Adjuvant treatment for melanoma in clinical practice – Trial versus reality

Abstract

Background: Little is known about outcomes of adjuvant-treated melanoma patients beyond the clinical trial setting. Since 2019, adjuvant-treated melanoma patients have been registered in the DMTR, a population-based registry to monitor the quality and safety of melanoma care in the Netherlands. This study aims to describe treatment patterns, relapse, and toxicity rates of adjuvant-treated melanoma patients beyond the clinical trial setting. Methods: Analyses were performed on adjuvant-treated melanoma patients included in the DMTR. Descriptive statistics were used to analyse patient-, and treatment characteristics. A baseline registration completeness analysis was performed, and an analysis on trial eligibility in clinical practice patients. Recurrence-free survival (RFS) at 12-months was estimated with the KaplaneMeier method. Results: A total of 641 patients were treated with adjuvant anti-PD-1 therapy. RFS at 12months was 70.6% (95% CI, 66.9e74.6) with a median follow-up of 12.8 months. Sex, stage of disease and Breslow thickness were associated with a higher hazard for RFS. Eighteen per cent of the anti-PD-1-treated patients developed grade 3 toxicity. Sixty-one per cent of patients prematurely discontinued anti-PD-1 therapy. Conclusion: Adjuvant anti-PD-1 treatment of resected stage III/IV melanoma in daily practice showed slightly higher toxicity rates and more frequent premature discontinuation but similar RFS rates compared to trials.

Application of Electronic Health Record Text Mining: Real-World Tolerability, Safety, and Efficacy of Adjuvant Melanoma Treatments

“…However, both for dabrafenib plus trametinib and nivolumab, the relative number of patients who ended treatment due to toxicity was higher than in the trials. This was also observed in the studies of de Meza et al and Hoffmann et al, which showed higher treatment-limiting AEs on ICI in clinical practice [ 21 , 22 ]. As far as we know, no other real-world data have been published with treatment-limiting toxicity rates for dabrafenib plus trametinib.…”

“…Furthermore, we reported severe hepatitis ( n = 2), asthenia ( n = 1), and diarrhea ( n = 1) during treatment with nivolumab and diarrhea ( n = 2), and colitis ( n = 1) during pembrolizumab. De Meza et al did report higher rates of severe AEs in clinical practice compared to the RCTs [ 21 ]. Due to the low incidence of the individual severe AEs, we could not determine if this was the case for our study population.…”

“…Even though this is indicative for comparable efficacy, and RFS seems to be a valid surrogate endpoint for overall survival for adjuvant melanoma therapy, it is too soon for conclusions on real-world effectiveness [ 33 ]. De Meza et al showed comparable 1-year survival rates of 87.0% for the stage IIIA, and 76.5% for stage IIIB, and 60.3% for stage IIIC in a population treated with ICI in Dutch clinical practice [ 21 ]. Hoffmann et al showed a RFS at 1-year of 77.1% after nivolumab and 63.5% after pembrolizumab in a Swiss population [ 22 ].…”

“…Data on this population have also been collected from EHR by data managers for the Dutch Melanoma Treatment Registry since 2011. However, this is done manually by data managers, is updated regularly and does not include <grade 3 adverse events [ 21 ]. This study shows that data extraction using text mining is feasible, and in the future, can potentially be extended to other hospitals and registries, for efficient inclusion of larger populations.…”

An Innovative Analysis of Predicting Melanoma Skin Cancer Using CNN and Random Forest Algorithm

“…The accuracy of this study was 65 percent to decision tree algorithms and CNN classifiers [15] [16]. Some essential pre-trained neural networks have struggled to learn a single class with excellent accuracy [8][17] [18]. The paper [16] has taken 200 melanoma and 300 standard samples.…”