TY - JOUR
T1 - A randomized, double-blind, controlled study of exemestane versus anastrozole for the first-line treatment of postmenopausal Japanese women with hormone-receptor-positive advanced breast cancer
AU - Iwata, Hiroji
AU - Masuda, Norikazu
AU - Ohno, Shinji
AU - Rai, Yoshiaki
AU - Sato, Yasuyuki
AU - Ohsumi, Shozo
AU - Hashigaki, Satoshi
AU - Nishizawa, Yoshinori
AU - Hiraoka, Masahiro
AU - Morimoto, Tadaoki
AU - Sasano, Hironobu
AU - Saeki, Toshiaki
AU - Noguchi, Shinzaburo
N1 - Funding Information:
Acknowledgments We would like to thank all participating patients and their families as well as the investigators, study coordinators, and operations staff. Financial support this study was provided by Pfizer Japan. Medical editorial/writing assistance was provided by Bret A. Wing, PhD, at Accuverus, a division of ProEd Communications, Inc., and was funded by Pfizer Inc. We thank Katsumasa Kuroi (Breast Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital) and Yasuo Ohashi (Biostatistics, School of Public Health, University of Tokyo), who were members of the independent data monitoring committee, and Izoh Kimishima (Surgery, Northern Fukushima Medical Center), Hirotaka Iwase (Breast and Endocrine Surgery, School of Medicine Kumamoto University), and Ryo Tamura (Department of Diagnostic Radiology, Tohoku University Graduate School of Medicine), who were members of the expert radiologic images review committee.
Funding Information:
Conflict of interest Authors Nishizawa and Hashigaki are employees of Pfizer. Author Noguchi has received grant/research support and honoraria from Pfizer and AstraZeneca, and is an advisor for AstraZeneca. Author Hiraoka has received research funding from Varian Medical Systems and Mitsubishi Heavy Industries. Author Sasano has received an educational grant from Pfizer. All other authors declare that they have no conflict of interest.
PY - 2013/6
Y1 - 2013/6
N2 - The aromatase inhibitors exemestane and anastrozole are approved in Japan for first-line treatment of postmenopausal patients with advanced, hormone-receptor-positive breast cancer. This phase 3, randomized, double-blind study directly compared time to progression (TTP) for exemestane and anastrozole therapy in this patient population. Eligible patients were randomized to receive exemestane 25 mg or anastrozole 1 mg, each once daily. The primary endpoint was TTP based on assessment by an expert radiologic images review committee (ERIRC). Secondary endpoints included investigator-assessed TTP, time to treatment failure, overall survival, objective response rate, clinical benefit rate, and safety. A total 298 patients were randomized to receive exemestane (n = 149; mean age 63.4 years) or anastrozole (n = 149; mean age 64.0 years). Median ERIRC-assessed TTP was 13.8 and 11.1 months (hazard ratio = 1.007; 95 % confidence interval [CI]: 0.771, 1.317) and median investigator-assessed TTP was 13.8 and 13.7 months (hazard ratio = 1.059; 95 % CI: 0.816, 1.374) in the exemestane and anastrozole arms, respectively. Median overall survival was 60.1 months in the anastrozole arm and was not reached in the exemestane arm at data cutoff. The objective response rate was 43.9 % (95 % CI: 35.3, 52.8) and 39.1 % (95 % CI: 30.6, 48.1) in the exemestane and anastrozole arms, respectively. Treatment-related adverse events grade ≥3 occurred in 9.4 and 6.0 % of patients, and treatment-related serious adverse events occurred in 4.0 and 3.4 % of patients in the exemestane and anastrozole arms, respectively. In this study, the efficacy and safety profiles of exemestane were similar to those of anastrozole in Japanese patients with advanced, hormone-receptor-positive breast cancer; however, TTP non-inferiority of exemestane versus anastrozole was not confirmed.
AB - The aromatase inhibitors exemestane and anastrozole are approved in Japan for first-line treatment of postmenopausal patients with advanced, hormone-receptor-positive breast cancer. This phase 3, randomized, double-blind study directly compared time to progression (TTP) for exemestane and anastrozole therapy in this patient population. Eligible patients were randomized to receive exemestane 25 mg or anastrozole 1 mg, each once daily. The primary endpoint was TTP based on assessment by an expert radiologic images review committee (ERIRC). Secondary endpoints included investigator-assessed TTP, time to treatment failure, overall survival, objective response rate, clinical benefit rate, and safety. A total 298 patients were randomized to receive exemestane (n = 149; mean age 63.4 years) or anastrozole (n = 149; mean age 64.0 years). Median ERIRC-assessed TTP was 13.8 and 11.1 months (hazard ratio = 1.007; 95 % confidence interval [CI]: 0.771, 1.317) and median investigator-assessed TTP was 13.8 and 13.7 months (hazard ratio = 1.059; 95 % CI: 0.816, 1.374) in the exemestane and anastrozole arms, respectively. Median overall survival was 60.1 months in the anastrozole arm and was not reached in the exemestane arm at data cutoff. The objective response rate was 43.9 % (95 % CI: 35.3, 52.8) and 39.1 % (95 % CI: 30.6, 48.1) in the exemestane and anastrozole arms, respectively. Treatment-related adverse events grade ≥3 occurred in 9.4 and 6.0 % of patients, and treatment-related serious adverse events occurred in 4.0 and 3.4 % of patients in the exemestane and anastrozole arms, respectively. In this study, the efficacy and safety profiles of exemestane were similar to those of anastrozole in Japanese patients with advanced, hormone-receptor-positive breast cancer; however, TTP non-inferiority of exemestane versus anastrozole was not confirmed.
KW - Advanced breast cancer
KW - Anastrozole
KW - Exemestane
KW - Hormone receptor
KW - Plasma lipoprotein
KW - Postmenopausal breast cancer
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U2 - 10.1007/s10549-013-2573-3
DO - 10.1007/s10549-013-2573-3
M3 - Article
C2 - 23715630
AN - SCOPUS:84878759120
VL - 139
SP - 441
EP - 451
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 2
ER -
