학술논문
Real Life Clinical Management and Survival in Advanced Cutaneous Melanoma: The Italian Clinical National Melanoma Registry Experience.
Document Type
Academic Journal
Author
Crispo A; Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.; Corradin MT; Dermatology Department, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.; Giulioni E; Dermatology Department, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.; Vecchiato A; Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.; Del Fiore P; Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.; Queirolo P; IRCCS Ospedale Policlinico San Martino, Genova, Italy.; Istituto Europeo di Oncologia - IRCCS, Milano, Italy.; Spagnolo F; IRCCS Ospedale Policlinico San Martino, Genova, Italy.; Vanella V; Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.; Caracò C; Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.; Tosti G; Istituto Europeo di Oncologia - IRCCS, Milano, Italy.; Pennacchioli E; Istituto Europeo di Oncologia - IRCCS, Milano, Italy.; Giudice G; Plastic and Reconstructive Surgery Department, Università degli Studi di Bari Aldo Moro, Bari, Italy.; Nacchiero E; Plastic and Reconstructive Surgery Department, Università degli Studi di Bari Aldo Moro, Bari, Italy.; Quaglino P; Clinica Dermatologica, Dipartimento di Scienze Mediche, Università di Torino, Torino, Italy.; Ribero S; Clinica Dermatologica, Dipartimento di Scienze Mediche, Università di Torino, Torino, Italy.; Giordano M; Oncology Department, Ospedale Sant'Anna di Como, Como, Italy.; Marussi D; Oncology Department, Ospedale Sant'Anna di Como, Como, Italy.; Barruscotti S; Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.; Guida M; IRCCS Istituto Tumori 'Giovanni Paolo II', Bari, Italy.; De Giorgi V; Dermatology Department, Università di Firenze, Firenze, Italy.; Occelli M; Oncology Department, Azienda ospedaliera Santa Croce e Carle, Cuneo, Italy.; Grosso F; Mesothelioma Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.; Cairo G; Oncology Department, ospedale 'Vito Fazzi' di Lecce, Lecce, Italy.; Gatti A; ULSS 2 Marca Trevigiana Ospedale Ca' Foncello Treviso, Treviso, Italy.; Massa D; Gruppo melanoma e tumori rari, Oncology Department, PO A Businco ARNAS G. Brotzu, Cagliari, Italy.; Atzori L; Dermatology Clinic, Department Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.; Calvani N; Oncology Department, Presidio Ospedaliero 'Senatore Antonio Perrino', Brindisi, Italy.; Fabrizio T; IRCCS Centro di Riferimento Oncologico Basilicata, Rionero in Vulture, Italy.; Mastrangelo G; Dermatology Clinic, Università degli studi di Padova, Padova, Italy.; Toffolutti F; Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano (PN), Italy.; Celentano E; Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.; Budroni M; Registro Tumori Provincia di Sassari, Azienda Ospedaliera Universitaria Sassari, Sassari, Italy.; Gandini S; Istituto Europeo di Oncologia - IRCCS, Milano, Italy.; Rossi CR; Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.; Dermatology Clinic, Università degli studi di Padova, Padova, Italy.; Testori A; Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.; Palmieri G; Istituto di Ricerca Genetica e Biomedica, CNR, Sassari, Italy.; Ascierto PA; Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.
Source
Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101568867 Publication Model: eCollection Cited Medium: Print ISSN: 2234-943X (Print) Linking ISSN: 2234943X NLM ISO Abbreviation: Front Oncol Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
2234-943X
Abstract
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: 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: 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: 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.
Competing Interests: 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.
(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.)
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: 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: 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.
Competing Interests: 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.
(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.)