Comprehensive molecular profiling (CMP) using next generation sequencing (NGS) panels is increasingly used to detect clinically relevant alterations and guide treatment decisions in patients with advanced cancers. As the clinical benefit of CMP is not clear, it raises practical and financial questions about the optimal type of panel used.
Retrospective analysis of NGS reports of patients with advanced solid tumors was performed. Profiling was accomplished using either a FDA-approved test system (FoundationMedicine, 324 genes) or laboratory developed test (LDT) (Solo Complex®, 411 genes). Each genomic alteration was ranked by its clinical actionability using ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). We analyzed frequency of detected alterations, its actionability, tests price difference and rate of matched therapy recommendation.
From 2019 to 2022 NGS reports of 235 patients were analyzed. Median age of patients was 57 years, 59,1% were female, 84,7% have already received at least one line of systemic therapy. There were 42,1% of patients with gastrointestinal tumors, 33,2% - non-small cell lung cancer and 6,8% - breast cancer. FDA-approved test was performed in 193 (82,1%) tumor samples, LDT - in 42 (17,9%) samples. Molecularly matched therapy was recommended to 16,7% and 17,1% respectively. Price of the FDT-approved test was 5800$ when LDT cost about 2300$ (cost difference 3500$). Frequency of alterations ranked as ESCAT tier 1-3 was 39% and 39% for both panels (p=0,8), ranked as tier 1-4 - 78% and 65% for FDA approved panel and LDT respectively (p=0,32). Detailed information on the number of molecular alterations of each tier per report is provided in the table.
ESCAT tier FDA-approved test (FoundationMedicine®) LDT (Solo Complex®) p-value I 0,12 0,1 0,37 II 0,25 0,08 0,21 IIIA 0,25 0,15 0,16 IIIB 0,12 0,08 0,27 IV 1,09 0,86 0,16
Use of LDT showed comparable frequency of clinically relevant alterations detection and rate of molecularly matched therapy recommendations regarding FDA-approved test with lower profiling costs.
The authors.
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All authors have declared no conflicts of interest.