Venlafaxine to prevent oxaliplatin-induced neuropathy?: A pilot randomized placebo-controlled trial.

Abstract

e20734 Background: Previous pilot data suggested venlafaxine could prevent acute and chronic oxaliplatin-related neuropathy (Durand et al, Ann Oncol, 2012, p200). The purpose of this randomized, placebo-controlled, double-blinded pilot study was to try to obtain additional data to support conducting a phase III trial to test the use of venlafaxine to prevent oxaliplatin neurotoxicity. Methods: 50 patients scheduled to undergo oxaliplatin-based therapy (FOLFOX) for stage II-III (67%) or stage IV (33%) colon cancer, from 9 sites between 02/2012 and 03/2014, were randomized to receive venlafaxine XR (37.5 mg) or placebo, twice daily, through last dose of oxaliplatin, and then titrated off. Acute neuropathy was evaluated with a standard patient questionnaire (Loprinzi et al, JCO, 2014, p997). Prior to each oxaliplatin dose, neurotoxicity was evaluated via several mechanisms: the EORTC QLQ CIPN20, the NCI CTCAE v4.0, an oxaliplatin-specific scale, and a Rydel-Seiffer graduated tuning fork. Results: Baseline pt...