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Ixabepilone-associated peripheral neuropathy: data from across the phase II and III clinical trials.
- Source :
- Supportive Care in Cancer; Nov2012, Vol. 20 Issue 11, p2661-2668, 8p
- Publication Year :
- 2012
-
Abstract
- Purpose: Dose-limiting neuropathy is a major adverse event associated with most of the microtubule-stabilizing agent-based chemotherapy regimens. Ixabepilone, a semisynthetic analogue of the natural epothilone B, has activity against a wide range of tumor types. Peripheral neuropathy (PN), associated with ixabepilone treatment, is usually mild to moderate, predominantly sensory and cumulative. Preclinical studies demonstrate that ixabepilone and taxanes produce a similar neurotoxicity profile. Methods: We searched databases of phase II/III clinical trials involving patients receiving ixabepilone as a monotherapy or in combination with capecitabine for incidences of neuropathy. Potential risk factors for grade 3/4 PN were identified by a Cox regression analysis on a dataset of 1,540 patients with different tumor types across multiple studies. Results: Rates for incidence of ixabepilone-induced severe PN (Common Terminology Criteria for Adverse Events grade 3/4) ranged from 1% in early untreated breast cancer up to 24% in heavily pretreated metastatic breast cancer; grade 4 PN was rare (≤1%). Common symptoms included numbness, paresthesias, and sometimes dysesthesias. Cox regression analysis identified only preexisting neuropathy as a risk factor for increased ixabepilone-associated PN. The management of PN has been primarily through dose adjustments (dose delays and/or dose reduction). Patients had resolution of their neuropathy within a median time of 5 to 6 weeks. Conclusions: PN is a dose-limiting toxicity associated with ixabepilone treatment, is reversible in most patients, and can be managed with dose reduction and delays. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09414355
- Volume :
- 20
- Issue :
- 11
- Database :
- Complementary Index
- Journal :
- Supportive Care in Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 82051854
- Full Text :
- https://doi.org/10.1007/s00520-012-1384-0