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

Abstract

BackgroundCutaneous 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).MethodsMelanoma-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.ResultsThe 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).ConclusionsThe 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.

Electrochemotherapy vs radiotherapy in the treatment of primary cutaneous malignancies or cutaneous metastases from primary solid organ malignancies: A systematic review and narrative synthesis

“…Two studies were excluded as they grouped data for electrochemotherapy with other interventions such as radiotherapy as ‘local therapies’ and any outcomes were inseparable and not suitable for extraction [ 33 , 34 ]. We contacted the authors of these studies to obtain extractable data but did not receive a response.…”

“…Through searching, additional data sets which included groups of patients treated with electrochemotherapy and with radiotherapy were identified, but due to the how the outcomes for these patients were grouped, no data could be extracted to allow indirect comparison [ 33 , 34 ]. Notably, there was no published data from any directly comparative trials between electrochemotherapy and radiotherapy.…”

Characteristics of Real-World Patients with High-Risk BRAFV600E/K-Mutated Melanoma Receiving Adjuvant Treatment with Dabrafenib Plus Trametinib After Surgical Resection, Through the Italian Managed Access Program

“…15 It should be noted that patients with stage IIIA disease and lymph-node metastases <1 mm were not eligible for either of these two trials; furthermore, patients with stage IIIA disease were excluded from other adjuvant immunotherapy trials 20,21 and were not included in a recent survival analysis of patients with melanoma receiving adjuvant therapy in a real-world setting. 18 Patient demographics in the MAP were similar to those of DESCRIBE-AD, an observational retrospective study of 65 patients with histologically confirmed and resected BRAF-mutated melanoma previously treated with dabrafenib plus trametinib in the adjuvant setting in Spain, 22 and to those in the COMBI-APlus trial. 13 Moreover, the characteristics of patients enrolled in the MAP were similar to those described in a retrospective analysis of 113 patients with stage III melanoma who received at least one cycle of adjuvant immunotherapy or targeted therapy at two Italian institutions, 19 and an analysis of 787 patients with advanced cutaneous melanoma from the Clinical National Melanoma Registry (CNMR); as previously mentioned, the latter did not include patients with stage IIIA disease.…”

“…Recent studies have been published that describe the adjuvant treatment of patients with melanoma in Italy; 18,19 however, these studies also include patients who received immunotherapy, and -as is often the case in real-world studies -lack information on treatment dosing and schedule, as well as on dose reductions and Our work describes the characteristics and the patient journey of patients with high-risk BRAF V600E/K -mutated melanoma who were treated with adjuvant dabrafenib plus trametinib after surgical resection as part of an Italian MAP. We also included a detailed analysis of the patient subgroup with stage IIIA disease, since this group was not always included in the pivotal clinical studies of adjuvant therapy for melanoma and is not included in some of the recently published real-world evidence studies either.…”

Real-World Evaluation of the Management, Treatment Pathways and Outcome of Melanoma Patients with Target Therapies in Italy

“…About 85% of cutaneous melanoma arising annually worldwide affect populations in North America, Europe, and Oceania, with the highest incidence in white people [ 4 ]. In recent years, an increasing trend in the incidence of melanoma has been reported for Europe which will likely continue in the next decades [ 5 ].…”