Abstract
The GILUPI CellCollector (CC) is a novel in vivo circulating tumor cell (CTC) detection device reported to overcome the limitations of small blood sample volumes. The aim of this prospective, blinded study was to evaluate the clinical application of the CC and to compare its performance to the CellSearch (CS) system in M0 and M1 colorectal cancer (CRC) patients. A total of 80 patients (31 M0, 49 M1) with CRC were enrolled. CTCs were simultaneously measured in the peripheral blood using CS and the CC, and the results of both assays were correlated to clinicopathological variables and overall survival. The total number of detected CTCs and CTC‐positive patients did not significantly differ between both assays. In the M0 patients, the CC detected CTCs more frequently than CS. There was no significant difference in total CTC numbers detected with the CC between M0 and M1 patients. In addition, no significant correlation with clinicopathological parameters or overall survival was observed with CC CTCs. In contrast, detection of CTCs with CS was significantly correlated with Union for International Cancer Control stage and reduced overall survival. There was no correlation between CTCs detected by the CC and the CS system. Using in silico analysis, we estimate that CC screens a volume of 0.33–18 mL during in vivo application, in contrast to much higher volumes reported elsewhere. In conclusion, while being safe and easy to use, the CC did not outperform CS in terms of CTC yield or sensitivity. While CTC detection in M0 CRC patients was significantly increased with the CC, the clinical relevance of these CTCs appears inferior to the cells identified by the CS system.
Highlights
Circulating tumor cells (CTC) enumerated by the CellSearch (CS) system have significant prognostic impact in colorectal cancer (CRC) and are considered promising biomarkers for the management of this disease
CTCs in colorectal cancer patients detected by CellCollector and to stratify them to adjuvant therapies
This prospective, investigator-blinded, single-center clinical study conducted at the Department of General, Visceral and Pediatric Surgery of the University Hospital Du€sseldorf, Germany, investigated CTC detection in CRC patients using the CC, a novel in vivo device for CTC detection, and the U.S Food and Drug Administration (FDA)-approved CS system
Summary
Circulating tumor cells (CTC) enumerated by the CellSearch (CS) system have significant prognostic impact in colorectal cancer (CRC) and are considered promising biomarkers for the management of this disease. CTCs in colorectal cancer patients detected by CellCollector and to stratify them to adjuvant therapies. In advanced metastatic CRC, the enumeration of CTCs can improve risk assessment, monitoring of systemic therapy, and detection of therapy resistance (Bork et al, 2015; Cristofanilli et al, 2004; Danila et al, 2007; Gazzaniga et al, 2013; Maheswaran et al, 2008; Tsai et al, 2016). A far greater potential for CTC-based liquid biopsies lies in subsequent molecular characterization of detected CTCs, for example, assessing resistance-conferring mutations for anti-epidermal growth factor receptor therapies (Bork et al, 2015; Cohen et al, 2009; Gazzaniga et al, 2013; Gorges et al, 2016; Hall et al, 2016; Krebs et al, 2015; Lucci et al, 2012; Romiti et al, 2014; Scher et al, 2015; Scherag et al, 2017; Tsai et al, 2016). An important unresolved challenge limiting the widespread use of CTC-based liquid biopsies in clinical routine is their infrequent and unreliable detection, which has been mainly attributed to the low volume of the investigated blood samples (Stoecklein et al, 2016)
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