Results: Of 143 Asian patients, 98 received EVE + EXE and 45 received PBO + EXE. Treatment with EVE + EXE significantly improved median PFS versus PBO + EXE among Asian patients by 38 % (HR = 0.62; 95 % CI, 0.41–0.94). Median PFS was also improved among non-Asian patients by 59 % (HR = 0.41; 95 % CI, 0.33–0.50). Median PFS duration among EVE-treated Asian patients was 8.48 versus 4.14 months for PBO + EXE, and 7.33 versus 2.83 months, respectively, in non-Asian patients. The most common grade 3/4 adverse events (stomatitis, anemia, elevated liver enzymes, hyperglycemia, and dyspnea) occurred at similar frequencies in Asian and non-Asian patients. Grade 1/2 interstitial lung disease occurred more frequently in Asian patients. Quality of life was similar between treatment arms in Asian patients.
Conclusion: Adding EVE to EXE provided substantial clinical benefit in both Asian and non-Asian patients with similar safety profiles. This combination represents an improvement in the management of postmenopausal women with HR+/HER2− advanced breast cancer progressing on nonsteroidal aromatase inhibitors, regardless of ethnicity.
Background: The addition of mTOR inhibitor everolimus (EVE) to exemestane (EXE) was evaluated in an international, phase 3 study (BOLERO-2) in patients with hormone-receptor-positive (HR+) breast cancer refractory to letrozole or anastrozole. The safety and efficacy of anticancer treatments may be influenced by ethnicity (Sekine et al. in Br J Cancer 99:1757–62, 2008). Safety and efficacy results from Asian versus non-Asian patients in BOLERO-2 are reported.
Methods: Patients were randomized (2:1) to 10 mg/day EVE + EXE or placebo (PBO) + EXE. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, clinical benefit rate, and safety.
Bibliographical noteFunding Information:
The BOLERO-2 trial was supported by Novartis Pharmaceuticals: ClinicalTrials.gov identifier NCT00863655. Funding for medical editorial support was also provided by Novartis. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We thank Kristin E. Larsen, PhD, ProEd Communications, Inc., for medical editorial assistance with this manuscript. The BOLERO-2 trial was conducted in the USA, Japan, Canada, Brazil, Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Spain, Sweden, Turkey, UK, Egypt, Australia, China (Hong Kong), New Zealand, South Korea, and Thailand. We thank the patients, study site personnel, and the study team for their participation in the trial.
© 2013, The Author(s).
All Science Journal Classification (ASJC) codes
- Radiology Nuclear Medicine and imaging
- Pharmacology (medical)