Health‐related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO‐2 trial12. Issue 10 (15th March 2013)

• Record Type: Journal Article
• Authors: Burris, Howard A.; Lebrun, Fabienne; Rugo, Hope S.; Beck, J. Thaddeus; Piccart, Martine; Neven, Patrick; Baselga, Jose; Petrakova, Katarina; Hortobagyi, Gabriel N.; Komorowski, Anna; Chouinard, Edmond; Young, Robyn; Gnant, Michael; Pritchard, Kathleen I.; Bennett, Lee; Ricci, Jean‐Francois; Bauly, Hounayda; Taran, Tetiana; Sahmoud, Tarek; Noguchi, Shinzaburo
• Is Part Of: Cancer. Volume 119:Issue 10(2013)
• Page Start: 1908
• Page End: 1915
• Publication Date: 2013-03-15
• Subjects: advanced breast cancer -- everolimus -- exemestane -- health‐related quality of life -- hormone receptor‐positive; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28010
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract: BACKGROUND: The randomized, controlled BOLERO‐2 (Breast Cancer Trials of Oral Everolimus) trial demonstrated significantly improved progression‐free survival with the use of everolimus plus exemestane (EVE + EXE) versus placebo plus exemestane (PBO + EXE) in patients with advanced breast cancer who developed disease progression after treatment with nonsteroidal aromatase inhibitors. This analysis investigated the treatment effects on health‐related quality of life (HRQOL). METHODS: Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core 30 (EORTC QLQ‐C30) questionnaire, HRQOL was assessed at baseline and every 6 weeks thereafter until disease progression and/or treatment discontinuation. The 30 items in 15 subscales of the QLQ‐C30 include global health status wherein higher scores (range, 0‐100) indicate better HRQOL. This analysis included a protocol‐specified time to definitive deterioration (TDD) analysis at a 5% decrease in HRQOL versus baseline, with no subsequent increase above this threshold. The authors report additional sensitivity analyses using 10‐point minimal important difference decreases in the global health status score versus baseline. Treatment arms were compared using the stratified log‐rank test and Cox proportional hazards model adjusted for trial stratum (visceral metastases, previous hormone sensitivity), age, sex, race, baseline global health status score and Eastern Cooperative Oncology Group performance status, prognostic risk factors, and treatment history. RESULTS: Baseline global health status scores were found to be similar between treatment groups (64.7 vs 65.3). The median TDD in HRQOL was 8.3 months with EVE + EXE versus 5.8 months with PBO + EXE (hazard ratio, 0.74; P = .0084). At the 10‐point minimal important difference, the median TDD with EVE + EXE was 11.7 months versus 8.4 months with PBO + EXE (hazard ratio, 0.80; P = .1017). CONCLUSIONS: In patients with advanced breast cancer who develop disease progression after treatment with nonsteroidal aromatase inhibitors, EVE + EXE was associated with a longer TDD in global HRQOL versus PBO + EXE. Cancer 2013. © 2013 American Cancer Society. Abstract : In the randomized, controlled BOLERO‐2 (Breast Cancer Trials of Oral Everolimus) trial, postmenopausal women with hormone receptor‐positive advanced breast cancer who developed disease progression while receiving letrozole or anastrozole and who then received treatment with everolimus plus exemestane (EVE + EXE) experienced a longer time to definitive deterioration in global health‐related quality of life (HRQOL) than those treated with placebo and EXE. Combined with significant improvements in clinical efficacy, these HRQOL findings provide added support for the benefit of EVE + EXE in this patient population.