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Meza, M.M. de; Ismail, R.K.; Rauwerdink, D.; Not, O.J. van; Breeschoten, J. van; Blokx, W.A.M.; ... ; Wouters, M.W.J.M. (2021)

Adjuvant treatment for melanoma in clinical practice: trial versus reality

Article / Letter to editor
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 Kaplan-Meier method.Results: A total of 641 patients were treated with adjuvant anti-PD-1 therapy. RFS at 12-months was 70.6% (95% CI, 66.9-74.6) with a median follow-up of 12...Show moreBackground: 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 Kaplan-Meier method.Results: A total of 641 patients were treated with adjuvant anti-PD-1 therapy. RFS at 12-months was 70.6% (95% CI, 66.9-74.6) 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. (C) 2021 The Authors. Published by Elsevier Ltd.Show less
Melanoma
Immune checkpoint inhibitors
Immunotherapy
Nivolumab
Pembrolizumab
Survival rate
Skin neoplasms
Data management
Registries
Quality of health care
All authors
Meza, M.M. de; Ismail, R.K.; Rauwerdink, D.; Not, O.J. van; Breeschoten, J. van; Blokx, W.A.M.; Boer, A. de; Dartel, M. van; Hilarius, D.L.; Ellebaek, E.; Bonenkamp, H.J.; Blank, C.U.; Aarts, M.J.B.; Akkooi, A.C.J. van; Berkmortel, F.W.P.J. van den; Boers-Sonderen, M.J.; Groot, J.W.B. de; Haanen, J.B.; Hospers, G.A.P.; Kapiteijn, E.W.; Piersma, D.; Rijn, R.S. van; Veldt, A.A.M. van der; Vreugdenhil, A.; Westgeest, H.M.; Eertwegh, A.J.M. van den; Suijkerbuijk, K.P.M.; Wouters, M.W.J.M.
Date
2021-11-01
Journal
European Journal of Cancer
Volume
158
Pages
234 - 245
DOI
doi:10.1016/j.ejca.2021.08.044