Abstract P5-19-01: Impact of palbociclib plus letrozole on patient-reported general health status compared with letrozole alone in ER+/HER2- advanced/metastatic breast cancer
Authors: Harbeck N , Dieras V , Finn R , Gelmon KA , Walshe JM , Shparyk Y , Mori A , Lui DR , Bhattacharyya H , Iyer S , Johnston S , Rugo HS 
Published: February 2018

Abstract
BACKGROUND: Palbociclib plus letrozole significantly improved progression-free survival (PFS) compared with letrozole plus placebo in treatment-naive postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) in the phase 3 PALOMA-2 trial. Here, we compare patient-reported general health status with extended (max 53 cycles) follow-up (data cut off May31st, 2017) (Pfizer: NCT01740427).
METHODS: PALOMA-2 randomized patients 2:1 to palbociclib + letrozole (n=444) or placebo + letrozole (n=222). Patient-reported outcomes were assessed at baseline, day 1 of cycles 1, 2, and 3, and day 1 of every other cycle from cycle 5 until the end of treatment using the EuroQol 5-Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized measure of health status that consists of a descriptive system comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression rated at 3 levels (no, some, or extreme problems) and a single index score for health status (ranges generally from 0 [dead] to 1 [full health]) calculated using a standard algorithm. In addition, a visual analog scale (VAS) measured self-rated health status from 0 (worst imaginable) to 100 (best imaginable). Repeated measures mixed-effects analyses were performed to compare overall index and VAS scores between treatments, controlling for baseline.
RESULTS: Completion rates at baseline were &gt;95% in each group. The mean (SD) scores at baseline were comparable between palbociclib plus letrozole and letrozole alone for the VAS (71.3 [21.2] vs 72.3 [19.8]) and the EQ-5D index scores (0.70 [0.25]) vs (0.73 [0.21]). Median follow up was 38 months for palbociclib plus letrozole and 37 months for letrozole only. No statistically significant difference in overall change from baseline in general health status was observed between the treatment arms. The proportion of patients reporting the presence of a problem at baseline was similar for palbociclib plus letrozole and letrozole, respectively: mobility (39% vs 39%), self-care (12% vs 12%), usual activities (44% vs 39%), pain (69% vs 65%), and anxiety/depression (54% vs 54%). No statistically significant difference in overall mean EQ-5D index scores (0.73 vs. 0.71) was observed between the treatment arms.
CONCLUSION: Addition of palbociclib to letrozole maintained general health status and EQ-5D index scores in ER+ HER2- advanced/metastatic breast cancer with no statistically significant differences observed compared to letrozole alone.
Citation Format: Harbeck N, Dieras V, Finn R, Gelmon KA, Walshe JM, Shparyk Y, Mori A, Lui DR, Bhattacharyya H, Iyer S, Johnston S, Rugo HS. Impact of palbociclib plus letrozole on patient-reported general health status compared with letrozole alone in ER+/HER2- advanced/metastatic breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-19-01.