Evangelos Terpos1, Eirini Katodritou2, Javier de la Rubia3, Vania Hungria2, Cyrille Hulin4, Maria Roussou1, Michel Delforge5, Greet Bries6, Anne-Marie Stoppa7, Jesper Aagesen8, Deniz Sargin9, Andrew Belch10, Lucia Ahlberg11, Joris Diels12, Robert A Olie13, Don Robinson14, Mike Spencer15, Anna Potamianou16, Helgi van de Velde17, Meletios A Dimopoulos1. 1. Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. 2. Department of Hematology, Theagenion Cancer Centre, Thessaloniki, Greece. 3. Department of Hematology, Hospital Dr Peset, Universidad Católica de Valencia, Valencia, Spain. 4. Service d'hématologie Hopital Haut leveque CHU Bordeaux, Bordeaux, France. 5. Department of Hematology, University Hospital Leuven, Leuven, Belgium. 6. Department of Hematology, AZ Turnhout, Turnhout, Belgium. 7. Département D'Onco-Hématologie, Institut Paoli-Calmettes, Marseilles, France. 8. Department of Medicine, Ryhov County Hospital, Jönköping, Sweden. 9. Division of Hematology, Department of Internal Medicine, Istanbul University, Istanbul, Turkey. 10. Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada. 11. Hematologliniken Universitetssjukhuset, Linköping, Sweden. 12. Division of Janssen Pharmaceutica NV, Janssen Research & Development, Beerse, Belgium. 13. Janssen-Cilag AG, Baar, Switzerland. 14. Janssen Global Services, Raritan, New Jersey. 15. Janssen-Cilag UK, High Wycombe, UK. 16. Janssen-Cilag Pharmaceutical SACI, Athens, Greece. 17. Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts.
Abstract
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® 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.
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® 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.
Authors: Cyrille Hulin; Javier de la Rubia; Meletios A Dimopoulos; Evangelos Terpos; Eirini Katodritou; Vania Hungria; Hadewijch De Samblanx; Anne-Marie Stoppa; Jesper Aagesen; Deniz Sargin; Anastasia Sioni; Andrew Belch; Joris Diels; Robert A Olie; Don Robinson; Anna Potamianou; Helgi van de Velde; Michel Delforge Journal: Health Sci Rep Date: 2018-12-07
Authors: Tomáš Kyca; Lucia Pavlíková; Viera Boháčová; Anton Mišák; Alexandra Poturnayová; Albert Breier; Zdena Sulová; Mário Šereš Journal: Int J Mol Sci Date: 2021-05-23 Impact factor: 5.923