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. 2021 Jul 8:11:672797.
doi: 10.3389/fonc.2021.672797. eCollection 2021.

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

Anna Crispo  1 , Maria Teresa Corradin  2 , Erika Giulioni  2 , Antonella Vecchiato  3 , Paolo Del Fiore  3 , Paola Queirolo  4   5 , Francesco Spagnolo  4 , Vito Vanella  1 , Corrado Caracò  1 , Giulio Tosti  5 , Elisabetta Pennacchioli  5 , Giuseppe Giudice  6 , Eleonora Nacchiero  6 , Pietro Quaglino  7 , Simone Ribero  7 , Monica Giordano  8 , Desire Marussi  8 , Stefania Barruscotti  9 , Michele Guida  10 , Vincenzo De Giorgi  11 , Marcella Occelli  12 , Federica Grosso  13 , Giuseppe Cairo  14 , Alessandro Gatti  15 , Daniela Massa  16 , Laura Atzori  17 , Nicola Calvani  18 , Tommaso Fabrizio  19 , Giuseppe Mastrangelo  20 , Federica Toffolutti  21 , Egidio Celentano  1 , Mario Budroni  22 , Sara Gandini  5 , Carlo Riccardo Rossi  3   20 , Alessandro Testori  9 , Giuseppe Palmieri  23 , Paolo A Ascierto  1 ; Clinical National Melanoma Registry Study Group at the Italian Melanoma Intergroup
Collaborators, Affiliations

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

Anna Crispo et al. Front Oncol. .

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.

Keywords: cutaneous melanoma; immunotherapy; ipilimumab; medical record systems; survival analysis.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Integrated management of CNMR. Two main complementary approaches are considered—Governance and Facilitating organization.
Figure 2
Figure 2
Overall Survival (OS) in patients with IIIB-IIIC (UNRESECTABLE), IV by Therapy (A–F). (A) Overall Survival (OS) Immunotherapy, (B) OS Immunotherapy: ANTI-CTL A4, (C) OS Immuno: ANTI-PD 1, (D) OS Immuno: ANTI-PD 1; ANTI-CTLA4; ANTI PD 1+ANTI-CTL A4, (E) OS Treatment Sequence:Immuno 1st, 2nd; Target 1st, 2nd; Target 1st & Immuno 2nd (F) OS BRAF vs. BRAFI+MEKI.
See this image and copyright information in PMC

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