Real-World Data Support Bortezomib Efficacy in Relapsed/Refractory Multiple Myeloma
Although the effectiveness and safety of bortezomib-based therapy for patients with R/R MM has been demonstrated in phase 2 and phase 3 clinical trials, data collected from real-world settings appear
Real-world data demonstrated that bortezomib-based regimens have favorable safety profiles and lead to good response rates and overall survival (OS) among patients with relapsed/refractory (R/R) multiple myeloma (MM), according to a study published in the European Journal of Haematology.1\
Evidence has shown that bortezomib-based treatment regimens are active among patients with R/R MM and improve clinical outcomes, but these benefits have been largely confined to phase 2 or 3 clinical studies. The safety and efficacy of bortezomib in the real-world setting had not yet been explored prior to the current study.
For the non-interventional, electronic Velcade observational study (eVOBS), researchers prospectively collected data from 873 patients with R/R MM scheduled to receive bortezomib-based therapy. At baseline, researchers recorded previous MM therapies administered to patients within the year leading up to bortezomib initiation, patient demographic and disease characteristics, concomitant medications, and laboratory parameters. Observational data were recorded electronically for up to 3 years after treatment initiation.
The overall response rate (defined as better than partial response) was 69%, including a 37% complete response/near-complete response rate among study patients. The median time to response, time to next therapy, and treatment-free interval was 1.8, 9.7, and 7.9 months, respectively.
After a median follow-up of 22.6 months, results showed that the median progression-free survival (PFS) was 12 months, and median OS was 26.1 months.
The most commonly reported adverse events included diarrhea, thrombocytopenia, and neuropathy. Of the 79% of patients who did report baseline neuropathy, the rate of new-onset neuropathy was 51% by cycle 8.
While receiving bortezomib therapy, 28% of patients were hospitalized, 39% underwent a diagnostic therapeutic procedure, and 43% attended an outpatient visit.
The authors concluded that “these real-world data demonstrate the effectiveness and safety of bortezomib-based therapy for RRMM as an important treatment option in Europe and confirm high response rates and long OS for this population.”
Disclosures: Multiple authors declare affiliations with the pharmaceutical industry.
- Terpos E, Katodritou E, de la Rubia J, et al. Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice [published online July 20, 2018]. Eur J Haematol. doi: 10.1111/ejh.13147