Tominaga T, Shimozuma K, Hasegawa K, Hayashibara K, Nakahiro K, Nakao I, Katayama K, Fukuda M, Majima H, Aoyama H
Dept. of Surgery, Tokyo Metropolitan Komagome Hospital.
Gan To Kagaku Ryoho. 1994 Jun;21(7):1009-15.
An early phase II study of MST-16 for breast cancer was conducted with the participation of 9 hospitals. MST-16 was administered at three doses; 1) 1,600 mg/body for 5 consecutive days repeating every 4 weeks, 2) 1,200 mg/body for 10-14 consecutive days every 5 weeks, and 3) 1,200 mg/body daily for at least 4 weeks. A total of 28 patients were entered, and 27 cases were eligible. Twenty-five cases were evaluated for efficacy and 27 cases for safety. One patient achieved complete response, 2 patients attained partial response, and the response rate thus obtained was 12.0%. Major side effects observed were myelosuppression represented by leukopenia (69.2%) followed by gastrointestinal disorders. These symptoms, however, were reversible by the cessation of administration.
一项针对乳腺癌的MST - 16早期II期研究在9家医院参与下进行。MST - 16以三种剂量给药：1）1600毫克/体，连续5天，每4周重复一次；2）1200毫克/体，每5周连续10 - 14天；3）1200毫克/体，每日给药至少4周。共纳入28例患者，27例符合条件。25例患者接受疗效评估，27例患者接受安全性评估。1例患者达到完全缓解，2例患者达到部分缓解，由此获得的缓解率为12.0%。观察到的主要副作用是骨髓抑制，以白细胞减少（69.2%）为代表，其次是胃肠道疾病。然而，这些症状在停药后是可逆的。
