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Meta-analysis of incidence and risk of peripheral neuropathy associated with intravenous bortezomib
Ling Peng1, Xianghua Ye, Yun Zhou
1Department of Thoracic Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
Background:
Bortezomib is a proteasome inhibitor which has demonstrated activity against recurrent or newly diagnosed multiple myeloma (MM) and mantle cell lymphoma. Peripheral neuropathy has been described with this agent, although the overall incidence and relative risk remain unclear. We performed a meta-analysis to calculate the incidence of peripheral neuropathy associated with the use of intravenous bortezomib in MM and lymphoma and to compare the relative risk compared with placebo.
Methods:
We searched PubMed, Embase, Cochrane databases, and meeting proceedings from the American Society of Clinical Oncology (ASCO) for relevant clinical trials. Eligible studies included prospective phase 2 and 3 clinical trials with toxicity profile on peripheral neuropathy associated with intravenous bortezomib in patients with MM and lymphoma. Statistical analyses were done to calculate summary incidences, relative risks (RRs), and 95 % confidence intervals (CIs), employing fixed- or random-effects models depending on the heterogeneity of the included studies.
Results:
Altogether, 34 clinical trials were selected for the meta-analysis, yielding a total of 6492 patients. The incidence of peripheral neuropathy (all grades) was 33.9 % (95 % CI, 29.9-38.5 %) and that of high-grade events was 8.1 % (95 % CI, 6.9-9.4 %). The relative risks of bortezomib-induced peripheral neuropathy compared to placebo were increased for all-grade (RR = 4.89; 95 % CI, 2.52-9.51) and high-grade (RR = 4.53; 95 % CI, 2.04-10.07) peripheral neuropathy (for randomized controlled trials only). Our analysis was also stratified by different underlying diseases, and patients with lymphoma had an increased incidence of all-grade peripheral neuropathy than those with MM when treated with intravenous bortezomib.
Conclusions:
Treatment with intravenous bortezomib is associated with an increased risk of developing peripheral neuropathy.
Insights
Bortezomib treatment for multiple myeloma and lymphoma increases the risk of peripheral neuropathy. This meta-analysis quantifies the incidence and relative risk of this side effect in patients receiving intravenous bortezomib.
Area of Science:
- Oncology
- Clinical Pharmacology
- Hematology
Background:
- Bortezomib is a proteasome inhibitor used for multiple myeloma (MM) and mantle cell lymphoma.
- Peripheral neuropathy is a known side effect, but its incidence and risk are not well-defined.
- A meta-analysis was conducted to assess these risks.
Purpose of the Study:
- To determine the incidence of peripheral neuropathy (all grades and high-grade) associated with intravenous bortezomib.
- To compare the relative risk of bortezomib-induced peripheral neuropathy versus placebo.
- To analyze incidence based on underlying disease (MM vs. lymphoma).
Main Methods:
- A systematic literature search was performed across PubMed, Embase, Cochrane, and ASCO meeting proceedings.
- Included were prospective phase 2 and 3 clinical trials reporting peripheral neuropathy toxicity.
- Meta-analysis techniques, including fixed- or random-effects models, were used to calculate incidence and relative risks (RRs) with 95% confidence intervals (CIs).
Main Results:
- 34 trials with 6492 patients were analyzed.
- The incidence of all-grade peripheral neuropathy was 33.9% (95% CI, 29.9-38.5%), and high-grade was 8.1% (95% CI, 6.9-9.4%).
- Bortezomib significantly increased the risk of all-grade (RR=4.89) and high-grade (RR=4.53) neuropathy compared to placebo (in RCTs). Lymphoma patients showed higher incidence than MM patients.
Conclusions:
- Intravenous bortezomib treatment is associated with a significantly increased risk of peripheral neuropathy.
- The findings highlight the importance of monitoring for and managing this adverse event in patients treated with bortezomib.
- Risk stratification by disease may be warranted.
