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Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2

 Shinzaburo Noguchi  ;  Norikazu Masuda  ;  Hiroji Iwata  ;  Hirofumi Mukai  ;  Jun Horiguchi  ;  Puttisak Puttawibul  ;  Vichien Srimuninnimit  ;  Yutaka Tokuda  ;  Katsumasa Kuroi  ;  Hirotaka Iwase  ;  Hideo Inaji  ;  Shozo Ohsumi  ;  Woo-Chul Noh  ;  Takahiro Nakayama  ;  Shinji Ohno  ;  Yoshiaki Rai  ;  Byeong-Woo Park  ;  Ashok Panneerselvam  ;  Mona El-Hashimy  ;  Tetiana Taran  ;  Tarek Sahmoud  ;  Yoshinori Ito 
 BREAST CANCER, Vol.21(6) : 703-714, 2014 
Journal Title
Issue Date
Adult ; Aged ; Androstadienes/administration & dosage ; Androstadienes/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Asian Continental Ancestry Group ; Breast Neoplasms/drug therapy* ; Breast Neoplasms/metabolism ; Everolimus ; Female ; Humans ; Middle Aged ; Quality of Life ; Receptor, ErbB-2/metabolism ; Sirolimus/administration & dosage ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives ; Sirolimus/pharmacology ; TOR Serine-Threonine Kinases/antagonists & inhibitors ; Treatment Outcome
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.

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.

TRIAL REGISTRATION: ClinicalTrials.gov NCT00863655.
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Park, Byeong Woo(박병우) ORCID logo https://orcid.org/0000-0003-1353-2607
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