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      Prognostic value of circulating tumor DNA in patients with colon cancer: Systematic review

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          Abstract

          The application of circulating tumor DNA(ctDNA) represents a non-invasive method for tumor detection. Its prognostic significance in patients with colorectal cancer is controversial. We performed a systematic review of data from published studies to assess the prognostic values of ctDNA in patients with colorectal cancer. We searched Medline, Embase, Web of Science, the Cochrane Library, and Scopus databases to identify eligible studies reporting disease-free survival (DFS) and overall survival (OS) stratified by ctDNA prior to December 6, 2016. We evaluated the quality and design of these studies. A total of 22 studies were eligible for systematic review. Among them, 11 studies investigated the prognostic value of ctDNA on disease-free survival (DFS). Seven of 11 studies showed that ctDNA was an independent variable to estimate the probability of DFS by multivariate analyses. Thirteen studies assessed the relationship between ctDNA and overall survival (OS). Eight of 13 studies showed that ctDNA was an independent predictor of worse OS through the use of multivariate analyses. This analysis provides evidence that ctDNA may be a prognostic biomarker, negatively correlated with the survival of patients with colorectal cancer.

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          Assessment of somatic k-RAS mutations as a mechanism associated with resistance to EGFR-targeted agents: a systematic review and meta-analysis of studies in advanced non-small-cell lung cancer and metastatic colorectal cancer.

          Helena Linardou, Issa Dahabreh, Dimitra Kanaloupiti … (2008)
          Somatic mutations of the k-RAS oncogene have been assessed as a mechanism of de-novo resistance to epidermal growth factor receptor (EGFR) tyrosine-kinase inhibition in patients with non-small-cell lung cancer (NSCLC), and to anti-EGFR monoclonal antibodies in patients with metastatic colorectal cancer (mCRC). The aim of this systematic review and meta-analysis was to assess if k-RAS mutations represent a candidate predictive biomarker for anti-EGFR-targeted therapeutic strategies in mCRC and NSCLC. We systematically identified articles pertaining to k-RAS mutational status in patients with NSCLC treated with tyrosine-kinase inhibitors (TKI), and patients with mCRC treated with any anti-EGFR-based regimens. Eligible studies had to report complete responses (CR) and partial responses (PR), stratified by k-RAS mutational status. Potential between-study heterogeneity was accommodated by use of random-effects models for bivariable meta-analysis of sensitivity and specificity (the primary endpoints). The positive and negative likelihood ratios (+LR and -LR, respectively) of k-RAS mutations for predicting an absence of response were considered as secondary endpoints and were calculated by use of pooled estimates for sensitivity and specificity. Of 252 retrieved manuscripts, 17 were deemed eligible for the NSCLC meta-analysis (165 of 1008 patients with mutated k-RAS). The presence of k-RAS mutations was significantly associated with an absence of response to TKIs (sensitivity=0.21 [95% CI 0.16-0.28], specificity=0.94 [0.89-0.97]; +LR=3.52; -LR=0.84). Of 68 retrieved manuscripts reporting on anti-EGFR monoclonal-antibody-based treatment of mCRC, eight studies were deemed eligible for the final analysis (306 of 817 patients with mutated k-RAS). The presence of k-RAS mutations was significantly associated with an absence of response to anti-EGFR monoclonal-antibody-based treatments (sensitivity=0.47 [0.43-0.52]; specificity=0.93 [0.83-0.97]; +LR=6.82; -LR=0.57). This analysis provides empirical evidence that k-RAS mutations are highly specific negative predictors of response (de-novo resistance) to single-agent EGFR TKIs in advanced NSCLC; and similarly to anti-EGFR monoclonal antibodies alone or in combination with chemotherapy in patients with mCRC. The low sensitivity and relatively high -LR of k-RAS mutations for determining non-responsiveness clearly shows that additional mechanisms of resistance to EGFR inhibitors exist.
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            Detection and Dynamic Changes of EGFR Mutations from Circulating Tumor DNA as a Predictor of Survival Outcomes in NSCLC Patients Treated with First-line Intercalated Erlotinib and Chemotherapy.

            Tony Mok, Yi-long Wu, Jin-Soo Lee … (2015)
            Blood-based circulating-free (cf) tumor DNA may be an alternative to tissue-based EGFR mutation testing in NSCLC. This exploratory analysis compares matched tumor and blood samples from the FASTACT-2 study.
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              Detection of free-circulating tumor-associated DNA in plasma of colorectal cancer patients and its association with prognosis.

              S Micard, Anne Berger, B Landi … (2002)
              Tumor cells are characterized by specific genetic alterations. When such genetic alterations are identified in body fluid including plasma, regardless of the presence of detectable tumor cells, it shows the existence of free-circulating tumor-associated DNA. The objective of our study was to assess the prognostic value of free-circulating tumor-associated DNA in colorectal cancer patients' plasma. The first step of our work was to find common genetic alterations in tumors that would subsequently be used for plasma DNA screening. We focused on KRAS2 mutations in codons 12 and 13 by the mutant allele-specific amplification (MASA) method and p16 hypermethylation by the methylation-specific polymerase chain reaction (MSP) method. Patients with a tumor presenting either alteration were selected for plasma screening; 58 tumors were analyzed for KRAS2 mutations and tested for p16 gene promoter methylation. Survival and recurrence rates were assessed in patients with and without free-circulating tumor-associated DNA alterations in plasma. Of the 58 tumors analyzed, 39 (67%) demonstrated either one or both of the studied genetic alterations. Twenty-two (38%) were mutated at KRAS2, and an identical alteration was detected in 10 (45%) of the 22 corresponding plasma samples. Thirty-one (53%) had p16 gene promoter hypermethylation that could also be detected in the plasma in 21 cases (68%). Among the 39 patients who had one or the other alteration in tumor DNA, 37 had at least one reliable plasma test. In 26 (70%) of the 37 patients, free-circulating tumor-associated DNA was detected in plasma. The 2-year overall survival rate was 48% in the group where free-circulating tumor-associated DNA was detected in plasma and 100% in the one where free-circulating tumor-associated DNA was not detected in plasma (p < 0.03). Among these 37 patients, 25 patients had a stage I, II or III disease. In this subgroup of patients, the 2-year recurrence-free survival rate for the 17 patients with free-circulating tumor-associated DNA detected in plasma was 66%, compared to 100% for the 8 patients without free-circulating tumor-associated DNA detected in plasma (p = 0.044). The presence of free-circulating tumor-associated DNA in plasma seems to be a relevant prognostic marker for patients with colorectal cancer and may be used to identify patients with a high risk of recurrence. Copyright 2002 Wiley-Liss, Inc.
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                Author and article information

                Contributors
                Kelvin Yuen Kwong Chan: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS ONE
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 10 February 2017
                Publication date Collection: 2017
                Volume: 12
                Issue: 2
                Electronic Location Identifier: e0171991
                Affiliations
                [1 ]National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, China
                [2 ]Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
                [3 ]Department of Clinical Laboratory, Shunyi Women and Children’s Hospital of Beijing Children’s Hospital, Beijing, China
                Hospital Authority, CHINA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                • Conceptualization: JL GF.

                • Data curation: XY GF KZ JD.

                • Formal analysis: GF.

                • Funding acquisition: JL.

                • Investigation: GF.

                • Methodology: JL GF.

                • Project administration: JL.

                • Resources: JL.

                • Software: GF.

                • Supervision: JL.

                • Validation: JL.

                • Visualization: GF.

                • Writing – original draft: GF.

                • Writing – review & editing: GF ZW.

                Article
                Publisher ID: PONE-D-15-47038
                DOI: 10.1371/journal.pone.0171991
                PMC ID: 5302475
                PubMed ID: 28187169
                SO-VID: 41ecf3ad-2d78-4119-bd53-35a8a891346d
                Copyright © © 2017 Fan et al
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 7 November 2015
                Date accepted : 29 January 2017
                Page count
                Figures: 2, Tables: 1, Pages: 17
                Funding
                There was no funding source associated with the study design, collection analysis, interpretation of data, or writing of the report.
                Categories
                Subject: Research Article
                Subject: Biology and life sciences
                Subject: Biochemistry
                Subject: Biomarkers
                Subject: Circulating tumor DNA
                Subject: Medicine and health sciences
                Subject: Diagnostic medicine
                Subject: Cancer detection and diagnosis
                Subject: Circulating tumor DNA
                Subject: Medicine and health sciences
                Subject: Oncology
                Subject: Cancer detection and diagnosis
                Subject: Circulating tumor DNA
                Subject: Medicine and Health Sciences
                Subject: Oncology
                Subject: Cancers and Neoplasms
                Subject: Colorectal Cancer
                Subject: Biology and life sciences
                Subject: Cell biology
                Subject: Chromosome biology
                Subject: Chromatin
                Subject: Chromatin modification
                Subject: DNA methylation
                Subject: Biology and life sciences
                Subject: Genetics
                Subject: Epigenetics
                Subject: Chromatin
                Subject: Chromatin modification
                Subject: DNA methylation
                Subject: Biology and life sciences
                Subject: Genetics
                Subject: Gene expression
                Subject: Chromatin
                Subject: Chromatin modification
                Subject: DNA methylation
                Subject: Biology and life sciences
                Subject: Genetics
                Subject: DNA
                Subject: DNA modification
                Subject: DNA methylation
                Subject: Biology and life sciences
                Subject: Biochemistry
                Subject: Nucleic acids
                Subject: DNA
                Subject: DNA modification
                Subject: DNA methylation
                Subject: Biology and life sciences
                Subject: Genetics
                Subject: Epigenetics
                Subject: DNA modification
                Subject: DNA methylation
                Subject: Biology and life sciences
                Subject: Genetics
                Subject: Gene expression
                Subject: DNA modification
                Subject: DNA methylation
                Subject: Research and Analysis Methods
                Subject: Mathematical and Statistical Techniques
                Subject: Statistical Methods
                Subject: Multivariate Analysis
                Subject: Physical Sciences
                Subject: Mathematics
                Subject: Statistics (Mathematics)
                Subject: Statistical Methods
                Subject: Multivariate Analysis
                Subject: Medicine and Health Sciences
                Subject: Diagnostic Medicine
                Subject: Prognosis
                Subject: Biology and Life Sciences
                Subject: Molecular Biology
                Subject: Molecular Biology Techniques
                Subject: Artificial Gene Amplification and Extension
                Subject: Polymerase Chain Reaction
                Subject: Research and Analysis Methods
                Subject: Molecular Biology Techniques
                Subject: Artificial Gene Amplification and Extension
                Subject: Polymerase Chain Reaction
                Subject: Biology and Life Sciences
                Subject: Cell Biology
                Subject: Cellular Types
                Subject: Animal Cells
                Subject: Immune Cells
                Subject: Antigen-Presenting Cells
                Subject: Biology and Life Sciences
                Subject: Immunology
                Subject: Immune Cells
                Subject: Antigen-Presenting Cells
                Subject: Medicine and Health Sciences
                Subject: Immunology
                Subject: Immune Cells
                Subject: Antigen-Presenting Cells
                Subject: Biology and Life Sciences
                Subject: Genetics
                Subject: Gene Identification and Analysis
                Subject: Mutation Detection
                Custom metadata
                Data Availability All relevant data are within the paper and its Supporting Information files.

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