• Sylvie Lantuejoul, Julien Adam, Nicolas Girard, Mickael Duruisseaux, Audrey Mansuet-Lupo, Aurélie Cazes, Isabelle Rouquette, Laure Gibault, Stéphane Garcia, Martine Antoine, Jean Michael Vignaud, Françoise Galateau-Sallé, Christine Sagan, Cécile Badoual, Frédérique Penault-Llorca, Diane Damotte, and pour le groupe pathologistes thoraciques de valorisation de l’expertise, de la recherche et de l’innovation (PATTERN). Fondation Synergie Lyon Cancer.
• Département de biopathologie et département de recherche translationnelle et d'innovations, centre Léon-Bérard UNICANCER, 28, rue Laennec, 69008 Lyon, France; Inserm U1209/CNRS 5309, Grenoble-Alpes université, Institute for Advanced Biosciences, 38700 La Tronche, France. Electronic address: sylvie.lantuejoul@lyon.unicancer.fr.
• Ann Pathol. 2018 Apr 1; 38 (2): 110-125.

AbstractLung cancer is the leading cause of cancer death in France with low response rates to conventional chemotherapy. Nevertheless, new therapies have emerged recently, among which PD1 immune checkpoint inhibitors (ICI), such as nivolumab (OPDIVO®, Bristol-Myers Squibb) and pembrolizumab (KEYTRUDA®, Merck & Co), or PD-L1 ICI, such as atezolizumab (TECENTRIQ®, Genentech), durvalumab (IMFINZI®, Astra-Zeneca), and avelumab (BAVENCIO®, EMD Serono). The prescription of pembrolizumab for advanced stage non-small cell lung carcinoma (NSCLC) patients requires the demonstration of PD-L1 expression by tumor cells by immunohistochemistry (IHC) (minimum of 50% of positive tumor cells is required for first-line setting, and of 1% for second-line and beyond) and PD-L1 assay is now considered as a companion diagnostic tool for this drug. Numerous standardized PD-L1 assays performed on dedicated platforms have been validated in clinical trials, each antibody being associated to one specific PD1 or PD-L1 inhibitor. However, not all pathologists have access to the dedicated platforms and the high cost of these assays is still a limitation to their implementation; in addition, the small size of the NSCLC tumor samples does not allow to perform at the same time multiple assays for multiple drugs. The use of laboratory-developed tests seems feasible but their validation must guarantee the same sensitivities and specificities as standardized tests. In this context, the French group of thoracic pathologists PATTERN has teamed up with thoracic oncologists to provide recommendations on the indication, the critical technical steps and the interpretation of the PD-L1 IHC test to help pathologists to implement quickly and in the best conditions this new theranostic test.Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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