TY - JOUR
T1 - Real Life Clinical Management and Survival in Advanced Cutaneous Melanoma: The Italian Clinical National Melanoma Registry Experience
AU - the Clinical National Melanoma Registry Study Group at the Italian Melanoma Intergroup
AU - Crispo, Anna
AU - Corradin, Maria Teresa
AU - Giulioni, Erika
AU - Vecchiato, Antonella
AU - Del Fiore, Paolo
AU - Queirolo, Paola
AU - Spagnolo, Francesco
AU - Vanella, Vito
AU - Caracò, Corrado
AU - Tosti, Giulio
AU - Pennacchioli, Elisabetta
AU - Giudice, Giuseppe
AU - Nacchiero, Eleonora
AU - Quaglino, Pietro
AU - Ribero, Simone
AU - Giordano, Monica
AU - Marussi, Desire
AU - Barruscotti, Stefania
AU - Guida, Michele
AU - De Giorgi, Vincenzo
AU - Occelli, Marcella
AU - Grosso, Federica
AU - Cairo, Giuseppe
AU - Gatti, Alessandro
AU - Massa, Daniela
AU - Atzori, Laura
AU - Calvani, Nicola
AU - Fabrizio, Tommaso
AU - Mastrangelo, Giuseppe
AU - Toffolutti, Federica
AU - Celentano, Egidio
AU - Budroni, Mario
AU - Gandini, Sara
AU - Rossi, Carlo Riccardo
AU - Testori, Alessandro
AU - Palmieri, Giuseppe
AU - Ascierto, Paolo A.
N1 - Funding Information:
We would like to express our special thanks to Dr. Maurizio Montella (? May 2, 2019) for his long-term contribution to the study and for his ideas and support of this current manuscript. The authors would like to thank the Intergruppo Melanoma Italiano (IMI), the Clinical Research Technology (CRT) and Dr. Giuseppe Porciello for graphical assistance.
Publisher 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.
PY - 2021/7/8
Y1 - 2021/7/8
N2 - 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.
AB - 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.
KW - cutaneous melanoma
KW - immunotherapy
KW - ipilimumab
KW - medical record systems
KW - survival analysis
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U2 - 10.3389/fonc.2021.672797
DO - 10.3389/fonc.2021.672797
M3 - Article
AN - SCOPUS:85111248875
SN - 2234-943X
VL - 11
SP - 672797
JO - Frontiers in Oncology
JF - Frontiers in Oncology
ER -