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International study on inter-reader variability for circulating tumor cells in breast cancer.

ABSTRACT: INTRODUCTION:Circulating tumor cells (CTCs) have been studied in breast cancer with the CellSearch® system. Given the low CTC counts in non-metastatic breast cancer, it is important to evaluate the inter-reader agreement. METHODS:CellSearch® images (N?=?272) of either CTCs or white blood cells or artifacts from 109 non-metastatic (M0) and 22 metastatic (M1) breast cancer patients from reported studies were sent to 22 readers from 15 academic laboratories and 8 readers from two Veridex laboratories. Each image was scored as No CTC vs CTC HER2- vs CTC HER2+. The 8 Veridex readers were summarized to a Veridex Consensus (VC) to compare each academic reader using % agreement and kappa (?) statistics. Agreement was compared according to disease stage and CTC counts using the Wilcoxon signed rank test. RESULTS:For CTC definition (No CTC vs CTC), the median agreement between academic readers and VC was 92% (range 69 to 97%) with a median ? of 0.83 (range 0.37 to 0.93). Lower agreement was observed in images from M0 (median 91%, range 70 to 96%) compared to M1 (median 98%, range 64 to 100%) patients (P?

SUBMITTER: Ignatiadis M

PROVIDER: S-EPMC4052944 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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International study on inter-reader variability for circulating tumor cells in breast cancer.

Ignatiadis Michail M Riethdorf Sabine S Bidard François-Clement FC Vaucher Isabelle I Khazour Mustapha M Rothé Françoise F Metallo Jessica J Rouas Ghizlane G Payne Rachel E RE Coombes Raoul R Teufel Ingrid I Andergassen Ulrich U Apostolaki Stella S Politaki Eleni E Mavroudis Dimitris D Bessi Silvia S Pestrin Marta M Di Leo Angelo A Campion Michael M Reinholz Monica M Perez Edith E Piccart Martine M Borgen Elin E Naume Bjorn B Jimenez Jose J Aura Claudia C Zorzino Laura L Cassatella Maria M Sandri Maria M Mostert Bianca B Sleijfer Stefan S Kraan Jaco J Janni Wolfgang W Fehm Tanja T Rack Brigitte B Terstappen Leon L Repollet Madeline M Pierga Jean-Yves JY Miller Craig C Sotiriou Christos C Michiels Stefan S Pantel Klaus K

Breast cancer research : BCR 20140423 2

<h4>Introduction</h4>Circulating tumor cells (CTCs) have been studied in breast cancer with the CellSearch® system. Given the low CTC counts in non-metastatic breast cancer, it is important to evaluate the inter-reader agreement.<h4>Methods</h4>CellSearch® images (N = 272) of either CTCs or white blood cells or artifacts from 109 non-metastatic (M0) and 22 metastatic (M1) breast cancer patients from reported studies were sent to 22 readers from 15 academic laboratories and 8 readers from two Ver ...[more]

PMID: 24758318

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Project description:Liquid biopsy analysis, mainly based on circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA), provides an extremely powerful tool for the molecular profiling of cancer patients in real time. In this study, we directly compared PIK3CA hotspot mutations (E545K, H1047R) in EpCAM-positive CTCs and paired plasma-ctDNA in breast cancer (BrCa). PIK3CA hotspot mutations in CTCs and ctDNA were analyzed using our previously developed highly sensitive (0.05%), specific, and validated assay in plasma-ctDNA from 77 early and 73 metastatic BrCa patients and 40 healthy donors. We further analyzed and directly compared PIK3CA hotspot mutations in DNAs isolated from CellSearch® cartridges (CTCs) and paired plasma-ctDNA, in 56 cases of early and 27 cases of metastatic breast cancer, and 16 corresponding primary tumors. In plasma-ctDNA, PIK3CA hotspot mutations were identified in 30/77(39.0%) early and 35/73(47.9%) metastatic BrCa cases; none (0/40, 0%) of the healthy donors' plasma-ctDNA samples were positive. Our direct comparison study in DNAs isolated from CellSearch® cartridges (CTCs) and paired plasma-ctDNA from the same blood draws has shown a lack of concordance in early BrCa (27/56, 48.2%), while the concordance in the metastatic setting was higher (18/27, 66.6%). Our results were validated by ddPCR methodology, and the concordance between our assay and ddPCR for PIK3CA E545K hotspot mutation was 30/37 (81.1%). In many cases, PIK3CA hotspot mutations were detected in samples found to be negative for CTCs in CellSearch® . Our data demonstrated for the first time that (a) PIK3CA hotspot mutations are present at high frequencies in CTCs isolated from CellSearch® cartridges and paired plasma-ctDNA both in early and metastatic BrCa, (b) the detection and concordance of PIK3CA hotspot mutations between plasma-ctDNA and CTCs are higher in the metastatic setting, (c) PIK3CA mutational status significantly changes after therapeutic intervention, and (d) PIK3CA mutation detection in CTCs and plasma-ctDNA provides complementary information.

Dataset Information

International study on inter-reader variability for circulating tumor cells in breast cancer.

Publications

International study on inter-reader variability for circulating tumor cells in breast cancer.

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