Please use this identifier to cite or link to this item: doi:10.22028/D291-35966
Title: Real-World Therapy with Pembrolizumab: Outcomes and Surrogate Endpoints for Predicting Survival in Advanced Melanoma Patients in Germany
Author(s): Mohr, Peter
Scherrer, Emilie
Assaf, Chalid
Bender, Marc
Berking, Carola
Chandwani, Sheenu
Eigentler, Thomas
Grimmelmann, Imke
Gutzmer, Ralf
Haferkamp, Sebastian
Hassel, Jessica C.
Hauschild, Axel
Herbst, Rudolf
Jiang, Ruixuan
Kähler, Katharina C.
Krepler, Clemens
Kreuter, Alexander
Leiter, Ulrike
Loquai, Carmen
Meier, Friedegund
Pföhler, Claudia
Rudolph, Anja
Schadendorf, Dirk
Schiavone, Maximo
Schley, Gaston
Terheyden, Patrick
Ugurel, Selma
Ulrich, Jens
Utikal, Jochen
Weishaupt, Carsten
Welzel, Julia
Weichenthal, Michael
Language: English
Title: Cancers
Volume: 14
Issue: 7
Publisher/Platform: MDPI
Year of Publication: 2022
Free key words: advanced melanoma
surrogate endpoint
real-world evidence
overall survival (OS)
time to next treatment (rwTtNT)
DDC notations: 610 Medicine and health
Publikation type: Journal Article
Abstract: Knowledge on the real-world characteristics and outcomes of pembrolizumab-treated advanced melanoma patients in Germany and on the value of different real-world endpoints as surrogates for overall survival (OS) is limited. A sample of 664 pembrolizumab-treated patients with advanced melanoma from the German registry ADOReg was used. We examined OS, real-world progression-free survival (rwPFS), real-world time to next treatment (rwTtNT), and real-world time on treatment (rwToT). Spearman’s rank and iterative multiple imputation (IMI)-based correlation coefficients were computed between the OS and the rwPFS, rwTtNT, and rwToT and reported for the first line of therapy and the overall sample. The median OS was 30.5 (95%CI 25.0–35.4) months, the rwPFS was 3.9 months (95%CI 3.5–4.9), the rwTtNT was 10.7 months (95%CI 9.0–12.9), and the rwToT was 6.2 months (95%CI 5.1–6.8). The rwTtNT showed the highest correlation with the OS based on the IMI (rIMI = 0.83), Spearman rank correlations (rs = 0.74), followed by the rwToT (rIMI = 0.74 and rs = 0.65) and rwPFS (rIMI = 0.69 and rs = 0.56). The estimates for the outcomes and correlations were similar for the overall sample and those in first-line therapy. The median OS was higher compared to recent real-world studies, supporting the effectiveness of pembrolizumab in regular clinical practice. The rwTtNT may be a valuable OS surrogate, considering the highest correlation was observed with the OS among the investigated real-world endpoints.
DOI of the first publication: 10.3390/cancers14071804
Link to this record: urn:nbn:de:bsz:291--ds-359665
ISSN: 2072-6694
Date of registration: 12-Apr-2022
Description of the related object: Supplementary Materials
Related object:
Faculty: M - Medizinische Fakultät
Department: M - Dermatologie
Professorship: M - Keiner Professur zugeordnet
Collections:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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