Tosi P, Visani G, Colombini R, Verlicchi F, Benfenati D, Cenacchi A, Russo D, Zuffa E, Papadopulu P, Tura S
Haematologica. 1989 Nov-Dec;74(6):555-8.
The antileukemic activity of Bisantrene, a new anthracene derivative, has been evaluated in a phase II clinical study in 10 patients affected by refractory or primary relapsed ANLL. The patients received an induction course consisting of 250 mg/m2/day for 7 days followed, in case of CR, by 250 mg/m2/day for 3 days (consolidation treatment). In case of partial response a reinduction course (250 mg/m2/day for 3 days) was administered. Four out of the 10 patients obtained CR (3 of them after a single induction course). No significant toxic effect was noticed, apart from fever (due to myelosuppression) and hypotension in one patient who soon recovered without residual effects. These preliminary results could suggest further evaluation of Bisantrene in association with other drugs in both relapsed patients and those at onset of the disease.
新型蒽衍生物比山屈的抗白血病活性已在一项II期临床研究中进行评估,该研究纳入了10例难治性或原发性复发性急性非淋巴细胞白血病(ANLL)患者。患者接受一个诱导疗程,剂量为250 mg/m²/天,持续7天,若达到完全缓解(CR),后续给予250 mg/m²/天,持续3天(巩固治疗)。若为部分缓解,则给予再次诱导疗程(250 mg/m²/天,持续3天)。10例患者中有4例达到CR(其中3例在单次诱导疗程后达到)。除了发热(由于骨髓抑制)和1例出现低血压但很快恢复且无残留影响的患者外,未观察到明显的毒性作用。这些初步结果表明,对于复发患者和疾病初发患者,比山屈与其他药物联合使用可能值得进一步评估。