Shinzaburo NoguchiNorikazu MasudaHiroji IwataHirofumi MukaiJun HoriguchiPuttisak PuttawibulVichien SrimuninnimitYutaka TokudaKatsumasa KuroiHirotaka IwaseHideo InajiShozo OhsumiWoo Chul NohTakahiro NakayamaShinji OhnoYoshiaki RaiByeong Woo ParkAshok PanneerselvamMona El-HashimyTetiana TaranTarek SahmoudYoshinori ItoOsaka UniversityOsaka National HospitalAichi Cancer Center Hospital and Research InstituteNational Cancer Center Hospital EastGunma University HospitalPrince of Songkla UniversityMahidol UniversityTokai UniversityTokyo Metropolitan Komagome HospitalKumamoto UniversityOsaka Medical Center for Cancer and Cardiovascular DiseasesNational Shikoku Cancer Center HospitalKorea Cancer Center HospitalNational Kyushu Cancer CenterSagara HospitalYonsei University College of MedicineNovartis Pharmaceuticals CorporationCancer Institute Hospital of Japan Foundation for Cancer Research2018-10-192018-10-192013-01-01Breast Cancer. Vol.21, No.6 (2013), 703-71418804233134068682-s2.0-84873499330https://repository.li.mahidol.ac.th/handle/20.500.14594/32705© 2013, The Author(s). 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.Mahidol UniversityMedicineArticleSCOPUS10.1007/s12282-013-0444-8