Cancers (Apr 2022)
Real-World Therapy with Pembrolizumab: Outcomes and Surrogate Endpoints for Predicting Survival in Advanced Melanoma Patients in Germany
- Peter Mohr,
- Emilie Scherrer,
- Chalid Assaf,
- Marc Bender,
- Carola Berking,
- Sheenu Chandwani,
- Thomas Eigentler,
- Imke Grimmelmann,
- Ralf Gutzmer,
- Sebastian Haferkamp,
- Jessica C. Hassel,
- Axel Hauschild,
- Rudolf Herbst,
- Ruixuan Jiang,
- Katharina C. Kähler,
- Clemens Krepler,
- Alexander Kreuter,
- Ulrike Leiter,
- Carmen Loquai,
- Friedegund Meier,
- Claudia Pföhler,
- Anja Rudolph,
- Dirk Schadendorf,
- Maximo Schiavone,
- Gaston Schley,
- Patrick Terheyden,
- Selma Ugurel,
- Jens Ulrich,
- Jochen Utikal,
- Carsten Weishaupt,
- Julia Welzel,
- Michael Weichenthal
Affiliations
- Peter Mohr
- Department of Dermatology, Elbe Kliniken Buxtehude, 21614 Buxtehude, Germany
- Emilie Scherrer
- Merck & Co., Inc., Kenilworth, NJ 07033, USA
- Chalid Assaf
- Department of Dermatology and Allergy, Skin Cancer Center Charité, Charité—Universitätsmedizin Berlin, 10117 Berlin, Germany
- Marc Bender
- Department of Dermatology, Elbe Kliniken Buxtehude, 21614 Buxtehude, Germany
- Carola Berking
- Department of Dermatology, Universitätsklinikum Erlangen, Comprehensive Cancer Center Erlangen EMN, Deutsches Zentrum Immuntherapie, Friedrich-Alexander University Erlangen-Nuremberg, 91054 Erlangen, Germany
- Sheenu Chandwani
- Merck & Co., Inc., Kenilworth, NJ 07033, USA
- Thomas Eigentler
- Department of Dermatology and Allergy, Skin Cancer Center Charité, Charité—Universitätsmedizin Berlin, 10117 Berlin, Germany
- Imke Grimmelmann
- Department of Dermatology, Skin Cancer Center Hannover, Hannover Medical School, 30625 Hannover, Germany
- Ralf Gutzmer
- Department of Dermatology, Johannes Wesling Medical Center, Ruhr University Bochum, Campus Minden, 32429 Minden, Germany
- Sebastian Haferkamp
- Department of Dermatology, University of Regensburg, 93040 Regensburg, Germany
- Jessica C. Hassel
- Department of Dermatology and National Center for Tumor Diseases, University Hospital Heidelberg, 69120 Heidelberg, Germany
- Axel Hauschild
- Department of Dermatology, Skin Cancer Center, University Hospital Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany
- Rudolf Herbst
- Department of Dermatology, Helios Klinikum Erfurt, 99089 Erfurt, Germany
- Ruixuan Jiang
- Merck & Co., Inc., Kenilworth, NJ 07033, USA
- Katharina C. Kähler
- Department of Dermatology, Skin Cancer Center, University Hospital Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany
- Clemens Krepler
- Merck & Co., Inc., Kenilworth, NJ 07033, USA
- Alexander Kreuter
- Department of Dermatology, Venereology and Allergology, HELIOS St. Elisabeth Hospital Oberhausen, University Witten/Herdecke, 46045 Oberhausen, Germany
- Ulrike Leiter
- Department of Dermatology, University Hospital Tuebingen, 72076 Tuebingen, Germany
- Carmen Loquai
- Department of Dermatology, University Medical Center Mainz, 55131 Mainz, Germany
- Friedegund Meier
- Skin Cancer Center at the University Cancer Centre Dresden and National Center for Tumor Diseases, 01307 Dresden, Germany
- Claudia Pföhler
- Department of Dermatology, Saarland University Medical School, 66123 Homburg, Germany
- Anja Rudolph
- IQVIA, 60549 Frankfurt, Germany
- Dirk Schadendorf
- Clinic for Dermatology, Venereology and Allergy, University of Essen, 45147 Essen, Germany
- Maximo Schiavone
- IQVIA, 60549 Frankfurt, Germany
- Gaston Schley
- Department of Dermatology, HELIOS Hospital Schwerin, 19055 Schwerin, Germany
- Patrick Terheyden
- Department of Dermatology, University of Lübeck, 23562 Lübeck, Germany
- Selma Ugurel
- Clinic for Dermatology, Venereology and Allergy, University of Essen, 45147 Essen, Germany
- Jens Ulrich
- Department of Dermatology and Allergy, Skin Cancer Center, 06484 Quedlinburg, Germany
- Jochen Utikal
- Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Heidelberg University, 68167 Mannheim, Germany
- Carsten Weishaupt
- Department of Dermatology, University Hospital Münster, 48149 Münster, Germany
- Julia Welzel
- Department of Dermatology and Allergology, University Hospital Augsburg, 86156 Augsburg, Germany
- Michael Weichenthal
- Department of Dermatology, Skin Cancer Center, University Hospital Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany
- DOI
- https://doi.org/10.3390/cancers14071804
- Journal volume & issue
-
Vol. 14,
no. 7
p. 1804
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.
Keywords
- advanced melanoma
- surrogate endpoint
- real-world evidence
- overall survival (OS)
- time to next treatment (rwTtNT)
- pembrolizumab
