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

被引：37

作者：

Iwata, Hiroji ^{[1
]}

Masuda, Norikazu ^{[2
]}

Ohno, Shinji ^{[3
]}

Rai, Yoshiaki ^{[4
]}

Sato, Yasuyuki ^{[5
]}

Ohsumi, Shozo ^{[6
]}

Hashigaki, Satoshi ^{[7
]}

Nishizawa, Yoshinori ^{[7
]}

Hiraoka, Masahiro ^{[8
]}

Morimoto, Tadaoki ^{[9
]}

Sasano, Hironobu ^{[10
]}

Saeki, Toshiaki ^{[11
]}

Noguchi, Shinzaburo ^{[12
]}

机构：

[1] Aichi Canc Ctr Hosp, Nagoya, Aichi, Japan

[2] Osaka Natl Hosp, Osaka, Japan

[3] Kyushu Natl Canc Ctr, Fukuoka, Japan

[4] Sagara Hosp, Kagoshima, Japan

[5] Nagoya Med Ctr, Nagoya, Aichi, Japan

[6] Shikoku Canc Ctr, Matsuyama, Ehime, Japan

[7] Pfizer Japan Inc, Tokyo, Japan

[8] Kyoto Univ, Grad Sch Med, Kyoto, Japan

[9] Shikoku Cent Hosp Mutual Aid, Matsuyama, Ehime, Japan

[10] Tohoku Univ, Sch Med, Sendai, Miyagi 980, Japan

[11] Saitama Med Univ, Int Med Ctr, Saitama, Japan

[12] Osaka Univ, Grad Sch Med, Dept Breast & Endocrine Surg, Suita, Osaka 5650871, Japan

来源：

BREAST CANCER RESEARCH AND TREATMENT | 2013年 / 139卷 / 02期

关键词：

Exemestane; Anastrozole; Advanced breast cancer; Hormone receptor; Postmenopausal breast cancer; Plasma lipoprotein; ADJUVANT ENDOCRINE THERAPY; FIRST-LINE THERAPY; AROMATASE INHIBITOR; PHASE-III; MEGESTROL-ACETATE; GROUP EFFICACY; TAMOXIFEN; LETROZOLE; MULTICENTER; MANAGEMENT;

D O I：

10.1007/s10549-013-2573-3

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 C3 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.

引用

页码：441 / 451

页数：11

共 44 条

[1]

American Cancer Society, 2011, CANC FACTS FIG 2011

[2] Toxicity of Adjuvant Endocrine Therapy in Postmenopausal Breast Cancer Patients: A Systematic Review and Meta-analysis [J].