Ibuka T, Sasaki T, Imai K, Sakai Y
Gan To Kagaku Ryoho. 1986 Aug;13(8):2612-7.
A phase II study of mitoxantrone (MIT) was performed in 13 cases of refractory malignant lymphoma, 1 of Hodgkin's disease and 12 of non-Hodgkin lymphoma. The twelve non-Hodgkin lymphomas were previously treated with adriamycin. MIT was diluted in 50 approximately 100 ml saline solution and intravenously administered by drip infusion in 15 approximately 30 minutes. The dose of MIT was 3 mg/m2/day for 5 days (A) or 10 approximately 14 mg/m2/day, for 1 day (B). There were 2 CR, 1 MR, 1 NC and 2 PD among 8 cases treated by schedule A, and two cases were not evaluable. With schedule B, there was 1 MR among 5 cases, and four cases were not evaluable. In the 7 evaluable cases, remission rate was 2/7 (29%) with remission durations of 6+ weeks and 55 weeks. The dose limiting toxicity was granulocytopenia but no serious infection was observed. With schedule A, it was difficult to repeat the treatment every 3 weeks because of the delay in granulocyte recovery. Gastrointestinal toxicities were observed in about half of the treatment courses but they were mild in degree. A prolongation of QTc (greater than 0.44) was observed in 3 cases (4 treatment courses) among 9 cases (10 treatment courses) whose baseline QTc values were within normal limits. Baseline QTc values were above the normal limit in 4 cases and in two of them, QTc showed further prolongation after MIT treatment. No arrhythmia or congestive heart failure was observed.
对13例难治性恶性淋巴瘤患者进行了米托蒽醌（MIT）的II期研究，其中1例为霍奇金病，12例为非霍奇金淋巴瘤。12例非霍奇金淋巴瘤患者此前接受过阿霉素治疗。将MIT稀释于约50至100ml生理盐水中，在15至30分钟内静脉滴注给药。MIT的剂量为3mg/m²/天，共5天（方案A）或10至14mg/m²/天，给药1天（方案B）。在按方案A治疗的8例患者中，有2例完全缓解（CR）、1例部分缓解（MR）、1例病情稳定（NC）和2例病情进展（PD），另有2例无法评估。按方案B治疗的5例患者中，有1例部分缓解，4例无法评估。在7例可评估的患者中，缓解率为2/7（29%），缓解持续时间分别为6周以上和55周。剂量限制性毒性为粒细胞减少，但未观察到严重感染。采用方案A时，由于粒细胞恢复延迟，难以每3周重复进行治疗。约一半的治疗疗程观察到胃肠道毒性，但程度较轻。在9例（10个治疗疗程）基线QTc值在正常范围内的患者中，有3例（4个治疗疗程）观察到QTc延长（大于0.44）。4例患者的基线QTc值高于正常范围，其中2例在MIT治疗后QTc进一步延长。未观察到心律失常或充血性心力衰竭。
