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International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study
F. Pagès, B. Mlecnik, F. Marliot, G. Bindea, FS. Ou, C. Bifulco, A. Lugli, I. Zlobec, TT. Rau, MD. Berger, ID. Nagtegaal, E. Vink-Börger, A. Hartmann, C. Geppert, J. Kolwelter, S. Merkel, R. Grützmann, M. Van den Eynde, A. Jouret-Mourin, A....
Language English Country England, Great Britain
Document type Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Grant support
NV15-28188A
MZ0
CEP Register
Digital library NLK
Full text - Article
Source
NLK
ProQuest Central
from 1992-01-04 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Health & Medicine (ProQuest)
from 1992-01-04 to 3 months ago
Family Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Psychology Database (ProQuest)
from 1992-01-04 to 3 months ago
Health Management Database (ProQuest)
from 1992-01-04 to 3 months ago
Public Health Database (ProQuest)
from 1992-01-04 to 3 months ago
- MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Recurrence, Local etiology MeSH
- Colonic Neoplasms classification diagnosis immunology MeSH
- Prognosis MeSH
- Proportional Hazards Models MeSH
- Reproducibility of Results MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Lymphocytes, Tumor-Infiltrating MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Research Support, N.I.H., Extramural MeSH
BACKGROUND: The estimation of risk of recurrence for patients with colon carcinoma must be improved. A robust immune score quantification is needed to introduce immune parameters into cancer classification. The aim of the study was to assess the prognostic value of total tumour-infiltrating T-cell counts and cytotoxic tumour-infiltrating T-cells counts with the consensus Immunoscore assay in patients with stage I-III colon cancer. METHODS: An international consortium of 14 centres in 13 countries, led by the Society for Immunotherapy of Cancer, assessed the Immunoscore assay in patients with TNM stage I-III colon cancer. Patients were randomly assigned to a training set, an internal validation set, or an external validation set. Paraffin sections of the colon tumour and invasive margin from each patient were processed by immunohistochemistry, and the densities of CD3+ and cytotoxic CD8+ T cells in the tumour and in the invasive margin were quantified by digital pathology. An Immunoscore for each patient was derived from the mean of four density percentiles. The primary endpoint was to evaluate the prognostic value of the Immunoscore for time to recurrence, defined as time from surgery to disease recurrence. Stratified multivariable Cox models were used to assess the associations between Immunoscore and outcomes, adjusting for potential confounders. Harrell's C-statistics was used to assess model performance. FINDINGS: Tissue samples from 3539 patients were processed, and samples from 2681 patients were included in the analyses after quality controls (700 patients in the training set, 636 patients in the internal validation set, and 1345 patients in the external validation set). The Immunoscore assay showed a high level of reproducibility between observers and centres (r=0·97 for colon tumour; r=0·97 for invasive margin; p<0·0001). In the training set, patients with a high Immunoscore had the lowest risk of recurrence at 5 years (14 [8%] patients with a high Immunoscore vs 65 (19%) patients with an intermediate Immunoscore vs 51 (32%) patients with a low Immunoscore; hazard ratio [HR] for high vs low Immunoscore 0·20, 95% CI 0·10-0·38; p<0·0001). The findings were confirmed in the two validation sets (n=1981). In the stratified Cox multivariable analysis, the Immunoscore association with time to recurrence was independent of patient age, sex, T stage, N stage, microsatellite instability, and existing prognostic factors (p<0·0001). Of 1434 patients with stage II cancer, the difference in risk of recurrence at 5 years was significant (HR for high vs low Immunoscore 0·33, 95% CI 0·21-0·52; p<0·0001), including in Cox multivariable analysis (p<0·0001). Immunoscore had the highest relative contribution to the risk of all clinical parameters, including the American Joint Committee on Cancer and Union for International Cancer Control TNM classification system. INTERPRETATION: The Immunoscore provides a reliable estimate of the risk of recurrence in patients with colon cancer. These results support the implementation of the consensus Immunoscore as a new component of a TNM-Immune classification of cancer. FUNDING: French National Institute of Health and Medical Research, the LabEx Immuno-oncology, the Transcan ERAnet Immunoscore European project, Association pour la Recherche contre le Cancer, CARPEM, AP-HP, Institut National du Cancer, Italian Association for Cancer Research, national grants and the Society for Immunotherapy of Cancer.
Cancer Center Statistics Department of Health Sciences Research Mayo Clinic Rochester MN USA
Center for Immuno Oncology University Hospital of Siena Istituto Toscano Tumori Siena Italy
Curandis Laboratories Boston MA USA
Department of Immunology and Immunotherapy Kurume University School of Medicine Kurume Japan
Department of Laboratory Medicine and Pathobiology University of Toronto Toronto ON Canada
Department of Medical Oncology University Hospital of Bern Bern Switzerland
Department of Oncology Pathology Karolinska Institutet Karolinska University Stockholm Sweden
Department of Pathology and Laboratory Medicine University Health Network Toronto ON Canada
Department of Pathology Cliniques Universitaires St Luc Brussels Belgium
Department of Pathology Memorial Sloan Kettering Cancer Center New York NY USA
Department of Pathology Providence Portland Medical Center Portland OR USA
Department of Pathology Sapporo Medical University School of Medicine Sapporo Japan
Department of Pathology University Erlangen Nürnberg Erlangen Germany
Department of Surgery Kindai University School of Medicine Osaka sayama Japan
Department of Surgery University Erlangen Nürnberg Erlangen Germany
General University Hospital Prague Prague Czech Republic
Humanitas University Rozzano Milan Italy
INSERM Laboratory of Integrative Cancer Immunology Paris France
Institut de Recherche Clinique et Experimentale Université Catholique de Louvain Brussels Belgium
Institute of Pathology 1st Faculty of Medicine Charles University Prague Czech Republic
Institute of Pathology University of Bern Bern Switzerland
IRCCS Istituto Nazionale Tumori Regina Elena Rome Italy
NanoString Technologies Seattle WA USA
Pathology Department Radboud University Nijmegen Netherlands
Research Branch Sidra Medical and Research Centre Doha Qatar
The Gujarat Cancer and Research Institute Asarwa Ahmedabad India
Translational Science Oncology IMED Biotech Unit AstraZeneca Cambridge UK
Université Paris Descartes Sorbonne Paris Cité Paris France
References provided by Crossref.org
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- $a Pagès, Franck $u INSERM, Laboratory of Integrative Cancer Immunology, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Centre de Recherche des Cordeliers, Université Pierre et Marie Curie, Sorbonne Universités, Paris, France; Immunomonitoring Platform, Laboratory of Immunology, AP-HP, Assistance Publique-Hopitaux de Paris, Georges Pompidou European Hospital, Paris, France. Electronic address: franck.pages@aphp.fr.
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- $a International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study / $c F. Pagès, B. Mlecnik, F. Marliot, G. Bindea, FS. Ou, C. Bifulco, A. Lugli, I. Zlobec, TT. Rau, MD. Berger, ID. Nagtegaal, E. Vink-Börger, A. Hartmann, C. Geppert, J. Kolwelter, S. Merkel, R. Grützmann, M. Van den Eynde, A. Jouret-Mourin, A. Kartheuser, D. Léonard, C. Remue, JY. Wang, P. Bavi, MHA. Roehrl, PS. Ohashi, LT. Nguyen, S. Han, HL. MacGregor, S. Hafezi-Bakhtiari, BG. Wouters, GV. Masucci, EK. Andersson, E. Zavadova, M. Vocka, J. Spacek, L. Petruzelka, B. Konopasek, P. Dundr, H. Skalova, K. Nemejcova, G. Botti, F. Tatangelo, P. Delrio, G. Ciliberto, M. Maio, L. Laghi, F. Grizzi, T. Fredriksen, B. Buttard, M. Angelova, A. Vasaturo, P. Maby, SE. Church, HK. Angell, L. Lafontaine, D. Bruni, C. El Sissy, N. Haicheur, A. Kirilovsky, A. Berger, C. Lagorce, JP. Meyers, C. Paustian, Z. Feng, C. Ballesteros-Merino, J. Dijkstra, C. van de Water, S. van Lent-van Vliet, N. Knijn, AM. Mușină, DV. Scripcariu, B. Popivanova, M. Xu, T. Fujita, S. Hazama, N. Suzuki, H. Nagano, K. Okuno, T. Torigoe, N. Sato, T. Furuhata, I. Takemasa, K. Itoh, PS. Patel, HH. Vora, B. Shah, JB. Patel, KN. Rajvik, SJ. Pandya, SN. Shukla, Y. Wang, G. Zhang, Y. Kawakami, FM. Marincola, PA. Ascierto, DJ. Sargent, BA. Fox, J. Galon,
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- $a BACKGROUND: The estimation of risk of recurrence for patients with colon carcinoma must be improved. A robust immune score quantification is needed to introduce immune parameters into cancer classification. The aim of the study was to assess the prognostic value of total tumour-infiltrating T-cell counts and cytotoxic tumour-infiltrating T-cells counts with the consensus Immunoscore assay in patients with stage I-III colon cancer. METHODS: An international consortium of 14 centres in 13 countries, led by the Society for Immunotherapy of Cancer, assessed the Immunoscore assay in patients with TNM stage I-III colon cancer. Patients were randomly assigned to a training set, an internal validation set, or an external validation set. Paraffin sections of the colon tumour and invasive margin from each patient were processed by immunohistochemistry, and the densities of CD3+ and cytotoxic CD8+ T cells in the tumour and in the invasive margin were quantified by digital pathology. An Immunoscore for each patient was derived from the mean of four density percentiles. The primary endpoint was to evaluate the prognostic value of the Immunoscore for time to recurrence, defined as time from surgery to disease recurrence. Stratified multivariable Cox models were used to assess the associations between Immunoscore and outcomes, adjusting for potential confounders. Harrell's C-statistics was used to assess model performance. FINDINGS: Tissue samples from 3539 patients were processed, and samples from 2681 patients were included in the analyses after quality controls (700 patients in the training set, 636 patients in the internal validation set, and 1345 patients in the external validation set). The Immunoscore assay showed a high level of reproducibility between observers and centres (r=0·97 for colon tumour; r=0·97 for invasive margin; p<0·0001). In the training set, patients with a high Immunoscore had the lowest risk of recurrence at 5 years (14 [8%] patients with a high Immunoscore vs 65 (19%) patients with an intermediate Immunoscore vs 51 (32%) patients with a low Immunoscore; hazard ratio [HR] for high vs low Immunoscore 0·20, 95% CI 0·10-0·38; p<0·0001). The findings were confirmed in the two validation sets (n=1981). In the stratified Cox multivariable analysis, the Immunoscore association with time to recurrence was independent of patient age, sex, T stage, N stage, microsatellite instability, and existing prognostic factors (p<0·0001). Of 1434 patients with stage II cancer, the difference in risk of recurrence at 5 years was significant (HR for high vs low Immunoscore 0·33, 95% CI 0·21-0·52; p<0·0001), including in Cox multivariable analysis (p<0·0001). Immunoscore had the highest relative contribution to the risk of all clinical parameters, including the American Joint Committee on Cancer and Union for International Cancer Control TNM classification system. INTERPRETATION: The Immunoscore provides a reliable estimate of the risk of recurrence in patients with colon cancer. These results support the implementation of the consensus Immunoscore as a new component of a TNM-Immune classification of cancer. FUNDING: French National Institute of Health and Medical Research, the LabEx Immuno-oncology, the Transcan ERAnet Immunoscore European project, Association pour la Recherche contre le Cancer, CARPEM, AP-HP, Institut National du Cancer, Italian Association for Cancer Research, national grants and the Society for Immunotherapy of Cancer.
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
- $a Patel, Prabhu S $u The Gujarat Cancer & Research Institute, Asarwa, Ahmedabad, India.
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- 700 1_
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- 700 1_
- $a Ascierto, Paolo A $u Melanoma, Cancer Immunotherapy and Innovative Therapies Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale", Napoli, Italy.
- 700 1_
- $a Sargent, Daniel J $u Cancer Center Statistics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
- 700 1_
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- $a Galon, Jérôme $u INSERM, Laboratory of Integrative Cancer Immunology, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Centre de Recherche des Cordeliers, Université Pierre et Marie Curie, Sorbonne Universités, Paris, France. Electronic address: jerome.galon@crc.jussieu.fr.
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