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1. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention

Author

Stratigos, Alexander J, Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Fargnoli, Maria Concetta, Forsea, Ana Maria, Frenard, Cecille, Harwood, Catherine Α, Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, R, Kelleners-Smeets, Nicole Wj, Malvehy, Josep, Del Marmol, Veronique, Middleton, Mark R, Moreno-Ramirez, David, Pellecani, Giovanni, Peris, Ketty, Saiag, Philippe, van den Beuken-van Everdingen, Marieke H J, Vieira, Ricardo, Zalaudek, Iris, Eggermont, Alexander M M, Grob, Jean-Jacques, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC), National and Kapodistrian University of Athens (NKUA), Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), North & East Hertfordshire NHS Trust [Northwood, UK], Odense University Hospital (OUH), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), University of L'Aquila [Italy] (UNIVAQ), University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), Queen Mary University of London (QMUL), Kiel University, Medizinische Universität Wien = Medical University of Vienna, Military Medical Academy [Belgrade, Serbia] (2MA), Frankfurt University Hospital, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), CIBER de Enfermedades Raras (CIBERER), Instituto de Salud Carlos III [Madrid] (ISC), Université libre de Bruxelles (ULB), Hôpital Erasme [Bruxelles], University of Oxford, Hospital Universitario Virgen Macarena [Sevilla, Spain] (HUVM), University - Hospital of Modena and Reggio Emilia [Modena, Italy], Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituto Neurologico Mediterraneo (NEUROMED I.R.C.C.S.), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA)-University of Naples Federico II = Università degli studi di Napoli Federico II, Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, Hôpital Ambroise Paré [AP-HP], University Veterinary Hospital [Coimbra, Portugal], Università degli studi di Trieste = University of Trieste, Princess Máxima Center for Pediatric Oncology, Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU), Novartis Les Laboratories Pierre Fabre Sanofi Bristol-Myers Squibb, BMS Pfizer Amgen Roche LEO Pharma Research Foundation Cilag Merck Meso Scale Diagnostics, MSD Genentech, The guidelines were supported by grants from the EADO for the guideline meetings. The authors did this work on a voluntary basis and did not receive any honorarium or reimbursements. Guidelines development group members stated their conflicts of interest in the relevant section., Dr. Stratigos reports personal fees and/or research support from Novartis , Roche , BMS , Abbvie , Sanofi , Regeneron , Genesis Pharma , outside the submitted work. Dr. Garbe reports personal fees from Amgen , personal fees from MSD , grants and personal fees from Novartis , grants and personal fees from NeraCare, grants and personal fees from BMS , personal fees from Pierre Fabre , personal fees from Philogen, grants and personal fees from Roche , grants and personal fees from Sanofi , outside the submitted work. Dr. Dessinioti has nothing to disclose. Dr. Lebbe reports grants and personal fees from Bristol-Myers Squibb , personal fees from MSD , personal fees from Novartis , personal fees from Amgen , grants and personal fees from Roche , personal fees from Avantis Medical Systems, personal fees from Pierre Fabre , personal fees from Pfizer , personal fees from Incyte, outside the submitted work. Dr. Bataille reports personal fees from Novartis , personal fees from Merck MSD , outside the submitted work. Dr. Bastholt reports personal fees for advisory board activity: BMS , Roche , Novartis , Pierre-Fabre, Astra Zeneca, InCyte, MSD / Merck , Bayer . Dr. Dréno reports grants and personal fees from BMS , personal fees from MSD , grants and personal fees from Roche , grants and personal fees from Fabre, grants and personal fees from Sanofi , outside the submitted work. Dr. Fargnoli reports grants and personal fees from Almirall, grants and personal fees from Leo Pharma, personal fees from Janssen, grants and personal fees from Novartis , personal fees from Lilly , grants and personal fees from Sanofi , personal fees from UCB , grants and personal fees from Abbvie , personal fees from Celgene , personal fees from Pierre Fabre , grants and personal fees from Galderma , personal fees from Mylan, personal fees from Medac Pharma, personal fees from Roche , personal fees from Sun Pharma , outside the submitted work. Dr. Forsea reports scientific consultant/speaker fee from Novartis , Leo Pharma, Solartium, Pierre-Fabre, outside the submitted work. Dr. Frenard has nothing to disclose. Dr. Harwood reports institutional research grants and honoraria from Sanofi , Novartis , Merck , Pfizer , Galderma , MEDA, Almirall, Pellepharm, Leo Pharma, CERIES. Dr. Hauschild reports honoraria and/or research grants from: Almirall, BMS , Roche , Novartis , Pierre-Fabre, Sunpharma, MerckSerono, SanofiAventis, Regeneron , MSD / Merck , Philogen, OncoSec outside the submitted work. Dr. Hoeller reports grants and personal fees from Amgen , personal fees from BMS , personal fees from MSD , personal fees from Novartis , personal fees from Pierre Fabre , personal fees from Roche , personal fees from Sanofi , personal fees from Incyte, outside the submitted work. Dr. Kandolf-Sekulovic reports speakers’ honoraria for Roche, Novartis, MSD, BMS, Janssen outside the submitted work. Dr. Kaufmann reports institutional research grants (clinical trials) from: AbbVie , Amgen , Biontech, BMS , Celgene , Galderma , Janssen, Leo, Lilly , Merck , MSD , Novartis , Pierre Fabre , Pfizer , Regeneron , Roche , Wyeth . Advisory Board and Honoraria from Merz, Roche, Novartis. Dr. Kelleners-Smeets reports grants from Netherlands Organization for Health Research and Development, other from Janssen-Cilag, other from AbbVie , other from Galderma , outside the submitted work. Dr. Malvehy reports research grants from Almirall, ISDIN, Leo Pharma, Galderma , GSK , Cantabria, participation in advisory board meetings for Almirall, Sunpharma, BMS , Roche , Novartis , Pierre-Fabre. Dr. del Marmol reports personal fees from MSD , from BMS , personal fees from Sanofi , grants and personal fees from ABVIE, grants from Jansen, outside the submitted work. Dr. Middleton reports personal fees and/or grants from Amgen , Roche , Astrazeneca, GSK , Novartis , Immunocore, BMS , Eisai and Merck . Institutional funding from Millennium, Vertex, Pfizer , Regeneron , TCBiopharma, BiolineRx, Replimune, outside the submitted work. Dr. Moreno-Ramírez has nothing to disclose. Dr. Pellecani reports grants from university of modena and reggio emilia, during the conduct of the study, grants from novartis, grants and personal fees from almirall, grants from leo pharma, from null, outside the submitted work. Dr. Peris reports honoraria for advisory board and grants from AbbVie , Almirall, Biogen Celgene , Lilly , Galderma , Leo Pharma, Novartis , Roche , Sanofi , Sun Pharma , Sandoz outside the submitted work. Dr. Saiag reports honoraria for advisory board and grants from Amgen , Bristol-Myers Squibb , MSD , Merck-Serono, Novartis , Pfizer , Roche- Genentech , Pierre Fabre , and Sanofi , outside the submitted work. Dr. van den Beuken-van Everdingen has nothing to disclose. Dr. Vieira has nothing to disclose. Dr. Zalaudek reports honoraria and advisory board and grants from Sanofi , Sun Pharma , Novartis , Galderma , Roche , Celgene , Almirall, Leofarma, Mylan, Difa Cooper, Cieffe Labs, La Roche Posay, Pierre Fabre . Dr. Eggermont reports over the last 5 years personal fees as a consultant advisor for Biocad, BioInvent, Bristol Myers Squibb ( BMS ), CatalYm, Ellipses, Glaxo Smith Kline ( GSK ), HalioDX, Incyte, IO Biotech, ISA Pharmaceuticals, Merck Sharpe & Dohme ( MSD ), Novartis , Pfizer , Polynoma, Regeneron , Sanofi , Sellas, SkylineDx. Dr. Grob reports personal fees for advisory board and as speaker from Amgen , Roche , GSK , Novartis , BMS , Pierre fabre, Merck , Sanofi , Merck , Pfizer outside the submitted work., European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC), HAL UVSQ, Équipe, Dermatologie, MUMC+: MA Dermatologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, RS: MHeNs - R3 - Neuroscience, MUMC+: TPZ Palliatieve Zorg (9), Stratigos, A. J., Garbe, C., Dessinioti, C., Lebbe, C., Bataille, V., Bastholt, L., Dreno, B., Fargnoli, M. C., Forsea, A. M., Frenard, C., Harwood, C. Alpha., Hauschild, A., Hoeller, C., Kandolf-Sekulovic, L., Kaufmann, R., Kelleners-Smeets, N. W., Malvehy, J., del Marmol, V., Middleton, M. R., Moreno-Ramirez, D., Pellecani, G., Peris, K., Saiag, P., van den Beuken-van Everdingen, M. H. J., Vieira, R., Zalaudek, I., Eggermont, A. M. M., Grob, J. -J., Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), and Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)

Subjects
0301 basic medicine, Cancer Research, Skin Neoplasms, Staging, Medical Oncology, Palpation, Imaging, Low-risk, 0302 clinical medicine, Protective Clothing, Metastatic cSCC, Positron Emission Tomography Computed Tomography, Diagnosis, Epidemiology, Societies, Medical, AMERICAN JOINT COMMITTEE, Skin, Ultrasonography, Invasive cutaneous squamous cell carcinoma, medicine.diagnostic_test, NONSTEROIDAL ANTIINFLAMMATORY DRUGS, High-risk common primary cSCC, RANDOMIZED CONTROLLED-TRIAL, Prognosis, Magnetic Resonance Imaging, 3. Good health, LYMPH-NODE BIOPSY, Oncology, 030220 oncology & carcinogenesis, Carcinoma, Squamous Cell, Sunlight, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Diagnosi, medicine.medical_specialty, Consensus, Prognosi, Sentinel lymph node, Locally advanced Cscc, Prevention, Dermatology, Humans, Lymph Nodes, Neoplasm Staging, Patient Education as Topic, Risk Assessment, Sunscreening Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, Physical examination, PERINEURAL INVASION, 03 medical and health sciences, BASAL-CELL, [SDV.CAN] Life Sciences [q-bio]/Cancer, Medical, Biopsy, medicine, CANCER PREVENTION, ORGAN TRANSPLANT RECIPIENTS, business.industry, Carcinoma, Cancer, Magnetic resonance imaging, Guideline, medicine.disease, Cancérologie, HIGH-RISK, 030104 developmental biology, Squamous Cell, SUN PROTECTION, Societies, business
Abstract

Invasive cutaneous squamous cell carcinoma (cSCC) is one of the most common cancers in the white populations, accounting for 20% of all cutaneous malignancies. Factors implicated in cSCC etiopathogenesis include ultraviolet radiation exposure and chronic photoaging, age, male sex, immunosuppression, smoking and genetic factors. A collaboration of multidisciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organisation of Research and Treatment of Cancer (EORTC) was formed to update recommendations on cSCC classification, diagnosis, risk stratification, staging and prevention, based on current literature, staging systems and expert consensus. Common cSCCs are typically indolent tumors, and most have a good prognosis with 5-year cure rates of greater than 90%, and a low rate of metastases (, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2020

2. Effectiveness and safety of nivolumab in patients with advanced melanoma: A multicenter, observational study

Author

Stéphane Dalle, Patrick Combemale, Yannick Le Corre, Caroline Dutriaux, E. Varey, Nathalie Beneton, Thomas Jouary, Caroline Robert, Henri Montaudié, Jean Philippe Arnault, Sandrine Monestier, Marie Thérèse Leccia, Sandrine Mansard, Laurent Mortier, Amir Khammari, Anne-Bénédicte Duval Modeste, François Skowron, Nicolas Meyer, Brigitte Dréno, Nabahet Ameur, Bernard Guillot, Philippe Saiag, E. Hainaut, Sophie Dalac-Rat, Service de dermatologie, vénéreologie et cancérologie cutanée [Hôpital de la Timone - APHM], Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 (ONCO-THAI), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, CHU Bordeaux [Bordeaux], Service de Dermatologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire [Grenoble] (CHU), CHU Clermont-Ferrand, Hôpital Archet 2 [Nice] (CHU), Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, Hôpital Ambroise Paré [AP-HP], Centre Léon Bérard [Lyon], CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Charles Nicolle [Rouen], Centre Hospitalier Le Mans (CH Le Mans), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Service de dermatologie [CHU d'Amiens-Picardie], CHU Amiens-Picardie, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre hospitalier de Pau, Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Amgen Bristol-Myers Squibb, BMS Pfizer Novartis Roche AbbVie Les Laboratories Pierre Fabre LEO Pharma Research Foundation, Sandrine Monestier has received consultant fees from BMS and Roche, support for travel/congress from BMS, Roche, GSK and MSD, and has participated as an investigator on clinical trials for BMS, Roche‐ Genentech, GSK, Amgen, Novartis, MSD, Merck‐Serono and Astra Zeneca. Stéphane Dalle has received congress invitation and fees coverage from BMS, Pierre Fabre and MSD, translational study grant to institution from BMS and MSD. Laurent Mortier received support to travel to medical congresses from BMS, MSD, Roche and Novartis. Caroline Dutriaux has been a member of advisory boards and received consultancy fees from BMS, MSD, Pierre Fabre and Novartis. Sophie Dalac‐Rat has received honoraria, provided consultancy and been on advisory committees for BMS, MSD, Novartis and Sun pharma. Nicolas Meyer has received honoraria from Sun Pharma, Roche, Novartis and Pierre Fabre, research funding from BMS, MSD, provided consultancy to BMS, MSD, Roche, Novartis and Pierre Fabre, been on advisory committees for Amgen, Incyte, BMS, MSD, Roche, Novartis and Pierre Fabre. Sandrine Mansard has worked on advisory boards for BMS and Novartis, has received congress and travel fees from BMS and Pierre Fabre. Henri Montaudié has worked on advisory boards for BMS, MSD, Pierre Fabre and Novartis, provided consultancy to MSD and Pierre Fabre, received honoraria from BMS, MSD, Pierre Fabre and Novartis, received research funding from BMS and Leo Pharma. Philippe Saiag has received personal fees from Amgen, Bristol‐Myers Squibb, MSD, Merck‐Serono, Pfizer, Roche‐Genentech, Pierre Fabre and Novartis, received nonfinancial support from Bristol‐Myers Squibb, MSD, Roche‐Genentech and Novartis, received a funding grant from Roche‐Genentech. Patrick Combemale has worked on advisory committees for Roche, Pierre Fabre and AstraZenecca. Ewa Hainaut has been a speaker for BMS, Novartis and Sanofi, worked on advisory boards for Novartis and Sanofi, received research funding from Abbvie. Caroline Robert has received consultancy fees from BMS, MSD, Roche, Novartis, Sanofi, Pierre Fabre and Amgen. Yannick Le Corre has provided consultancy to BMS, MSD and Novartis, worked on advisory boards for BMS, MSD, Novartis and Pierre Fabre, received congress invitation from BMS, MSD and Novartis, has received honoraria from BMS. Nabahet Ameur is employee of Bristol‐Myers‐Squibb. Brigitte Dréno has received research funding from Amgen, BMS, Novartis and Roche, provided consultancy to BMS and Roche, worked on advisory boards for BMS, Roche and Pierre Fabre. Jean Philippe Arnault has been a speaker for BMS. Marie Thérèse Leccia, Bernard Guillot, François Skowron, Anne‐Bénédicte Duval Modeste, Nathalie Bénéton, Thomas Jouary, Emilie Varey, and Amir Khammari have no conflicts of interest to declare., Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Rouen, Normandie Université (NU)-Normandie Université (NU), HAL UVSQ, Équipe, and Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, advanced melanoma, safety, Cancer Research, medicine.medical_specialty, real-world, Databases, Factual, effectiveness, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, 0302 clinical medicine, Antineoplastic Agents, Immunological, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, medicine, Humans, In patient, Adverse effect, Melanoma, Advanced melanoma, Aged, Retrospective Studies, Aged, 80 and over, nivolumab, business.industry, Incidence (epidemiology), Retrospective cohort study, Middle Aged, Survival Analysis, 3. Good health, Clinical trial, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Observational study, France, Nivolumab, business
Abstract

International audience; This retrospective observational study aimed to determine the effectiveness, safety and patterns of the use of nivolumab in patients with advanced melanoma in real-world clinical practice in France using data from a Temporary Authorization for Use Program (ATU). Data were collected from patients with unresectable or metastatic melanoma enrolled in a French national database (Réseau pour la Recherche et l'Investigation Clinique sur le Mélanome: Ric-Mel) and treated with nivolumab during the ATU program (12 September 2014 to 31 August 2015). The primary objectives of the study were to evaluate the effect of patient characteristics on clinical response and overall survival (OS). Among 400 included patients (median age 66 years), the majority (83%) received nivolumab as second- or subsequent-line therapy. The median durations of progression-free survival and OS were 3.3 and 14.1 months, respectively, and 31.6% of patients achieved an objective response with a median duration of 20.1 months (range: 0-34.7). The safety profile of nivolumab was manageable and consistent with those of previous clinical trials, with an incidence of grade 3-5 adverse events of 13.8%. The safety and effectiveness of nivolumab in patients with advanced melanoma in real-world clinical practice in France were in line with the data reported in the Phase 3 trials CheckMate 066 and 037 of nivolumab in this patient population.

Published
2021

3. Efficacy, safety and factors associated with disease progression in patients with unresectable (stage III) or distant metastatic (stage IV) BRAF V600-mutant melanoma: An open label, non-randomized, phase IIIb study of trametinib in combination with dabrafenib

Author

Sandrine Mansard, Philippe Saiag, Hervé Maillard, Amine Denden, Caroline Robert, Laurent Mortier, S. Dalac-Rat, Charlée Nardin, Olivier Dereure, Thierry Lesimple, Laurent Machet, Eve-Marie Neidhardt, Florent Grange, Alexandra Szenik, Caroline Dutriaux, Christophe Bedane, Céleste Lebbé, Jean-Jacques Grob, HAL UVSQ, Équipe, Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, Hôpital Ambroise Paré [AP-HP], Service de dermatologie, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Service de dermatologie, vénéreologie et cancérologie cutanée [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Lille, Université de Lille, CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Service de Dermatologie [AP-HP Hôpital Saint-Louis], Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Léon Bérard [Lyon], Centre Eugène Marquis (CRLCC), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université Francois Rabelais [Tours], Service de Dermatologie [CHU Limoges], CHU Limoges, Service de dermatologie [CH Le Mans], Centre Hospitalier Le Mans (CH Le Mans), Service de Dermatologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Novartis Pharma S.A.S., CHU Bordeaux [Bordeaux], Amgen, Bristol-Myers Squibb, BMS, Pfizer, Merck, Novartis, Roche, Sanofi, Meso Scale Diagnostics, MSD, Novartis Pharma, Les Laboratories Pierre Fabre, This work was supported by Novartis Pharma S.A.S. , France., Philippe Saiag has received personal fees from Amgen, Bristol-Myers Squibb, MSD, Merck-Serono, Pfizer, Roche-Genentech, Pierre Fabre, Sanofi and Novartis, he has received non-financial support from Bristol-Myers Squibb, MSD, Roche-Genentech and Novartis, and has received a funding grant from Roche-Genentech., Céléste Lebbe has received honoraria from BMS, MSD, Roche, Novartis, Amgen, Merck, Pierre Fabre, Pfizer and Incyte, has acted as a consultant or has served as a member of an advisory board for BMS, and has received travel grant support from BMS and MSD., Jean-Jacques Grob has received honoraria from BMS, MSD, Merck, Pfizer, Incyte, Novartis, Roche, Amgen and Pierre Fabre, has received travel grant support from BMS, MSD and Roche, and has acted as a consultant and advisor for BMS, MSD, Roche, Novartis, Amgen, Merck, Pierre Fabre, Pfizer and Incyte., and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)

Subjects
Adult, Male, Proto-Oncogene Proteins B-raf, Oncology, Cancer Research, medicine.medical_specialty, Pyridones, Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, Pyrimidinones, 030204 cardiovascular system & hematology, Regression tree, 03 medical and health sciences, BRAF V600-mutation, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Trametinib, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Oximes, medicine, Humans, Prospective Studies, Stage (cooking), Prospective cohort study, education, neoplasms, Melanoma, Aged, Neoplasm Staging, education.field_of_study, Proportional hazards model, business.industry, Dabrafenib, Imidazoles, Middle Aged, medicine.disease, 3. Good health, 030220 oncology & carcinogenesis, Mutation, Disease Progression, Female, business, Brain metastasis, medicine.drug
Abstract

International audience; Background: BRAF and MEK inhibitors combination, including dabrafenib (D) and trametinib (T) have transformed the treatment of BRAF V600-mutant advanced melanoma patients, including patients with brain metastasis (BM). In a large phase IIIb, single-arm, open-label, multicenter French study, we assessed safety, response to treatment, progression-free survival (PFS) and factors associated with progression, and stratified the population into risk groups. Methods: Patients with unresectable, advanced, BRAF V600-mutant melanoma were included, including those with the presence of BM, Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2, elevated lactate dehydrogenase (LDH) or previous melanoma treatments. Responses were determined locally, without central review. PFS was estimated using the Kaplan–Meier analysis and modelled with multivariate Cox model. Risk subgroups were identified using a regression tree analysis. Results: Between March 2015 and November 2016, 856 patients received at least one D + T dose. Overall, 92% had stage IV melanoma, 38% ECOG PS ≥1, 32% BM and 37.5% elevated LDH. Median PFS was 8.02 months (95% confidence interval [CI] 7.33–8.77). Significant factors associated with lower PFS were ECOG PS ≥1, elevated LDH, ≥3 metastatic sites and presence of BM. Patients with

Published
2021

4. Place of anti-EGFR therapy in older patients with metastatic colorectal cancer in 2020

Author

Marine Gilabert, Frédérique Rousseau, Astrid Lièvre, Brice Chanez, Simon Triby, Pauline Ries, Eric Francois, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Amgen Inc., Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Oncogenesis, Stress, Signaling (OSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Les Laboratories Pierre Fabre, Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), Chemistry, Oncogenesis, Stress and Signaling (COSS), Institut National de la Santé et de la Recherche Médicale (INSERM)-CRLCC Eugène Marquis (CRLCC)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), and CCSD, Accord Elsevier

Subjects
medicine.medical_specialty, Colorectal cancer, medicine.medical_treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Older patients, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, Epidermal growth factor receptor, Contraindication, Aged, Anti-EGFR, Chemotherapy, biology, Rectal Neoplasms, business.industry, Metastatic colorectal cancer, Antibodies, Monoclonal, medicine.disease, 3. Good health, Clinical trial, Regimen, Oncology, Treatment dose, 030220 oncology & carcinogenesis, Colonic Neoplasms, biology.protein, Geriatrics and Gerontology, Colorectal Neoplasms, business
Abstract

International audience; Almost half of the new cases of colorectal cancer concern patients aged ≥70 years. However, very few clinical trials have specifically included older patients. As a consequence, the treatment of these patients is controversial because the balance between clinical benefits and toxicities remains uncertain. In patients without comorbidities and with an ECOG performance score of 0-1, treatment indications are similar to those of younger patients. For frail patients, chemotherapy is possible, but a comprehensive geriatric assessment is recommended. Anti-EGFR (epidermal growth factor receptor) therapy is indicated either in combination with chemotherapy in the first-line or second-line setting or as monotherapy in the third-line setting (i.e., after failure of chemotherapy). For fit older patients, clinical trials that compared chemotherapy alone with doublet chemotherapy plus anti-EGFR in either first-line or second-line setting suggested that age is not an absolute contraindication for the use of this regimen. In frail patients, anti-EGFR monotherapy in the first-line, second-line or third-line setting has shown feasibility and antitumor activity and had mainly cutaneous toxicities that were easily managed. In any case, administration of treatment must be very cautious in older patients and the treatment dose needs to be adapted according to comorbidities.

Published
2020

5. Nocturia and Nocturnal Polyuria in Neurological Patients: From Epidemiology to Treatment. A Systematic Review of the Literature

Author

Philip Van Kerrebroeck, Pierre Denys, Kim Pauwaert, Karel Everaert, Dirk De Ridder, Salvador Arlandis, Giulio Del Popolo, Jalesh N. Panicker, Antonella Giannantoni, Rebecca Haddad, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Fonds de dotation Kerpape Astellas Pharma Allergan Novartis Pharma Société Française de Médecine d'Urgence, SFMU Les Laboratories Pierre Fabre Ferring Dentsply Sirona Bayer HealthCare, BHC, Financial disclosures: Rebecca Haddad certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Dr. Arlandis reports personal fees from Astellas, Medtronic, Wellspect, Coloplast, Boston Scientific, Rovi, Lacer, and Apogepha, nonfinancial support from Astellas, Coloplast, and Boston Scientific, other from Presurgy, outside the submitted work. Dr. De Ridder reports unlimited grants from Astellas, Ipsen, and Janssen Pharma, other from Ferring, Medtronic, and Bluewind, outside the submitted work. Dr. Denys reports equity interest from Menox, personal fees from Medtronic, Wellspect, Coloplast, Ipsen, Astellas, and Allergan, being part of the advisory board of Medtronic, Ipsen, and Allergan, nonfinancial support from Coloplast, Ipsen, and Allergan, outside the submitted work. Dr. Del Popolo reports personal fees from Pierre Fabre and Wellspect, outside the submitted work. Dr. Everaert reports grants from Ferring, Astellas, and Medtronic, outside the submitted work. Dr. Giannantoni reports personal fees from Allergan and Merz, nonfinancial support from Astellas, outside the submitted work. Dr. Haddad reports grants from Fonds de dotation Renaitre, Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi Périnéologie, and Société Française de Médecine Physique et de Réadaptation during the conduct of the study, personal fees from Astellas, MedDay Pharmaceuticals, and Novartis Pharma SAS, nonfinancial support from Dentsply Sirona France, Astellas, Pierre Fabre Medicament, Allergan France, Bayer HealthCare SAS, and Vifor France SA, outside the submitted work. Dr. Panicker is supported in part by funding from the UK’s Department of Health NIHR Biomedical Research Centres funding scheme, and reports personal fees from Astellas, Cambridge University Press, and Wellspect, outside the submitted work. Dr. Pauwaert reports grants from Ferring during the conduct of the study. Dr. Van Kerrebroeck reports personal fees from Astellas, Axonics, Ferring, Medtronic, BlueWind, and Neuspera, outside the submitted work.

Subjects
medicine.medical_specialty, Urology, Population, 030232 urology & nephrology, TIBIAL NERVE-STIMULATION, Neurogenic, Nocturnal polyuria, Disease, urologic and male genital diseases, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, CORD INJURED PATIENTS, Lower urinary tract symptoms, Nocturia, Systematic review, 03 medical and health sciences, NEUROGENIC DETRUSOR OVERACTIVITY, 0302 clinical medicine, Internal medicine, Epidemiology, medicine, Humans, MULTIPLE-SCLEROSIS PATIENTS, Desmopressin, education, education.field_of_study, Solifenacin, PARKINSONS-DISEASE PATIENTS, business.industry, Polyuria, DIURNAL BLOOD-PRESSURE, URINARY-TRACT SYMPTOMS, OPEN-LABEL, medicine.disease, female genital diseases and pregnancy complications, 3. Good health, 030220 oncology & carcinogenesis, BLADDER DYSFUNCTION, Etiology, medicine.symptom, Nervous System Diseases, NONMOTOR SYMPTOMS, business, medicine.drug
Abstract

International audience; Context: Nocturia is among the most common and bothersome lower urinary tract symptoms (LUTS), but there is no clear consensus on how to identify and manage this symptom in the neurological population. Objective: To systematically review the literature about nocturia in neurological patients. Evidence acquisition: Studies were identified by electronic search of Cochrane and Medline databases. The studies were included if their participants had acquired neurological pathology among multiple sclerosis (MS), Parkinson's disease (PD), stroke, spinal cord injury (SCI), and reported data on the epidemiology, aetiology, diagnosis, or treatment of nocturia. An independent extraction of the articles was performed by two authors using predetermined datasets, including quality-of-study indicators. Evidence synthesis: A total of 132 studies were included; 46 evaluated the epidemiology of nocturia, 28 the possible aetiologies, 10 the diagnostic tools, and 60 the treatments. Nocturia prevalence ranged from 15% to 96% depending on the pathology and definition used. It was one of the most frequently reported LUTS in PD and stroke patients. Several validated questionnaires were found to screen for nocturia in this population. Causalities were numerous: LUT, renal, sleep, cardiovascular dysfunctions, etc. Treatments targeted these mechanisms, with an overall risk of bias assessed as high or serious. The highest level of evidence was seen in MS patients: pelvic floor muscle training, cannabinoids, and desmopressin were effective, but not melatonin. In stroke patients, transcutaneous sacral and transcutaneous tibial nerve stimulation (TTNS) improved nocturia; in PD patients, TTNS, solifenacin, and rotigotine did not. Conclusions: Nocturia is highly prevalent in patients with neurological disorders. Causalities and treatments are not different from the general population, but are poorly studied in neurological patients. Patient summary: In this report, we looked at the published studies about nocturia—the fact of waking to void during the hours of sleep—in patients with neurological diseases. We found that nocturia is very frequent in this population, that the causes are the same as in the general population but may be combined, and that treatments are also the same but have an overall weak level of evidence. We conclude that more research is needed on this topic. Nocturia is highly prevalent in patients with neurological diseases. Causalities are not different from general population, but may be combined. The diagnostic strategy has not yet been studied fully. The level of evidence of the treatments used for nocturia is weak.

Published
2020

6. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 2. Treatment

Author

Stratigos, Alexander J, Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Concetta Fargnoli, Maria, Forsea, Ana M, Frenard, Cecille, Harwood, Catherine A, Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole W J, Malvehy, Josep, Del Marmol, Veronique, Middleton, Mark R, Moreno-Ramirez, David, Pellecani, Giovanni, Peris, Ketty, Saiag, Philippe, van den Beuken-van Everdingen, Marieke H J, Vieira, Ricardo, Zalaudek, Iris, Eggermont, Alexander M M, Grob, Jean-Jacques, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC), HAL UVSQ, Équipe, National and Kapodistrian University of Athens (NKUA), Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), North & East Hertfordshire NHS Trust [Northwood, UK], Odense University Hospital (OUH), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), University of L'Aquila [Italy] (UNIVAQ), University of Bucharest (UniBuc), Queen Mary University of London (QMUL), Kiel University, Medizinische Universität Wien = Medical University of Vienna, Military Medical Academy [Belgrade, Serbia] (2MA), Frankfurt University Hospital, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), CIBER de Enfermedades Raras (CIBERER), Université libre de Bruxelles (ULB), University of Oxford, Hospital Universitario Virgen Macarena [Sevilla, Spain] (HUVM), Università degli Studi di Modena e Reggio Emilia = University of Modena and Reggio Emilia (UNIMORE), Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, Hôpital Ambroise Paré [AP-HP], Coimbra Hospital and Universitary Centre [Coimbra, Portugal] (CHUC), Università degli studi di Trieste = University of Trieste, Princess Máxima Center for Pediatric Oncology, Aix Marseille Université (AMU), Assistance Publique - Hôpitaux de Marseille (APHM), Amgen Bristol-Myers Squibb, BMS Pfizer AstraZeneca GlaxoSmithKline, GSK Merck Novartis Roche Sanofi AbbVie Meso Scale Diagnostics, MSD Merck Sharp and Dohme, MSD DUSA Pharmaceuticals Les Laboratories Pierre Fabre Cilag LEO Pharma Research Foundation, The development of the current set of guideline was supported solely by funds of the EADO which were used to mainly support the consensus meeting.Dr. Stratigos reports personal fees and/or research support from Novartis, Roche, BMS, AbbVie, Sanofi, Regeneron, Genesis Pharma, outside the submitted work. Dr. Garbe reports personal fees from Amgen, personal fees from MSD, grants and personal fees from Novartis, grants and personal fees from NeraCare, grants and personal fees from BMS, personal fees from Pierre Fabre, personal fees from Philogen, grants and personal fees from Roche, grants and personal fees from Sanofi, outside the submitted work. Dr. Dessinioti has nothing to disclose. Dr. Lebbe reports grants and personal fees from Bristol-Myers Squibb, personal fees from MSD, personal fees from Novartis, personal fees from Amgen, grants and personal fees from Roche, personal fees from Avantis Medical Systems, personal fees from Pierre Fabre, personal fees from Pfizer, personal fees from Incyte, outside the submitted work. Dr. Bataille reports personal fees from Novartis, personal fees from Merck MSD, outside the submitted work. Dr. Bastholt reports personal fees for advisory board activity: BMS, Roche, Novartis, Pierre Fabre, AstraZeneca, Incyte, MSD/Merck, Bayer. Dr. Dr?no reports grants and personal fees from BMS, personal fees from MSD, grants and personal fees from Roche, grants and personal fees from Fabre, grants and personal fees from Sanofi, outside the submitted work. Dr. Fargnoli reports grants and personal fees from Almirall, grants and personal fees from Leo Pharma, personal fees from Janssen, grants and personal fees from Novartis, personal fees from Lilly, grants and personal fees from Sanofi, personal fees from UCB, grants and personal fees from AbbVie, personal fees from Celgene, personal fees from Pierre Fabre, grants and personal fees from Galderma, personal fees from Mylan, personal fees from Medac Pharma, personal fees from Roche, personal fees from Sun Pharma, outside the submitted work. Dr. Forsea reports scientific consultant/speaker fee from Novartis, Leo Pharma, Solartium, Pierre Fabre, outside the submitted work. Dr. Frenard has nothing to disclose. Dr. Harwood reports institutional research grants and honoraria from Sanofi, Novartis, Merck, Pfizer, Galderma, Meda, Almirall, PellePharm, Leo Pharma, Ceries. Dr. Hauschild reports honoraria and/or research grants from Almirall, BMS, Roche, Novartis, Pierre Fabre, Sun Pharma, Merck Serono, Sanofi-Aventis, Regeneron, MSD/Merck, Philogen, OncoSec outside the submitted work. Dr. Hoeller reports grants and personal fees from Amgen, personal fees from BMS, personal fees from MSD, personal fees from Novartis, personal fees from Pierre Fabre, personal fees from Roche, personal fees from Sanofi, personal fees from Incyte, outside the submitted work. Dr. Kandolf-Sekulovic reports speakers? honoraria for Roche, Novartis, MSD, BMS, Janssen outside the submitted work. Dr. Kaufmann reports institutional research grants (clinical trials) from AbbVie, Amgen, Biontech, BMS, Celgene, Galderma, Janssen, Leo, Lilly, Merck, MSD, Novartis, Pierre Fabre, Pfizer, Regeneron, Roche, Wyeth. Advisory board and honoraria from Merz, Roche, Novartis. Dr. Kelleners-Smeets reports grants from Netherlands Organization for Health Research and Development, other from Janssen-Cilag, other from AbbVie, other from Galderma, outside the submitted work. Dr. Malvehy reports research grants from Almirall, ISDIN, Leo Pharma, Galderma, GSK, Cantabria, participation in advisory board meetings for Almirall, Sun Pharma, BMS, Roche, Novartis, Pierre Fabre. Dr. del Marmol reports personal fees from MSD, from BMS, personal fees from Sanofi, grants and personal fees from AbbVie, grants from Janssen, outside the submitted work. Dr. Middleton reports personal fees and/or grants from Amgen, Roche, AstraZeneca, GSK, Novartis, Immunocore, BMS, Eisai and Merck. Institutional funding from Millennium, Vertex, Pfizer, Regeneron, TC Biopharm, BioLineRx, Replimune, outside the submitted work. Dr. Moreno-Ram?rez has nothing to disclose. Dr. Pellecani reports grants from university of Modena and Reggio Emilia, during the conduct of the study, grants from Novartis, grants and personal fees from Almirall, grants from Leo Pharma, from null, outside the submitted work. Dr. Peris reports honoraria for advisory board and grants from AbbVie, Almirall, Biogen Celgene, Lilly, Galderma, Leo Pharma, Novartis, Roche, Sanofi, Sun Pharma, Sandoz outside the submitted work. Dr. Saiag reports honoraria for advisory board and grants from Amgen, Bristol-Myers Squibb, MSD, Merck Serono, Novartis, Pfizer, Roche-Genentech, Pierre Fabre, and Sanofi, outside the submitted work. Dr. van den Beuken-van Everdingen has nothing to disclose. Dr. Vieira has nothing to disclose. Dr. Zalaudek reports honoraria and advisory board and grants from Sanofi, Sun Pharma, Novartis, Galderma, Roche, Celgene, Almirall, Leo Pharma, Mylan, Difa Cooper, Cieffe Labs, La Roche Posay, Pierre Fabre. Dr. Eggermont reports over the last 5 years personal fees as a consultant advisor for BIOCAD, BioInvent, Bristol-Myers Squibb (BMS), CatalYm, Ellipses, GlaxoSmithKline (GSK), HalioDx, Incyte, IO Biotech, ISA Pharmaceuticals, Merck Sharpe & Dohme (MSD), Novartis, Pfizer, Polynoma, Regeneron, Sanofi, SELLAS, SkylineDx. Dr. Grob reports personal fees for advisory board and as speaker from Amgen, Roche, GSK, Novartis, BMS, Pierre Fabre, Merck, Sanofi, Merck, Pfizer outside the submitted work., Dr. Stratigos reports personal fees and/or research support from Novartis, Roche, BMS, AbbVie, Sanofi, Regeneron, Genesis Pharma, outside the submitted work. Dr. Garbe reports personal fees from Amgen, personal fees from MSD, grants and personal fees from Novartis , grants and personal fees from NeraCare , grants and personal fees from BMS , personal fees from Pierre Fabre, personal fees from Philogen, grants and personal fees from Roche , grants and personal fees from Sanofi , outside the submitted work. Dr. Dessinioti has nothing to disclose. Dr. Lebbe reports grants and personal fees from Bristol-Myers Squibb , personal fees from MSD, personal fees from Novartis, personal fees from Amgen, grants and personal fees from Roche , personal fees from Avantis Medical Systems, personal fees from Pierre Fabre, personal fees from Pfizer, personal fees from Incyte, outside the submitted work. Dr. Bataille reports personal fees from Novartis, personal fees from Merck MSD, outside the submitted work. Dr. Bastholt reports personal fees for advisory board activity: BMS, Roche, Novartis, Pierre Fabre, AstraZeneca, Incyte, MSD/Merck, Bayer. Dr. Dréno reports grants and personal fees from BMS , personal fees from MSD, grants and personal fees from Roche , grants and personal fees from Fabre , grants and personal fees from Sanofi , outside the submitted work. Dr. Fargnoli reports grants and personal fees from Almirall , grants and personal fees from Leo Pharma , personal fees from Janssen, grants and personal fees from Novartis , personal fees from Lilly, grants and personal fees from Sanofi , personal fees from UCB, grants and personal fees from AbbVie , personal fees from Celgene, personal fees from Pierre Fabre, grants and personal fees from Galderma , personal fees from Mylan, personal fees from Medac Pharma, personal fees from Roche, personal fees from Sun Pharma, outside the submitted work. Dr. Forsea reports scientific consultant/speaker fee from Novartis, Leo Pharma, Solartium, Pierre Fabre, outside the submitted work. Dr. Frenard has nothing to disclose. Dr. Harwood reports institutional research grants and honoraria from Sanofi , Novartis , Merck , Pfizer , Galderma , Meda , Almirall , PellePharm , Leo Pharma , Ceries . Dr. Hauschild reports honoraria and/or research grants from Almirall , BMS , Roche , Novartis , Pierre Fabre , Sun Pharma , Merck Serono , Sanofi-Aventis , Regeneron , MSD/Merck , Philogen , OncoSec outside the submitted work. Dr. Hoeller reports grants and personal fees from Amgen , personal fees from BMS, personal fees from MSD, personal fees from Novartis, personal fees from Pierre Fabre, personal fees from Roche, personal fees from Sanofi, personal fees from Incyte, outside the submitted work. Dr. Kandolf-Sekulovic reports speakers’ honoraria for Roche, Novartis, MSD, BMS, Janssen outside the submitted work. Dr. Kaufmann reports institutional research grants (clinical trials) from AbbVie , Amgen , Biontech , BMS , Celgene , Galderma , Janssen , Leo , Lilly , Merck , MSD , Novartis , Pierre Fabre , Pfizer , Regeneron , Roche , Wyeth . Advisory board and honoraria from Merz, Roche, Novartis. Dr. Kelleners-Smeets reports grants from Netherlands Organization for Health Research and Development , other from Janssen-Cilag, other from AbbVie, other from Galderma, outside the submitted work. Dr. Malvehy reports research grants from Almirall , ISDIN , Leo Pharma , Galderma , GSK , Cantabria, participation in advisory board meetings for Almirall, Sun Pharma, BMS, Roche, Novartis, Pierre Fabre. Dr. del Marmol reports personal fees from MSD, from BMS, personal fees from Sanofi, grants and personal fees from AbbVie, grants from Janssen , outside the submitted work. Dr. Middleton reports personal fees and/or grants from Amgen , Roche , AstraZeneca , GSK , Novartis , Immunocore , BMS , Eisai and Merck . Institutional funding from Millennium , Vertex , Pfizer , Regeneron , TC Biopharm , BioLineRx , Replimune , outside the submitted work. Dr. Moreno-Ramírez has nothing to disclose. Dr. Pellecani reports grants from university of Modena and Reggio Emilia , during the conduct of the study, grants from Novartis , grants and personal fees from Almirall , grants from Leo Pharma , from null, outside the submitted work. Dr. Peris reports honoraria for advisory board and grants from AbbVie , Almirall , Biogen Celgene , Lilly , Galderma , Leo Pharma , Novartis , Roche , Sanofi , Sun Pharma , Sandoz outside the submitted work. Dr. Saiag reports honoraria for advisory board and grants from Amgen , Bristol-Myers Squibb , MSD , Merck Serono , Novartis , Pfizer , Roche-Genentech , Pierre Fabre , and Sanofi , outside the submitted work. Dr. van den Beuken-van Everdingen has nothing to disclose. Dr. Vieira has nothing to disclose. Dr. Zalaudek reports honoraria and advisory board and grants from Sanofi , Sun Pharma , Novartis , Galderma , Roche , Celgene , Almirall , Leo Pharma , Mylan , Difa Cooper , Cieffe Labs , La Roche Posay , Pierre Fabre . Dr. Eggermont reports over the last 5 years personal fees as a consultant advisor for BIOCAD, BioInvent, Bristol-Myers Squibb (BMS), CatalYm, Ellipses, GlaxoSmithKline (GSK), HalioDx, Incyte, IO Biotech, ISA Pharmaceuticals, Merck Sharpe & Dohme (MSD), Novartis, Pfizer, Polynoma, Regeneron, Sanofi, SELLAS, SkylineDx. Dr. Grob reports personal fees for advisory board and as speaker from Amgen, Roche, GSK, Novartis, BMS, Pierre Fabre, Merck, Sanofi, Merck, Pfizer outside the submitted work., European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC), Stratigos, A. J., Garbe, C., Dessinioti, C., Lebbe, C., Bataille, V., Bastholt, L., Dreno, B., Concetta Fargnoli, M., Forsea, A. M., Frenard, C., Harwood, C. A., Hauschild, A., Hoeller, C., Kandolf-Sekulovic, L., Kaufmann, R., Kelleners-Smeets, N. W. J., Malvehy, J., del Marmol, V., Middleton, M. R., Moreno-Ramirez, D., Pellecani, G., Peris, K., Saiag, P., van den Beuken-van Everdingen, M. H. J., Vieira, R., Zalaudek, I., Eggermont, A. M. M., Grob, J. -J., Dermatologie, MUMC+: MA Dermatologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, RS: MHeNs - R3 - Neuroscience, Anesthesiologie, MUMC+: MA Anesthesiologie (9), and MUMC+: TPZ Palliatieve Zorg (9)

Subjects
0301 basic medicine, Oncology, Cancer Research, Skin Neoplasms, medicine.medical_treatment, Dermatologic Surgical Procedures, Aftercare, Anti-PD-1 antibody, Cemiplimab, Chemotherapy, Cutaneous squamous cell carcinoma, EGFR inhibitors, Follow-up, Locally advanced, Metastatic, Radiotherapy, Surgical excision, Treatment, Medical Oncology, Metastasis, METASTATIC CUTANEOUS HEAD, 0302 clinical medicine, Antineoplastic Agents, Immunological, Quality of life, IN-TRANSIT METASTASIS, Monoclonal, ADJUVANT RADIOTHERAPY, Lymph node, Humanized, Societies, Medical, Skin, Cetuximab, Palliative Care, Margins of Excision, Chemoradiotherapy, 3. Good health, EGFR inhibitor, Dissection, medicine.anatomical_structure, Immunological, 030220 oncology & carcinogenesis, PHASE-II, Carcinoma, Squamous Cell, Sunlight, Settore MED/35 - MALATTIE CUTANEE E VENEREE, medicine.drug, medicine.medical_specialty, Consensus, Clinical Decision-Making, [SDV.CAN]Life Sciences [q-bio]/Cancer, Antineoplastic Agents, CERVICAL LYMPH-NODES, Dermatology, Antibodies, Monoclonal, Humanized, ELECTIVE NECK DISSECTION, Antibodies, 03 medical and health sciences, [SDV.CAN] Life Sciences [q-bio]/Cancer, Patient Education as Topic, Internal medicine, Humans, Lymph Node Excision, Lymph Nodes, Neoplasm Staging, Patient Care Team, Medical, medicine, ORGAN TRANSPLANT RECIPIENTS, business.industry, Carcinoma, Guideline, medicine.disease, Cancérologie, Radiation therapy, 030104 developmental biology, Squamous Cell, INTERFERON-ALPHA, business, GROWTH-FACTOR RECEPTOR, Societies, INTRALESIONAL METHOTREXATE
Abstract

In order to update recommendations on treatment, supportive care, education and follow-up of patients with invasive cutaneous squamous cell carcinoma (cSCC), a multidisciplinary panel of experts from the European Dermatology Forum, the European Association of Dermato-Oncology and the European Organization of Research and Treatment of Cancer was formed. Recommendations were based on evidence-based literature review, guidelines and expert consensus. Treatment recommendations are presented for common primary cSCC (low risk, high risk), locally advanced cSCC, regional metastatic cSCC (operable or inoperable) and distant metastatic cSCC. For common primary cSCC (the most frequent cSCC type), first-line treatment is surgical excision with postoperative margin assessment or microscopically controlled sugery. Safety margins containing clinical normal-appearing tissue around the tumour during surgical excision and negative margins as reported in the pathology report are necessary to minimise the risk of local recurrence and metastasis. In case of positive margins, a re-excision shall be done, for operable cases. Lymph node dissection is recommended for cSCC with cytologically or histologically confirmed regional nodal involvement. Radiotherapy should be considered as curative treatment for inoperable cSCC, or for non-surgical candidates. Anti-PD-1 antibodies are the first-line systemic treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, with cemiplimab being the first approved systemic agent for advanced cSCC by the Food and Drug Administration/European Medicines Agency. Second-line systemic treatments for advanced cSCC include epidermal growth factor receptor inhibitors (cetuximab) combined with chemotherapy or radiation therapy. Multidisciplinary board decisions are mandatory for all patients with advanced disease who require more than surgery. Patients should be engaged with informed decisions on management and be provided with best supportive care to optimise symptom management and improve quality of life. Frequency of follow-up visits and investigations for subsequent new cSCC depend on underlying risk characteristics., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2020

7. European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment - Update 2019

Author

Garbe, Claus, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Bastholt, Lars, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria Concetta, Grob, Jean-Jacques, Höller, Christoph, Kaufmann, Roland, Lallas, Aimilios, Lebbé, Celeste, Malvehy, Josep, Middleton, Mark, Moreno-Ramirez, David, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Vieira, Ricardo, Zalaudek, Iris, Eggermont, Alexander M M, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization for Research and Treatment of Cancer (EORTC), Garbe, Clau, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Bastholt, Lar, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria Concetta, Grob, Jean-Jacque, Höller, Christoph, Kaufmann, Roland, Lallas, Aimilio, Lebbé, Celeste, Malvehy, Josep, Middleton, Mark, Moreno-Ramirez, David, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Vieira, Ricardo, Zalaudek, Iri, Eggermont, Alexander M M, Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Aix-Marseille Université - Faculté des sciences médicales et paramédicales (AMU SMPM), Aix Marseille Université (AMU), Service de Dermatologie [AP-HP Hôpital Saint-Louis], Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Ambroise Paré [AP-HP], Novartis Les Laboratories Pierre Fabre Berlin Mathematical School, BMS AbbVie Sanofi Pfizer Amgen Eisai GlaxoSmithKline, GSK Roche DUSA Pharmaceuticals Merck KGaA Meso Scale Diagnostics, MSD, C.G. reports receiving personal fees from Amgen, Pierre Fabre, Philogen and MSD, and reports receiving grants and personal fees from Novartis, NeraCare, BMS, Roche and Sanofi, outside the submitted work.T.A. reports receiving personal fees and other grants from BMS, Novartis, Pierre Fabre, Neracare and Sanofi, outside the submitted work.K.P. reports receiving personal fees from Novartis, Roche, Sanofi, Lilly, Leopharma, Pierre Fabre, Almirall and Celgene, outside the submitted work.A.H. reports receiving grants and personal fees from Amgen, BMS, MerckSerono, MSD / Merck, Philogen, Pierre Fabre, Provectus, Regeneron, Roche, Sanofi-Genzyme, and Novartis Pharma, receiving personal fees from OncoSec and Sun Pharma, outside the submitted work.P.A. reports receiving personal fees from Amgen, MSD, Novartis, BMS and Roche, outside the submitted work.L.B. reports receiving grants from BMS, during the conduct of the study, personal fees from BMS, Novartis, Merck MSD, Roche, Incyte, Bayer, outside the submitted work.V.B. reports receiving personal fees from Novartis and Merck MSD, outside the submitted work.V.d.M. reports receiving personal fees from MSD, BMS and Sanofi, grants and personal fees from ABVIE, grants from Jansen, outside the submitted work.B.M. reports grants and personal fees from BMS, Roche, Fabre and Sanofi, personal fees from MSD, outside the submitted work.M.C.F. reports receiving grants and personal fees from Almirall, Leo Pharma, Novartis, Sanofi, Abbvie and Galderma, personal fees from Janssen, Lilly, UCB, Celgene, Pierre Fabre, Mylan, Medac Pharma, Roche, Sun Pharma, outside the submitted work.J.J.G. reports receiving personal fees from Amgen, MSD, Novartis, BMS, Roche, Pierre fabre, MercK / Pfizer, outside the submitted work.C.H. reports receiving personal fees from Amgen, MSD, Novartis, Incyte, BMS, Pierre Fabre, Roche, Sanofi, outside the submitted work.R.K. reports receiving grants and personal fees from Novartis and Roche, and grants from AbbVie, Amgen, Bionteck, BMS, Celgene, Galderma, Janssen, Leo, Lilly, Merck, MSD, Pierre Fabre, Regeneron and Wyeth, outside the submitted work.A.L. reports personal fees from Amgen, Novartis, BMS and, Sanofi grants and personal fees from Roche, outside the submitted work.C.L. reports receiving grants and personal fees from Bristol-Myers Squibb and Roche, personal fees from MSD, Novartis, Amgen, Avantis Medical Systems, Pierre Fabre, Pfizer, Incyte, outside the submitted work.J.M. reports personal fees from Amgen, personal fees from MSD, grants from Novartis, grants and personal fees from BMS, grants and personal fees from Roche, grants and personal fees from Almirall, personal fees from Sun Pharma, outside the submitted work.M.M. reports receiving personal fees from Amgen and BiolineRx, grants and personal fees from Roche and GSK, grants from Astrazeneca, personal fees and other from Novartis, Eisai, Array Biopharma (now Pfizer), Rigontec (acquired by MSD), and BMS, other from Millennium, Regeneron Pfizer, personal fees, non-financial support and other from Immunocore, Replimun and Merck / MSD, outside the submitted work.G.P. reports receiving personal fees from Novartis, personal fees from Sanofi, grants from Novartis, instruments from 3Gen, Vidix, Fotofinder and MAVIG GmbH, outside the submitted work.P.S. reports receiving personal fees from Amgen, MSD and Pierre Fabre / array, grants and personal fees from Novartis, NeraCare, BMS, Roche, and Sanofi, outside the submitted work.A.J.S. reports personal fees and/or research support from Novartis, Roche, BMS, Abbvie, Sanofi, Regeneron, Genesis Pharma, outside the submitted work. Dr. Vieira has nothing to disclose.I.Z. reports receiving personal fees from Difa Cooper, MSD, Sanofi, Almirall Hermal, Novartis, Mylan and Sunpharma, grants and personal fees from Roche, outside the submitted work.A.M.M.E. reports receiving personal fees from Biocad, Biovent, BMS, CatalYm, Ellipses, GSK, Incyte, IO Biotech, ISA Pharmaceuticals, Merck GmbH, MSD, Novartis, Pfizer, Polynoma, Regeneron, Sanofi, SkylineDx, Stellas, other from RiverD, SkylineDx, Theranovir, all outside the submitted work., Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Portuguese Air Force Health Care Direction [Lisbon, Portugal] (PAFHCD), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University Medical Center of Schleswig–Holstein = Universitätsklinikum Schleswig-Holstein (UKSH), Kiel University, Charles University [Prague] (CU), Odense University Hospital (OUH), King‘s College London, Université libre de Bruxelles (ULB), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), University of L'Aquila [Italy] (UNIVAQ), Assistance Publique - Hôpitaux de Marseille (APHM), Medizinische Universität Wien = Medical University of Vienna, Frankfurt University Hospital, Aristotle University of Thessaloniki, Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), University of Oxford, Hospital Universitario Virgen Macarena [Séville], University - Hospital of Modena and Reggio Emilia [Modena, Italy], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Athens Medical School [Athens], Universidade de Coimbra [Coimbra], Università degli studi di Trieste = University of Trieste, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Princess Máxima Center for Pediatric Oncology, and Dupuis, Christine

Subjects
0301 basic medicine, Oncology, Cancer Research, [SDV]Life Sciences [q-bio], Systemic treatment, Primary diagnosis, 0302 clinical medicine, Dermatoscopy, Stage (cooking), Melanoma, Trametinib, Adjuvant treatment, Cutaneous melanoma, Excisional margins, Interferon-α, Metastasectomy, Sentinel lymph node dissection, Tumour thickness, Combined Modality Therapy, 3. Good health, [SDV] Life Sciences [q-bio], 030220 oncology & carcinogenesis, Practice Guidelines as Topic, Excisional margin, Confocal reflectance microscopy, Settore MED/35 - MALATTIE CUTANEE E VENEREE, medicine.drug, Diagnostic Imaging, medicine.medical_specialty, Consensus, Follow-up examinations, Sentinel lymph node, Mutation testing, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, AJCC classification, Internal medicine, medicine, Humans, European Union, Neoplasm Staging, Interdisciplinary Communication, Total body photography, business.industry, Cancer, Dabrafenib, Guideline, medicine.disease, Imaging diagnostics, Cancérologie, 030104 developmental biology, Sequential digital dermatoscopy, business
Abstract

A unique collaboration of multidisciplinary experts from the European Dermatology Forum, the European Association of Dermato-Oncology and the European Organization for Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with 1- to 2-cm safety margins. Sentinel lymph node dissection shall be performed as a staging procedure in patients with tumour thickness ≥1.0 mm or ≥0.8 mm with additional histological risk factors, although there is as yet no clear survival benefit for this approach. Therapeutic decisions in stage III/IV patients should be primarily made by an interdisciplinary oncology team (“Tumor Board”). Adjuvant therapies in stage III/IV patients are primarily anti–PD-1, independent of mutational status, or dabrafenib plus trametinib for BRAF-mutant patients. In distant metastasis, either resected or not, systemic treatment is indicated. For first-line treatment, particularly in BRAF wild-type patients, immunotherapy with PD-1 antibodies alone or in combination with CTLA-4 antibodies shall be considered. In particular scenarios for patients with stage IV melanoma and a BRAF-V600 E/K mutation, first-line therapy with BRAF/MEK inhibitors can be offered as an alternative to immunotherapy. In patients with primary resistance to immunotherapy and harbouring a BRAF-V600 E/K mutation, this therapy shall be offered in second-line. Systemic therapy in stage III/IV melanoma is a rapidly changing landscape, and it is likely that these recommendations may change in the near future., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2019

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