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Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma
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Titel: |
Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma |
In: | British Journal of Haematology, 178, 2017, 4, S. 571-582 |
veröffentlicht: |
Wiley
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Umfang: | 571-582 |
ISSN: |
0007-1048 1365-2141 |
DOI: | 10.1111/bjh.14733 |
Zusammenfassung: | <jats:title>Summary</jats:title><jats:p>The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double‐blind, placebo‐controlled Phase <jats:styled-content style="fixed-case">III TOURMALINE</jats:styled-content>‐<jats:styled-content style="fixed-case">MM</jats:styled-content>1 study of ixazomib‐Rd (<jats:styled-content style="fixed-case">IR</jats:styled-content>d) versus placebo‐Rd in patients with relapsed/refractory multiple myeloma. <jats:styled-content style="fixed-case">IR</jats:styled-content>d resulted in a significant improvement in progression‐free survival versus placebo‐Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with <jats:styled-content style="fixed-case">IR</jats:styled-content>d versus placebo‐Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long‐term <jats:styled-content style="fixed-case">IR</jats:styled-content>d treatment. Safety data from <jats:styled-content style="fixed-case">TOURMALINE</jats:styled-content>‐<jats:styled-content style="fixed-case">MM</jats:styled-content>1 are reviewed and guidance for managing clinically relevant adverse events associated with <jats:styled-content style="fixed-case">IR</jats:styled-content>d is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.</jats:p> |
Format: | E-Article |
Quelle: | Wiley (CrossRef) |
Sprache: | Englisch |