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.
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.
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)
Marwan Fakih, MD, professor, Department of Medical Oncology and Therapeutics Research, associate director for Clinical Investigations, Comprehensive Cancer Center, medical director, Judy and Bernard Briskin Center for Clinical Research, co-director, Gastrointestinal Cancer Program, and section head, Gastrointestinal Medical Oncology, City of Hope, discusses the clinical utility of the Immunoscore in patients with colorectal cancer (CRC) at the 2019 Gastrointestinal Cancers Symposium
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