Early termination does not negatively impact the outcome of adjuvant immunotherapy in melanoma.

Tomsitz D, Livingstone E, Loquai C, Kaatz M, Leiter U, Schilling B, Terheyden P, Hassel J, Sachse M, Ulrich J, Dippel E, Meiss F, Pföhler C, Kreuter A, Herbst R, Weichenthal M, Zimmer L, Meier F, Rauschenberg R, Mohr P, Brunnert F, von Wasielewski I, Gutzmer R, Schadendorf D, Berking C, Ugurel S, Heinzerling L (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Book Volume: 39

Pages Range: 1975-1986

Journal Issue: 11

DOI: 10.1111/jdv.20650

Abstract

BACKGROUND: Adjuvant treatment with anti-PD1 antibodies has been shown to effectively reduce the risk of recurrence in patients with resected metastatic melanoma. Whether a full 12-month duration of treatment is needed to achieve full clinical benefit is not known. This study investigated the survival outcome depending on the duration of adjuvant anti-PD1 therapy. METHODS: From the prospective multicentre real-world skin cancer registry ADOREG data of 620 patients who finished adjuvant treatment with nivolumab or pembrolizumab for AJCCv8 stage III/IV resected melanoma was analyzed. Recurrence-free survival (RFS) and overall survival (OS) were compared between patients with regular treatment duration (52 ± 4 weeks; n = 229) and no disease recurrence during therapy (A1) and patients with a premature end of treatment (<48 weeks; n = 214, B). Patients with disease recurrence during adjuvant treatment were included in cohort A2. RESULTS: The median duration of follow-up was 26.0 months [interquartile range (IQR) 18.0-34.0] in group A1 [median treatment duration 51.3 weeks (IQR 50.0-52.1) and 19.0 months (IQR 13.0-29.0)] in group B [median treatment duration 22.2 weeks (IQR 10.0-34.8)]. Reasons for early discontinuation were treatment-related side effects in 45.3% (n = 97) and other reasons than toxicity in 54.7% (n = 117). The 2-year rate of RFS was 72.4% (95% CI, 68.5-76.3) for patients in group B and 51.5% (95% CI, 48.8-54.2) in patients with regular and intended regular treatment duration (A1 plus A2). When analysing the patients who did not relapse during adjuvant treatment (A1), there was a significantly higher RFS rate of 84.1% (95% CI, 81.5-86.7). When only assessing patients with a recurrence after more than 12 months after initiation of therapy, there was a trend towards better RFS in patients with regular treatment duration. CONCLUSIONS: In patients with resected metastatic melanoma, shorter treatment duration with anti-PD1 antibodies is not associated with a worse outcome.

Authors with CRIS profile

Involved external institutions

Universitätsklinikum Essen Germany (DE) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Elbe Kliniken Stade-Buxtehude Germany (DE) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) Johannes Wesling Klinikum Minden Germany (DE) Klinikum der Universität München (LMU Klinikum) Germany (DE) Klinikverbund Bremen (Gesundheit Nord) Germany (DE) DRK Krankenhaus Chemnitz-Rabenstein Germany (DE) Universitätsklinikum Tübingen Germany (DE) Universitätsklinikum Würzburg Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum Heidelberg Germany (DE) Klinikum Bremerhaven-Reinkenheide Germany (DE) Harzklinikum Dorothea Christiane Erxleben Germany (DE) Klinikum der Stadt Ludwigshafen am Rhein gGmbH Germany (DE) Universitätsklinikum Freiburg Germany (DE) Universitätsklinikum des Saarlandes (UKS) Germany (DE) Universität Witten/Herdecke Germany (DE) HELIOS Kliniken Germany (DE)

How to cite

APA:

Tomsitz, D., Livingstone, E., Loquai, C., Kaatz, M., Leiter, U., Schilling, B.,... Heinzerling, L. (2025). Early termination does not negatively impact the outcome of adjuvant immunotherapy in melanoma. Journal of the European Academy of Dermatology and Venereology, 39(11), 1975-1986. https://doi.org/10.1111/jdv.20650

MLA:

Tomsitz, Dirk, et al. "Early termination does not negatively impact the outcome of adjuvant immunotherapy in melanoma." Journal of the European Academy of Dermatology and Venereology 39.11 (2025): 1975-1986.

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