Real Life Clinical Management and Survival in Advanced Cutaneous Melanoma: The Italian Clinical National Melanoma Registry Experience.

cutaneous melanoma immunotherapy ipilimumab medical record systems survival analysis

Journal

Frontiers in oncology
ISSN: 2234-943X
Titre abrégé: Front Oncol
Pays: Switzerland
ID NLM: 101568867

Informations de publication

Date de publication:
2021
Historique:
received: 04 03 2021
accepted: 22 06 2021
entrez: 26 7 2021
pubmed: 27 7 2021
medline: 27 7 2021
Statut: epublish

Résumé

Cutaneous melanoma (CM) is one of the most aggressive types of skin cancer. Currently, innovative approaches such as target therapies and immunotherapies have been introduced in clinical practice. Data of clinical trials and real life studies that evaluate the outcomes of these therapeutic associations are necessary to establish their clinical utility. The aim of this study is to investigate the types of oncological treatments employed in the real-life clinical management of patients with advanced CM in several Italian centers, which are part of the Clinical National Melanoma Registry (CNMR). Melanoma-specific survival and overall survival were calculated. Multivariate Cox regression models were used to estimate the hazard ratios adjusting for confounders and other prognostic factors. The median follow-up time was 36 months (range 1.2-185.1). 787 CM were included in the analysis with completed information about therapies. All types of immunotherapy showed a significant improved survival compared with all other therapies (p=0.001). 75% was the highest reduction of death reached by anti-PD-1 (HR=0.25), globally immunotherapy was significantly associated with improved survival, either for anti-CTLA4 monotherapy or combined with anti-PD-1 (HR=0.47 and 0.26, respectively) and BRAFI+MEKI (HR=0.62). The nivolumab/pembrolizumab in combination of ipilimumab and the addition of ant-MEK to the BRAFi can be considered the best therapies to improve survival in a real-world-population. The CNMR can complement clinical registries with the intent of improving cancer management and standardizing cancer treatment.

Sections du résumé

BACKGROUND BACKGROUND
Cutaneous melanoma (CM) is one of the most aggressive types of skin cancer. Currently, innovative approaches such as target therapies and immunotherapies have been introduced in clinical practice. Data of clinical trials and real life studies that evaluate the outcomes of these therapeutic associations are necessary to establish their clinical utility. The aim of this study is to investigate the types of oncological treatments employed in the real-life clinical management of patients with advanced CM in several Italian centers, which are part of the Clinical National Melanoma Registry (CNMR).
METHODS METHODS
Melanoma-specific survival and overall survival were calculated. Multivariate Cox regression models were used to estimate the hazard ratios adjusting for confounders and other prognostic factors.
RESULTS RESULTS
The median follow-up time was 36 months (range 1.2-185.1). 787 CM were included in the analysis with completed information about therapies. All types of immunotherapy showed a significant improved survival compared with all other therapies (p=0.001). 75% was the highest reduction of death reached by anti-PD-1 (HR=0.25), globally immunotherapy was significantly associated with improved survival, either for anti-CTLA4 monotherapy or combined with anti-PD-1 (HR=0.47 and 0.26, respectively) and BRAFI+MEKI (HR=0.62).
CONCLUSIONS CONCLUSIONS
The nivolumab/pembrolizumab in combination of ipilimumab and the addition of ant-MEK to the BRAFi can be considered the best therapies to improve survival in a real-world-population. The CNMR can complement clinical registries with the intent of improving cancer management and standardizing cancer treatment.

Identifiants

pubmed: 34307142
doi: 10.3389/fonc.2021.672797
pmc: PMC8298066
doi:

Types de publication

Journal Article

Langues

eng

Pagination

672797

Investigateurs

Maddalena Cespa (M)
Rosachiara Forcignanò (R)
Gianmichele Moise (G)
Maria Concetta Fargnoli (MC)
Caterina Ferreli (C)
Maria Grimaldi (M)
Guido Zannetti (G)
Saverio Cinieri (S)
Giusto Trevisan (G)
Ignazio Stanganelli (I)
Giovanna Moretti (G)
Francesca Bruder (F)
Luca Bianchi (L)
Maria Teresa Fierro (MT)
Luigi Mascheroni (L)
Salvatore Asero (S)
Caterina Catricalà (C)
Stefania Staibano (S)
Gaetana Rinaldi (G)
Riccardo Pellicano (R)
Laura Milesi (L)
Marilena Visini (M)
Franco Di Filippo (F)
Leonardo Zichichi (L)
Maria Antonietta Pizzichetta (MA)
Carmelo Iacono (C)
Massimo Guidoboni (M)
Giovanni Sanna (G)
Michele Maio (M)
Lucia Lospalluti (L)
Rosanna Barbati (R)
Leonardi Vita (L)
Annamaria Pollio (A)
Carlo Riberti (C)

Informations de copyright

Copyright © 2021 Crispo, Corradin, Giulioni, Vecchiato, Del Fiore, Queirolo, Spagnolo, Vanella, Caracò, Tosti, Pennacchioli, Giudice, Nacchiero, Quaglino, Ribero, Giordano, Marussi, Barruscotti, Guida, De Giorgi, Occelli, Grosso, Cairo, Gatti, Massa, Atzori, Calvani, Fabrizio, Mastrangelo, Toffolutti, Celentano, Budroni, Gandini, Rossi, Testori, Palmieri, Ascierto and the Clinical National Melanoma Registry Study Group at the Italian Melanoma Intergroup.

Déclaration de conflit d'intérêts

PA has/had a consultant/advisory role for Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Array, Merck Serono, Pierre-Fabre, Incyte, Medimmune, AstraZeneca, Syndax, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, Alkermes, Italfarmaco, Nektar, Boehringer-Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Oncosec, Pfizer. He also received research funding from Bristol Myers Squibb, Roche-Genentech, Array and travel support from MSD. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Auteurs

Anna Crispo (A)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.

Maria Teresa Corradin (MT)

Dermatology Department, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.

Erika Giulioni (E)

Dermatology Department, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.

Antonella Vecchiato (A)

Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.

Paolo Del Fiore (P)

Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.

Paola Queirolo (P)

IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Istituto Europeo di Oncologia - IRCCS, Milano, Italy.

Francesco Spagnolo (F)

IRCCS Ospedale Policlinico San Martino, Genova, Italy.

Vito Vanella (V)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.

Corrado Caracò (C)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.

Giulio Tosti (G)

Istituto Europeo di Oncologia - IRCCS, Milano, Italy.

Elisabetta Pennacchioli (E)

Istituto Europeo di Oncologia - IRCCS, Milano, Italy.

Giuseppe Giudice (G)

Plastic and Reconstructive Surgery Department, Università degli Studi di Bari Aldo Moro, Bari, Italy.

Eleonora Nacchiero (E)

Plastic and Reconstructive Surgery Department, Università degli Studi di Bari Aldo Moro, Bari, Italy.

Pietro Quaglino (P)

Clinica Dermatologica, Dipartimento di Scienze Mediche, Università di Torino, Torino, Italy.

Simone Ribero (S)

Clinica Dermatologica, Dipartimento di Scienze Mediche, Università di Torino, Torino, Italy.

Monica Giordano (M)

Oncology Department, Ospedale Sant'Anna di Como, Como, Italy.

Desire Marussi (D)

Oncology Department, Ospedale Sant'Anna di Como, Como, Italy.

Stefania Barruscotti (S)

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.

Michele Guida (M)

IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.

Vincenzo De Giorgi (V)

Dermatology Department, Università di Firenze, Firenze, Italy.

Marcella Occelli (M)

Oncology Department, Azienda ospedaliera Santa Croce e Carle, Cuneo, Italy.

Federica Grosso (F)

Mesothelioma Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.

Giuseppe Cairo (G)

Oncology Department, ospedale "Vito Fazzi" di Lecce, Lecce, Italy.

Alessandro Gatti (A)

ULSS 2 Marca Trevigiana Ospedale Ca' Foncello Treviso, Treviso, Italy.

Daniela Massa (D)

Gruppo melanoma e tumori rari, Oncology Department, PO A Businco ARNAS G. Brotzu, Cagliari, Italy.

Laura Atzori (L)

Dermatology Clinic, Department Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Nicola Calvani (N)

Oncology Department, Presidio Ospedaliero "Senatore Antonio Perrino", Brindisi, Italy.

Tommaso Fabrizio (T)

IRCCS Centro di Riferimento Oncologico Basilicata, Rionero in Vulture, Italy.

Giuseppe Mastrangelo (G)

Dermatology Clinic, Università degli studi di Padova, Padova, Italy.

Federica Toffolutti (F)

Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano (PN), Italy.

Egidio Celentano (E)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.

Mario Budroni (M)

Registro Tumori Provincia di Sassari, Azienda Ospedaliera Universitaria Sassari, Sassari, Italy.

Sara Gandini (S)

Istituto Europeo di Oncologia - IRCCS, Milano, Italy.

Carlo Riccardo Rossi (CR)

Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
Dermatology Clinic, Università degli studi di Padova, Padova, Italy.

Alessandro Testori (A)

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.

Giuseppe Palmieri (G)

Istituto di Ricerca Genetica e Biomedica, CNR, Sassari, Italy.

Paolo A Ascierto (PA)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.

Classifications MeSH