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.
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 (23% vs 8% 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 a High Immunoscore® did benefit from 6 months of FOLFOXtreatment 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.
Immunoscore® surpasses TNM for prediction of tumor recurrence and survival in CRC patients.
Kirilovsky A, Marliot F, El Sissy C et al. Rational bases for the use of the Immunoscore in routine clinical settings as a prognostic and predictive biomarker in cancer patients. Int Immunol. 2016;28(8)
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.
Sinicrope F, Shi Q, Hermitte F et al. Association of immune markers and Immunoscore with survival of stage III colon carcinoma (CC) patients (pts) treated with adjuvant FOLFOX: NCCTG N047 (Alliance). J Clin Oncol. 2017; 35:15s (suppl; abstr 3579)
Immunoscore® provides prognostic and predictive information in low and high T/N risk subsets of Stage III CC.
Pages F, Andre T, Taieb J et al. 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 Ann Oncol. 2020; Apr 12;S0923-7534(20)36415-2
Sinicrope F, Shi Q, Hermitte F et al. 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. 2018; 36:4s (suppl; abstr 614)
The immune contexture and Immunoscore in cancer prognosis and therapeutic efficacy
Nature Reviews Cancer
Official French SARS-CoV-2 guidelines for cancer patients, a triage solution with precision 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
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
For Patients & Caregivers (English)
For Healthcare Professionals (CLIA US version)
For Healthcare Professionals (CE/IVD version)
For Patients & Caregivers (Spanish)
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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)
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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
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International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study.
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).
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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)]
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Immunoscore® analytical performance
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Rational bases for the use of the Immunoscore in routine clinical settings as a prognostic and predictive biomarker in cancer patients.
Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability.
The tumor microenvironment and Immunoscore are critical determinants of dissemination to distant metastasis.
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Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction.
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Type, density, and location of immune cells within human colorectal tumors predict clinical outcome.