2013 journal article
Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy.
Current Medical Research and Opinion.
Contributors: L. Bennett*
MeSH headings : Adult; Aged; Androstadienes / adverse effects; Androstadienes / therapeutic use; Antineoplastic Agents / therapeutic use; Antineoplastic Combined Chemotherapy Protocols / adverse effects; Antineoplastic Combined Chemotherapy Protocols / therapeutic use; Breast Neoplasms / drug therapy; Breast Neoplasms / metabolism; Disease Progression; Disease-Free Survival; Everolimus; Female; Health Status; Humans; Immunosuppressive Agents / therapeutic use; Middle Aged; Placebos / therapeutic use; Quality of Life; Receptor, ErbB-2 / metabolism; Receptors, Estrogen / metabolism; Receptors, Progesterone / metabolism; Sirolimus / adverse effects; Sirolimus / analogs & derivatives; Sirolimus / therapeutic use; Surveys and Questionnaires; Treatment Outcome
TL;DR:
These analyses confirm that EVE’s+ EXE provides clinical benefit without adversely impacting HRQOL in patients with HR+ ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.
(via Semantic Scholar)
UN Sustainable Development Goal Categories
3. Good Health and Well-being
(OpenAlex)
Source: ORCID
Added: April 18, 2023
Abstract Objective: Everolimus (EVE)+exemestane (EXE; n = 485) more than doubled median progression-free survival versus placebo (PBO) + EXE (n = 239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR+) advanced breast cancer (ABC) who recurred or progressed on/after nonsteroidal aromatase inhibitor (NSAI) therapy. To further evaluate EVE + EXE impact on disease burden, we conducted additional post-hoc analyses of patient-reported HRQOL. Research design and methods: HRQOL was assessed using EORTC QLQ-C30 and QLQ-BR23 questionnaires at baseline and every 6 weeks thereafter until treatment discontinuation because of disease progression, toxicity, or consent withdrawal. Endpoints included the QLQ-C30 Global Health Status (QL2) scale, the QLQ-BR23 breast symptom (BRBS), and arm symptom (BRAS) scales. Between-group differences in change from baseline were assessed using linear mixed models with selected covariates. Sensitivity analysis using pattern-mixture models determined the effect of study discontinuation on/before week 24. Treatment arms were compared using differences of least squares mean (LSM) changes from baseline and 95% confidence intervals (CIs) at each timepoint and overall. Clinical trial registration: Clinicaltrials.gov: NCT00863655. Main outcome measures: Progression-free survival, survival, response rate, safety, and HRQOL. Results: Linear mixed models (primary model) demonstrated no statistically significant overall difference between EVE + EXE and PBO + EXE for QL2 (LSM difference = −1.91; 95% CI = −4.61, 0.78), BRBS (LSM difference = −0.18; 95% CI = −1.98, 1.62), or BRAS (LSM difference = −0.42; 95% CI = −2.94, 2.10). Based on pattern-mixture models, patients who dropped out early had worse QL2 decline on both treatments. In the expanded pattern-mixture model, EVE + EXE-treated patients who did not drop out early had stable BRBS and BRAS relative to PBO + EXE. Key limitations: HRQOL data were not collected after disease progression. Conclusions: These analyses confirm that EVE + EXE provides clinical benefit without adversely impacting HRQOL in patients with HR+ ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.