Safety and efficacy of everolimus with exemestane vs. exemestane alone in elderly patients with HER2-negative, hormone receptor-positive breast cancer in BOLERO-2 Journal Article
| Authors: | Pritchard, K. I.; Burris, H. A. 3rd; Ito, Y.; Rugo, H. S.; Dakhil, S.; Hortobagyi, G. N.; Campone, M.; Csöszi, T.; Baselga, J.; Puttawibul, P.; Piccart, M.; Heng, D.; Noguchi, S.; Srimuninnimit, V.; Bourgeois, H.; Gonzalez Martin, A.; Osborne, K.; Panneerselvam, A.; Taran, T.; Sahmoud, T.; Gnant, M. |
| Article Title: | Safety and efficacy of everolimus with exemestane vs. exemestane alone in elderly patients with HER2-negative, hormone receptor-positive breast cancer in BOLERO-2 |
| Abstract: | Background Postmenopausal women with hormone receptor-positive (HR +) breast cancer in whom disease progresses or there is recurrence while taking a nonsteroidal aromatase inhibitor (NSAI) are usually treated with exemestane (EXE), but no single standard of care exists in this setting. The BOLERO-2 trial demonstrated that adding everolimus (EVE) to EXE improved progression-free survival (PFS) while maintaining quality of life when compared with EXE alone. Because many women with HR+ advanced breast cancer are elderly, the tolerability profile of EVE plus EXE in this population is of interest. Patients and Methods BOLERO-2, a phase III randomized trial, compared EVE (10 mg/d) and placebo (PBO), both plus EXE (25 mg/d), in 724 postmenopausal women with HR+ advanced breast cancer recurring/progressing after treatment with NSAIs. Safety and efficacy data in elderly patients are reported at 18-month median follow-up. Results Baseline disease characteristics and treatment histories among the elderly subsets (≥ 65 years, n = 275; ≥ 70 years, n = 164) were generally comparable with younger patients. The addition of EVE to EXE improved PFS regardless of age (hazard ratio, 0.59 [≥ 65 years] and 0.45 [≥ 70 years]). Adverse events (AEs) of special interest (all grades) that occurred more frequently with EVE than with PBO included stomatitis, infections, rash, pneumonitis, and hyperglycemia. Elderly EVE-treated patients had similar incidences of these AEs as did younger patients but had more on-treatment deaths. Conclusion Adding EVE to EXE offers substantially improved PFS over EXE and was generally well tolerated in elderly patients with HR + advanced breast cancer. Careful monitoring and appropriate dose reductions or interruptions for AE management are recommended during treatment with EVE in this patient population. © 2013 Elsevier Inc. All rights reserved. |
| Keywords: | adult; cancer survival; controlled study; aged; major clinical study; overall survival; constipation; drug tolerability; fatigue; cancer recurrence; cancer combination chemotherapy; cancer growth; cancer risk; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; side effect; bone metastasis; follow up; cancer incidence; progression free survival; quality of life; drug eruption; infection; breast cancer; nausea; randomized controlled trial; stomatitis; thrombocytopenia; opiate; epidermal growth factor receptor 2; weight reduction; bisphosphonic acid derivative; creatinine blood level; patient monitoring; risk assessment; exemestane; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; asthenia; backache; cancer hormone therapy; coughing; drug fever; dyspnea; gamma glutamyl transferase blood level; hyperglycemia; nail disease; pneumonia; pruritus; drug induced headache; insomnia; liver metastasis; lung metastasis; multicenter study; proton pump inhibitor; urinary tract infection; peripheral edema; xerostomia; benzodiazepine derivative; tamoxifen; visceral metastasis; antihypertensive agent; safety; letrozole; phase 3 clinical trial; hypercholesterolemia; anastrozole; hormone receptor; double blind procedure; postmenopause; alopecia; epistaxis; hydroxymethylglutaryl coenzyme a reductase inhibitor; everolimus; thyroid hormone; analgesic agent; fulvestrant; dysgeusia; anticoagulant agent; rhinopharyngitis; progression-free survival; geriatric; central nervous system metastasis; decreased appetite; geriatric disorder; advanced breast cancer; chemotherapy induced nausea and vomiting; chemotherapy induced anemia; intention to treat analysis; human; female; article; endocrine resistance |
| Journal Title: | Clinical Breast Cancer |
| Volume: | 13 |
| Issue: | 6 |
| ISSN: | 1526-8209 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2013-12-01 |
| Start Page: | 421 |
| End Page: | 432 |
| Language: | English |
| DOI: | 10.1016/j.clbc.2013.08.011 |
| PROVIDER: | scopus |
| PUBMED: | 24267730 |
| DOI/URL: | |
| Notes: | Export Date: 2 January 2014 -- CODEN: CBCLB -- Source: Scopus |
