Impact of neratinib on patient-reported outcomes.

Abstract

e11078 Background: Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor was evaluated in an open label multi-center phase 2 study, with a daily oral dose in advanced breast cancer patients split into 2 cohorts, based on prior trastuzumab (n=66) and no prior trastuzumab treatment (n=70) with the primary endpoint being 16- week progression free survival rate (59% vs 78% with and without prior trastuzumab respectively) as reported by Burstein et al. Here we assess the impact of Neratinib on patient reported outcomes (PROs). Methods: PROs were measured as secondary endpoints at screening, months 3, 5 and final visit using EORTC-QLQ breast cancer module (BR-23) that includes 5 multi-item scales assessing breast symptoms, arm symptoms, side effects, body image, sexual functioning and 3 items assessing sexual enjoyment, hair loss and future perspective. Items are measured on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). Raw scores were transformed using a standard algorithm i...