학술논문
Daratumumab with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma patients - real world evidence analysis.
Document Type
Academic Journal
Author
Stork M; Department of Internal Medicine, Hematology and Oncology, Faculty of Medicine, University Hospital Brno, Masaryk University, Brno, Czech Republic.; Spicka I; 1st Medical Department - Clinical Department of Hematology of the First Faculty of Medicine, General Teaching Hospital Charles University, Prague, Czech Republic.; Radocha J; 4th Department of Medicine - Hematology, Faculty of Medicine, Charles University Hospital, Hradec Kralove, Czech Republic.; Minarik J; Department of Hemato-Oncology, Faculty of Medicine and Dentistry, University Hospital Olomouc, Palacky University Olomouc, Olomouc, Czech Republic.; Jelinek T; Department of Hematooncology, Faculty of Medicine, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.; Jungova A; Hematology and Oncology Department, Charles University Hospital, Pilsen, Czech Republic.; Pavlicek P; Department of Internal Medicine and Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.; Pospisilova L; Institute of Biostatistics and Analyses, Ltd., Brno, Czech Republic.; Sedlak F; 1st Medical Department - Clinical Department of Hematology of the First Faculty of Medicine, General Teaching Hospital Charles University, Prague, Czech Republic.; Straub J; 1st Medical Department - Clinical Department of Hematology of the First Faculty of Medicine, General Teaching Hospital Charles University, Prague, Czech Republic.; Pika T; Department of Hemato-Oncology, Faculty of Medicine and Dentistry, University Hospital Olomouc, Palacky University Olomouc, Olomouc, Czech Republic.; Knechtova Z; Department of Internal Medicine, Hematology and Oncology, Faculty of Medicine, University Hospital Brno, Masaryk University, Brno, Czech Republic.; Fidrichova A; Department of Internal Medicine, Hematology and Oncology, Faculty of Medicine, University Hospital Brno, Masaryk University, Brno, Czech Republic.; Boichuk I; Department of Internal Medicine, Hematology and Oncology, Faculty of Medicine, University Hospital Brno, Masaryk University, Brno, Czech Republic.; Sevcikova S; Babak Myeloma Group, Department of Pathophysiology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.; Maisnar V; 4th Department of Medicine - Hematology, Faculty of Medicine, Charles University Hospital, Hradec Kralove, Czech Republic.; Hajek R; Department of Hematooncology, Faculty of Medicine, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.; Pour L; Department of Internal Medicine, Hematology and Oncology, Faculty of Medicine, University Hospital Brno, Masaryk University, Brno, Czech Republic. Pour.ludek@fnbrno.cz.; Babak Myeloma Group, Department of Pathophysiology, Faculty of Medicine, Masaryk University, Brno, Czech Republic. Pour.ludek@fnbrno.cz.
Source
Publisher: Springer Verlag Country of Publication: Germany NLM ID: 9107334 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0584 (Electronic) Linking ISSN: 09395555 NLM ISO Abbreviation: Ann Hematol Subsets: MEDLINE
Subject
Language
English
Abstract
We performed real world evidence (RWE) analysis of daratumumab, lenalidomide and dexamethasone (Dara-Rd) versus lenalidomide and dexamethasone (Rd) treatment in relapsed/refractory multiple myeloma patients (RRMM). In total, 240 RRMM patients were treated with Dara-Rd from 2016 to 2022 outside of clinical trials in all major Czech hematology centers. As a reference, 531 RRMM patients treated with Rd were evaluated. Patients' data were recorded in the Czech Registry of Monoclonal Gammopathies (RMG). Partial response (PR) or better response (ORR) was achieved in significantly more patients in Dara-Rd than in Rd group (91.2% vs. 69.9%; p < 0.001). The median progression free survival (PFS) was 26.9 months in the Dara-Rd and 12.8 months in the Rd group (p < 0.001). Median overall survival (OS) was not reached in the Dara-Rd compared to 27.2 months in the Rd group (p = 0.023). In patients with 1-3 previous treatment lines, there was significant PFS benefit of Dara-Rd compared to Rd (median PFS not reached vs. 13.2 months; p < 0.001). In patients with > 3 previous treatment lines, there was no significant PFS benefit of Dara-Rd treatment (7.8 months vs. 9.9 months; p = 0.874), similarly in patients refractory to PI + IMIDs (11.5 months vs. 9.2 months; p = 0.376). In RWE conditions, the median PFS in RRMM patients treated with Dara-Rd is shorter when compared to clinical trials. In heavily pretreated RRMM patients, efficacy of Dara-Rd treatment is limited; best possible outcomes of Dara-Rd are achieved in minimally pretreated patients.
(© 2023. The Author(s).)
(© 2023. The Author(s).)