Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Real Life Clinical Management and Survival in Cutaneous Malignant Melanoma: the Italian Clinical National Melanoma Registry (CNMR) Experience

Version 1 : Received: 25 October 2020 / Approved: 29 October 2020 / Online: 29 October 2020 (16:02:44 CET)

How to cite: Crispo, A.; Corradin, M.T.; Giulioni, E.; Vecchiato, A.; Del Fiore, P.; Queirolo, P.; Spagnolo, F.; Vanella, V.; Caracò, C.; Tosti, G.; Pennacchioli, E.; Giudice, G.; Nacchiero, E.; Quaglino, P.; Ribero, S.; Giordano, M.; Marussi, D.; Barruscotti, S.; Guida, M.; De Giorgi, V.; Occelli, M.; Grosso, F.; Cairo, G.; Gatti, A.; Massa, D.; Atzori, L.; Calvani, N.; Fabrizio, T.; Mastrangelo, G.; Toffolutti, F.; Celentano, E.; Budroni, M.; Gandini, S.; Rossi, C.R.; Testori, A.A.E.; Palmieri, G.; Ascierto, P.A. Real Life Clinical Management and Survival in Cutaneous Malignant Melanoma: the Italian Clinical National Melanoma Registry (CNMR) Experience. Preprints 2020, 2020100624. https://doi.org/10.20944/preprints202010.0624.v1 Crispo, A.; Corradin, M.T.; Giulioni, E.; Vecchiato, A.; Del Fiore, P.; Queirolo, P.; Spagnolo, F.; Vanella, V.; Caracò, C.; Tosti, G.; Pennacchioli, E.; Giudice, G.; Nacchiero, E.; Quaglino, P.; Ribero, S.; Giordano, M.; Marussi, D.; Barruscotti, S.; Guida, M.; De Giorgi, V.; Occelli, M.; Grosso, F.; Cairo, G.; Gatti, A.; Massa, D.; Atzori, L.; Calvani, N.; Fabrizio, T.; Mastrangelo, G.; Toffolutti, F.; Celentano, E.; Budroni, M.; Gandini, S.; Rossi, C.R.; Testori, A.A.E.; Palmieri, G.; Ascierto, P.A. Real Life Clinical Management and Survival in Cutaneous Malignant Melanoma: the Italian Clinical National Melanoma Registry (CNMR) Experience. Preprints 2020, 2020100624. https://doi.org/10.20944/preprints202010.0624.v1

Abstract

Background: Cutaneous malignant melanoma (CMM) 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 for the treatment of metastatic CMM. 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 CMM in several Italian centers which are part of the Clinical National Melanoma Registry (CNMR), and the oncological outcomes obtained. Methods: CNMR collects data of patients with a histologically confirmed diagnosis of primary CMM treated in one of the 38 Italian institutions (hospitals, research institutes, etc.) participating in the network. Melanoma-specific survival and Overall survival were calculated. Kaplan-Meier curves and medians of OS and 95% CI are presented overall and by immunotherapy and target treatments. The Log-rank test compared curves by treatments. 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 CMM were included in the analysis with completed information about therapies.Global immunotherapy showed a significant improved survival compared with all other therapies (p=0.001). 75% was the highest reduction of death reached by nivolumab/pembrolizumab immunotherapy (anti-PD1 HR=0.25 95% CI 0.14-0.42), globally immunotherapy was significantly associated with improved survival, either for anti-CTL A4 monotherapy or combined with anti-PD1 (HR=0.47;95% CI 0.33-0.66 and HR=0.26; 95% CI 0.15-0.46, respectively). Conclusions: The nivolumab/pembrolizumab and the combination of ipilimumab can be considered the best therapy 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.

Keywords

medical record systems; cutaneous malignant melanoma; survival analysis; immunotherapy

Subject

Medicine and Pharmacology, Immunology and Allergy

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