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(2''R)-4'-0-四氢吡喃阿霉素(THP)用于血液系统恶性肿瘤患者的II期研究。THP研究组

[A phase II study of (2''R)-4'-0-tetrahydropyranyladriamycin (THP) in patients with hematological malignancies. THP Study Group].

作者信息

Kimura K

出版信息

Gan To Kagaku Ryoho. 1986 Feb;13(2):368-75.

PMID:3947112
Abstract

A Phase II study of a new anthracycline, (2''R)-4'-0-tetrahydropyranyladriamycin (THP), was conducted in 162 patients with various hematological malignancies in a multi-institutional cooperative study. THP was given intravenously at a dose of either 10-30 mg/body for 3-5 consecutive days or 40-60 mg/body at 3-week intervals. Of 22 patients with AML, complete remission (CR) was observed in 2 patients and partial remission (PR) in 2. Of 18 patients with ALL, CR was observed in 5 and PR in 3. Of 68 patients with NHL, CR was observed in 11 and PR in 22. Of 8 patients with HD, CR was observed in 4 and PR in 2. One CML case showed CR and one ATL case showed PR. PR was noted in one of 2 patients with mycosis fungoides. Overall remission rate was 43.1% (CR 23 cases and PR 33 cases). The predominant toxicity was myelosuppression. Leukopenia (less than 4,000/mm3) was noted in 67 (77.6%) and thrombocytopenia (less than 10 X 10(4)/mm3) in 24 (27.0%). Nausea/vomiting and anorexia were common, and were observed in 61 (43.3%) and 65 (46.1%) cases, respectively. Hair loss and cardiotoxicity were mild and recovered quickly on discontinuation of THP. Thus, THP was found to be effective for various hematological malignancies including acute leukemia and malignant lymphoma.

摘要

一项关于新型蒽环类药物(2''R)-4'-O-四氢吡喃阿霉素(THP)的II期研究在一项多机构合作研究中对162例患有各种血液系统恶性肿瘤的患者进行。THP静脉给药,剂量为10 - 30mg/体,连续3 - 5天,或40 - 60mg/体,间隔3周。22例急性髓系白血病(AML)患者中,2例完全缓解(CR),2例部分缓解(PR)。18例急性淋巴细胞白血病(ALL)患者中,5例CR,3例PR。68例非霍奇金淋巴瘤(NHL)患者中,11例CR,22例PR。8例霍奇金病(HD)患者中,4例CR,2例PR。1例慢性粒细胞白血病(CML)患者显示CR,1例成人T细胞白血病(ATL)患者显示PR。2例蕈样肉芽肿患者中有1例出现PR。总缓解率为43.1%(CR 23例,PR 33例)。主要毒性为骨髓抑制。67例(77.6%)出现白细胞减少(低于4000/mm³),24例(27.0%)出现血小板减少(低于10×10⁴/mm³)。恶心/呕吐和厌食很常见,分别在61例(43.3%)和65例(46.1%)中观察到。脱发和心脏毒性较轻,停用THP后恢复迅速。因此,发现THP对包括急性白血病和恶性淋巴瘤在内的各种血液系统恶性肿瘤有效。

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Gan To Kagaku Ryoho. 1986 Apr;13(4 Pt 1):1032-7.

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