Witjes J A
Department of Urology, University Hospital, Nijmegen, The Netherlands.
Eur Urol. 1997;31 Suppl 1:27-30. doi: 10.1159/000474528.
To explore new treatment strategies in high-risk superficial bladder cancer patients, such as recurrent carcinoma in situ (CIS) or pT1 transitional cell carcinoma after intravesical bacillus Calmette-Guérin (BCG).
Mechanism of action, pharmacology and the results of clinical phase I and II trials with the oral biological response modifier bropirimine are reviewed.
In a phase II trial in which CIS patients were treated, 17 complete responses were seen in 29 patients (59%) at the 3,000-mg dose level. Moreover, this trial indicated that bropirimine is a promising alternative in BCG recurrent or BCG intolerant patients: in 13 BCG failures, 6 complete responses were seen. Side effects are mild to moderate, mainly flu-like symptoms.
These results suggest that bropirimine is effective at 3,000 mg/day, and that patients with prior BCG therapy may be salvaged by bropirimine treatment.
探索高危浅表性膀胱癌患者的新治疗策略,如卡介苗(BCG)膀胱灌注后复发的原位癌(CIS)或pT1期移行细胞癌。
回顾口服生物反应调节剂布罗匹明的作用机制、药理学以及I期和II期临床试验结果。
在一项针对CIS患者的II期试验中,3000毫克剂量组的29例患者中有17例(59%)获得完全缓解。此外,该试验表明布罗匹明对于BCG治疗后复发或不耐受BCG的患者是一种有前景的替代疗法:在13例BCG治疗失败的患者中,有6例获得完全缓解。副作用为轻至中度,主要是流感样症状。
这些结果表明,布罗匹明每日3000毫克有效,先前接受过BCG治疗的患者可能通过布罗匹明治疗得到挽救。