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

Terpos, Evangelos; Katodritou, Eirini; Rubia, Javier de la; Hungria, Vania T.M.; Hulin, Cyrille; Ρούσσου, Μαρία; Delforge, Michel; Bries, Greet; Stoppa, Anne‐Marie; Aagesen, Jesper; Sargın, Deniz; Belch, Andrew; Ahlberg, Lucia; Diels, Joris; Olie, Robert A.; Robinson, Don; Spencer, M.; Potamianou, Anna; Velde, Helgi van de; Dimopoulos, Meletios A.

doi:10.1111/ejh.13147

Cited by 15 publications

(16 citation statements)

References 44 publications

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“…Of the 96 patients included in this study who were eventually retreated with bortezomib, 75% achieved ≥PR after their initial bortezomib treatment, including 44% CR/nCR. These rates are slightly higher than the 69% ≥PR rate and 37% CR/nCR rate observed in the overall eVOBS study population following initial bortezomib‐based treatment . Although the populations were generally similar, differences in patient and baseline disease characteristics between the overall study population and the retreated population may have contributed to these observed results .…”

Section: Discussionmentioning

confidence: 69%

“…Due to concerns about data quality, 700 patients enrolled in Russia were excluded from the primary study analysis, leaving 873 evaluable patients. Demographics and baseline characteristics for the entire eVOBS population have been reported previously …”

Section: Resultsmentioning

confidence: 99%

“…Electronic VELCADE OBservational Study was an open‐label, non‐interventional, observational study designed to collect prospective data from MM patients undergoing bortezomib‐based therapy within any of the locally approved indications in the real‐world oncology practice setting. Details of study design and conduct have been published recently . In brief, any adults initiating bortezomib treatment for MM in participating centers were eligible for inclusion and all those with at least a baseline assessment are reported here.…”

Section: Methodsmentioning

confidence: 99%

“…The two‐sided log‐rank test was used to assess the significance of any differences between the stratified data; the conventional significance threshold of 0.05 was used across all analyses. As described in Terpos et al, missing data were not substituted nor imputed . Statistical analysis was performed using SAS version 9.2.…”

Section: Methodsmentioning

confidence: 99%

“…To date, however, data on the use of bortezomib retreatment in the “real‐world” oncology practice setting are limited. To address this gap, we conducted a sub‐analysis of the prospective, international, non‐interventional, electronic VELCADE OBservational Study (eVOBS) that was designed to study the efficacy and safety of bortezomib‐based therapies for MM in real‐world medical practice . In our sub‐analysis, we examined the efficacy and safety of bortezomib‐based retreatment for relapsed MM during the monitoring period of eVOBS.…”

Section: Introductionmentioning

confidence: 99%

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Bortezomib retreatment for relapsed and refractory multiple myeloma in real‐world clinical practice

Hulin

Rubia

Dimopoulos

et al. 2018

Health Science Reports

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AimsStudies have shown that bortezomib retreatment is effective in relapsed/refractory multiple myeloma (MM). The observational, prospective electronic VELCADE® OBservational Study (eVOBS) study assessed bortezomib‐based therapies for patients with MM in everyday practice. Here, we report on those patients receiving retreatment with bortezomib.MethodsConsenting adults scheduled to receive bortezomib for MM were enrolled at 162 sites across Europe, Canada, Brazil, Russia, and Turkey between 2006 and 2010. Retrospective data on prior therapies and prospective observational data after bortezomib initiation were captured electronically at baseline, after every bortezomib cycle, and every 12 weeks after discontinuation or progression. Investigator‐assessed responses and adverse events (AEs) were evaluated.ResultsNinety‐six of 873 patients enrolled to eVOBS received bortezomib as first retreatment for progressive disease during the prospective observation period. Median age was 62 years, 53% were male, and median number of prior therapies at retreatment was 4. Overall, 41% of patients initiated bortezomib retreatment in combination with dexamethasone, 16% in combination with lenalidomide, and 21% received monotherapy. Rate of partial response or better (≥PR) was 75% at initial bortezomib therapy, including 44% complete response (CR)/near CR (nCR); at retreatment, ≥PR rate was 46%, including 15% CR/nCR. Median progression‐free survival was 11.4 months (95% confidence interval [CI]: 9.1‐12.7) from start of initial bortezomib treatment and 6.4 months (95% CI: 4.4‐7.2) from start of retreatment. Median overall survival from start of retreatment was 17.6 months (95% CI: 14.4‐23.5). Of the 96 patients retreated with bortezomib, 77% reported an AE. Peripheral neuropathy during bortezomib retreatment occurred in 49% of patients, including 10% grade 3/4.ConclusionThese data suggest that retreatment with bortezomib is a feasible option for patients with relapsed/refractory MM.

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Section: Discussionmentioning

confidence: 69%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Bortezomib retreatment for relapsed and refractory multiple myeloma in real‐world clinical practice

Hulin

Rubia

Dimopoulos

et al. 2018

Health Science Reports

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Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation

Pulini

Caetano

Clautiaux

et al. 2020

Ther Innov Regul Sci

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The Role of Salvage Second Autologous Hematopoietic Cell Transplantation in Relapsed Multiple Myeloma

Hagen

Stiff

2019

Biology of Blood and Marrow Transplantation

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Multiple myeloma (MM), a malignant disorder of plasma cells affecting primarily elderly patients, is the second most commonly diagnosed hematologic neoplasm. With the recent influx of effective new agents available, including proteasome inhibitors, immunomodulators, targeted monoclonal antibodies, and now chimeric antigen receptor T cell (CAR-T) therapy, the treatment landscape is evolving rapidly. Although the role of consolidative autologous stem cell transplantation (ASCT) in first remission is well established, in the relapsed setting after upfront ASCT, the role of a second ASCT (SAT) following reinduction is less clear and understudied. Practice patterns vary significantly across institutions, and most of the literature available to guide clinical decisions consists of single-institution experiences, with only 1 randomized study evaluating the role of SAT compared with a nontransplantation approach. SAT is likely underused, because it has not been included in clinical trials examining novel regimens for relapsed disease. Furthermore, outcomes likely can be improved with approaches to intensify the preparative regimen and the use of standard post-transplantation maintenance. In this review, we examine the role of SAT in the current MM treatment landscape in the context of recent data on the efficacy of CART therapy in this disease. We caution the abandonment of SAT, given that CART therapy is in its infancy in MM treatment, and that real-world data in the relapsed setting are consistently inferior to clinical trial outcomes.

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

Abstract: 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.

Cited by 15 publications

References 44 publications

Bortezomib retreatment for relapsed and refractory multiple myeloma in real‐world clinical practice

Bortezomib retreatment for relapsed and refractory multiple myeloma in real‐world clinical practice

Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation

The Role of Salvage Second Autologous Hematopoietic Cell Transplantation in Relapsed Multiple Myeloma

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