Masaoka T, Oguma S, Shibata H, Nagai K, Horiuchi A, Kitani T, Yonezawa T, Kawagoe H, Yasunaga K
Gan To Kagaku Ryoho. 1986 Sep;13(9):2793-9.
A phase II study of mitoxantrone was conducted on acute leukemia. Mitoxantrone 4 mg/m2/day was administered for 5 consecutive days in most cases. For cases showing insufficient decrease of leukemic cells even at nadir, a second course of the same regimen was given. Enrolled were 38 cases in total, of which 34 were evaluable. In 14 cases for first remission induction, the drug efficacy was evaluated at the completion of the first or second course, then further combination drug therapy followed immediately. Of 14 cases for first remission induction, 6, or 43%, achieved CR and of 20 cases for reinduction of remission, 4, or 20%, achieved CR. Two out of 7 cases of ALL (29%) and 8 out of 27 cases of ANLL (30%) achieved CR. Of 19 cases with previous anthracycline therapy, 4 cases, or 21%, achieved CR, showing that the cross-resistance was partial. Gastrointestinal symptoms were the main side effects, but cases of symptoms severer than grade 3 were very rare. Cardiotoxicity occurred at a rate as low as 11%. Mitoxantrone thus appears to be a promising drug for the treatment of acute leukemia.
开展了一项米托蒽醌治疗急性白血病的II期研究。多数情况下，米托蒽醌以4 mg/m²/天的剂量连续给药5天。对于即使在最低点时白血病细胞减少仍不足的病例，给予相同方案的第二个疗程。总共纳入38例患者，其中34例可评估。在14例首次缓解诱导病例中，在第一个或第二个疗程结束时评估药物疗效，然后立即进行进一步的联合药物治疗。在14例首次缓解诱导病例中，6例（43%）达到完全缓解（CR）；在20例再次诱导缓解病例中，4例（20%）达到CR。7例急性淋巴细胞白血病（ALL）中有2例（29%）达到CR，27例急性非淋巴细胞白血病（ANLL）中有8例（30%）达到CR。在19例既往接受过蒽环类药物治疗的病例中，4例（21%）达到CR，表明存在部分交叉耐药。胃肠道症状是主要副作用，但严重程度超过3级的病例非常罕见。心脏毒性发生率低至11%。因此，米托蒽醌似乎是一种有前景的治疗急性白血病的药物。
