Efficacy of venlafaxine for the prevention and relief of oxaliplatin-induced acute neurotoxicity: Results of EFFOX, a randomized, double-blind, placebo-controlled phase III trial

J. P. Durand, G. Deplanque, V. Montheil, J. M. Gornet, F. Scotte, O. Mir, A. Cessot, R. Coriat, E. Raymond, E. Mitry, P. Herait, Y. Yataghene, F. Goldwasser

Research output: Contribution to journalArticlepeer-review

164 Citations (Scopus)

Abstract

Background: Oxaliplatin neurosensory toxicity is dose limiting and may present as acute symptoms and/or cumulative peripheral neuropathy. Patients and methods: From October 2005 to May 2008, patients with oxaliplatin-induced acute neurotoxicity were randomized into a double-blind study, to receive either venlafaxine 50 mg 1 h prior oxaliplatin infusion and venlafaxine extended release 37.5 mg b.i.d. from day 2 to day 11 or placebo. Neurotoxicity was evaluated using numeric rating scale (NRS) for pain intensity and experienced relief under treatment, the Neuropathic Pain Symptom Inventory and the oxaliplatin-specific neurotoxicity scale. The primary end point was the percentage of patients with a 100% relief under treatment. Results: Forty-eight patients were included (27 males, median age: 67.6 years). Most patients had colorectal cancer (72.9%). Median number of cycles administered at inclusion was 4.5 (mean cumulative oxaliplatin dose: 684.6 mg). Twenty out of 24 patients in arm A (venlafaxine) and 22 out of 24 patients in arm B (placebo) were assessable for neurotoxicity. Based on the NRS, full relief was more frequent in the venlafaxine arm: 31.3% versus 5.3% (P = 0.03). Venlafaxine side-effects included grade 1-2 nausea (43.1%) and asthenia (39.2%) without grade 3-4 events. Conclusion: Venlafaxine has clinical activity against oxaliplatin-induced acute neurosensory toxicity.

Original languageEnglish
Pages (from-to)200-205
Number of pages6
JournalAnnals of Oncology
Volume23
Issue number1
DOIs
Publication statusPublished - 1 Jan 2012
Externally publishedYes

Keywords

  • Neurotoxicity
  • Oxaliplatin
  • Venlafaxine

Cite this