Clinical Validity of Detecting Circulating Tumor Cells by AdnaTest Assay Compared With Direct Detection of Tumor mRNA in Stabilized Whole Blood, as a Biomarker Predicting Overall Survival for Metastatic Castration-Resistant Prostate Cancer Patients.

Circulating tumor cell (CTC) number measured with the CellSearch assay is prognostic for survival in metastatic castration-resistant prostate cancer before and after therapy. Using a standard operating protocol for sample collection, processing, and analysis, we compared detection rates of CellSearc...

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Published in:Cancer Journal Vol. 22; no. 5; pp. 315 - 321
Main Authors: Danila, Daniel C., Samoila, Aliaksandra, Patel, Chintan, Schreiber, Nicole, Herkal, Amrita, Anand, Aseem, Bastos, Diogo, Heller, Glenn, Fleisher, Martin, Scher, Howard I.
Format: research tables/charts Journal Article
Published: Lippincott Williams & Wilkins Sep2016
Online Access:View this record in EBSCOhost
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      dt: Sep2016
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      pub: Lippincott Williams & Wilkins
      place: Baltimore, Maryland
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        atl: Clinical Validity of Detecting Circulating Tumor Cells by AdnaTest Assay Compared With Direct Detection of Tumor mRNA in Stabilized Whole Blood, as a Biomarker Predicting Overall Survival for Metastatic Castration-Resistant Prostate Cancer Patients.
      aug:
        au:
          Danila, Daniel C.
          Samoila, Aliaksandra
          Patel, Chintan
          Schreiber, Nicole
          Herkal, Amrita
          Anand, Aseem
          Bastos, Diogo
          Heller, Glenn
          Fleisher, Martin
          Scher, Howard I.
        affil: Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
      sug:
        subj:
          RNA Blood
          Prostatic Neoplasms, Castration-Resistant Pathology
          Prostatic Neoplasms, Castration-Resistant Blood
          Neoplasm Metastasis Pathology
          Aged, 80 and Over
          Prostatic Neoplasms, Castration-Resistant
          Male
          Survival Analysis
          Cell Separation
          Middle Age
          Aged
          Neoplasm Metastasis
          Human
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Funding Source
          Aged, 80 & over
          Middle Aged: 45-64 years
          Aged: 65+ years
          Male
      ab: Circulating tumor cell (CTC) number measured with the CellSearch assay is prognostic for survival in metastatic castration-resistant prostate cancer before and after therapy. Using a standard operating protocol for sample collection, processing, and analysis, we compared detection rates of CellSearch performed using US Food and Drug Administration-cleared methodology with a second positive selection assay, AdnaTest, and a nonselection polymerase chain reaction (PCR)-based (direct detection PCR [DDPCR]) assay in 55 blood samples from 47 men with progressive metastatic castration-resistant prostate cancer. AdnaTest requires processing within 4 hours of the draw and detects KLK3, PSMA, and EGFR transcripts in cells captured on magnetic beads. The DDPCR assay can be processed up to 7 days after a draw and detects KLK2, KLK3, HOXB13, GRHL2, and FOXA1 genes. AdnaTest and DDPCR were considered positive if at least 1 transcript was detected. AdnaTest detected CTCs in 34 samples (62%; 95% confidence interval [CI], 48%-75%), of which 23 (68%) had unfavorable CTC counts by CellSearch. A positive DDPCR result was seen in 38 cases (69%; 95% CI, 55%-81%), including 24 (63%) with unfavorable CellSearch CTC counts. CellSearch found unfavorable CTC counts in 25 samples (45%; 95% CI, 33%-58%). Sensitivities were similar between the AdnaTest and DDPCR assays, and both were more sensitive than CellSearch. Concordance probability estimates (possible values, 0.5-1.0) associating the biomarker result with survival were similar: 0.77 (SE, 0.07) for AdnaTest, 0.72 (SE, 0.08) for DDPCR, and 0.76 (SE, 0.06) for CellSearch. Overall detection rates between the AdnaTest and DDPCR assays were similar, and both were superior to CellSearch. The DDPCR assay required the lowest blood volume, least on-site processing, and longest stability for batch processing.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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