학술논문
Real-world evidence of efficacy and safety of pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients: Czech registry data.
Document Type
Academic Journal
Author
Sandecka V; Department of Internal Medicine, Hematology and Oncology, University Hospital, Brno, Czech Republic.; Faculty of Medicine, Masaryk University, Brno, Czech Republic.; Pour L; Department of Internal Medicine, Hematology and Oncology, University Hospital, Brno, Czech Republic.; Faculty of Medicine, Masaryk University, Brno, Czech Republic.; Špička I; 1st Department of Medicine-Department of Hematology, First Faculty of Medicine, Charles University and General Hospital,, Prague, Czech Republic.; Minařík J; Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Olomouc, Czech Republic.; Radocha J; 4th Department of Internal Medicine-Hematology, University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.; Jelínek T; Department of Hematooncology, University Hospital, Ostrava, Czech Republic.; Department of Hematooncology, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.; Pavlíček P; Department of Internal Medicine and Hematology, 3rd Faculty of Medicine, Charles University and Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic.; Jungová A; Hematology and Oncology Department, Charles University Hospital Pilsen, Pilsen, Czech Republic.; Kessler P; Department of Hematology and Transfusion Medicine, Hospital Pelhrimov, Pelhrimov, Czech Republic.; Wróbel M; Department of Clinical Hematology, Hospital Novy Jicin, Novy Jicin, Czech Republic.; Štork M; Department of Internal Medicine, Hematology and Oncology, University Hospital, Brno, Czech Republic.; Faculty of Medicine, Masaryk University, Brno, Czech Republic.; Štraub J; 1st Department of Medicine-Department of Hematology, First Faculty of Medicine, Charles University and General Hospital,, Prague, Czech Republic.; Pika T; Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Olomouc, Czech Republic.; Čápková L; Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.; Ševčíková S; Babak Myeloma Group, Department of Pathological Physiology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.; Maisnar V; 4th Department of Internal Medicine-Hematology, University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.; Hájek R; Department of Hematooncology, University Hospital, Ostrava, Czech Republic.; Department of Hematooncology, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
Source
Publisher: AE Press Country of Publication: Slovakia NLM ID: 0377266 Publication Model: Print Cited Medium: Print ISSN: 0028-2685 (Print) Linking ISSN: 00282685 NLM ISO Abbreviation: Neoplasma Subsets: MEDLINE
Subject
Language
English
ISSN
0028-2685
Abstract
We assessed the outcomes of pomalidomide and dexamethasone treatment in relapsed/refractory multiple myeloma (RRMM) patients with ≥1 prior line of therapy. We analyzed the data of all RRMM patients treated with pomalidomide and dexamethasone at nine Czech centers between 2013 and 2018. The source of the data was the Registry of Monoclonal Gammopathies of the Czech Republic. Primary endpoints included response rates based on International Myeloma Working Group criteria and survival measures, including progression-free survival (PFS) and overall survival (OS). Secondary endpoints were toxicities and previous treatment patterns, including refractory to lenalidomide, and their impact on final outcomes. The overall response rate was 51.8% and the clinical benefit rate (including patients with minimal response) was 67.1%, with 0.6% of complete responses, 8.5% of very good partial responses, and 42.1% of partial responses (PR). Overall, 16.5% of patients had a minimal response, and 32.3% had stable disease /progression. Median PFS was 8.8 months and the median OS was 14.2 months. In patients who achieved ≥PR, the median PFS and OS were significantly longer compared to non-responders (median PFS (12.1 vs. 4.5 months, p≤0.001 respectively), median OS (22.1 vs. 7.7 months, p≤0.001, respectively). The most frequent adverse events (AEs) were neutropenia (29.9%) and anemia (18.9%), non-hematological AEs included infections (14.6%) and fatigue (7.3%). Our analysis confirmed the effectiveness of pomalidomide and dexamethasone in a real-world setting. This therapy achieved reasonable outcomes comparable to the data from clinical trials even though this was an unbiased cohort of patients.