Immunoscore®* is an in vitro diagnostic test predicting the risk of relapse in early stage colon cancer patients, by measuring the host immune response at the tumor site.
It is a risk-assessment tool that provides independent and superior prognostic value than the usual tumor risk parameters, and should be used as an adjunct to the TNM classification (Pagès F et al. The Lancet 2018, Sinicrope F et al. J Clin Oncol 2018). Immunoscore® can thus improve individual patient treatment strategies, particularly the modulation of adjuvant chemotherapy in stage II and stage III.
* CE-IVD for European Community countries, performed in CLIA certified laboratory for the US.
The Immunoscore® scoring has been defined in a large international SITC-led retrospective validation study conducted on more than 2500 St I-III CC patients (Pagès et al, The Lancet May 2018).
Immunoscore® under its CE-IVD version is the first immune scoring diagnostic tests used in routine by pathology labs leveraging advanced image analysis. The accuracy and robustness of the test relies on precise counting of positive immune cells in predefined regions and automatic calculation of Immunoscore® for each patient based on specific algorithm.
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Immunoscore® is a test predicting the risk of relapse of patients with localized CC to help guiding treatment strategies. By evaluating the immune reaction at the tumor site, it provides independent and superior prognostic value to usual risk factors.
Figures extracted from Pagès F et al. The Lancet 2018
This information supports decision about adjuvant chemotherapy need (stage II) and duration of treatment (stage III).
In the large Immunoscore® SITC study (more than 2,500 stage I-III patients), Immunoscore® was strongly predictive of the patient outcome and surpassed the TNM classification prognostic performance.
Focusing on stage II (n = 1,434 patients), Immunoscore® identified a subgroup of high-risk (Immunoscore® Low) stage II patients (27%) who may benefit from chemotherapy.
Patients with Immunoscore® Low had reduced survival, irrespective of their microsatellite status. Conversely, patients with highly infiltrated tumors (Immunoscore® High) had a survival advantage.
Following international IDEA collaboration results, it has been suggested that the duration of adjuvant FOLFOX or CAPOX chemotherapy should be guided by a risk-based approach, based on T and N risk groups (T1-3 N1 versus T4 or N2).
Immunoscore® has been tested on 600 resected tumors of stage III CC patients from the FOLFOX arm of the prospective NCCTG N0147 clinical trial.This retro-prospective study demonstrated that Immunoscore Low was associated with a higher risk of recurrence including among the low risk T1-3 N1 subgroup with significantly worse 3-years DFS (78% vs 92%, see figure on the right).
These data underscore the limitations of T and N staging and provide validation for Immunoscore® to identify high risk T1-3 N1 patients for whom a 3 months chemotherapy course might be detrimental.
Oncologists and patients are invited to contact HalioDx which market and distribute Immunoscore® assay in your country.
Luminy Biotech Entreprises
163 Avenue de Luminy
13288 Marseille Cedex 9
FRANCE
Phone: +33 (0) 4 91 29 30 90
Immunoscore® surpasses TNM for prediction of tumor recurrence and survival in CRC patients.
Stage II CC patients with Immunoscore-Low have a higher risk of recurrence.
Immunoscore® is a stronger predictor of survival than MSI in CC.
Stage III CC patients with Immunoscore-High have a lower risk of recurrence regardless of the MSI status.
Immunoscore® provides prognostic information in low and high T/N risk subsets of Stage III CC.
International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study
The Lancet, 2018
May 10, 2018
More infoComprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival.
J Natl Cancer Inst. 2018 ;
Jan 1;110(1). doi: 10.1093
More infoDensity of tumor-infiltrating lymphocytes correlates with extent of brain edema and overall survival time in patients with brain metastases.
Oncoimmunology 2016 ;
Jun 9;5(1):e1057388
More infoRational bases for the use of the Immunoscore in routine clinical settings as a prognostic and predictive biomarker in cancer patients
Int Immunol. 2016
doi: 10.1093/intimm/dxw021
More infoBiomarkers immune monitoring technology primer: Immunoscore® Colon
Journal for ImmunoTherapy of Cancer 2016
DOI: 10.1186/s40425-016-0161-x
More infoValidation of the Immunoscore (IM) as a prognostic marker in stage I/II/III colon cancer: Results of a worldwide consortium-based analysis of 1,336 patients.
2016 ASCO Annual Meeting
J Clin Oncol 34, 2016 (suppl; abstr 3500)
More infoIntegrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability.
Immunity. 2016 ;
Mar 15;44(3):698-711.
More infoThe tumor microenvironment and Immunoscore are critical determinants of dissemination to distant metastasis.
Sci Transl Med. 2016 ;
24 Feb 2016, Vol. 8, Issue 327, pp. 327ra26.
More infoTowards the introduction of the 'Immunoscore' in the classification of malignant tumours
J Pathol. 2014
Jan;232(2):199-209.
More infoCancer classification using the Immunoscore: a worldwide task force.
J Transl Med 2012 ;
10 : 205.
More infoHistopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction.
J Clin Oncol 2011 ;
29 : 610-8.
More infoIn situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer.
J Clin Oncol 2009 ;
27 : 5944-51.
More infoType, density, and location of immune cells within human colorectal tumors predict clinical outcome.
Science 2006 ;
313 : 1960-4.
More info