The consensus Immunoscore in phase 3 clinical trials; potential impact on patient management decisions

Abstract

The consensus Immunoscore has a prognostic value that has been confirmed in two randomized phase 3 clinical trials, and it provides a reliable estimate of the recurrence risk in colon cancer. The latest edition of the WHO classification of the Digestive System Tumors introduced for the first time the immune response as an essential and desirable diagnostic criteria for digestive cancers. Therefore, the immune response and Immunoscore evaluation within the tumor microenvironment is clinically relevant. In addition, the evaluation of the Immunoscore in stage III colon cancer patients from the IDEA France clinical trial evaluating 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy demonstrated the predictive value of Immunoscore for treatment duration. Immunoscore predicted response to 6 months FOLFOX chemotherapy both in low- and high-risk Stage III patients. Low-risk patients (T_1-3, N₁) with High-Immunoscore had the 3-year DFS of 91.4% when treated with the 6-month FOLFOX, and only 80.8% with the 3-month regimen. The international validation of the prognostic value of the consensus Immunoscore together with its predictive value to guide treatment provides important information for the personalized management of colon cancer patients.

Keywords: Immunoscore; cancer classification; chemotherapy; immunity; phase 3 trial; predictive; prognosis; tumor microenvironment.

Figure 1.

Treatment decision-tree using low pathological risk (T_1-3, N₁) high pathological risk (T₄ and/or N₂) categories, and the consensus Immunoscore (IS) with pre-defined categories (high >70%, and low <70%). The 3 years DFS rates (%) (black), and proportion of patients (%) (blue) are illustrated. The predictive value of Immunoscore is calculated comparing 3 to 6 months FOLFOX treatment using Log rank statistical test.