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Title: Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2
Authors: 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
Osaka University
Osaka National Hospital
Aichi Cancer Center Hospital and Research Institute
National Cancer Center Hospital East
Gunma University Hospital
Prince of Songkla University
Mahidol University
Tokai University
Tokyo Metropolitan Komagome Hospital
Kumamoto University
Osaka Medical Center for Cancer and Cardiovascular Diseases
National Shikoku Cancer Center Hospital
Korea Cancer Center Hospital
National Kyushu Cancer Center
Sagara Hospital
Yonsei University College of Medicine
Novartis Pharmaceuticals Corporation
Cancer Institute Hospital of Japan Foundation for Cancer Research
Keywords: Medicine
Issue Date: 1-Jan-2013
Citation: Breast Cancer. Vol.21, No.6 (2013), 703-714
Abstract: © 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.
ISSN: 18804233
Appears in Collections:Scopus 2011-2015

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