• Marie-Blanche Valnet-Rabier, Charles Marcucci, Samuel Limat, Siamak Davani, François Aubin, and Virginie Nerich.
• Centre régional de pharmacovigilance, CHU de Besançon, 25030 Besançon, France. Electronic address: mbrabier@chu-besancon.fr.
• Therapie. 2019 Jun 1; 74 (3): 355-367.

AbstractThe immunotherapies known as "inhibitors of checkpoint" (ICP) are monoclonal antibodies used since 2010 and have dramatically modified the management of the advanced or metastatic melanomas. By reactivating the anti-tumoral immune response, these antibodies can activate the immune system in all the tissues with a risk to induce immune related adverse events (IrAE). Thus, the adverse effect's profile of ICP is considered as very different from that usually associated with conventional chemotherapies. The objectives of our retrospective monocentric study were the evaluation of the real life's safety and efficiency of the ipilimumab and the pembrolizumab in patients with an advanced melanoma. Seventy-two patients treated by ipilimumab and\or pembrolizumab between August 1st, 2008 and December 31st, 2016 were investigated. The main IrAE occurring involved the gastro- intestinal, skin, and the endocrine systems. The average onset time of IrAE was 39, 104 and 68 days, respectively and their respective duration was of 67, 50 and 111 days. There were 13 events of grade III and IV along with one death. The overall survival was 5 months for the patients treated in monotherapy with ipilimumab, and 14 months for those treated by pembrolizumab. Our real life's study tends to confirm the current safety profile of ICP treatment. Moreover and according to our analyses, the drug sequence seems to have a global survival impact.Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

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