Novel neurosensory testing in cancer patients treated with the epothilone B analog, ixabepilone

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background: We have previously established the recommended phase II dose (RPTD) of ixabepilone as 40 mg/m2 administered over 1 h repeated every 3 weeks with neuropathy as a cumulative dose-limiting toxicity. We expanded the cohort at the RPTD to include detailed assessment of nerve damage in these patients. We report our findings on vibration perception threshold (VPT) and neuropathy. Patients and methods: Forty-four patients were treated with a median (range) of three (1-14) cycles of ixabepilone. The VPT (5-min duration) and nerve conduction test (NCT, 10-min duration) were carried out in the office, before ixabepilone dosing, and every two cycles thereafter. Results: Neuropathy (grade 1 and grades 2-3) was observed in 17 (38.6%) and 11 (25%) patients, respectively. The mean increase in VPT as a function of grade 0-1 versus grades 2-3 neuropathy was 0.235 ± 0.03 versus 0.869 ± 0.09 (P = 0.049) vibration units. The F-wave frequency and distal motor latency, as assessed using the NCT, did not correlate with clinical neurotoxicity. Conclusion: The change in VPT is observed early and likely reflects early vibration perception change. Mean change in VPT correlates with the severity of clinical neuropathy. Whether VPT change predicts onset of severe neuropathy warrants prospective testing and validation.

Original languageEnglish (US)
Pages (from-to)2048-2052
Number of pages5
JournalAnnals of Oncology
Volume19
Issue number12
DOIs
StatePublished - 2008

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Vibration
Neoplasms
epothilone B
ixabepilone
Neural Conduction

Keywords

  • Ixabepilone
  • Nerve conduction test (NCT)
  • Phase I
  • Solid tumors
  • Vibration perception threshold (VPT)

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Novel neurosensory testing in cancer patients treated with the epothilone B analog, ixabepilone. / Goel, Sanjay; Goldberg, G. L.; Kuo, Dennis Yi-Shin; Muggia, F.; Arezzo, Joseph C.; Mani, Sridhar.

In: Annals of Oncology, Vol. 19, No. 12, 2008, p. 2048-2052.

Research output: Contribution to journalArticle

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abstract = "Background: We have previously established the recommended phase II dose (RPTD) of ixabepilone as 40 mg/m2 administered over 1 h repeated every 3 weeks with neuropathy as a cumulative dose-limiting toxicity. We expanded the cohort at the RPTD to include detailed assessment of nerve damage in these patients. We report our findings on vibration perception threshold (VPT) and neuropathy. Patients and methods: Forty-four patients were treated with a median (range) of three (1-14) cycles of ixabepilone. The VPT (5-min duration) and nerve conduction test (NCT, 10-min duration) were carried out in the office, before ixabepilone dosing, and every two cycles thereafter. Results: Neuropathy (grade 1 and grades 2-3) was observed in 17 (38.6{\%}) and 11 (25{\%}) patients, respectively. The mean increase in VPT as a function of grade 0-1 versus grades 2-3 neuropathy was 0.235 ± 0.03 versus 0.869 ± 0.09 (P = 0.049) vibration units. The F-wave frequency and distal motor latency, as assessed using the NCT, did not correlate with clinical neurotoxicity. Conclusion: The change in VPT is observed early and likely reflects early vibration perception change. Mean change in VPT correlates with the severity of clinical neuropathy. Whether VPT change predicts onset of severe neuropathy warrants prospective testing and validation.",
keywords = "Ixabepilone, Nerve conduction test (NCT), Phase I, Solid tumors, Vibration perception threshold (VPT)",
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AU - Goel, Sanjay

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AU - Arezzo, Joseph C.

AU - Mani, Sridhar

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N2 - Background: We have previously established the recommended phase II dose (RPTD) of ixabepilone as 40 mg/m2 administered over 1 h repeated every 3 weeks with neuropathy as a cumulative dose-limiting toxicity. We expanded the cohort at the RPTD to include detailed assessment of nerve damage in these patients. We report our findings on vibration perception threshold (VPT) and neuropathy. Patients and methods: Forty-four patients were treated with a median (range) of three (1-14) cycles of ixabepilone. The VPT (5-min duration) and nerve conduction test (NCT, 10-min duration) were carried out in the office, before ixabepilone dosing, and every two cycles thereafter. Results: Neuropathy (grade 1 and grades 2-3) was observed in 17 (38.6%) and 11 (25%) patients, respectively. The mean increase in VPT as a function of grade 0-1 versus grades 2-3 neuropathy was 0.235 ± 0.03 versus 0.869 ± 0.09 (P = 0.049) vibration units. The F-wave frequency and distal motor latency, as assessed using the NCT, did not correlate with clinical neurotoxicity. Conclusion: The change in VPT is observed early and likely reflects early vibration perception change. Mean change in VPT correlates with the severity of clinical neuropathy. Whether VPT change predicts onset of severe neuropathy warrants prospective testing and validation.

AB - Background: We have previously established the recommended phase II dose (RPTD) of ixabepilone as 40 mg/m2 administered over 1 h repeated every 3 weeks with neuropathy as a cumulative dose-limiting toxicity. We expanded the cohort at the RPTD to include detailed assessment of nerve damage in these patients. We report our findings on vibration perception threshold (VPT) and neuropathy. Patients and methods: Forty-four patients were treated with a median (range) of three (1-14) cycles of ixabepilone. The VPT (5-min duration) and nerve conduction test (NCT, 10-min duration) were carried out in the office, before ixabepilone dosing, and every two cycles thereafter. Results: Neuropathy (grade 1 and grades 2-3) was observed in 17 (38.6%) and 11 (25%) patients, respectively. The mean increase in VPT as a function of grade 0-1 versus grades 2-3 neuropathy was 0.235 ± 0.03 versus 0.869 ± 0.09 (P = 0.049) vibration units. The F-wave frequency and distal motor latency, as assessed using the NCT, did not correlate with clinical neurotoxicity. Conclusion: The change in VPT is observed early and likely reflects early vibration perception change. Mean change in VPT correlates with the severity of clinical neuropathy. Whether VPT change predicts onset of severe neuropathy warrants prospective testing and validation.

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