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 information in low and high T/N risk subsets of Stage III CC.
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)
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