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Adjuvant treatment for melanoma in clinical practice – Trial versus reality

2021; Elsevier BV; Volume: 158; Linguagem: Inglês

10.1016/j.ejca.2021.08.044

1879-0852

Melissa M. de Meza, Rawa K. Ismail, Daan Jan Willem Rauwerdink, Olivier J. van Not, Jesper van Breeschoten, Willeke A.M. Blokx, Anthonius de Boer, Maaike van Dartel, Doranne L. Hilarius, Eva Ellebæk, Han J. Bonenkamp, Christian U. Blank, Maureen J.B. Aarts, Alexander C.J. van Akkooi, Franchette W.P.J. van den Berkmortel, Marye J. Boers‐Sonderen, Jan Willem B. de Groot, John B.A.G. Haanen, Geke A.P. Hospers, Ellen Kapiteijn, Djura Piersma, Roos S. van Rijn, Astrid A.M. van der Veldt, Art Vreugdenhil, Hans M. Westgeest, Alfons J.M. van den Eertwegh, Karijn P.M. Suijkerbuijk, Michel W.J.M. Wouters,

Immunotherapy and Immune Responses

BackgroundLittle 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.MethodsAnalyses 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.ResultsA 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.ConclusionAdjuvant 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.