Lenalidomide long-term neurotoxicity: Clinical and neurophysiologic prospective study

Neurology. 2016 Sep 13;87(11):1161-6. doi: 10.1212/WNL.0000000000003093. Epub 2016 Aug 17.

Abstract

Objective: To evaluate long-term lenalidomide neurotoxicity and correlation with cumulative dose and hematologic response.

Methods: Nineteen myeloma patients (7 men, mean age 63.2 years) underwent clinical and neurophysiologic assessment at baseline and at 2 (8 patients, group A) or 5 years (11 patients, group B) after starting lenalidomide therapy for relapsed/refractory multiple myeloma. Neuropathy was scored with Total Neuropathy Score clinical version (TNSc). Lenalidomide cumulative dose was correlated with severity of neuropathy and hematologic response.

Results: At enrollment, 7/19 patients (3 in group A, 4 in group B) had neurophysiologic signs of neuropathy secondary to previous chemotherapy, in 2 of them subclinical. Neurophysiologic evidence of sensory axonal neuropathy occurred in 4/8 patients at 2 years follow-up (group A) and in 3/11 patients at 5 years follow-up (group B). Dorsal sural nerve sensory action potential amplitude was the earliest neurophysiologic abnormality. No relevant (≥4) clinical changes were found in TNSc score. Hematologic overall response was 62% in group A and 100% in group B. No correlation was found between lenalidomide cumulative dose and neuropathy or between neuropathy and hematologic response.

Conclusions: In our study, up to 50% of myeloma patients on long-term lenalidomide therapy developed sensory axonal neuropathy. Reduced dorsal sural nerve sensory action potential amplitude was the first neurophysiologic alteration. Neuropathy was usually subclinical or mild, however. Neurotoxicity was independent of lenalidomide cumulative dose and hematologic response.

Publication types

  • Clinical Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / adverse effects*
  • Angiogenesis Inhibitors / therapeutic use
  • Dose-Response Relationship, Drug
  • Drug Resistance, Neoplasm
  • Female
  • Follow-Up Studies
  • Humans
  • Lenalidomide
  • Male
  • Middle Aged
  • Multiple Myeloma / drug therapy
  • Neurotoxicity Syndromes / physiopathology*
  • Peripheral Nervous System Diseases / etiology
  • Peripheral Nervous System Diseases / physiopathology
  • Prospective Studies
  • Recurrence
  • Sensory Receptor Cells / drug effects
  • Sensory Receptor Cells / physiology
  • Severity of Illness Index
  • Thalidomide / adverse effects
  • Thalidomide / analogs & derivatives*
  • Thalidomide / therapeutic use
  • Time Factors

Substances

  • Angiogenesis Inhibitors
  • Thalidomide
  • Lenalidomide