[Phase II study of (2''R)-4'-O-tetrahydropyranyladriamycin (THP) in patients with solid tumors. Multi-Institutional Cooperative Study].
[Phase II study of (2''R)-4'-O-tetrahydropyranyladriamycin (THP) in patients with solid tumors. Multi-Institutional Cooperative Study].
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[(2R)-4-O-四氢吡喃霉素 (THP) 在实体瘤患者中的 II 期研究。
DOI：
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发表时间：
1986
期刊：
影响因子：
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通讯作者：
Y. Koyama
中科院分区：
文献类型：
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作者：
T. Saito;Y. Kasai;A. Wakui;H. Furue;H. Majima;H. Nitani;T. Niijima;C. Takeda;O. Abe;Y. Koyama
由44家合作研究机构开展了（2 '' R）-4 '-O-四氢吡喃阿霉素（THP）在各种实体瘤患者中的II期研究。700例五十六例静脉给药患者入组本研究。其中，对499例患者进行了客观缓解评价。THP主要以40 ~ 60 mg/人，每3 ~ 4周或20 ~ 30 mg/人，每周1次的剂量给药。头颈部癌、胃癌、乳腺癌、膀胱癌、肾盂及泌尿系肿瘤、卵巢癌、子宫癌的有效率分别为18.8%、13.1%、21.4%、22.2%、30%、26.8%、24.2%。完全缓解10例，部分缓解67例，总有效率15.4%。不良反应与I期研究中先前报告的相似，包括胃肠道毒性和骨髓抑制。脱发和口腔炎是其他蒽环类药物的主要副作用，但相当轻微。ECG改变的发生率为2.8%，未观察到充血性心力衰竭。
A Phase II Study of (2''R)-4'-O-tetrahydropyranyladriamycin (THP) in patients with various solid tumors was carried out by 44 cooperative study institutions. Seven hundred fifty-six patients administered the drug intravenously were entered into this study. Of these, 499 patients were evaluated for objective responses. THP was given mainly at a dose of 40 to 60 mg/body every 3 to 4 weeks or 20 to 30 mg/body once a week. Response rates were 18.8% for head and neck cancer, 13.1% for stomach cancer, 21.4% for breast cancer, 22.2% for bladder cancer, 30% for renal pelvic and urinary tract tumor, 26.8% for ovarian cancer and 24.2% for uterine cancer. Overall response rate was 15.4% including 10 complete responses and 67 partial responses. Adverse reactions were similar to those previously reported in the phase I study, including gastrointestinal toxicities and myelosuppression. Alopecia and stomatitis, which are major side effects of other anthracyclines, were rather mild. Incidence of ECG changes was 2.8% and no congestive heart failure was observed.