Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice.

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.

• Authors: Evangelos Terpos, Eirini Katodritou, Javier de la Rubia, Vania Hungria, Cyrille Hulin, Maria Roussou, Michel Delforge, Greet Bries, Anne-Marie Stoppa, Jesper Aagesen, Deniz Sargin, Andrew Belch, Lucia Ahlberg, Joris Diels, Robert A Olie, Don Robinson Jr, Mike Spencer, Anna Potamianou, Helgi van de Velde, Meletios A Dimopoulos
• Journal: European journal of haematology (Eur J Haematol) Vol. 101 Issue 4 Pg. 556-565 (Oct 2018) ISSN: 1600-0609 [Electronic] England
• PMID: 30027641 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Bortezomib

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Bortezomib (administration & dosage)
• Combined Modality Therapy
• Comorbidity
• Drug Resistance, Neoplasm
• Female
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Multiple Myeloma (drug therapy, mortality, pathology)
• Recurrence
• Retreatment
• Treatment Outcome