Adjuvant treatment for melanoma in clinical practice – Trial versus reality

• Published in: European journal of cancer (1990) Vol. 158; pp. 234 - 245
• Main 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.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.11.2021; Elsevier Science Ltd
• Subjects: Adjuvant therapy; Adjuvants, Immunologic - therapeutic use; Adult; Aged; Aged, 80 and over; Antineoplastic Agents - therapeutic use; Clinical medicine; Clinical trials; Data management; Disease-Free Survival; Female; Health services; Humans; Immune checkpoint inhibitors; Immunotherapy; Male; Melanoma; Melanoma - drug therapy; Melanoma - pathology; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Neoplasm Staging - methods; Netherlands; Nivolumab; Patients; PD-1 protein; Pembrolizumab; Prospective Studies; Quality of health care; Registries; Skin neoplasms; Statistical analysis; Survival rate; Toxicity; Young Adult; Netherlands; Pembrolizumab; Data management; Skin neoplasms; Quality of health care; Immunotherapy; Nivolumab; Melanoma; Registries; Immune checkpoint inhibitors; Survival rate
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2021.08.044

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. 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. 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. 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. •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.