Oral bropirimine immunotherapy of bladder carcinoma in situ after prior intravesical bacille Calmette-Guerin

Michael F. Sarosdy, Michael J. Manyak, Arthur I. Sagalowsky, Arie Belldegrun, Mitchell C. Benson, William Bihrle, Peter R. Carroll, William J. Ellis, M'Liss A. Hudson, Francis E. Sharkey

Research output: Contribution to journalArticlepeer-review

39 Scopus citations


Objectives. Bropirimine is an oral immunomodulator that has demonstrated anticancer activity in transitional cell carcinoma in situ (CIS) in both the bladder and upper urinary tract. Activity also has been documented in patients after prior therapy with bacille Calmette-Guerin (BCG). To more accurately estimate bropirimine's efficacy in BCG-resistant bladder CIS, a Phase II trial was performed. A separate analysis was performed in additional patients intolerant of BCG toxicity. Methods. Patients received bropirimine 3.0 g/day by mouth for 3 consecutive days, weekly, for up to 1 year. Bladder biopsies and cytologic examination were performed quarterly. Complete response (CR) required negative biopsy and cytology results. Results. Twenty- one of 86 patients entered were not evaluable. CR was seen in 21 (32%; 95th percentile confidence interval [CI], 21% to 44%) of 65 evaluable patients, including 14 (30%, CI 17% to 43%) of 47 BCG-resistant, and 7 (39%, CI 16% to 61%) of 18 BCG-intolerant patients. Overall, by intent-to-treat analysis, CR was thus seen in 21 (24%) of 86 subjects. Most BCG-resistant patients were failures to BCG without relapse, and had received 12 to 36 (median 12) BCG treatments; intolerant patients had received 4 to 11 treatments (median 6). Response duration ranged from 65 to 810 days, with median not yet reached (but greater than 12 months). Thirteen (15%) of 86 stopped bropirimine due to toxicity. Progression to invasive or metastatic disease during or immediately after therapy was documented in only 4 patients (6%), all nonresponders. Conclusions. Bropirimine may be an alternative to cystectomy for some patients with bladder CIS who have failed or have not tolerated BCG. Further evaluation to improve responses and durability is warranted.

Original languageEnglish (US)
Pages (from-to)226-231
Number of pages6
Issue number2
StatePublished - Feb 1998
Externally publishedYes

ASJC Scopus subject areas

  • Urology


Dive into the research topics of 'Oral bropirimine immunotherapy of bladder carcinoma in situ after prior intravesical bacille Calmette-Guerin'. Together they form a unique fingerprint.

Cite this