Cancer classification using the Immunoscore: a worldwide task force

Jérôme Galon, Franck Pagès, Francesco M Marincola, Helen K Angell, Magdalena Thurin, Alessandro Lugli, Inti Zlobec, Anne Berger, Carlo Bifulco, Gerardo Botti, Fabiana Tatangelo, Cedrik M Britten, Sebastian Kreiter, Lotfi Chouchane, Paolo Delrio, Hartmann Arndt, Martin Asslaber, Michele Maio, Giuseppe V Masucci, Martin Mihm, Fernando Vidal-Vanaclocha, James P Allison, Sacha Gnjatic, Leif Hakansson, Christoph Huber, Harpreet Singh-Jasuja, Christian Ottensmeier, Heinz Zwierzina, Luigi Laghi, Fabio Grizzi, Pamela S Ohashi, Patricia A Shaw, Blaise A Clarke, Bradly G Wouters, Yutaka Kawakami, Shoichi Hazama, Kiyotaka Okuno, Ena Wang, Jill O'Donnell-Tormey, Christine Lagorce, Graham Pawelec, Michael I Nishimura, Robert Hawkins, Réjean Lapointe, Andreas Lundqvist, Samir N Khleif, Shuji Ogino, Peter Gibbs, Paul Waring, Noriyuki Sato, Toshihiko Torigoe, Kyogo Itoh, Prabhu S Patel, Shilin N Shukla, Richard Palmqvist, Iris D Nagtegaal, Yili Wang, Corrado D'Arrigo, Scott Kopetz, Frank A Sinicrope, Giorgio Trinchieri, Thomas F Gajewski, Paolo A Ascierto, Bernard A Fox

Prediction of clinical outcome in cancer is usually achieved by histopathological evaluation of tissue samples obtained during surgical resection of the primary tumor. Traditional tumor staging (AJCC/UICC-TNM classification) summarizes data on tumor burden (T), presence of cancer cells in draining and regional lymph nodes (N) and evidence for metastases (M). However, it is now recognized that clinical outcome can significantly vary among patients within the same stage. The current classification provides limited prognostic information, and does not predict response to therapy. Recent literature has alluded to the importance of the host immune system in controlling tumor progression. Thus, evidence supports the notion to include immunological biomarkers, implemented as a tool for the prediction of prognosis and response to therapy. Accumulating data, collected from large cohorts of human cancers, has demonstrated the impact of immune-classification, which has a prognostic value that may add to the significance of the AJCC/UICC TNM-classification. It is therefore imperative to begin to incorporate the 'Immunoscore' into traditional classification, thus providing an essential prognostic and potentially predictive tool. Introduction of this parameter as a biomarker to classify cancers, as part of routine diagnostic and prognostic assessment of tumors, will facilitate clinical decision-making including rational stratification of patient treatment. Equally, the inherent complexity of quantitative immunohistochemistry, in conjunction with protocol variation across laboratories, analysis of different immune cell types, inconsistent region selection criteria, and variable ways to quantify immune infiltration, all underline the urgent requirement to reach assay harmonization. In an effort to promote the Immunoscore in routine clinical settings, an international task force was initiated. This review represents a follow-up of the announcement of this initiative, and of the J Transl Med. editorial from January 2012. Immunophenotyping of tumors may provide crucial novel prognostic information. The results of this international validation may result in the implementation of the Immunoscore as a new component for the classification of cancer, designated TNM-I (TNM-Immune).