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Ignatiadis, Michail; Riethdorf, Sabine; Bidard, Franois-Clement; Vaucher, Isabelle; Khazour, Mustapha; Roth, Franoise; Metallo, Jessica; Rouas, Ghizlane; Payne, Rachel E.; Coombes, Raoul Charles; Teufel, Ingrid; Andergassen, Ulrich; Apostolaki, Stella; Politaki, Eleni; Mavroudis, Dimitris; Bessi, Silvia; Pestrin, Marta; Di Leo, Angelo; Campion, Michael; Reinholz, Monica; Perez, Edith; Piccart, Martine; Borgen, Elin; Naume, Bjorn; Jimenez, Jose; Aura, Claudia Monica; Zorzino, Laura; Cassatella, Maria Cristina; Sandri, Maria Teresa; Mostert, Bianca; Sleijfer, Stefan; Kraan, Jaco; Janni, Wolfgang; Fehm, Tanja; Rack, Brigitte; Terstappen, Leon; Repollet, Madeline; Pierga, Jean-Yves; Miller, Craig; Sotiriou, Christos; Michiels, Stefan; Pantel, Klaus (2014): International study on inter-reader variability for circulating tumor cells in breast cancer. In: Breast Cancer Research 16:R43


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 < 0.001) and from M0 and < 3CTCs (median 87%, range 66 to 95%) compared to M0 and >= 3CTCs samples (median 95%, range 77 to 99%), (P < 0.001). For CTC HER2 expression (HER2-vs HER2+), the median agreement was 87% (range 51 to 95%) with a median. of 0.74 (range 0.25 to 0.90). Conclusions: The inter-reader agreement for CTC definition was high. Reduced agreement was observed in M0 patients with low CTC counts. Continuous training and independent image review are required.