AIM:To test the methodical and pre-analytical performance of a new multiplex cancer biomarker panel using magnetic beads. METHODS: The MILLIPLEX® MAP Human Circulating Cancer Biomarker Magnetic Bead Panel 1 comprises the tumor markers carcinoembryonic antigen, alpha-fetoprotein, total prostate-specific antigen, cancer antigen 15-3, cancer antigen 19-9, cancer antigen 125, cytokeratine 19-fragment, β-human chorionic gonadotropin, human epididymis protein 4, osteopontin, prolactin, the cell death and angiogenesis markers soluble Fas, soluble Fas-ligand, tumor necrosis factor related apoptosisinducing ligand, vascular endothelial growth factor and the immunological markers interleukin-6 (IL-6), IL-8, tumor necrosis factor-α, transforming growth factor α, fibroblast growth factor-2, macrophage migration inhibitory factor, leptin, hepatocyte growth factor, and stem cell factor. We determined intra-and inter-assay imprecision as well as dilution linearity using quality controls and serum pools. Furthermore, the stability of the 24 biomarkers examined in this panel was ascertained by testing the influence of different storage temperatures and time span before centrifugation. RESULTS:For all markers measured in the synthetic internal quality controls, the intra-assay imprecision ranged between 2.26% and 9.41%, while for 20 of 24 measured markers in the physiological serum pools, it ranged between 1.68% and 12.87%. The inter-assay imprecision ranged between 1.48%-17.12% for 23 biomarkers in synthetic, and between 4.59%-23.88% for 18 biomarkers in physiological quality controls. Here, single markers with very low concentration levels had increased imprecision rates. Dilution linearity was acceptable (70%-130% recovery) for 20 biomarkers. Regarding pre-analytical influencing factors, most markers were stable if blood centrifugation was delayed or if serum was stored for up to 24 h at 4 ℃ and 25 ℃ after centrifugation. Comparable results were obtained in serum and plasma for most markers. However, great changes were observed for single markers. CONCLUSION: MILLIPLEX® MAP Human Circulating Cancer Biomarker Magnetic Bead Panel 1 assay is a stable and precise method for detection of most biomarkers included in the kit. However, single markers have to be interpreted with care.© 2014 Baishideng Publishing Group Inc. All rights reserved.Key words: Multiplex immunoassay; Tumor marker; Cytokines; Cell death markers; Methodical evaluation Core tip: In this study, the methodological quality of a new research-use-only multiplex magnetic bead assay,
Differential diagnosis of CRC can be improved by new biomarker classes and their combination assessed by novel multiplex immunoassay.
Multiple factors contribute to the development and progression of breast cancer. Markers of tumor growth and invasion, cell death, immune activation, and angiogenesis can be assessed in parallel by a novel multiplex immunoassay panel. The diagnostic performance of a multiplex cancer biomarker magnetic bead panel comprising 24 tumor associated parameters was evaluated in sera of 154 women including 77 patients with breast cancer, 10 with precancerous lesions, 31 with benign breast diseases, and 36 healthy controls. Marker levels were log-transformed for variance stabilization. Significance testing was done using t-test or Wilcoxon rank-sum test with correction of p values for multiple testing. Furthermore, receiver operating characteristic analyses were performed. Serum levels of several biomarkers were significantly (p ≤ 0.001) higher in cancer patients than in healthy controls, particularly alpha-fetoprotein, cancer antigen 15-3, cancer antigen 19-9, migration inhibitory factor, carcinoembryonic antigen, cancer antigen 125, hepatocyte growth factor, soluble Fas, tumor necrosis factor-α, stem cell factor, and osteopontin. As most markers were also elevated in benign breast diseases, only cancer antigen 15-3 showed significant differences to cancer patients (p ≤ 0.001). The resulting areas under the curve in receiver operating characteristic curves for discrimination between benign and malignant breast diseases achieved 0.71 with a sensitivity of 33.8% at 95% specificity. Multiplexing enables parallel analysis of different biomarker classes for cancer detection. Established cancer antigen 15-3 proved to be most relevant for differential diagnosis.
Over the past few decades, there has been growing support for the idea that cancer needs an interdisciplinary approach. Therefore, the international cancer community has developed several strategies as outlined in the WHO non-communicable diseases Action Plan (which includes cancer control) as the World Health Assembly and the UICC World Cancer Declaration, which both include primary prevention, early diagnosis, treatment, and palliative care. This paper highlights experiences/ideas in cancer control for international collaborations between low, middle, and high income countries, including collaborations between the European Union (EU) and African Union (AU) Member States, the Latin-American and Caribbean countries, and the Eastern Mediterranean countries. These proposals are presented within the context of the global vision on cancer control set forth by WHO in partnership with the International Union Against Cancer (UICC), in addition to issues that should be considered for collaborations at the global level: cancer survival (similar to the project CONCORD), cancer control for youth and adaptation of Clinical Practice Guidelines. Since cancer control is given lower priority on the health agenda of low and middle income countries and is less represented in global health efforts in those countries, EU and AU cancer stakeholders are working to put cancer control on the agenda of the EU-AU treaty for collaborations, and are proposing to consider palliative care, population-based cancer registration, and training and education focusing on primary prevention as core tools. A Community of Practice, such as the Third International Cancer Control Congress (ICCC-3), is an ideal place to share new proposals, learn from other experiences, and formulate new ideas. The aim of the ICCC-3 is to foster new international collaborations to promote cancer control actions in low and middle income countries. The development of supranational collaborations has been hindered by the fact that cancer control is not part of the objectives of the Millennium Development Goals (MGGs). As a consequence, less resources of development aids are allocated to control NCDs including cancer.
Introduction The mainstay of management for locally advanced rectal cancer is chemoradiotherapy followed by surgical resection. Following chemoradiotherapy, a complete response may be detected clinically and radiologically (cCR) prior to surgery or pathologically after surgery (pCR). We aim to report the overall complete pathological response (pCR) rate and the reliability of detecting a cCR by conventional pre‐operative imaging. Methods A pre‐planned analysis of the European Society of Coloproctology (ESCP) 2017 audit was performed. Patients treated by elective rectal resection were included. A pCR was defined as a ypT0 N0 EMVI negative primary tumour; a partial response represented any regression from baseline staging following chemoradiotherapy. The primary endpoint was the pCR rate. The secondary endpoint was agreement between post‐treatment MRI restaging (yMRI) and final pathological staging. Results Of 2572 patients undergoing rectal cancer surgery in 277 participating centres across 44 countries, 673 (26.2%) underwent chemoradiotherapy and surgery. The pCR rate was 10.3% (67/649), with a partial response in 35.9% (233/649) patients. Comparison of AJCC stage determined by post‐treatment yMRI with final pathology showed understaging in 13% (55/429) and overstaging in 34% (148/429). Agreement between yMRI and final pathology for T‐stage, N‐stage, or AJCC status were each graded as ‘fair’ only (n = 429, Kappa 0.25, 0.26 and 0.35 respectively). Conclusion The reported pCR rate of 10% highlights the potential for non‐operative management in selected cases. The limited strength of agreement between basic conventional post‐chemoradiotherapy imaging assessment techniques and pathology suggest alternative markers of response should be considered, in the context of controlled clinical trials.
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