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• W3028164555 abstract "Changes in ctDNA levels may predict response to a variety of drugs, including CDK4/6i; however, the best assay and method are still to be defined. This is a prospective single-center study in hormone receptor-positive/HER2-negative advanced breast cancer pts treated with CDK4/6i and endocrine therapy (ET). Paired plasma samples were collected at cycle 1 day 1 (C1) and cycle 2 day 1 (C2). Somatic alterations and variant allele fraction (VAF) were assessed using the 74-gene Guardant360 assay (Guardant Health). A VAF ratio (VAFR) was calculated for each alteration with a VAF of ≥ 0.4% at C1 or C2. Molecular response was defined for each patient as the mean of all VAFRs (mVAFR). Pts with VAFs < 0.4% at C1 and C2 were considered to have low-shedding tumors. Progression free survival (PFS) hazard ratios (HR) were calculated using a univariate Cox model. PAM50 subtypes and tumor infiltrating lymphocytes (TILs) were determined in a subset. 48 pts treated with ET and palbociclib (89%) or ribociclib (11%) were analyzed with a median follow-up of 12.0 months (IQR 6.7-14.6). Clinical characteristics: 65% had visceral disease, 48% were treated as 1st-line, 35% as 2nd-line, 57% used fulvestrant and 33% an aromatase inhibitor. PAM50 subtype distribution (n=27): Luminal A (n=9), Luminal B (n=10), HER2-enriched (n=4), Normal (n=3) and Basal-like (n=1). ctDNA was detected in 96% of pts. mVAFR < 0.3 (high-ctDNA responders) (n=12) and low-shedding tumors (n=13) correlated with significantly improved PFS (HR=0.39, p=0.025), especially when compared to pts with ctDNA mVAFR > 1 (HR=0.27, p=0.010, n=12). Within PAM50 tested tumors, non-Luminal (n=5) were low-ctDNA responders (mVAFR > 0.3) (n=3) or low-shedding (n=2); Luminal A or B were high-ctDNA responders (n=8), low-ctDNA responders (n=7) and low-shedding (n=4). TILs were increased in low relative to high-ctDNA responders (mean 3.3% vs 1.8%). ctDNA dynamics are an early surrogate of CDK4/6i + ET efficacy. The clinical utility of this biomarker should be tested in prospective clinical trials in which pts with unfavorable ctDNA responses are randomized to alternative treatment strategies." @default.
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• W3028164555 date "2020-05-01" @default.
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• W3028164555 title "5P Circulating tumour DNA (ctDNA) dynamics using a standardized multi-gene panel in advanced breast cancer patients (pts) treated with CDK4/6 inhibitors (CDK4/6i)" @default.
• W3028164555 doi "https://doi.org/10.1016/j.annonc.2020.03.141" @default.
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