Ideström K, Kimby E, Björkholm M, Mellstedt H, Engstedt L, Gahrton G, Johansson B, Killander D, Robérts K H, Stalfelt A M, Udén A M, Wadman B, Wählby S
Eur J Cancer Clin Oncol. 1982 Nov;18(11):1117-23. doi: 10.1016/0277-5379(82)90092-x.
Prednimustine, a new antitumour drug, is a chlorambucil ester of prednisolone. The present prospective randomized study compares the effect of continuous low-dose (B) and intermittent high-dose (C) prednimustine in previously untreated patients with progressive CLL and WDLL. The control group received continuous chlorambucil/prednisolone therapy (A). One hundred and eighteen patients, 88 CLL and 30 WDLL, were evaluable. Response to therapy (greater than 50% improvement) was noted in 61, 55 and 57% in groups A, B and C respectively. The difference was not statistically significant. Time to response, response duration and survival did not show any differences between the groups. Responding patients survived longer than patients with stationary and progressive disease. Median survival time was 72 months from diagnosis and 52 months from start of therapy, with no differences between the treatment groups. Toxicity of prednimustine was usually mild and similar to that of the two constituents. Treatment schedule C showed a slight advantage with regard to frequency of side effects. In conclusion, in this study the therapeutic effect of prednimustine was equal to that of its constituents administrated separately.
泼尼莫司汀是一种新型抗肿瘤药物，是泼尼松龙的苯丁酸氮芥酯。本前瞻性随机研究比较了持续低剂量（B组）和间歇高剂量（C组）泼尼莫司汀对既往未治疗的进行性慢性淋巴细胞白血病（CLL）和惰性淋巴细胞淋巴瘤（WDLL）患者的疗效。对照组接受持续苯丁酸氮芥/泼尼松龙治疗（A组）。118例患者可进行评估，其中88例CLL患者和30例WDLL患者。A、B、C三组的治疗缓解率（改善超过50%）分别为61%、55%和57%。差异无统计学意义。三组在缓解时间、缓解持续时间和生存率方面均无差异。缓解的患者比病情稳定和进展的患者存活时间更长。从诊断开始的中位生存时间为72个月，从治疗开始为52个月，各治疗组之间无差异。泼尼莫司汀的毒性通常较轻，与两种成分的毒性相似。治疗方案C在副作用发生频率方面显示出轻微优势。总之，在本研究中，泼尼莫司汀的治疗效果与其单独使用两种成分的效果相当。
