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• W3205432007 abstract "Prospective real-world data studies integrated into routine clinical workflows can capture multimodal longitudinal data in patients (pts) with cancer treated in community settings. One modality is circulating tumor DNA (ctDNA), a minimally invasive, readily available test for genomic profiling, investigating resistance or monitoring disease. Using the PCG study platform to prospectively collect and link real-world clinico-genomic, imaging and outcomes data, this exploratory analysis assessed the association of longitudinal ctDNA measurement and clinical response. Eligible pts had metastatic NSCLC or extensive-stage SCLC and initiated systemic antineoplastic treatment, regardless of therapy line, in the Flatiron Health Network. Following consent, clinical data were collected from a nationwide Flatiron Health electronic health record (EHR)–derived de-identified database, including clinician documented assessment of disease burden change (rwR; data cutoff Sep 1, 2020). ctDNA profiling was done using FoundationOne®Liquid before treatment start, on-treatment (±14 days of first tumor assessment) and at end of therapy. In this analysis, pts had ctDNA results for ≥2 timepoints and ≥1 rwR assessment. ctDNA levels were estimated using composite tumor fraction (cTF), a metric based on aneuploidy and variant allele fraction. As of Dec 31, 2020, 585 pts were enrolled. In the current analysis of 123 pts (31 SCLC, 92 NSCLC), median age was 67 y, 96% were current/former smokers and 70% initiated 1L therapy. Of the 92 pts with NSCLC, 73% had non-squamous (NSq) histology. Prior to therapy, median cTF was 4% (IQR, 1, 23) and was higher in SCLC vs NSCLC (49% [IQR, 5, 66] vs 2% [1, 14]; P<0.001), with 1% (0, 5; n=67) in NSq and 4% (1, 24; n=25) in Sq NSCLC (P<0.05). A significantly greater reduction in median % change in cTF on treatment from baseline was seen in pts with an rwR (rwPR, rwCR) vs those without an rwR (rwSD, rwPD) (Table) for all pts with SCLC and pts with NSCLC who had cTF of ≥1% (P<0.05).Tabled 1Enrollment cTFPts, nMedian cTF % change (IQR)Pts, nMedian cTF % change (IQR)ResponderNon− responderNSCLCAll52-49 (-94, 12)40-3 (-61, 52)≥ 1%33-88 (-98, -32)30-7 (-57, 41)< 1%1927 (-22, 67)1015 (-79, 81)SCLCAll25-97 (-98, -76)6-20 (-65, -3)≥ 1%25-97 (-98, -76)5-34 (-76, -2)< 1%001-6 Open table in a new tab Preliminary data showed that serial ctDNA assessment in the PCG study is feasible. Pts with SCLC shed higher levels of ctDNA than pts with NSCLC, and those with rwR had strong cTF reductions close to clearance. Pts with NSCLC had varied levels of cTF at baseline and reduction in cTF, with an rwR occurring in higher ctDNA shedders. Our data encourage further studies using ctDNA response and rwR assessments to study treatment effects, early predictors for clinical outcome and to gain biological insights in the real-world setting." @default.
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• W3205432007 date "2021-10-01" @default.
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• W3205432007 title "P10.14 ctDNA and Real-World Response (rwR) in Patients With Lung Cancer From A Prospective Real-World Clinico-Genomic (PCG) Study" @default.
• W3205432007 doi "https://doi.org/10.1016/j.jtho.2021.08.319" @default.
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