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Rafal Dziadziuszko Tiffany Hung Kun Wang Voleak Choeurng Alexander Drilon Robert C. Doebele Fabrice Barlesi Charlie Wu Lucas Dennis Joel Skoletsky Ryan Woodhouse Meijuan Li ChingWei Chang Brian Simmons Todd Riehl Timothy R. Wilson 《Molecular oncology》2022,16(10):2000
Genomic tumour profiling informs targeted treatment options. Entrectinib is a tyrosine kinase inhibitor with efficacy in NTRK fusion‐positive (‐fp) solid tumours and ROS1‐fp non‐small cell lung cancer. FoundationOne® Liquid CDx (F1L CDx), a non‐invasive in vitro next‐generation sequencing (NGS)‐based diagnostic, detects genomic alterations in plasma circulating tumour DNA (ctDNA). We evaluated the clinical validity of F1L CDx as an aid in identifying patients with NTRK‐fp or ROS1‐fp tumours and assessed the genomic landscape pre‐ and post‐entrectinib treatment. Among evaluable pre‐treatment clinical samples (N = 85), positive percentage agreements between F1L CDx and clinical trial assays (CTAs) were 47.4% (NTRK fusions) and 64.5% (ROS1 fusions); positive predictive value was 100% for both. The objective response rate for CTA+ F1L CDx+ patients was 72.2% in both cohorts. The median duration of response significantly differed between F1L CDx+ and F1L CDx− samples in ROS1‐fp (5.6 vs. 17.3 months) but not NTRK‐fp (9.2 vs. 12.9 months) patients. Fifteen acquired resistance mutations were detected. We conclude that F1L CDx is a clinically valid complement to tissue‐based testing to identify patients who may benefit from entrectinib and those with acquired resistance mutations associated with disease progression. 相似文献
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Roland Seiler Ewan A. Gibb Mandeep Takhar Kim Van Kessel Bas W.G. van Rhijn Brian Winters James Douglas Qiqi Wang Voleak Choeurng Nicholas Erho Christine Buerki Elai Davicioni Gottfrid Sjödahl George N. Thalmann Ellen C. Zwarthoff Joost L. Boormans Marc Dall’Era Michiel S. van der Heijden Peter C. Black 《Urologic oncology》2017,35(10):618
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R. Jeffrey Karnes Voleak Choeurng Ashley E. Ross Edward M. Schaeffer Eric A. Klein Stephen J. Freedland Nicholas Erho Kasra Yousefi Mandeep Takhar Elai Davicioni Matthew R. Cooperberg Bruce J. Trock 《European urology》2018,73(2):168-175
Background
Risk of prostate cancer-specific mortality (PCSM) is highly variable for men with adverse pathologic features at radical prostatectomy (RP); a majority will die of other causes. Accurately stratifying PCSM risk can improve therapy decisions.Objective
Validate the 22 gene Decipher genomic classifier (GC) to predict PCSM in men with adverse pathologic features after RP.Design, setting, and participants
Men with adverse pathologic features: pT3, pN1, positive margins, or Gleason score > 7 who underwent RP in 1987–2010 at Johns Hopkins, Cleveland Clinic, Mayo Clinic, and Durham Veteran's Affairs Hospital. We also analyzed subgroups at high risk (prostate-specific antigen > 20 ng/ml, RP Gleason score 8–10, or stage > pT3b), or very high risk of PCSM (biochemical recurrence in < 2 yr [BCR2], or men who developed metastasis after RP [MET]).Outcome measurements and statistical analysis
Logistic regression evaluated the association of GC with PCSM within 10 yr of RP (PCSM10), adjusted for the Cancer of the Prostate Risk Assessment Postsurgical Score (CAPRA-S). GC performance was evaluated with area under the receiver operating characteristic curve (AUC) and decision curves.Results and limitations
Five hundred and sixty-one men (112 with PCSM10), median follow-up 13.0 yr (patients without PCSM10). For high GC score (> 0.6) versus low-intermediate (≤ 0.6), the odds ratio for PCSM10 adjusted for CAPRA-S was 3.91 (95% confidence interval: 2.43–6.29), with AUC = 0.77, an increase of 0.04 compared with CAPRA-S. Subgroup odds ratios were 3.96, 3.06, and 1.95 for high risk, BCR2, or MET, respectively (all p < 0.05), with AUCs 0.64–0.72. GC stratified cumulative PCSM10 incidence from 2.8% to 30%. Combined use of case-control and cohort data is a potential limitation.Conclusions
In a large cohort with the longest follow-up to date, Decipher GC demonstrated clinically important prediction of PCSM at 10 yr, independent of CAPRA-S, in men with adverse pathologic features, BCR2, or MET after RP.Patient summary
Decipher genomic classifier may improve treatment decision-making for men with adverse or high risk pathology after radical prostatectomy. 相似文献
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