演題抄録

プレナリーセッション

開催概要
開催回
第51回・2013年・京都
 

Ph III BOLERO-2 study of everolimus plus exemestane: Japanese subgroup analysis

演題番号 : PS2-2

[筆頭演者]
Norikazu Masuda:1 
[共同演者]
Yoshinori Ito:2、Hiroji Iwata:3、Hirofumi Mukai:4、Jun Horiguchi:5、Yutaka Tokuda:6、Katsumasa Kuroi:7、Tarek Sahmoud:8、Nobutsugu Ohno:9、Shinzaburo Noguchi:10

1:Department of Surgery, Breast Oncology, National Hospital Organization, Osaka National Hospital, Japan、2:Breast Medical Oncology, Breast Oncology Center, Cancer Institute Hospital of JFCR, Japan、3:Department of Breast Oncology, Aichi Cancer Center Hospital, Japan、4:Divisions of Oncology/Hematology, National Cancer Center Hospital East, Japan、5:Department of Thoracic and Visceral Organ Surgery, Gunma University Hospital, Japan、6:Department of Breast and Endocrine Surgery, Tokai University Hospital, Japan、7:Division of Breast Surgery, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Japan、8:Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States of America、9:Novartis Pharma K.K., Japan、10:Department of Breast and Endocrine Surgery, Osaka University Hospital, Japan

 

Background: In BOLERO-2, an international study, mTOR inhibitor everolimus (EVE) + exemestane (EXE) more than doubled progression-free survival (PFS) vs placebo (PBO) + EXE (6.9 months vs. 2.8 months) in patients with hormone-receptor-positive (HR+), HER2-negative advanced breast cancer recurring or progressing on/after nonsteroidal aromatase inhibitors (NSAI) (Baselga J, et al. NEJM 2012). Ito et al. reported Japanese patients in the trial treated with EVE + EXE showed similar PFS benefits as the overall population and a manageable safety profile (JSMO 2012). This report presents the updated data including final PFS at 18 months follow-up from the Japanese population.
Methods: The primary endpoint was PFS by local assessment. Secondary endpoints included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and safety. Eligible patients were randomized (2:1) to EVE, (10mg/day) or PBO, with both arms receiving EXE (25mg/day). Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent.
Results: Of 724 patients from 24 countries enrolled in this study, 106 patients were Japanese (71 EVE+EXE and 35 PBO + EXE). The final PFS in the Japanese population showed the addition of EVE to EXE prolonged median PFS (8.5 months vs 4.2 months; P = 0.012), increased ORR (22.5% vs 0%), and CBR (62.0% vs 25.7%) compared with PBO+EXE. In the EVE + EXE arm, most common adverse events (AEs) were stomatitis (88.7%), rash (54.9%), and dysgeusia (31.0%). Although the incidence of non-infectious lung-related AEs were 31.0% (all grade), which was higher than in the overall population, the majority of these events were grade 1 or 2 (4.2% of grade3 and 0% of grade4) and manageable.
Conclusion: These updated results were consisting with previous report. Therefore, EVE + EXE is a promising new therapeutic option for Japanese women with HR+, HER2-negative advanced breast cancer who have recurred/progressed on or after NSAIs.

キーワード

臓器別:乳腺

手法別:分子標的治療

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