Sarosdy M F
Division of Urology, University of Texas Health Science Center, San Antonio 78284-7845, USA.
Eur Urol. 1997;31 Suppl 1:20-6. doi: 10.1159/000474527.
Bropirimine has been shown to have activity against carcinoma in situ (CIS) of the bladder in a previous phase-I trial. A review of three completed clinical trials as well as ongoing studies is presented to provide a current update.
Details of the initial phase-I trial are reviewed, as are findings of a subsequent phase-II trial in bladder CIS and a multicenter study in upper tract CIS. All have used a dose of 3 g/day for 3 consecutive days each week, repeated weekly for up to 1 year. Cytology must be positive prior to treatment, and both biopsies and cytology must be negative after therapy for the patient to be considered a complete response.
In the phase-II trial in bladder CIS, 20 (61%) of 33 patients had a complete response. Responders included patients with prior bacillus Calmette-Guérin (BCG) therapy, uni- and multifocal CIS, and primary and secondary CIS. Responses were seen in 10 (48%) of 21 evaluable patients with upper tract CIS. Toxicities in both studies were manageable in most patients. Trials underway include bropirimine in BCG-failed CIS, a randomized comparison to BCG in previously untreated patients, and a trial of the two together.
Bropirimine does have activity against both bladder and upper tract CIS on the dose schedule used to date.
在之前的一项I期试验中，已证明布罗匹明对膀胱原位癌（CIS）具有活性。本文对三项已完成的临床试验以及正在进行的研究进行综述，以提供最新信息。
回顾了最初I期试验的详细情况，以及随后一项针对膀胱CIS的II期试验和一项针对上尿路CIS的多中心研究的结果。所有试验均采用每周连续3天、每天3克的剂量，每周重复，持续长达1年。治疗前细胞学检查必须呈阳性，治疗后活检和细胞学检查均为阴性的患者才被视为完全缓解。
在膀胱CIS的II期试验中，33例患者中有20例（61%）完全缓解。缓解者包括先前接受卡介苗（BCG）治疗的患者、单灶和多灶CIS患者以及原发性和继发性CIS患者。21例可评估的上尿路CIS患者中有10例（48%）出现缓解。大多数患者在两项研究中的毒性都是可控的。正在进行的试验包括布罗匹明用于BCG治疗失败的CIS、在未接受过治疗的患者中与BCG进行随机对照比较以及两者联合试验。
就目前使用的剂量方案而言，布罗匹明对膀胱和上尿路CIS均有活性。
