Patient-reported physical, emotional, and social functioning in advanced breast cancer: Insights from BOLERO-2.

• DOI: 10.1200/jco.2013.31.26_suppl.155
• Publication Date: 2017-02-24T11:10:11Z
• Authors: Denise Aysel Yardley; Gabriel N. Hortob...; Fabienne Lebrun; J. Thaddeus Beck; Patrick Neven; Jose Baselga; Katarina Petrakova; Shaker R. Dakhil; Silvia Sabatini; Anna Komorowski; Edmond Emilien Ch...; Robyn R. Young; Michael Gnant; Kathleen I. Pritc...; Jie Zhang; Ryan Ziemiecki; Thomas Brechenmacher; Tanya Taran; Tarek Sahmoud; Shinzaburo Noguchi
• Keywords: Exemestane; Discontinuation; Clinical endpoint

155 Background: The phase III BOLERO-2 study at 18 months’ median follow-up showed that everolimus (EVE) + exemestane (EXE) significantly improved progression-free survival (PFS) vs EXE alone in 724 patients with hormone receptor–positive (HR+) advanced breast cancer (ABC) recurrence/progression during/after nonsteroidal aromatase inhibitor (NSAI) therapy. A higher rate of grade 3/4 adverse events was noted EVE but not associated deterioration quality life (QOL) based on the EORTC QLQ-C30 Global Health Status scale. Additional patient-reported post hoc analyses QOL are reported herein. Methods: During BOLERO-2, (EORTC and QLQ-BR23) assessed baseline q 6 wk thereafter until progression or discontinuation. Physical, emotional, social functioning subscales were analyzed. Time to definitive (TTD) defined either a 5% (protocol-specified) 10-point (more stringent) decrease from for each subscale analyzed by Kaplan-Meier methods. difference between treatments log-rank test stratified randomization factors. Results: compliance >80% week 48. Among 3 protocol-specified subscales, longer TTD both physical emotional group (log-rank p = 0.0120 0.0277, respectively). TTDs similar treatment arms 0.3374). Analyses indicated (15.2 mo) (9.7 mo; 0.0211). alone: 13.9 13.8, respectively 0.4023), 11.5 9.5, 0.2507). Conclusions: goal ABC is maximize clinical benefit minimal negative effects QOL. These additional confirmed more than doubling PFS accompanied maintained physical, compared HR+ progressing after NSAI. Clinical trial information: NCT00863655.