Adjuvant treatment for melanoma in clinical practice – Trial versus reality
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.
(2021) European Journal of Cancer, volume 158, pp. 234 - 245
(Article)
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
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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.
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Keywords: Data management, Immune checkpoint inhibitors, Immunotherapy, Melanoma, Nivolumab, Pembrolizumab, Quality of health care, Registries, Skin neoplasms, Survival rate, Oncology, Cancer Research, Journal Article
ISSN: 0959-8049
Publisher: Elsevier Limited
Note: Funding Information: AvdE has advisory relationships with Amgen, Bristol Myers Squibb, Roche, Novartis, MSD, Pierre Fabre, Sanofi, Pfizer, Ipsen, Merck and has received research study grants not related to this paper from Sanofi, Roche, Bristol Myers Squibb, Idera and TEVA and has received travel expenses from MSD Oncology, Roche, Pfizer and Sanofi and has received speaker honoraria from BMS and Novartis. MBS has consultancy/advisory relationships with Pierre Fabre, MSD and Novartis. JdG has consultancy/advisory relationships with Bristol Myers Squibb, Pierre Fabre, Servier, MSD, Novartis. GH consultancy/advisory relationships with Amgen, Bristol Myers Squibb, Roche, MSD, Pfizer, Novartis, Pierre Fabre and has received research grants not related to this paper from Bristol Myers Squibb, Seerave. EK has consultancy/advisory relationships with BristolMyers Squibb, Novartis, Merck, Pierre Fabre, and received research grants not related to this paper from Bristol Myers Squibb. KS has advisory relationships with Bristol Myers Squibb, Novartis, MSD, Pierre Fabre, Abbvie and received honoraria from Novartis, MSD and Roche. AvdV has consultancy relationships with Bristol Myers Squibb, MSD, Roche, Novartis, Pierre Fabre, Pfizer, Sanofi, Ipsen, Eisai, Merck. JH has advisory relationships with Achilles Therapeutics, Bristol Myers Squibb, BioNTech, Immunocore, Ipsen, MSD, Merck Serono, Molecular Partners, Novartis, Neogene Therapeutics, PokeAcel, Pfizer, Roche/Genentech, Sanofi, T-Knife, Third Rock Ventures, and has received research grants not related to this paper from Amgen, Bristol Myers Squibb, MSD, BioNTech, Neogene Therapeutics and Novartis. All grants were paid to the institutions. The funders had no role in the writing of this article or decision to submit it for publication. AvA has advisory board/consultancy honoraria from Amgen, Bristol Myers Squibb, Novartis, MSD-Merck, Merck-Pfizer, Pierre Fabre, Sanofi, Sirius Medical, 4SC. Research grants from Amgen, Merck-Pfizer. All outside of current work and all paid to institute. MA has advisory board/consultancy honoraria from Amgen, Bristol Myers Squibb, Novartis, MSD-Merck, Merck-Pfizer, Pierre Fabre, Sanofi, Astellas, Bayer. Research grants Merck-Pfizer. Not related to current work and paid to institute. HMW has received travel expenses from Ipsen and Astellas and has received honoraria from Roche and Astellas. RvR has received expert meeting fees from Roche and advisory board fees from Pfizer. EE has received speaker honoraria from BMS, Pierre Fabre, Kyowa Kirin, and travel/conference expenses from MSD. All remaining authors have declared no conflicts of interest. Funding Information: For the Dutch Melanoma Treatment Registry (DMTR), the Dutch Institute for Clinical Auditing foundation received a start-up grant from the governmental organization The Netherlands Organization for Health Research and Development (ZonMW, grant number 836002002 ). The DMTR is structurally funded by Bristol Myers Squibb , Merck Sharpe & Dohme , Novartis and Roche Pharma . Roche Pharma stopped and Pierre Fabre started the funding of the DMTR in 2019. For this work, no funding was granted. Publisher Copyright: © 2021 The Authors Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
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