Ixazomib-associated cardiovascular adverse events in multiple myeloma: a systematic review and meta-analysis

References

• Bachier, C.R., Matous, J.V., and Berdeja, J.G., 2017. Open-label study to determine the feasibility of ixazomib As maintenance after allogeneic stem cell transplant for multiple myeloma. Blood, 137 (Suppl 1), 5573.
   Google Scholar
• Chauhan, D., et al., 2011. In vitro and in vivo selective antitumor activity of a novel orally bioavailable proteasome inhibitor MLN9708 against multiple myeloma cells. Clinical Cancer Research, 17 (16), 5311–5321.
   PubMed Web of Science ®Google Scholar
• DerSimonian, R., and Laird, N., 1986. Meta-analysis in clinical trials. Controlled Clinical Trials, 7 (3), 177–188.
   PubMedGoogle Scholar
• Dimopoulos, M.A., et al., 2019. All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. European Journal of Cancer, 106, 89–98.
   PubMed Web of Science ®Google Scholar
• Dimopoulos, M.A., et al., TOURMALINE-MM3 study group. 2019. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet (London, England), 393 (10168), 253–264.
   PubMed Web of Science ®Google Scholar
• Gupta, N., et al., 2015. Pharmacokinetics and safety of ixazomib plus lenalidomide-dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study. Journal of Hematology & Oncology, 8, 103.
   PubMed Web of Science ®Google Scholar
• Gupta, N., et al., 2016. The effect of a high-fat meal on the pharmacokinetics of ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors or lymphoma. Journal of Clinical Pharmacology, 56 (10), 1288–1295.
   PubMed Web of Science ®Google Scholar
• Gupta, N., et al., 2018. Effects of strong CYP3A inhibition and induction on the pharmacokinetics of ixazomib, an oral proteasome inhibitor: results of drug-drug interaction studies in patients with advanced solid tumors or lymphoma and a physiologically based pharmacokinetic analysis. Journal of Clinical Pharmacology, 58 (2), 180–192.
   PubMed Web of Science ®Google Scholar
• Gupta, N., et al., 2019. Clinical pharmacology of ixazomib: the first oral proteasome inhibitor. Clinical Pharmacokinetics, 58 (4), 431–449.
   PubMed Web of Science ®Google Scholar
• Hasinoff, B.B., Patel, D., and Wu, X., 2017. Molecular mechanisms of the cardiotoxicity of the proteasomal-targeted drugs bortezomib and carfilzomib. Cardiovascular Toxicology, 17 (3), 237–250.
   PubMed Web of Science ®Google Scholar
• Herrmann, J., et al., 2013. Primary proteasome inhibition results in cardiac dysfunction. European Journal of Heart Failure, 15 (6), 614–623.
   PubMed Web of Science ®Google Scholar
• Hou, J., et al., 2017. Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study. Journal of Hematology & Oncology, 10 (1), 137.
   PubMed Web of Science ®Google Scholar
• Imam, F., et al., 2017. Rutin attenuates carfilzomib-induced cardiotoxicity through inhibition of NF-κB, hypertrophic gene expression and oxidative stress. Cardiovascular Toxicology, 17 (1), 58–66.
   PubMed Web of Science ®Google Scholar
• Jouni, H., et al., 2017. Ixazomib cardiotoxicity: a possible class effect of proteasome inhibitors. American Journal of Hematology, 92 (2), 220–221.
   PubMed Web of Science ®Google Scholar
• Kistler, K.D., et al., 2012. Cardiac event rates in patients with newly diagnosed and relapsed multiple myeloma in US clinical practice. Blood, 120 (21), 2916–2916.,
   Web of Science ®Google Scholar
• Krishnan, A., et al., 2018. Phase I/II trial of the oral regimen ixazomib, pomalidomide, and dexamethasone in relapsed/refractory multiple myeloma. Leukemia, 32 (7), 1567–1574.
   PubMed Web of Science ®Google Scholar
• Kristinsson, S.Y., Anderson, W.F., and Landgren, O., 2014. Improved long-term survival in multiple myeloma up to the age of 80 years. Leukemia, 28 (6), 1346–1348.
   PubMed Web of Science ®Google Scholar
• Kumar, S.K., et al., 2014a. Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma. Blood, 124 (7), 1047–1055.
   PubMed Web of Science ®Google Scholar
• Kumar, S.K., et al., 2014b. Safety and tolerability of ixazomib, an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma: an open-label phase 1/2 study. The Lancet Oncology, 15 (13), 1503–1512.
   PubMed Web of Science ®Google Scholar
• Kumar, S.K., et al., 2016. Randomized phase 2 trial of ixazomib and dexamethasone in relapsed multiple myeloma not refractory to bortezomib. Blood, 128 (20), 2415–2422.
   PubMed Web of Science ®Google Scholar
• Kumar, S.K., et al., 2019a. Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance. Leukemia, 33 (7), 1736–1746.
   PubMed Web of Science ®Google Scholar
• Kumar, S.K., et al., 2019b. Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma. British Journal of Haematology, 184 (4), 536–546.
   PubMed Web of Science ®Google Scholar
• Moher, D., PRISMA-P Group., et al., 2015. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews, 4, 1.
   PubMed Web of Science ®Google Scholar
• Moreau, P., CH., et al., 2016. Ixazomib-lenalidomide-dexamethasone (IRd) combination before and after autologous stem cell transplantation (ASCT) followed by ixazomib maintenance is a safe and effective strategy in patients with newly diagnosed multiple myeloma (NDMM): a phase 2 study from the Intergroupe Francophone Du Myélome (IFM). Blood, 128 (22), 674–674.
   Web of Science ®Google Scholar
• Moreau, P., TOURMALINE-MM1 Study Group., et al., 2016. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. The New England Journal of Medicine, 374 (17), 1621–1634.
   PubMed Web of Science ®Google Scholar
• Nowis, D., et al., 2010. Cardiotoxicity of the anticancer therapeutic agent bortezomib. The American Journal of Pathology, 176 (6), 2658–2668.
   PubMed Web of Science ®Google Scholar
• Reu, F.J., et al., 2015. A phase I study of ixazomib in combination with panobinostat and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood, 126 (23), 4221–4221.
   Web of Science ®Google Scholar
• Richardson, P.G., et al., 2014. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood, 124 (7), 1038–1046.
   PubMed Web of Science ®Google Scholar
• Richardson, P.G., et al., 2018. Twice-weekly ixazomib in combination with lenalidomide-dexamethasone in patients with newly diagnosed multiple myeloma. British Journal of Haematology, 182 (2), 231–244.
   PubMed Web of Science ®Google Scholar
• San-Miguel, J.F., et al., 2018. A phase I/II dose-escalation study investigating all-oral ixazomib-melphalan-prednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma. Haematologica, 103 (9), 1518–1526.
   PubMed Web of Science ®Google Scholar
• SEER Stat Fact Sheets: Myeloma. https://seer.cancer.gov/statfacts/html/mulmy.html
   Google Scholar
• Stijnen, T., Hamza, T.H., and Ozdemir, P., 2010. Random effects meta-analysis of event outcome in the framework of the generalized linear mixed model with applications in sparse data. Statistics in Medicine, 29 (29), 3046–3067.
   PubMed Web of Science ®Google Scholar
• Suzuki, K., et al., 2017. Phase 1 study of ixazomib alone or combined with lenalidomide-dexamethasone in Japanese patients with relapsed/refractory multiple myeloma. International Journal of Hematology, 105 (4), 445–452.
   PubMed Web of Science ®Google Scholar
• Thanarajasingam, G., et al., 2015. The imperative for a new approach to toxicity analysis in oncology clinical trials. Journal of the National Cancer Institute, 107 (10), djv216. doi: https://doi.org/10.1093/jnci/djv216.
   PubMedGoogle Scholar
• Voorhees, P.M., et al., 2015. A phase I/II study of pomalidomide, dexamethasone and ixazomib versus pomalidomide and dexamethasone for patients with multiple myeloma refractory to lenalidomide and proteasome inhibitor based therapy: phase I results. Blood, 126 (23), 375–375.
   Google Scholar
• Waxman, A.J., et al., 2018. Carfilzomib-associated cardiovascular adverse events: a systematic review and meta-analysis. JAMA Oncology, 4 (3), e174519
   PubMed Web of Science ®Google Scholar
• Witteles, R.M., and Telli, M., 2012. Underestimating cardiac toxicity in cancer trials: lessons learned? Journal of Clinical Oncology, 30 (16), 1916–1918.
   PubMed Web of Science ®Google Scholar
• Xiao, Y., et al., 2014. Incidence and risk of cardiotoxicity associated with bortezomib in the treatment of cancer: a systematic review and meta-analysis. PloS One, 9 (1), e87671.
   PubMed Web of Science ®Google Scholar
• Zweegman, S., et al., 2018. Ixazomib-thalidomide-low dose dexamethasone (ITd) induction followed by maintenance therapy with ixazomib or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; initial results from the randomized phase II HOVON-126/Nmsg 21.13 trial. Blood, 132 (Supplement 1), 800–800.
   Web of Science ®Google Scholar