Sarosdy M F, Lamm D L, Williams R D, Moon T D, Flanigan R C, Crawford E D, Wilks N E, Earhart R H, Merritt J A
Department of Urology, University of Texas Health Science Center, San Antonio.
J Urol. 1992 Jan;147(1):31-3. doi: 10.1016/s0022-5347(17)37126-4.
A total of 34 patients with measurable superficial transitional cell cancer of the bladder entered into a phase 1, nonrandomized, noncomparative trial to assess the toxicity of the oral interferon inducer bropirimine. Of the patients 26 were also evaluable for response. The toxicity of bropirimine was minimal. At the 3-month evaluation 6 patients had experienced complete regression of tumor and had negative cytology studies, and 2 had partial responses. The majority of complete responses were in patients with carcinoma in situ only, with most responses seen at higher dose levels. One patient with papillary tumor and carcinoma in situ had a complete response. Some early responses appear to be durable. Most importantly, a high rate of complete response was noted at higher dose levels among patients who had failed prior therapy with bacillus Calmette-Guerin. Further clinical trials of bropirimine in bladder cancer appear warranted.
共有34例可测量的膀胱浅表性移行细胞癌患者进入一项1期非随机、非对照试验，以评估口服干扰素诱导剂布罗昔宁的毒性。其中26例患者也可评估疗效。布罗昔宁的毒性极小。在3个月评估时，6例患者肿瘤完全消退且细胞学检查为阴性，2例患者部分缓解。大多数完全缓解仅见于原位癌患者，且大多在较高剂量水平出现。1例乳头状肿瘤合并原位癌患者完全缓解。一些早期缓解似乎持久。最重要的是，在先前接受卡介苗治疗失败的患者中，较高剂量水平的完全缓解率较高。布罗昔宁在膀胱癌中的进一步临床试验似乎是必要的。
