According to findings presented at the ESMO Asia Virtual Congress 2020, held November 20 – 22, 2020, the Immunoscore assay (HalioDx) can assess the risk of recurrence in early-stage colon cancer and may be used together with TNM classification to guide clinical decision-making. The study was funded by the French National Institute of Health and Medical Research (INSERM), the LabEx Immuno-oncology, and others.[1]

Jérôme Galon MD. Ph.D. of the Cordeliers Research Center, INSERM (Team 15) and head of an INSERM Laboratory of Integrative Cancer Immunology in Paris, France, reported how Immunoscore, an in vitro diagnostic test designed to predict the risk of relapse in early-stage Colon Cancer, may be used to predict the risk of relapse in early‐stage colon cancer by measuring the patient’s immune response at the tumor site.

Galon explained that the risk‐assessment tool has been shown to provide independent prognostic value that is superior to the usual risk parameters and is intended for use as an adjunct to the TNM classification for clinical decision.

Asian population
Galon and colleagues conducted this study to evaluate the clinical performance of Immunoscore in an Asian population using data from the Society for Immunotherapy of Cancer (SITC)-led validation study, wherein 423 patients of the 2,681 eligible stage I-III patients enrolled in the international Immunoscore study were recruited from 4 expert centers.

Patients enrolled in the study included 330 patients from Japan, 35 from China, and 58  from India.[1][2]

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The investigators compared the time to recurrence (TTR) according to Immunoscore categories. Patient classification by Immunoscore (IS) was done using pre-defined cut-offs: IS Low (IS 0-1) and IS High (IS 2-4). A significant positive association was found between Immunoscore and TTR in the Asian subgroup that was consistent with data from the entire study population

Jérôme Galon MD. Ph.D. is currently the Director of Research at the French National Institute of Health and Medical Research (INSERM) and continues to lead the Integrative Cancer Immunology Laboratory at the Cordeliers Research Centre in Paris, France. Photo courtesy: INSERM. Used with permission.

In the Asian cohort, 158 (37%) patients were categorized as Immunoscore Low, while 266 (63%) were categorized as Immunoscore High.

At 5 years, 86.9% (95% confidence interval [CI] 82.7-91.4), of Immunoscore High patients were event-free compared to 77% (95% CI 70,5-84,1) of Immunoscore Low patients (hazard ratio [HR] 0.52; 95% CI 0.32-0.86; p = 0.0085).

Furthermore, with model adjustments including Immunoscore, age, gender, T-stage, N-stage, sidedness and microsatellite instability (MSI), and stratification by the center, Immunoscore maintained this association (HR 0.45; 95% CI 0.22-0.91; p = 0.027). When stratified according to the 5 Immunoscore categories (high to low), the 5-year TTR rates were 100%, 96%, 84%, 80%, and 73.5% for IS4, IS3, IS2, IS1, IS0, respectively.

Galon and his team noted that these results were similar to those found in European and North American patients. They further concluded that Immunoscore is a strong prognostic indicator of the risk of recurrence in stage I-III colon cancer patients who receive standard of care treatment in real-life clinical practice in Asia, and suggest that this first standardized immune-based assay risk assessment tool can be used reliably to guide clinical decision according to each patient’s information.

The prognostic value of Immunoscore and its predictive value of response to chemotherapy has been shown in multiple published studies. Immunoscore is also associated with time to recurrence and overall survival in the Asian population. The clinical utility of Immunoscore has been demonstrated and Immunoscore has been included in the WHO digestive cancer classification and into the ESMO clinical guidelines for gastrointestinal tumors in 2020. It has not yet been included in Asian and Japanese guidelines. © 2020 Jérôme Galon.

ASCO Quality Care Symposium
Earlier this year, results of a study led by Afsaneh Barzi, M.D., Ph.D., from ‘City of Hope‘, a comprehensive cancer center based in Southern California, were presented during the Virtual ASCO Quality Care Symposium held October 9-10, 2020, demonstrated that incorporation of the Immunoscore classification data into the risk assessment process resulted in significant changes to the post-surgical management strategy for stage II colon cancer patients in 55% of all cases treated.

This change was especially clear in the treatment of patients with high-risk disease.[3]

This study involved a panel of 25 gastrointestinal oncologists from different cancer centers in the United States that evaluated several clinical cases (real-life, de-identified stage II cases submitted for clinical Immunoscore testing), representing a range of practice settings from academic medical centers, to high-volume hospital networks, to private community practices were included in

Based on these results, Barzi and his colleagues concluded that including the Immunoscore data can help improve the value of care by reducing unnecessary adjuvant chemotherapy, while, at the same time, improve the precision of care by delivering treatment to the right patient.

Immunoscore® is a registered trademark from the INSERM licensed to HalioDx.

[1] Pagès F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10. PMID: 29754777.
[2] Galon J, Kawakami Y, Torigoe T, et al. Clinical performance of Immunoscore in early colon cancer in the Asian population. ESMO Asia Virtual Congress 2020 (November 20 – 22, 2020). Abstract 79O. Annals of Oncology (2020) 31 (suppl_6): S1273-S1286. 10.1016/annonc/annonc355
[3] Barzi A, Poage GM, Catteau A, Vernerey D. Impact of Immune Assessment on Patterns of Care In Stage II Colon Cancer. J Clin Oncol 38, 2020 (suppl 29; abstract 295). DOI: 10.1200/JCO.2020.38.29_suppl.295 [Abstract][Presentation]

Featured image: ESMO Asia 2018, held at the Suntec Singapore Convention & Exhibition Center, November 23 – 25, 2018. Photo courtesy: © 2018 – 2020 ESMO. Used with permission.

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