Perdrizet Kirstin, Stockley Tracy L, Law Jennifer H, Smith Adam, Zhang Tong, Fernandes Roxanne, Shabir Muqdas, Sabatini Peter, Youssef Nadia Al, Ishu Christine, Li Janice Jn, Tsao Ming-Sound, Pal Prodipto, Cabanero Michael, Schwock Joerg, Ko Hyang Mi, Boerner Scott, Ruff Heather, Shepherd Frances A, Bradbury Penelope A, Liu Geoffrey, Sacher Adrian G, Leighl Natasha B
Princess Margaret Cancer Centre/University Health Network, Toronto, Canada; William Osler Health System, Brampton, Ontario, Canada.
Princess Margaret Cancer Centre/University Health Network, Toronto, Canada; Advanced Molecular Diagnostics Laboratory, University Health Network, Toronto, Canada.
Cancer Treat Res Commun. 2022;31:100534. doi: 10.1016/j.ctarc.2022.100534. Epub 2022 Feb 18.
Standard molecular testing for patients with stage IV non-small cell lung cancer (NSCLC) in the Canadian publicly funded health system includes single gene testing for EGFR, ALK, and ROS-1. Comprehensive genomic profiling (CGP) may broaden treatment options for patients. This study examined the impact of CGP in a publicly funded health system.
Consenting patients with stage IV NSCLC without known targetable alterations underwent CGP on diagnostic samples. Patients that had progressed on targeted therapy were also eligible. The CGP assay was a hybrid capture next generation sequencing (NGS) panel (Oncomine Comprehensive Assay Version 3, ThermoFisher). The number of actionable alterations, changes in treatment, clinical trial eligibility and costs as a result of CGP were evaluated and patient willingness-to-pay.
Of 182 screened patients,134 (74%) had successful CGP testing. Twenty percent had received prior targeted therapy. Incremental actionable alterations were identified in 31% of patients. The most common novel targets identified were mutations in ERBB2 (exon 20 insertions), MET (exon 14 skipping) and KRAS (G12C). At data cut off (31/12/2020), 16% of patients had a change in treatment as a result of CGP. Additional clinical trial options were identified for 75% of patients. The incremental direct laboratory cost for CGP beyond public reimbursement for single gene tests was $747 CAD/case.
CGP identifies additional actionable targets beyond single gene tests with a direct impact on patient treatment and increased clinical trial eligibility. These benefits highlight the value of CGP in patients with NSCLC in public health systems.
在加拿大公共资助的医疗系统中,对IV期非小细胞肺癌(NSCLC)患者进行的标准分子检测包括对表皮生长因子受体(EGFR)、间变性淋巴瘤激酶(ALK)和ROS-1进行单基因检测。全面基因组分析(CGP)可能会为患者拓宽治疗选择。本研究探讨了CGP在公共资助医疗系统中的影响。
对同意参与研究的IV期NSCLC患者,在诊断样本上进行CGP检测,这些患者无已知的可靶向改变。在靶向治疗中病情进展的患者也符合条件。CGP检测采用杂交捕获二代测序(NGS)平台(Oncomine Comprehensive Assay Version 3,赛默飞世尔科技公司)。评估了CGP检测导致的可操作改变的数量、治疗变化、临床试验资格和成本,以及患者的支付意愿。
在182例筛查患者中,134例(74%)成功进行了CGP检测。20%的患者曾接受过靶向治疗。31%的患者发现了新增的可操作改变。确定的最常见新靶点是ERBB2(外显子20插入)、MET(外显子14跳跃)和KRAS(G12C)突变。在数据截止时(2020年12月31日),16%的患者因CGP检测导致治疗发生改变。75%的患者确定了更多的临床试验选择。CGP检测超出单基因检测公共报销部分的直接实验室增量成本为每例747加元。
CGP检测除了单基因检测外还能确定更多可操作靶点,对患者治疗有直接影响,并增加了临床试验资格。这些益处凸显了CGP检测在公共卫生系统中NSCLC患者中的价值。