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

Authors

null

Franck Pages

INSERM, Laboratory of Integrative Cancer Immunology, Equipe Labellisée Ligue Contre le Cancer, Paris, France

Franck Pages , Thierry Andre , Julien Taieb , Dewi Vernerey , Julie Henriques , Christophe Borg , Florence Marliot , Rim Ben Jannet , Christophe Louvet , Laurent Mineur , Jaafar Bennouna , Jérôme Desrame , Roger Faroux , Alex Duval , Pierre Laurent-Puig , Magali Svrcek , Fabienne Hermitte , Aurelie Catteau , Jerome Galon , Jean-François Emile

Organizations

INSERM, Laboratory of Integrative Cancer Immunology, Equipe Labellisée Ligue Contre le Cancer, Paris, France, Saint-Antoine Hospital and Sorbonne Universités, Paris, France, Hôpital Européen Georges-Pompidou, Sorbonne Paris Cite/Paris Descartes University, Paris, France, Methodology and Quality of Life in Oncology Unit, Besançon University Hospital, Besançon, France, Methodology and Quality of Life Unit, Department of Oncology University Hospital, Besançon, France, University Hospital of Besançon, Besançon, France, INSERM, Laboratory of Integrative Cancer Immunology, Equipe Labellisée Ligue Contre le Cancer, Sorbonne Université, Université Sorbonne Paris Cité, Université Paris Descartes, Université Paris Diderot, Centre de Recherche des Cordeliers, Paris, France, Paris, France, EA4340-BECCOH, Versailles University, Boulogne, France, Institut Mutualiste Montsouris, Paris, France, Institut Sainte-Catherine, Avignon, France, University Hospital of Nantes, Digestive Oncology, Nantes, France, Hopital Prive Jean Mermoz, Lyon, France, CHD Vendée, La Roche-Sur-Yon, France, Sorbonne Universités, UPMC Univ Paris 06, INSERM, Centre de Recherche Saint-Antoine (CRSA), Paris, France, Paris Descartes University, Paris, France, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris and Sorbonne Université, Paris, France, HalioDx, Marseille, France, Laboratory of Integrative Cancer Immunology, INSERM, Paris, France, Ambroise Paré Hospital, Versailles University, Boulogne, France, Boulogne, France

Research Funding

Other

Background: The Immunoscore (IS), which has been shown to prognostically classify Stage I-III colon cancer (CC) patients, was assessed in the IDEA France cohort study evaluating 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy in Stage III CC patients. Methods: Densities of CD3+ and cytotoxic CD8+ T cells in the tumor and invasive margin of each patient were quantified by digital pathology and converted to IS using pre-defined published cut-off. The performance of IS to predict disease-free survival (DFS) was assessed in the modified intention-to-treat population, in each study arm, and was adjusted with relevant clinical features in multivariable Cox models. Harrell’s C-statistics was used to investigate the IS performance. Results: 1322 patients were included; 82 were excluded due to pre-analytical non-conformity. IS was successfully analyzed in 1062 (85.6%) eligible patients. In a 2-category IS analysis, Low and (Int+High) IS were observed in n=599 (43.6%) and n=463 (56.4%) patients, respectively. IS was significantly correlated with T stage, T/N stage (T1-3 and N1 versus T4 and/or N2), and microsatellite instability status. The study met its primary objective of validating that Low IS identifies patients with higher-risk of relapse or death [HR=1.54; 95%CI 1.24-1.93, p=0.0001]. The 3-year DFS rates were 66.80% [95%CI 62.23-70.95] and 77.14% [95%CI 73.50-80.35] for Low IS and (Int+High) IS, respectively. In multivariable analysis, IS remained independently associated with DFS (p<0.0012) when combined with T/N stage. The addition of IS to the T/N stage significantly improved the model discrimination capacity [bootstrap C index mean difference, 0.022; 95%CI 0.005-0.04]. In addition, IS in 3 categories (Low, Int, High) and as a continuous variable were also both significantly associated with DFS (all p<0.001). In univariable analysis, IS was also associated with DFS in 6 months arm (p<0.0001); a similar trend was observed in 3 months arm (p=0.09). Conclusions: IS was confirmed as a prognostic factor of DFS in Stage III CC patients in the prospective IDEA France cohort study. Clinical trial information: NCT03422601

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Advanced Disease

Clinical Trial Registration Number

NCT03422601

Citation

J Clin Oncol 37, 2019 (suppl; abstr 3513)

DOI

10.1200/JCO.2019.37.15_suppl.3513

Abstract #

3513

Poster Bd #

5

Abstract Disclosures