Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice
Por:
Terpos E, Katodritou E, de la Rubia J, Hungria V, Hulin C, Roussou M, Delforge M, Bries G, Stoppa AM, Aagesen J, Sargin D, Belch A, Ahlberg L, Diels J, Olie RA, Robinson D, Spencer M, Potamianou A, van de Velde H and Dimopoulos MA
Publicada:
1 oct 2018
Resumen:
Objective: The efficacy and safety of bortezomib-based therapy for relapsed/refractory multiple myeloma (RRMM) in clinical trials may differ from the oncology practice experience. The electronic VELCADE (R) OBservational Study was designed to prospectively evaluate bortezomib for multiple myeloma (MM) in real-world medical practice.
Method: Patients scheduled to receive intravenous bortezomib for MM were eligible. The primary objective was to evaluate clinical outcomes, including response, time to response, time to next therapy, treatment-free interval, progression-free survival (PFS), and overall survival (OS). Secondary objectives included safety and healthcare resource utilization.
Results: In total, 873 patients with a median of two therapy lines prior to initiating bortezomib were included. The overall response rate (>= partial response) was 69%, including 37% complete response/near-complete response. Median time to response was 1.8 months, median time to next therapy was 9.7 months, and median treatment-free interval was 7.9 months. After 22.6 months' median follow-up, median PFS was 12.0 months and median OS was 36.1 months. The most common adverse events (AEs) were neuropathy not otherwise specified (19%), diarrhea NOS, and thrombocytopenia (each 17%); 230 (26%) patients discontinued bortezomib due to AEs. Of 689 (79%) patients without baseline peripheral neuropathy (PN), the rate of new-onset any-grade PN increased to 51% (12% grade 3/4) by cycle 8. Overall, 244 (28%) patients were hospitalized, 372 (43%) attended an outpatient visit, and 341 (39%) underwent a diagnostic/therapeutic procedure during bortezomib treatment.
Conclusion: These prospective real-world data demonstrate the effectiveness and safety of bortezomib-based therapy for RRMM and confirm high response rates and long OS for this population.
Filiaciones:
Terpos E:
Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece
Katodritou E:
Department of Hematology, Theagenion Cancer Centre, Thessaloniki, Greece
:
Department of Hematology, Hospital Dr Peset, Universidad Católica de Valencia, Valencia, Spain
Hungria V:
Department of Hematology, Theagenion Cancer Centre, Thessaloniki, Greece
Hulin C:
Service d'hématologie Hopital Haut leveque CHU Bordeaux, Bordeaux, France
Roussou M:
Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece
Delforge M:
Department of Hematology, University Hospital Leuven, Leuven, Belgium
Bries G:
Department of Hematology, AZ Turnhout, Turnhout, Belgium
Stoppa AM:
Département D'Onco-Hématologie, Institut Paoli-Calmettes, Marseilles, France
Aagesen J:
Department of Medicine, Ryhov County Hospital, Jönköping, Sweden
Sargin D:
Division of Hematology, Department of Internal Medicine, Istanbul University, Istanbul, Turkey
Belch A:
Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada
Ahlberg L:
Hematologliniken Universitetssjukhuset, Linköping, Sweden
Diels J:
Division of Janssen Pharmaceutica NV, Janssen Research Development, Beerse, Belgium
Olie RA:
Janssen-Cilag AG, Baar, Switzerland
Robinson D:
Janssen Global Services, Raritan, New Jersey
Spencer M:
Janssen-Cilag UK, High Wycombe, UK
Potamianou A:
Janssen-Cilag Pharmaceutical SACI, Athens, Greece
van de Velde H:
Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts
Dimopoulos MA:
Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece
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