RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study
RAS mutations are currently sought for in tumor samples, which takes a median of almost 3weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circula...
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| Published in | Annals of oncology Vol. 29; no. 5; pp. 1211 - 1219 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Ltd
01.05.2018
Oxford University Press Elsevier |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0923-7534 1569-8041 1569-8041 |
| DOI | 10.1093/annonc/mdy061 |
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| Abstract | RAS mutations are currently sought for in tumor samples, which takes a median of almost 3weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort.
Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision±0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary.
From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64–0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84–0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio=0.11 (95% CI, 0.06–0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers.
This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients.
Clinicaltrials.gov, NCT02502656. |
|---|---|
| AbstractList | RAS mutations are currently sought for in tumor samples, which takes a median of almost 3 weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort.BackgroundRAS mutations are currently sought for in tumor samples, which takes a median of almost 3 weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort.Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision ± 0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary.Patients and methodsPlasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision ± 0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary.From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64-0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84-0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio = 0.11 (95% CI, 0.06-0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers.ResultsFrom July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64-0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84-0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio = 0.11 (95% CI, 0.06-0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers.This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients.ConclusionThis prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients.Clinicaltrials.gov, NCT02502656.Clinical Trial registrationClinicaltrials.gov, NCT02502656. Background:RAS mutations are currently sought for in tumor samples, which takes a median of almost 3 weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort.Patients and methods:Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision ± 0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary.Results:From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64-0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84-0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio = 0.11 (95% CI, 0.06-0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers.Conclusion:This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients.Clinical Trial registration:Clinicaltrials.gov, NCT02502656. Abstract Background RAS mutations are currently sought for in tumor samples, which takes a median of almost 3 weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort. Patients and methods Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision ± 0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary. Results From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64–0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84–0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio = 0.11 (95% CI, 0.06–0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers. Conclusion This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients. Clinical Trial registration Clinicaltrials.gov, NCT02502656. RAS mutations are currently sought for in tumor samples, which takes a median of almost 3weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort. Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision±0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary. From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64–0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84–0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio=0.11 (95% CI, 0.06–0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers. This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients. Clinicaltrials.gov, NCT02502656. RAS mutations are currently sought for in tumor samples, which takes a median of almost 3 weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort. Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision ± 0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary. From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64-0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84-0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio = 0.11 (95% CI, 0.06-0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers. This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients. Clinicaltrials.gov, NCT02502656. |
| Author | Tougeron, D. Bouché, O. Gornet, J.M. Marthey, L. Thirot-Bidault, A. Dubreuil, O. Mary, F. Louafi, S. Meurisse, A. Taly, V. Coriat, R. Garcia, M.L. Blons, H. Lecomte, T. Vernerey, D. Bonnetain, F. Taieb, J. Aparicio, T. Bachet, J.B. Normand, C. Baumgaertner, I. Laurent-Puig, P. Artru, P. |
| Author_xml | – sequence: 1 givenname: J.B. surname: Bachet fullname: Bachet, J.B. organization: Sorbonne Universités, UPMC Université, Paris – sequence: 2 givenname: O. surname: Bouché fullname: Bouché, O. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 3 givenname: J. surname: Taieb fullname: Taieb, J. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 4 givenname: O. surname: Dubreuil fullname: Dubreuil, O. organization: Department of Hepato-Gastroenterology, Groupe Hospitalier Pitié Salpêtrière, Paris – sequence: 5 givenname: M.L. surname: Garcia fullname: Garcia, M.L. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 6 givenname: A. surname: Meurisse fullname: Meurisse, A. organization: Department of Methodology and Quality of Life in Oncology, INSERM UMR 1098, Hôpital Universitaire de Besancon, Besancon – sequence: 7 givenname: C. surname: Normand fullname: Normand, C. organization: Université Sorbonne Paris Cité, INSERM UMR-S1147 MEPPOT, CNRS SNC5014, Centre Universitaire des Saints-Pères, Equipe Labellisée Ligue Nationale Contre le Cancer, Paris – sequence: 8 givenname: J.M. surname: Gornet fullname: Gornet, J.M. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 9 givenname: P. surname: Artru fullname: Artru, P. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 10 givenname: S. surname: Louafi fullname: Louafi, S. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 11 givenname: F. surname: Bonnetain fullname: Bonnetain, F. organization: Department of Methodology and Quality of Life in Oncology, INSERM UMR 1098, Hôpital Universitaire de Besancon, Besancon – sequence: 12 givenname: A. surname: Thirot-Bidault fullname: Thirot-Bidault, A. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 13 givenname: I. surname: Baumgaertner fullname: Baumgaertner, I. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 14 givenname: R. surname: Coriat fullname: Coriat, R. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 15 givenname: D. surname: Tougeron fullname: Tougeron, D. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 16 givenname: T. surname: Lecomte fullname: Lecomte, T. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 17 givenname: F. surname: Mary fullname: Mary, F. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 18 givenname: T. surname: Aparicio fullname: Aparicio, T. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 19 givenname: L. surname: Marthey fullname: Marthey, L. organization: AGEO (Association des Gastroentérologues Oncologues), Paris – sequence: 20 givenname: V. surname: Taly fullname: Taly, V. organization: Université Sorbonne Paris Cité, INSERM UMR-S1147 MEPPOT, CNRS SNC5014, Centre Universitaire des Saints-Pères, Equipe Labellisée Ligue Nationale Contre le Cancer, Paris – sequence: 21 givenname: H. surname: Blons fullname: Blons, H. organization: Université Sorbonne Paris Cité, INSERM UMR-S1147 MEPPOT, CNRS SNC5014, Centre Universitaire des Saints-Pères, Equipe Labellisée Ligue Nationale Contre le Cancer, Paris – sequence: 22 givenname: D. surname: Vernerey fullname: Vernerey, D. organization: Department of Methodology and Quality of Life in Oncology, INSERM UMR 1098, Hôpital Universitaire de Besancon, Besancon – sequence: 23 givenname: P. surname: Laurent-Puig fullname: Laurent-Puig, P. email: pierre.laurent-puig@parisdescartes.fr organization: Université Sorbonne Paris Cité, INSERM UMR-S1147 MEPPOT, CNRS SNC5014, Centre Universitaire des Saints-Pères, Equipe Labellisée Ligue Nationale Contre le Cancer, Paris |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29438522$$D View this record in MEDLINE/PubMed https://inserm.hal.science/inserm-02299512$$DView record in HAL |
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| ContentType | Journal Article |
| Copyright | 2018 THE AUTHORS The Author(s) 2018. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2018 Distributed under a Creative Commons Attribution 4.0 International License |
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| SubjectTerms | accuracy Adult Aged Aged, 80 and over Biochemistry, Molecular Biology Biomarkers, Tumor - blood Biomarkers, Tumor - genetics Cancer circulating tumor DNA Circulating Tumor DNA - genetics colorectal cancer Colorectal Neoplasms - blood Colorectal Neoplasms - genetics Colorectal Neoplasms - pathology DNA Mutational Analysis - methods Female Humans Life Sciences liver metastases Liver Neoplasms - blood Liver Neoplasms - genetics Liver Neoplasms - secondary Male methylated biomarker Middle Aged NGS Patient Selection Predictive Value of Tests Prospective Studies Randomized Controlled Trials as Topic ras Proteins - genetics Young Adult |
| Title | RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study |
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