Adjuvant treatment for melanoma in clinical practice – Trial versus reality. (November 2021)

• Record Type: Journal Article
• Authors: de Meza, Melissa M.; Ismail, Rawa K.; Rauwerdink, Daan; van Not, Olivier J.; van Breeschoten, Jesper; Blokx, Willeke A.M.; de Boer, Anthonius; van Dartel, Maaike; Hilarius, Doranne L.; Ellebaek, Eva; Bonenkamp, Han J.; Blank, Christian U.; Aarts, Maureen J.B.; van Akkooi, Alexander C.J.; van den Berkmortel, Franchette W.P.J.; Boers-Sonderen, Marye J.; de Groot, Jan Willem B.; Haanen, John B.; Hospers, Geke A.P.; Kapiteijn, Ellen W.; Piersma, Djura; van Rijn, Roos S.; van der Veldt, Astrid A.M.; Vreugdenhil, Art; Westgeest, Hans M.; van den Eertwegh, Alfons J.M.; Suijkerbuijk, Karijn P.M.; Wouters, Michel W.J.M.
• Is Part Of: European journal of cancer. Volume 158(2021)
• Page Start: 234
• Page End: 245
• Publication Date: 2021-11
• Subjects: Melanoma -- Immune checkpoint inhibitors -- Immunotherapy -- Nivolumab -- Pembrolizumab -- Survival rate -- Skin neoplasms -- Data management -- Registries -- Quality of health care; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2021.08.044
• Languages: English
• ISSNs: 0959-8049

Abstract

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 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. Highlights: Similar RFS for real-world adjuvant anti-PD-1 treated patients compared to trials. More premature adjuvant anti-PD-1 discontinuation compared to clinical trials. Slightly higher adjuvant anti-PD-1 toxicity in real-world compared to trials.