Taguchi T, Koyama H, Yayoi K, Wada T, Takatsuka Y, Sonoo H, Morimoto K, Tominaga T, Abe R, Enomoto K
Dept. of Surgery, Center for Adult Diseases, Osaka.
Gan To Kagaku Ryoho. 1995 Mar;22(4):477-94.
A comparative phase II study was performed with different doses of TAP-144-SR in ER-positive or ER-unknown premenopausal patients with advanced or recurrent breast cancer. One hundred and six patients were randomly allocated to either 3.75 mg or 7.5 mg treatment by a centralized telephone registration system. TAP-144-SR was administered sc at 4-week intervals for 12 weeks (a total of 3 injections). Ninety-five cases were evaluated with the response rate of 30.4% (14/46) in the 3.75 mg group and 24.5% (12/49) in the 7.5 mg group, respectively. Serum estradiol was decreased to postmenopausal level (< 30 pg/ml) within 3-4 weeks after the first dose in the both dose groups, and this suppression was maintained throughout the treatment period. The adverse reactions most frequently observed were climacteric disturbances like hot flashes which was likely to be due to the hypoestrogen status. In conclusion, there was no significant difference between both dose groups in terms of response rates, adverse effects, and hormonal suppression. Therefore, the lower dose is recommended for the further study.
对不同剂量的TAP-144-SR进行了一项比较性II期研究，研究对象为雌激素受体（ER）阳性或ER情况未知的绝经前晚期或复发性乳腺癌患者。通过集中电话登记系统将106例患者随机分配至3.75mg或7.5mg治疗组。TAP-144-SR每4周皮下注射一次，共注射12周（总计3次注射）。95例患者接受评估，3.75mg组的缓解率为30.4%（14/46），7.5mg组为24.5%（12/49）。两个剂量组在首次给药后3-4周内血清雌二醇均降至绝经后水平（<30pg/ml），且在整个治疗期间这种抑制作用持续存在。最常观察到的不良反应是潮热等更年期紊乱，这可能归因于雌激素水平降低。总之，两个剂量组在缓解率、不良反应和激素抑制方面均无显著差异。因此，建议采用较低剂量进行进一步研究。
