PMID- 32078191 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20220531 IS - 1468-3083 (Electronic) IS - 0926-9959 (Linking) VI - 34 IP - 9 DP - 2020 Sep TI - Cutaneous adverse events: a predictor of tumour response under anti-PD-1 therapy for metastatic melanoma, a cohort analysis of 189 patients. PG - 2096-2105 LID - 10.1111/jdv.16311 [doi] AB - INTRODUCTION: Cutaneous adverse events (AEs) are the most prevalent toxicity under checkpoint inhibitors in clinical trials. In 'real-life' conditions of use, skin toxicities under anti-PD-1 have not been described to date in a large cohort. The objective of this study was to determine the clinical features of skin toxicities in patients with advanced melanoma receiving anti-PD-1 therapy under 'real-life' conditions of use. Secondary objectives were to evaluate the characteristics of patients with skin toxicities and to analyse associated extra-cutaneous toxicities, progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: Advanced melanoma patients treated with nivolumab or pembrolizumab between August 2014 and October 2017 were included. Patients lost to follow-up or receiving anti-PD-1 as part of a clinical trial were excluded. RESULTS: One hundred and eighty-nine patients with metastatic melanoma (with 109 men (57.7%) were included. Cutaneous AE occurred in 39 patients (20.6%). The three most prevalent cutaneous AEs were skin eruption (macular-papular or eczematous) (n = 18, 9.5%), vitiligo (n = 16; 8.5%) and isolated pruritus (n = 5, 2.6%). Grade 3-4 skin toxicity was diagnosed in five patients (2.6%). Atopy (28.2% vs. 12.0%; P = 0.024), hypereosinophilia (20.5% vs. 8.7%; P = 0.046), thyroiditis (17.9% vs. 4.7%; P = 0.011) and renal toxicity (15.4% vs. 4%; P = 0.019) were significantly associated with cutaneous AE. Patients with skin eruption (log-rank = 0.001), vitiligo (log-rank = 0.001) and any type of cutaneous AE (log-rank < 0.001) had a better overall survival. CONCLUSIONS: Cutaneous AEs are frequent and often manageable toxicity and were a predictor of tumour response in melanoma patients under anti-PD-1 therapy in this cohort. CI - (c) 2020 European Academy of Dermatology and Venereology. FAU - Bottlaender, L AU - Bottlaender L AD - Department of Dermatology, ImmuCare, Cancer Research Centre of Lyon, Centre Hospitalier Lyon Sud, Lyon 1 University, Pierre Benite Cedex, France. FAU - Amini-Adle, M AU - Amini-Adle M AUID- ORCID: 0000-0003-2366-6238 AD - Department of Dermatology, ImmuCare, Cancer Research Centre of Lyon, Centre Hospitalier Lyon Sud, Lyon 1 University, Pierre Benite Cedex, France. FAU - Maucort-Boulch, D AU - Maucort-Boulch D AD - Service de Biostatistique - Bioinformatique, Pole Sante Publique, Hospices Civils de Lyon, Lyon, France. AD - Universite de Lyon, Lyon, France. AD - Universite Lyon 1, Villeurbanne, France. AD - CNRS, UMR5558, Laboratoire de Biometrie et Biologie Evolutive, Equipe Biostatistique-Sante, Villeurbanne, France. FAU - Robinson, P AU - Robinson P AD - DRCI, Hospices Civils de Lyon, Lyon, France. FAU - Thomas, L AU - Thomas L AUID- ORCID: 0000-0003-1995-2434 AD - Department of Dermatology, ImmuCare, Cancer Research Centre of Lyon, Centre Hospitalier Lyon Sud, Lyon 1 University, Pierre Benite Cedex, France. AD - Cancer Research Center of Lyon, Claude Bernard Lyon 1 University, Lyon, France. FAU - Dalle, S AU - Dalle S AD - Department of Dermatology, ImmuCare, Cancer Research Centre of Lyon, Centre Hospitalier Lyon Sud, Lyon 1 University, Pierre Benite Cedex, France. AD - Service de Biostatistique - Bioinformatique, Pole Sante Publique, Hospices Civils de Lyon, Lyon, France. LA - eng PT - Journal Article DEP - 20200427 PL - England TA - J Eur Acad Dermatol Venereol JT - Journal of the European Academy of Dermatology and Venereology : JEADV JID - 9216037 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Antibodies, Monoclonal/adverse effects MH - *Antineoplastic Agents/adverse effects MH - Cohort Studies MH - Female MH - Humans MH - Male MH - *Melanoma/drug therapy MH - Nivolumab/adverse effects EDAT- 2020/02/23 06:00 MHDA- 2021/05/15 06:00 CRDT- 2020/02/21 06:00 PHST- 2019/08/19 00:00 [received] PHST- 2019/12/31 00:00 [accepted] PHST- 2020/02/23 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/02/21 06:00 [entrez] AID - 10.1111/jdv.16311 [doi] PST - ppublish SO - J Eur Acad Dermatol Venereol. 2020 Sep;34(9):2096-2105. doi: 10.1111/jdv.16311. Epub 2020 Apr 27.