Kimura Morihiko, Tominaga Takeshi, Kimijima Izo, Takatsuka Yuichi, Takashima Shigemitsu, Nomura Yasuo, Kasumi Fujio, Yamaguchi Akihiro, Masuda Norikazu, Noguchi Shinzaburo, Eshima Nobuoki
Department of Surgery, Gunma Cancer Center, Ota, Japan,
Breast Cancer. 2014 May;21(3):275-83. doi: 10.1007/s12282-012-0394-6. Epub 2012 Sep 12.
Toremifene, a selective estrogen receptor modulator, is used as adjuvant therapy for postmenopausal patients with breast cancer in Japan. For Japanese patients, however, only limited data are available on the efficacy and safety profile of toremifene. To establish the long term efficacy and safety of toremifene for Japanese patients, we conducted a prospective, multicenter, randomized phase III trial comparing toremifene and tamoxifen.
The subjects were postmenopausal Japanese patients who had undergone surgery for node-negative breast cancer. Toremifene or tamoxifen was administered for 2 years. The primary endpoint was demonstration of the non-inferiority of toremifene compared with tamoxifen in respect of 5-year survival. Secondary endpoints were cumulative overall survival, cumulative disease-free survival, effects on lipid profiles, and adverse events.
A total of 253 patients were enrolled. The baseline characteristics of the two treatment groups were well-balanced. Median follow-up was 66.5 months. Five-year survival was similar for toremifene and tamoxifen (97.0 vs. 96.9 %; 90 % confidence interval -3.9 to 4.1), indicating that toremifene is not inferior to tamoxifen for postmenopausal Japanese patients with early breast cancer. Cumulative overall survival and cumulative disease-free survival were also very similar for toremifene and tamoxifen (97.5 vs. 97.3 %, log-rank test P = 0.9458; 88.4 vs. 90.6 %, log-rank test P = 0.3359, respectively). Adverse events in both groups were similar and mostly mild or moderate. Thus, both are equally effective and well tolerated.
Our results suggest that the efficacy and safety of toremifene and tamoxifen are equivalent for postmenopausal Japanese patients with early breast cancer.
托瑞米芬是一种选择性雌激素受体调节剂，在日本被用作绝经后乳腺癌患者的辅助治疗药物。然而，对于日本患者，关于托瑞米芬疗效和安全性的可用数据有限。为确定托瑞米芬对日本患者的长期疗效和安全性，我们开展了一项前瞻性、多中心、随机III期试验，比较托瑞米芬和他莫昔芬。
受试者为绝经后接受过淋巴结阴性乳腺癌手术治疗的日本患者。托瑞米芬或他莫昔芬给药2年时间。主要终点为证明托瑞米芬在5年生存率方面不劣于他莫昔芬。次要终点为累积总生存率、累积无病生存率、对血脂的影响以及不良事件。
共纳入253例患者。两个治疗组的基线特征均衡良好。中位随访时间为66.5个月。托瑞米芬组和他莫昔芬组的5年生存率相似（97.0%对96.9%；90%置信区间为-3.9至4.1），表明托瑞米芬对于绝经后日本早期乳腺癌患者并不劣于他莫昔芬。托瑞米芬组和他莫昔芬组的累积总生存率和累积无病生存率也非常相似（分别为97.5%对97.3%，对数秩检验P = 0.9458；88.4%对90.6%，对数秩检验P = 0.3359）。两组的不良事件相似，大多为轻度或中度。因此，二者疗效相当且耐受性良好。
我们的结果表明，对于绝经后日本早期乳腺癌患者，托瑞米芬和他莫昔芬的疗效及安全性相当。
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