25%的患者获得了批准的MTT处方,而16%的患者在MTB评估后获得了实验性药物;值得注意的是,18%的患者没有接受任何MTT治疗,因为该方案在我国尚未报销。各治疗组的中位生存期和OS各不相同,标准化疗/免疫疗法分别为7.7个月和10.7个月,获批的酪氨酸激酶抑制剂分别为18.8个月和23.9个月,MTB讨论后的MTT分别为14个月和23.4个月:FPG项目(NSCLC队列)的早期数据支持在临床实践中实施CGP和MTB,使携带可操作分子改变的患者获得最有效的个体化治疗方案,从而改善他们的生存预后。
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Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary Results From the Lung Cancer Cohort of the FPG500 Program.

Purpose: The clinical and research FPG500 program (ClinicalTrials.gov identifier: NCT06020625) is currently ongoing at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS to tailor matched targeted therapies (MTTs) according to biomarkers predictive of response identified by comprehensive genome profiling (CGP).

Materials and methods: The non-small cell lung cancer (NSCLC) cohort results from the FPG500 program are outlined. CGP was performed by TruSight Oncology 500 High Throughput (TSO500HT) assay or Oncomine Focus Assay plus Archer's FusionPlex Lung Panel according to tumor cell content and DNA/RNA quantity. Relevant issues for Molecular Tumor Board (MTB) evaluation included uncommon genomic findings, evaluation for off-label therapies, uncertain result confirmation, and variants of suspect germline origin requiring genetic counseling. Progression-free survival (PFS) and overall survival (OS) for the enrolled patients were assessed using Kaplan-Meier analysis.

Results: In 2022, 283 patients with NSCLC were considered for sequencing, with 93% meeting eligibility criteria. TSO500HT sequencing was conducted in 76% of patients. Follow-up data were obtained for 187 patients, among whom 81% received treatment. Potential driver alterations were identified in 59% of patients, with 41% receiving MTT: 25% were prescribed approved MTTs, whereas 16% gained access to experimental drugs post-MTB evaluation; of note, 18% did not receive any MTT because the regimen was not yet reimbursed in our country. Median PFS and OS varied among treatment groups, with standard chemotherapy/immunotherapy at 7.7 and 10.7 months, approved tyrosine kinase inhibitors at 18.8 and 23.9 months, and MTT post-MTB discussion at 14 and 23.4 months, respectively.

Conclusion: The early data of the FPG program (NSCLC cohort) support the implementation of CGP and MTB in clinical practice to grant access to patients harboring actionable molecular alterations to the most effective and individualized available treatment options, thus improving their survival outcomes.

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