Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment

Conditions

Colorectal Cancer, Stage III Colon Cancer

Brief summary

The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy. Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment). Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.

Detailed description

Adult patients of both genders who have underwent surgical resection of stage III colon carcinoma and randomised to receive a 6-month or 3-month adjuvant therapy with modified FOLFOX 6 or CAPOX in the IDEA France trial.

Pagès F, André T, Taieb J, Vernerey D, Henriques J, Borg C, Marliot F, Ben Jannet R, Louvet C, Mineur L, Bennouna J, Desrame J, Faroux R, Kirilovsky A, Duval A, Laurent-Puig P, Svrcek M, Hermitte F, Catteau A, Galon J, Emile JF.

2020-04-12119 citations

10.1016/j.annonc.2020.03.310

Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with mFOLFOX6 (three versus six months) in the prospective IDEA France cohort study (PRODIGE-GERCOR).

Franck Pagès, Thierry André, Julien Taı̈eb, Déwi Vernerey, Julie Henriques et al. (20 authors)

Journal of Clinical Oncology2020-02-013 citations

10.1200/jco.2020.38.4_suppl.10

Validation of the Immunoscore prognostic value in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France cohort study (PRODIGE-GERCOR).

Franck Pagès, Thierry André, Julien Taı̈eb, Déwi Vernerey, Julie Henriques et al. (20 authors)

Journal of Clinical Oncology2019-05-208 citations

10.1200/jco.2019.37.15_suppl.3513

Interventions

DIAGNOSTIC_TESTImmunoscore test

To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patient and tumor characteristics; 3-year clinical Follow-Up * Data regarding other markers (eg. MSI) * FFPE blocks available, including core tumor + invasive margin regions

Exclusion criteria

• Bouin fixative Sample type: • adjacent FFPE slices (4 μm each) per case (although only one slide is required for CD3 and one for CD8, with center of tumor (CT) and the invasive margin(IM) cut from FFPE blocks no more than 4 months before the Immunoscore® testing

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival (DFS)	3 years	DFS is defined as the time from randomization to relapse or death, whichever occurred first. Secondary colon cancers are regarded as DFS events, whereas non-colon tumors are to be disregarded in the analysis. Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation which showed no evidence of relapse, or secondary primary colon cancer.

Countries

France

Outcome results

None listed