TY - JOUR
T1 - Adjuvant treatment for melanoma in clinical practice – Trial versus reality
AU - de Meza, Melissa M.
AU - Ismail, Rawa K.
AU - Rauwerdink, Daan
AU - van Not, Olivier J.
AU - van Breeschoten, Jesper
AU - Blokx, Willeke A.M.
AU - de Boer, Anthonius
AU - van Dartel, Maaike
AU - Hilarius, Doranne L.
AU - Ellebaek, Eva
AU - Bonenkamp, Han J.
AU - Blank, Christian U.
AU - Aarts, Maureen J.B.
AU - van Akkooi, Alexander C.J.
AU - van den Berkmortel, Franchette W.P.J.
AU - Boers-Sonderen, Marye J.
AU - de Groot, Jan Willem B.
AU - Haanen, John B.
AU - Hospers, Geke A.P.
AU - Kapiteijn, Ellen W.
AU - Piersma, Djura
AU - van Rijn, Roos S.
AU - van der Veldt, Astrid A.M.
AU - Vreugdenhil, Art
AU - Westgeest, Hans M.
AU - van den Eertwegh, Alfons J.M.
AU - Suijkerbuijk, Karijn P.M.
AU - Wouters, Michel W.J.M.
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
KW - Data management
KW - Immune checkpoint inhibitors
KW - Immunotherapy
KW - Melanoma
KW - Nivolumab
KW - Pembrolizumab
KW - Quality of health care
KW - Registries
KW - Skin neoplasms
KW - Survival rate
UR - http://www.scopus.com/inward/record.url?scp=85116049321&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2021.08.044
DO - 10.1016/j.ejca.2021.08.044
M3 - Journal article
C2 - 34600790
AN - SCOPUS:85116049321
SN - 0959-8049
VL - 158
SP - 234
EP - 245
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -