Taguchi T, Wakui A, Niitani H, Furue H, Majima H, Ota K, Ariyoshi H, Hattori T, Sugimachi K, Tsukagoshi S
Research Institute for Microbial Diseases, Osaka University.
Gan To Kagaku Ryoho. 1997 Aug;24(10):1253-61.
An early Phase II study with TUT-7 (menogaril), a new anthracycline antitumor antibiotic, was conducted in patients with various malignant tumors at 81 departments of 65 institutions nationwide. One course of TUT-7 treatment consisted of seven (7) or fourteen (14) consecutive days of administration at 75 or 100 mg/body/day with two-week drug withdrawal; at least two courses of treatment were given in principle. Among the 165 patients registered, 145 patients were eligible and 128 patients were evaluable for antitumor efficacy. In 11 patients with malignant lymphoma, one (1) had CR and five (5) had PR (54.5%); in three (3) patients with prostate cancer, one (1) had PR (33.3%); and in 12 patients with uterine cervical cancer, two (2) had PR (16.7%). Adverse drug reactions frequently observed were digestive organ disorders (anorexia and nausea/vomiting) and malaise. The abnormality in laboratory tests observed frequently was myelosuppression (leukopenia and neutropenia).
一项针对新型蒽环类抗肿瘤抗生素TUT-7（米诺加 ril）的早期II期研究在全国65家机构的81个科室中对患有各种恶性肿瘤的患者进行。TUT-7治疗的一个疗程包括连续7天或14天给药，剂量为75或100毫克/体/天，停药两周；原则上至少给予两个疗程的治疗。在登记的165例患者中，145例符合条件，128例可评估抗肿瘤疗效。在11例恶性淋巴瘤患者中，1例完全缓解（CR），5例部分缓解（PR）（54.5%）；在3例前列腺癌患者中，1例部分缓解（33.3%）；在12例子宫颈癌患者中，2例部分缓解（16.7%）。经常观察到的药物不良反应是消化器官紊乱（厌食和恶心/呕吐）和不适。经常观察到的实验室检查异常是骨髓抑制（白细胞减少和中性粒细胞减少）。
