Resumen estructurado de revisiones sistemáticas

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Bortezomib (Velcade) for multiple myeloma within a transplant setting

Año 2011
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Bortezomib (Velcade) for multiple myeloma within a transplant setting Birmingham: National Horizon Scanning Centre (NHSC). Horizon Scanning Review. 2011

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Resumen estructurado de revisiones sistemáticas

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Bortezomib for relapsed and/or refractory follicular non-Hodgkins lymphoma

Año 2010
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Bortezomib for relapsed and/or refractory follicular non-Hodgkins lymphoma. Birmingham: National Horizon Scanning Centre (NHSC). Horizon Scanning Technology Briefing. 2008

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Resumen estructurado de revisiones sistemáticas

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Bortezomib for multiple myeloma - horizon scanning review

Año 2003
Autores NHSC
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

NHSC. Bortezomib for multiple myeloma - horizon scanning review. Birmingham: National Horizon Scanning Centre (NHSC). 2003

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Resumen estructurado de revisiones sistemáticas

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Use of Bortezomib (Velcade®) within NHS Wales

Año 2012
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

All Wales Medicines Strategy Group (AWMSG). Use of Bortezomib (Velcade®) within NHS Wales Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). 2005

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Resumen estructurado de revisiones sistemáticas

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Bortezomib (Velcade®) 3.5 mg subcutaneous injection

Año 2013
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

All Wales Medicines Strategy Group (AWMSG). Bortezomib (Velcade®) 3.5 mg subcutaneous injection Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 3812. 2012

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Estudio primario

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Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer.

Año 2006
Revista Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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PURPOSE:

To evaluate the efficacy and toxicity of bortezomib +/- docetaxel as second-line therapy in patients with relapsed or refractory advanced non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Patients were randomly assigned to bortezomib 1.5 mg/m2 (arm A) or bortezomib 1.3 mg/m2 plus docetaxel 75 mg/m2 (arm B). A treatment cycle of 21 days comprised four bortezomib doses on days 1, 4, 8, and 11, plus, in arm B, docetaxel on day 1. Patients could receive unlimited cycles. The primary end point was response rate.

RESULTS:

A total of 155 patients were treated, 75 in arm A and 80 in arm B. Baseline characteristics were comparable. Investigator-assessed response rates were 8% in arm A and 9% in arm B. Disease control rates were 29% in arm A and 54% in arm B. Median time to progression was 1.5 months in arm A and 4.0 months in arm B. One-year survival was 39% and 33%, and median survival was 7.4 and 7.8 months in arms A and B, respectively. Adverse effect profiles were as expected in both arms, with no significant additivity. The most common grade > or = 3 adverse events were neutropenia, fatigue, and dyspnea (4% and 53%, 19% and 26%, and 17% and 14% of patients in arms A and B, respectively).

CONCLUSION:

Bortezomib has modest single-agent activity in patients with relapsed or refractory advanced NSCLC using this schedule, with minor enhancement in combination with docetaxel. Additional investigation of bortezomib in NSCLC is warranted in combination with other drugs known to be active, or using different schedules.

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Estudio primario

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Effect of cumulative bortezomib dose on survival in multiple myeloma patients receiving bortezomib-melphalan-prednisone in the phase III VISTA study.

Año 2015
Revista American journal of hematology
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This analysis, using data from the bortezomib-melphalan-prednisone (VMP) arm of the Phase III VISTA study, investigated whether increased cumulative bortezomib dose could improve overall survival (OS) in transplant-ineligible patients with previously untreated multiple myeloma. Median cumulative bortezomib dose received by the 340 patients was 39 mg/m(2); this was selected as the cut-off for defining the dose groups to be compared for OS. Patient characteristics were well balanced between dose groups except for age. OS was significantly longer in the higher (≥39 mg/m(2)) versus lower (<39 mg/m(2)) cumulative bortezomib dose group (median 66.3 vs. 46.2 months; hazard ratio (HR) 0.533, P < 0.0001; age-adjusted HR 0.561, P = 0.0002). To overcome confounding effects of early discontinuations/deaths, which were more common in the lower cumulative dose group (27 vs. 4% of patients discontinued due to adverse events (AEs) in the lower and higher cumulative dose groups, respectively), a landmark analysis was conducted at 180 days, eliminating patients who died or discontinued before this time from the analysis. OS from this landmark remained significantly longer in the higher dose group (median 60.4 vs. 50.3 months; HR 0.709, P = 0.0372). Thus, higher cumulative bortezomib dose, reflecting prolonged treatment duration and/or dose intensity, appears associated with improved OS. Approaches to achieve higher cumulative doses could include subcutaneous bortezomib administration, dose/schedule modifications, continuing therapy in responding patients, and proactive AE management.

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Revisión sistemática

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Meta-analysis of the efficacy and safety of bortezomib re-treatment in patients with multiple myeloma.

Año 2014
Revista Clinical lymphoma, myeloma & leukemia
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INTRODUCTION:

Bortezomib is administered for a finite course; thus, patients might remain sensitive to bortezomib-based therapy at relapse. We report a meta-analysis of bortezomib-based retreatment in relapsed/refractory myeloma.

PATIENTS AND METHODS:

A systematic literature review identified studies of bortezomib-based retreatment in relapsed/refractory myeloma. Proportions of bortezomib-refractory patients and additional prognostic factors were extracted and used in weighted stratified analyses of TTP and OS. Random-effect pooled estimates were calculated for overall response rate (ORR) and rates of common AEs.

RESULTS:

Twenty-three studies (n = 1051 patients) were identified. Bortezomib was administered intravenously in all studies. Across studies in which data were available, pooled, weighted average ORR was 39.1% (95% confidence interval, 30.8%-47.4%), and pooled, weighted average median TTP and OS were 7.5 and 16.6 months, respectively. Patients with fewer previous therapies (<= 4) and relapsed (not refractory) patients achieved higher ORRs, of 43.4% and 57.2%, respectively. Random-effects meta-regression analysis confirmed that relapsed patients were associated with a higher ORR by 28 to 41 percentage points versus refractory patients. In relapsed patients, median TTP and OS were 8.5 and 19.7 months, respectively. Common Grade 3/4 AEs included thrombocytopenia (35%), neutropenia (15%), anemia (14%), pneumonia (10%), and peripheral neuropathy (3%).

CONCLUSION:

Based on these findings, bortezomib retreatment is well tolerated and appears efficacious in relapsed patients. In an era of new and emerging treatment options for relapsed and/or refractory myeloma, these data indicate that bortezomib retreatment might be a highly effective option in previously treated patients.

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Revisión sistemática

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Efficacy and Safety of Bortezomib Maintenance in Patients with Newly Diagnosed Multiple Myeloma: A Meta-Analysis.

Año 2017
Autores Sun CY , Li JY , Chu ZB , Zhang L , Chen L , Hu Y
Revista Bioscience reports
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Multiple myeloma (MM) is a B-cell neoplasm with a high incidence of relapse. Bortezomib has been extensively studied for the maintenance treatment of MM. Here we carried out a meta-analysis to determine the efficacy and safety of maintenance therapy with bortezomib. We searched for clinical trials in PubMed (Medline), Embase (OVID) and the Cochrane Library. Two randomized controlled trials (RCTs) enrolling a total of 1338 patients were included. Bortezomib maintenance statistically significantly improved both PFS (HR 0.67, 95% CI = 0.51 to 0.87, P = 0.003) and OS (HR= 0.75 therapy, 95% CI = 0.63 to 0.89, P = 0.001) more than did non-bortezomib maintenance therapy. Our analysis revealed higher incidence of neutropenia (RR = 1.39; 95% CI=1.08 to 1.79), peripheral neuropathy (RR = 2.23; 95% CI= 1.38 to 3.61, P=0.001) and cardiologic events (RR = 1.91; 95% CI= 1.12 to 3.28, P=0.02) in patients with bortezomib maintenance therapy. Our meta-analysis demonstrates OS and PFS benefits of bortezomib maintenance therapy in patients with newly diagnosed MM. However, the therapy is associated with increased risk of adverse events. Additionally, more RCTs are needed for better understanding and determination of optimal bortezomib maintenance therapy in MM.

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Revisión sistemática

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Weekly versus biweekly bortezomib given in patients with indolent non-Hodgkin lymphoma: A meta-analysis.

Año 2017
Autores Yuan T , Zhang F , Yao QM , Liu YX , Zhu XJ , Wang X
Revista PloS one
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BACKGROUND:

Bortezomib is recently studied as a novel agent in indolent lymphoma. The optimal schedule of bortezomib used in indolent lymphoma is still uncertain.

METHODS:

We did a systematic review and meta-analysis of the clinical trials comparing the efficacy and toxicity of the weekly and biweekly schedules of bortezomib in patients with indolent lymphoma. We searched Pubmed, Cochrane Library and Emabase from inception to July 29, 2016. The primary outcome was the overall response rate including the complete response rate and the partial response rate. The secondary outcomes were the proportions of patients in each group experiencing the adverse events including the neutropathy, fatigue, diarrhea, nausea and neutropenia.

FINDINGS:

After final screening, six trials were considered eligible for analysis. The results showed that the overall response rate of biweekly schedule was higher than that of weekly schedule in indolent lymphoma (OR 1.691;95%CI 1.02-2.80). Furthermore, there were no significant differences between the two schedules of bortezomib for the main adverse events.

INTERPRETATION:

The biweekly schedule of bortezomib was more effective than the weekly schedule in indolent lymphoma, with similar proportion of toxicities.

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