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.
Download general presentation of Immunoscore® (EU version)
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.
Among stage II patients (n = 1,434), Immunoscore® identified a subgroup of high-risk patients (Immunoscore Low) with a significantly higher risk of recurrence at 5 years (28% vs 13% in patients with Immunoscore High).
In a retro-prospective study from the prospective NCCTG N0147 clinical trial, Immunoscore® has been tested on 600 resected tumors of stage III CC patients from the FOLFOX arm.
These data demonstrate the ability of Immunoscore® to further refine prognostication and was confirmed in the prospective IDEA France cohort study.
Furthermore, in the prospective IDEA France cohort study only patients with an Immunoscore High did benefit from 6 months of FOLFOX treatment compared with 3 months, both in low (T1-3, N1) and high (T4 and/or N2) clinical risk groups.
Stage III colon cancer patients with Immunoscore Low had no additional benefit to a longer treatment duration.
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 and predictive information in low and high T/N risk subsets of Stage III CC.
For Patients & Caregivers (English)
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Impact of Immune Assessment with Immunoscore® on Patterns of Care In Stage II Colon Cancer
Multicenter International Society for Immunotherapy of Cancer Study of the Consensus Immunoscore for the Prediction of Survival and Response to Chemotherapy in Stage III Colon Cancer
J Clin Oncol.
A Diagnostic Biopsy-Adapted Immunoscore Predicts Response to Neoadjuvant Treatment and Selects Patients with Rectal Cancer Eligible for a Watch-and-Wait Strategy
Clin Cancer Res
The consensus Immunoscore in phase 3 clinical trials; potential impact on patient management decisions
OncoImmunology
The immune contexture and Immunoscore in cancer prognosis and therapeutic efficacy
Nature Reviews Cancer
The consensus Immunoscore in phase 3 clinical trial (N0147) and impact on patient management decisions
OncoImmunology
The consensus immunoscore: toward a new classification of colorectal cancer
OncoImmunology
Official French SARS-CoV-2 guidelines for cancer patients, a triage solution with precision medicine
Future Medicine
Immunoscore is the most powerful parameter predicting time to recurrence and disease-free survival in T4N0 stage II colon cancer patients Abstract 4105
Analytical validation of the Immunoscore and its associated prognostic value in patients with colon cancer
BMJ
Prognostic and Predictive Value of the Immunoscore in Stage III Colon Cancer Patients Treated With Oxaliplatin in the Prospective IDEA France PRODIGE-GERCOR Cohort Study
Annals of Oncology
Contribution of Immunoscore and Molecular Features to Survival Prediction in Stage III Colon Cancer
JNCI Cancer Spectrum
Immunoscore®: A Diagnostic Assay for Clinical Management of Colon Cancer
Molecular Diagnosis & Therapy volume
Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with mFOLFOX6 (3 vs 6 months) in the prospective IDEA France cohort study
In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer.
Journal of Clinical Oncology
For Patients & Caregivers (Spanish)
The Immunoscore: Colon Cancer and Beyond.
Clin Cancer Res.
Significant differences in outcome between Immunoscore categories in stage I colon cancer patients
Validation of the Immunoscore Prognostic Value in Stage III Colon Cancer Patients treated with Oxaliplatin in the prospective IDEA France cohort study (PRODIGE-GERCOR).
Validation of the Immunoscore prognostic value in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France cohort study (PRODIGE-GERCOR)
Journal of Clinical Oncology
The Immunoscore in the Clinical Practice of Patients with Colon and Rectal Cancers.
Chirurgia (Bucur).
Immunoscore clinical utility to identify good prognostic Colon Cancer Stage II patients with high-risk clinico-pathological features for whom adjuvant treatment may be avoided
UCGI 34 - PROSCORE: A prospective study assessing whether Immunoscore® test impacts the choice of adjuvant chemotherapy, in a multidisciplinary meeting, for treating non-metastatic colon cancer patients after curative-intent surgery
MSI status plus Immunoscore to select metastatic colorectal cancer patients for immunotherapies
Immunoscore feasibility study in routine postsurgical pathologic review for early‐stage colon cancer (CC) cases risk‐assessment
Evolution of Metastases in Space and Time under Immune Selection.
Cell
International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study.
Lancet
Immunoscore provides prognostic information in low (T3N1) and high (T4 or N2) risk subsets of stage III colon carcinoma patients treated with adjuvant FOLFOX in a phase III trial [NCCTG N0147 (Alliance)
Immunoscore to provide prognostic information in low- (T1-3N1) and high-risk (T4 or N2) subsets of stage III colon carcinoma patients treated with adjuvant FOLFOX in a phase III trial (NCCTG N0147; Alliance).
J Clin Oncol.
Comprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival.
J Natl Cancer Inst.
Prognostic utility of immune markers and validation of Immunoscore® in stage III colon carcinoma patients treated with adjuvant FOLFOX in a phase III trial [NCCTG N0147 (Alliance)]
Association of immune markers and Immunoscore with survival of stage III colon carcinoma (CC) patients (pts) treated with adjuvant FOLFOX: NCCTG N0147 (Alliance).
J Clin Oncol.
Validation 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.
J Clin Oncol.
Immunoscore® analytical performance
Biomarkers immune monitoring technology primer: Immunoscore® Colon.
Journal for ImmunoTherapy of Cancer
Rational bases for the use of the Immunoscore in routine clinical settings as a prognostic and predictive biomarker in cancer patients.
Int Immunol.
Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability.
Immunity
The tumor microenvironment and Immunoscore are critical determinants of dissemination to distant metastasis.
Sci Transl Med.
Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction.
Journal of Clinical Oncology
Type, density, and location of immune cells within human colorectal tumors predict clinical outcome.
Science