1. Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe.
- Author
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Weichenthal, Michael, Mangana, Joanna, Gavrilova, Iva, Lugowska, Iwona, Shalamanova, Gergana Krumova, Kandolf, Lidija, Chiarion-Sileni, Vanna, Mohr, Peter, Karanikolova, Teodora Sotirova, Teterycz, Pawel, Espinosa, Enrique, Schnecko, Philipp, Cheng, Phil, Bender, Marc, Jiang, Shan, Burke, Thomas, Ascierto, Paolo Antonio, Gogas, Helen, Rodas, Ivan Marquez, and Rutkowski, Piotr
- Subjects
MELANOMA prognosis ,THERAPEUTIC use of monoclonal antibodies ,MELANOMA ,CANCER relapse ,RESEARCH funding ,SCIENTIFIC observation ,TREATMENT effectiveness ,CANCER patients ,RETROSPECTIVE studies ,DESCRIPTIVE statistics ,KAPLAN-Meier estimator ,MEDICAL records ,ACQUISITION of data ,TUMOR classification ,COMPARATIVE studies ,CONFIDENCE intervals ,DATA analysis software ,PROGRESSION-free survival ,PROPORTIONAL hazards models - Abstract
Simple Summary: We studied real-world patient trends and cancer survival in adult patients in a European registry, EUMelaReg. We included 200 patients with stage III melanoma with lymph node involvement who had complete resection and received adjuvant treatment with pembrolizumab. Patients initiated treatment with adjuvant pembrolizumab from 1 January 2019 to 17 April 2021 with a median follow-up of 16.5 months. Comparison with previously published real-world data showed that patients were older and more likely to have stage IIIC and IIID disease than those in the Keynote 054 clinical trial. Background: Although data on patients treated with pembrolizumab are available from clinical trials and single-country real-world reports, to our knowledge no multi-country real-world studies have investigated the use of pembrolizumab as an adjuvant treatment for stage III melanoma. Methods: We used the European Melanoma Registry (EUMelaReg), a disease entity-based registry specific for melanoma, to examine treatment and outcomes for adult patients with stage III melanoma with lymph node involvement who had complete resection and received adjuvant treatment with pembrolizumab. The primary objectives were to describe the demographic and clinical characteristics of the included patients as well as time on adjuvant pembrolizumab treatment (TOT), real-world recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) from adjuvant pembrolizumab initiation. Secondary objectives were time to next treatment (TTNT) after adjuvant use of pembrolizumab, next-line therapy for stage III and unresectable stage IV melanoma and overall survival (OS) from initiation of pembrolizumab. Results: Patients were stratified according to age, sex, BRAF status, number of positive lymph nodes and disease substage. Median TOT was 11.1 (9.2–11.5) months, median RFS was 29.6 [18.7–not reached (NR)] months and median DMFS was 32.4 (22.7–NR) months. TTNT was 29.9 (22.2–NR) months, while median OS was not reached. Conclusions: The results of this study offer insights into the real-world use of pembrolizumab as an adjuvant therapy for melanoma in Europe. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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