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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 |
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| 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 |
| Institution: | 1. Department of Breast and Endocrine Surgery, Osaka University, Osaka, Japan 2. Department of Surgery, Breast Oncology, National Hospital Organization, Osaka National Hospital, Osaka, Japan 3. Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan 4. Department of Breast Oncology, National Cancer Center Hospital East, Kashiwa, Japan 5. Breast and Endocrine Surgery, Gunma University Hospital, Maebashi, Japan 6. Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand 7. Siriraj Hospital, Mahidol University, Bangkok, Thailand 8. Department of Breast and Endocrine Surgery, Tokai University Hospital, Isehara, Japan 9. Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan 10. Department of Breast and Endocrine Surgery, Kumamoto University, Kumamoto, Japan 11. Department of Breast and Endocrine Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan 12. Department of Breast Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan 13. Department of Surgery, Korea Cancer Center Hospital, Seoul, Korea 14. Department of Breast Oncology, National Kyushu Cancer Center, Fukuoka, Japan 15. Department of Breast Surgery, Hakuaikai Sagara Hospital, Kagoshima, Japan 16. Department of Surgery, Yonsei University College of Medicine, Seoul, Korea 17. Department of Global Oncology Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA 18. Department of Medical Oncology, Breast Oncology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan |
| Abstract: | BackgroundThe 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.MethodsPatients 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.ResultsOf 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.ConclusionAdding 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. |
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