Colon Cancer Genescreen

WHAT IS IMMUNOSCORE?

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 tumour site. It is a risk-assessment tool that provides independent and superior prognostic value than the usual tumour risk parameters and is intended to be used as an adjunct to the TNM classification to guide patients’ management

WHY IMMUNOSCORE?

Tumour, node and metastasis staging (TNM) limitations:

  • Survival is not linearly correlated to TNM stages
  • Clinical outcomes can significantly vary among patients within the same histological tumour stage

Therefore there is a need to identify High-risk patients more accurately than TNM and in complement to TNM staging and for a better risk factor to improve patients’ prognostication and optimize adjuvant treatment decisions. Immunoscore® has demonstrated its prognostic performance in a large international SITC-led study (Pages et al, 2018 ) . Using it in addition to the TNM classification refines the patient’s risk profile.

 IMMUNOSCORE ADD RESOLUTION TO YOUR TRADITIONAL RISK ASSESSMENT TOOLS

Immunoscore® had the highest relative contribution to the risk of all clinical parameters, including the TNM classification system The ability of Immunoscore® to predict OS was superior to that of existing tumour risk parameters such as the grade of differentiation, MSI status, mucinous colloid type, sidedness, venous emboli, lymphatic invasion, perineural invasion, and VELIPI Immunoscore® provides a reliable evaluation of the risk of recurrence in patients with colon cancer (Pages et al, 2018)


The World Health Organization (WHO), in its latest edition of the Digestive System Tumours (5th edition), introduced immune response as an essential and desirable diagnostic criterion for colorectal cancer. The standardized method used in the SITC validation effort (i.e. Immunoscore®) is referenced in the WHO Classification of Tumours, 5th edition, as the most recent evidence of the immune response prognostic power in colon cancer (Pages et al, 2018). Immune response assessment is now an essential complement to the traditional TNM1 staging system in colon cancer, Immunoscore® being the reference assay for its evaluation.

CLINICAL UTILITY

Refine the risk profile of stage II patients


For stage II patients, in the large Immunoscore® SITC study (Pages et al, 2018), Immunoscore® has confirmed its ability to identify patients at high risk of relapse. Conversely, despite the presence of clinical high-risk features, 7 out of 10 patients are Immunoscore® High and have a survival similar to the untreated, low-risk patients (2 ). Those patients might get unnecessary exposure to chemotherapy and could be spared from it


Choose the best treatment duration for stage III patients


The prospective IDEA Fance study (n=1062) validated the prognostic and predictive value of Immunoscore in Stage III patients. Further, Immunoscore® clarifies your standard treatment duration identifying patients for whom 6 months of FOLFOX is beneficial and those who have reached the maximum benefit of FOLFOX after 3 months of treatment. Similar prognostic results obtained in the FOLFOX arem NCCTG N0147 prospective clinical trail.

Demonstrated on the prospective IDEA France study (n=1062):
– Immunoscore Low: 3-year DFS= 67% [95%CI 62- 71]
– Immunoscore High: 3-year DFS=77% [95%CI 74-80]

How to order the test:



A COMPREHENSIVE BODY OF CLINICAL EVIDENCE



Immunoscore® surpasses TNM for prediction of tumor recurrence and survival in CRC patients.

  • Pagès F, Mlecnik B, Marliot F et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018; 391 (10135).
  • 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).
  • Mlecnik B, Tosolini M, Kirilovsky A et al. Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction. J Clin Oncol. 2011;29(6).
  • Pagès F, Kirilovsky A, Mlecnik B et al. In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer. J Clin Oncol. 2009;27(35).
  • Galon J, Costes A, Sanchez-Cabo F et al. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006;313(5795).

Stage II CC patients with Immunoscore-Low have a higher risk of recurrence.

  • Pagès F, Mlecnik B, Marliot F et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018; 391 (10135).

Immunoscore® is a stronger predictor of survival than MSI in CC.

  • Pagès F, Mlecnik B, Marliot F et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018; 391 (10135).
  • Mlecnik B, Bindea G, Angell HK et al. Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability. Immunity.2016;15;44(3).

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).