Late-onset adverse events of anti-PD1 therapy in melanoma patients: An observational study from MELBASE, a nationwide prospective cohort

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:86

Article

Carlet, Clementine^1,2  Dalle, Stephane³  Leccia, Marie-Therese⁴  Mortier, Laurent⁵  Dalac-Rat, Sophie⁶  Dutriaux, Caroline⁷  Legoupil, Delphine⁸  Montaudie, Henri^9,10  Dereure, Olivier¹¹  De Quatrebarbes, Julie¹²  Granel-Brocard, Florence¹³  Le-Bouar, Myrtille³  Charles, Julie⁴  Brunet-Possenti, Florence¹⁴  Dreno, Brigitte¹⁵  Lefevre, Wendy^16,17  Allayous, Clara^16,17  Lebbe, Celeste^16,17  Nardin, Charlee^1,2 

[1] Ctr Hosp Univ, Serv Dermatol, Besancon, France

[2] Unite Mixte Rech 1098, Besancon, France

[3] Hosp Civils Lyon, Ctr Rech Cancerol Lyon, Immucare, Lyon, France

[4] Ctr Hosp Univ, Grenoble, France

[5] Ctr Hosp Univ, Lille, France

[6] Ctr Hosp Univ, Dijon, France

[7] Ctr Hosp Univ, Bordeaux, France

[8] Ctr Hosp Univ, Brest, France

[9] Ctr Hosp Univ, Nice, France

[10] Ctr Mediterraneen Med Mol, INSERM U1065, Nice, France

[11] Ctr Hosp Univ, Montpellier, France

[12] Ctr Hosp, Annecy, France

[13] Ctr Hosp Univ, Nancy, Vandoeuvre Les, France

[14] Ctr Hosp Univ, Bichat Claude Bernard, Paris, France

[15] Ctr Hosp Univ, Nantes, France

[16] Ctr Hosp Univ St Louis, Paris, France

[17] Ctr Invest Clin, U976, Paris, France

关键词: adverse event;    anti-PD1;    immune checkpoint inhibitor;    immunotherapy;    late-onset adverse events;    melanoma;    nivolumab;    pembrolizumab;    toxicities;   

DOI  :  10.1016/j.jaad.2021.06.849

来源: Elsevier

【 摘 要 】

Background: Late-onset adverse events (AEs) of anti-programmed cell death 1 (anti-PD1) antibodies have not been systematically described. Objectives: The purpose was to evaluate late-onset AEs in melanoma patients treated with anti-PD1 administered for at least 2 years in a real-life setting. Methods: Patients were screened from MelBase, a French multicentric biobank dedicated to the prospective follow up of unresectable stage III or IV melanoma. The study included 119 patients who received anti-PD1 during at least 2 years from January 2013 to November 2019. Median follow up was 41.7 months (range, 25.2-57.5 months). Fifty-three patients received nivolumab and 66 patients received pembrolizumab. Results: AEs occurred in 99 patients (83%) with a median time of 13.3 months (range, 0-53.9 months), including severe AEs (grade 3 or 4) in 30 patients (30%). Late-onset AEs, mostly grades 1 or 2, occurred in 51 (43%) patients and led to 5 (4%) hospitalizations, of which 4 were severe. Factors associated with lateonset AEs in multivariate analysis were early-onset AEs (within the first 2 years of treatment) and treatment duration (P = .02 and P = .03, respectively). Conclusions: Our data demonstrate the possibility of late-onset AEs occurring after 2 years of anti-PD1 therapy. Late-onset AEs appear frequently and were mostly mild or moderate. Early-onset AEs and prolonged anti-PD1 treatment may increase the risk of late-onset AEs.

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