Early termination does not negatively impact the outcome of adjuvant immunotherapy in melanoma
Year: 2025
Type: article
Study design: Observational Study
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 (A 1 ) and patients with a premature end of treatment (<48 weeks; n = 214, B). Patients with disease recurrence during adjuvant treatment were included in cohort A 2 . Results The median duration of follow‐up was 26.0 months [interquartile range (IQR) 18.0–34.0] in group A 1 [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 (A 1 plus A 2 ). When analysing the patients who did not relapse during adjuvant treatment (A 1 ), 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.
DOI: 10.1111/jdv.20650
Authors: Dirk Tomsitz, Elisabeth Livingstone, Carmen Loquai, Martin Kaatz, Ulrike Leiter, Bastian Schilling, Patrick Terheyden, Jessica Hassel, Michael Sachse, Jens Ulrich, Edgar Dippel, Frank Meiss, Claudia Pföhler, Alexander Kreuter, Rudolf Herbst, Michael Weichenthal, Lisa Zimmer, Friedegund Meier, Ricarda Rauschenberg, Peter Mohr, Fiona Brunnert, Imke von Wasielewski, Ralf Gutzmer, Dirk Schadendorf, Carola Berking, Selma Ugurel, Lucie Heinzerling
Institutions: LMU Klinikum, Ludwig-Maximilians-Universität München, Essen University Hospital, Deutsches Konsortium für Translationale Krebsforschung, Stiftung Universitätsmedizin Essen, German Red Cross, Universitätsklinikum Tübingen, University of Tübingen, Universitätsklinikum Würzburg, University Hospital Schleswig-Holstein, University of Lübeck, Heidelberg University, University Hospital Heidelberg, National Center for Tumor Diseases, Klinikum Bremerhaven-Reinkenheide, Klinikum Ludwigshafen, University of Freiburg, University Medical Center Freiburg, Universitätsklinikum des Saarlandes, Saarland University, Witten/Herdecke University, HELIOS St. Elisabeth Klinik Oberhausen, Helios Klinikum Erfurt, University Hospital Carl Gustav Carus, Nationales Centrum für Tumorerkrankungen Dresden, Elbe Kliniken Stade-Buxtehude, Medizinische Hochschule Hannover, Johannes Wesling Klinikum Minden, Ruhr University Bochum, University of Duisburg-Essen, Universitätsklinikum Erlangen, Comprehensive Cancer Center Erlangen
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,450
OpenAlex ID: W4408749747