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      Prognostic Impact of HER2 and ER Status of Circulating Tumor Cells in Metastatic Breast Cancer Patients with a HER2-Negative Primary Tumor 1

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          Abstract

          BACKGROUND: Preclinical and clinical studies have reported that human epidermal growth factor receptor 2 (HER2) overexpression yields resistance to endocrine therapies. Here the prevalence and prognostic impact of HER2-positive circulating tumor cells (CTCs) were investigated retrospectively in metastatic breast cancer (MBC) patients with a HER2-negative primary tumor receiving endocrine therapy. Additionally, the prevalence and prognostic significance of HER2-positive CTCs were explored in a chemotherapy cohort, as well as the prognostic impact of the estrogen receptor (ER) CTC status in both cohorts. METHODS: Included were MBC patients with a HER2-negative primary tumor, with ≥1 detectable CTC, starting a new line of treatment. CTCs were enumerated using the CellSearch system, characterized for HER2 with the CellSearch anti-HER2 phenotyping reagent, and characterized for ER mRNA expression. Primary end point was progression-free rate after 6 months (PFR6months) of endocrine treatment in HER2-positive versus HER2-negative CTC patients. RESULTS: HER2-positive CTCs were present in 29% of all patients. In the endocrine cohort ( n = 72), the PFR6months was 53% for HER2-positive versus 68% for HER2-negative CTC patients ( P = .23). In the chemotherapy cohort ( n = 82), no prognostic value of HER2-positive CTCs on PFR6months was observed either. Discordances in ER status between the primary tumor and CTCs occurred in 25% of all patients but had no prognostic value in exploratory survival analyses. CONCLUSION: Discordances regarding HER2 status and ER status between CTCs and the primary tumor occurred frequently but had no prognostic impact in our MBC patient cohorts.

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          REporting recommendations for tumor MARKer prognostic studies (REMARK).

          Lisa McShane, Douglas G. Altman, Willi Sauerbrei … (2006)
          Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, pre-planned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.
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            Whole exome sequencing of circulating tumor cells provides a window into metastatic prostate cancer

            Jens Lohr, Viktor Adalsteinsson, Kristian Cibulskis … (2014)
            Comprehensive analyses of cancer genomes promise to inform prognoses and precise cancer treatments. A major barrier, however, is inaccessibility of metastatic tissue. A potential solution is to characterize circulating tumor cells (CTCs), but this requires overcoming the challenges of isolating rare cells and sequencing low-input material. Here we report an integrated process to isolate, qualify and sequence whole exomes of CTCs with high fidelity, using a census-based sequencing strategy. Power calculations suggest that mapping of >99.995% of the standard exome is possible in CTCs. We validated our process in two prostate cancer patients including one for whom we sequenced CTCs, a lymph node metastasis and nine cores of the primary tumor. Fifty-one of 73 CTC mutations (70%) were observed in matched tissue. Moreover, we identified 10 early-trunk and 56 metastatic-trunk mutations in the non-CTC tumor samples and found 90% and 73% of these, respectively, in CTC exomes. This study establishes a foundation for CTC genomics in the clinic.
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              Detection and HER2 expression of circulating tumor cells: prospective monitoring in breast cancer patients treated in the neoadjuvant GeparQuattro trial.

              Gunter von Minckwitz, Frank Holms, Holger Eidtmann … (2010)
              This study was aimed at detecting and characterizing circulating tumor cells (CTC) before and after neoadjuvant therapy (NT) in the peripheral blood of patients with breast cancer. The clinical trial GeparQuattro incorporated NT approaches (epirubicin/cyclophosphamide prior to randomization to docetaxel alone, docetaxel in combination with capecitabine, or docetaxel followed by capecitabine) and additional trastuzumab treatment for patients with HER2-positive tumors. We used the Food and Drug Administration-approved CellSearch system for CTC detection and evaluation of HER2 expression and developed HER2 immunoscoring for CTC. We detected > or =1 CTC/7.5 mL in 46 of 213 patients (21.6%) before NT and in 22 of 207 patients (10.6%) after NT (P = 0.002). Twenty (15.0%) initially CTC-positive cases were CTC-negative after NT, whereas 11 (8.3%) cases were CTC-positive after NT, although no CTC could be found before NT. CTC detection did not correlate with primary tumor characteristics. Furthermore, there was no association between tumor response to NT and CTC detection. HER2-overexpressing CTC were observed in 14 of 58 CTC-positive patients (24.1%), including 8 patients with HER2-negative primary tumors and 3 patients after trastuzumab treatment. CTC scored HER2-negative or weakly HER2-positive before or after NT were present in 11 of 21 patients with HER2-positive primary tumors. HER2 overexpression on CTC was restricted to ductal carcinomas and associated with high tumor stage (P = 0.002). CTC number was low in patients with primary breast cancer. The decrease in CTC incidence during treatment was not correlated with standard clinical characteristics and primary tumor response. Information on the HER2 status of CTC might be helpful for stratification and monitoring of HER2-directed therapies. Copyright 2010 AACR.
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                Author and article information

                Contributors
                Nick Beije
                Journal
                Journal ID (nlm-ta): Neoplasia
                Journal ID (iso-abbrev): Neoplasia
                Title: Neoplasia (New York, N.Y.)
                Publisher: Neoplasia Press
                ISSN (Print): 1522-8002
                ISSN (Electronic): 1476-5586
                Publication date PMC-release: 17 October 2016
                Publication date Collection: November 2016
                Publication date (Electronic): 17 October 2016
                Volume: 18
                Issue: 11
                Pages: 647-653
                Affiliations
                [* ]Erasmus MC Cancer Institute, Erasmus University Medical Center, Department of Medical Oncology and Cancer Genomics Netherlands, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands
                [† ]Franciscus Gasthuis, Department of Internal Medicine, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands
                [‡ ]Oncology Center GZA Hospitals Sint Augustinus, Translational Cancer Research Unit, Department of Medical Oncology, Oosterveldlaan 26, 2610, Antwerp, Belgium
                [§ ]Ikazia Hospital, Department of Internal Medicine, Montessoriweg 1, 3083 AN, Rotterdam, The Netherlands
                Author notes
                [* ]Address all correspondence to: Nick Beije, MD, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.Wytemaweg 80Rotterdam3015 CNThe Netherlands n.beije@ 123456erasmusmc.nl
                Article
                Publisher ID: S1476-5586(16)30133-6
                DOI: 10.1016/j.neo.2016.08.007
                PMC ID: 5071539
                PubMed ID: 27764697
                SO-VID: b5e12a87-a0a7-45de-8d0f-3f2b917860d0
                Copyright © © 2016 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 4 August 2016
                Date revision received : 24 August 2016
                Date accepted : 29 August 2016
                Categories
                Subject: Original article

                Keywords: ctc, circulating tumor cell,er, estrogen receptor,her2, human epidermal growth factor receptor 2,mbc, metastatic breast cancer,pfr6months, progression-free-rate after 6 months,pt, primary tumor
                Data availability:
                Keywords: ctc, circulating tumor cell, er, estrogen receptor, her2, human epidermal growth factor receptor 2, mbc, metastatic breast cancer, pfr6months, progression-free-rate after 6 months, pt, primary tumor

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