Aoyama H, Asaishi K, Abe R, Kajiwara T, Enomoto K, Yoshida M, Ohasi Y, Tominaga T, Abe O
Dept. of Surgery, National Nagoya Hospital.
Gan To Kagaku Ryoho. 1994 Mar;21(4):477-84.
A multi-institutional late-phase II clinical trial of CGS 16949A was conducted at the dose of 1 mg twice daily in postmenopausal patients with advanced or recurrent breast cancer. Seventy patients entered into the study; 65 were eligible and 53 were complete cases. There were 3 CR, 11 PR, 10 long-NC, 14 NC and 25 PD with an overall response rate of 22.2% in 63 evaluable cases. The median period of overall duration of responses was 327.5 days. There were 22 cases that drug was found useful or better, and global usefulness rate was 33.8%. Forty six (76.7%) of patients experienced no side effects in this therapy. Grade 2 toxicities included anorexia (1 pt.), feeling of distension of abdomen (1 pt.), vomiting (1 pt.), fatigue (1 pt.), and only one patient experienced Grade 3 toxicity (anorexia). Grade 2 laboratory abnormalities were confirmed in two patients; one with elevated gamma-GTP and another with elevated LDH, and both were in the absence of liver metastasis. From these results, it is concluded that CGS16949A seemed to be a useful hormonal agent in the treatment of postmenopausal breast cancer.
一项关于CGS 16949A的多机构II期晚期临床试验，针对绝经后晚期或复发性乳腺癌患者，采用每日两次、每次1毫克的剂量进行。70名患者进入研究；65名符合条件，53名是完整病例。在63例可评估病例中，有3例完全缓解（CR）、11例部分缓解（PR）、10例长期病情稳定（long-NC）、14例病情稳定（NC）和25例疾病进展（PD），总缓解率为22.2%。缓解的总持续时间中位数为327.5天。有22例患者发现药物有效或效果更好，总体有效率为33.8%。46名（76.7%）患者在该治疗中未出现副作用。2级毒性包括厌食（1例）、腹胀感（1例）、呕吐（1例）、疲劳（1例），只有1例患者出现3级毒性（厌食）。两名患者确认有2级实验室异常；1例γ-谷氨酰转肽酶（gamma-GTP）升高，另1例乳酸脱氢酶（LDH）升高，且两人均无肝转移。从这些结果得出结论，CGS16949A似乎是治疗绝经后乳腺癌的一种有用的激素药物。
