Kimura K, Yoshikawa S, Yoshikawa H, Yamada K, Hirano M, Ikeda Y, Ohta K, Ohara K, Kobayashi M, Shirakawa S
Gan To Kagaku Ryoho. 1986 Aug;13(8):2573-80.
A phase II study of acute leukemia with mitoxantrone (MIT) was conducted by the Tokai Blood Cancer Study Group. The drug efficacy was evaluable in 31 cases (14 of ALL and 17 of ANLL) out of 37 entered at 13 institutions. Five cases were for first induction remission and 26 cases for re-induction remission; ages ranged from 7 to 69 (median: 43); 18 males and 13 females. MIT dosage was intravenous injection of 3-6 mg/m2/day X 5 consecutive days as a rule. Of the 14 cases of ALL, 2 achieved CR and 3, PR; the efficacy rate was 36%. Of the 17 cases of ANLL, 4 achieved CR and 3, PR: the efficacy rate was 41%. Of the 5 first induction remission cases, 3 achieved CR, and 1, PR, the efficacy rate being 80%, whereas out of the 26 re-induction remission cases, 3 achieved CR, 5 PR, and the efficacy rate was 31%. In 3 of 6 cases of CR, large cumulative doses of anthracyclines such as DNR 140 mg plus ACR 410 mg, DNR 360 mg plus ADR 120 mg plus ADR 120 mg, and DNR 240 mg plus ADR 540 mg, had been administered previously in each case. As to complications, sepsis and other infections were observed at the rates of 15% and 32%, respectively, from which it was inferred that in therapy with mitoxantrone, leukopenia should be observed carefully. The major non-hematological toxicity was gastrointestinal symptoms, but the degree was mild. From the results of this trial, it was concluded that mitoxantrone was an effective form of therapy for acute leukemia. Further clinical trials on mitoxantrone in combination with other drugs are scheduled.
东海血液癌症研究组开展了一项使用米托蒽醌（MIT）治疗急性白血病的II期研究。在13家机构登记入组的37例患者中，31例（急性淋巴细胞白血病[ALL]14例，急性非淋巴细胞白血病[ANLL]17例）的药物疗效可评估。5例为首次诱导缓解，26例为再次诱导缓解；年龄范围为7至69岁（中位数：43岁）；男性18例，女性13例。米托蒽醌剂量通常为静脉注射3 - 6mg/m²/天，连续5天。在14例ALL患者中，2例达到完全缓解（CR），3例部分缓解（PR）；有效率为36%。在17例ANLL患者中，4例达到CR，3例PR；有效率为41%。在5例首次诱导缓解患者中，3例达到CR，1例PR，有效率为80%，而在26例再次诱导缓解患者中，3例达到CR，5例PR，有效率为31%。在6例CR患者中的3例中，此前各例分别曾给予大累积剂量的蒽环类药物，如柔红霉素（DNR）140mg加阿克拉霉素（ACR）410mg、DNR 360mg加阿霉素（ADR）120mg加ADR 120mg、以及DNR 240mg加ADR 540mg。关于并发症，败血症和其他感染的发生率分别为15%和32%，由此推断在米托蒽醌治疗中，应密切观察白细胞减少情况。主要的非血液学毒性为胃肠道症状，但程度较轻。根据该试验结果，得出结论：米托蒽醌是治疗急性白血病的一种有效治疗方式。计划进一步开展米托蒽醌与其他药物联合的临床试验。
