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
{"title":"Early termination does not negatively impact the outcome of adjuvant immunotherapy in melanoma.","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","doi":"10.1111/jdv.20650","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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<sub>1</sub>) 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<sub>2</sub>.</p><p><strong>Results: </strong>The median duration of follow-up was 26.0 months [interquartile range (IQR) 18.0-34.0] in group A<sub>1</sub> [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<sub>1</sub> plus A<sub>2</sub>). When analysing the patients who did not relapse during adjuvant treatment (A<sub>1</sub>), 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.</p><p><strong>Conclusion: </strong>In patients with resected metastatic melanoma, shorter treatment duration with anti-PD1 antibodies is not associated with a worse outcome.</p>","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4000,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the European Academy of Dermatology and Venereology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jdv.20650","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
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.
Conclusion: In patients with resected metastatic melanoma, shorter treatment duration with anti-PD1 antibodies is not associated with a worse outcome.
期刊介绍:
The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV).
The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology.
The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.