Faculty Collaboration Database

Oral bropirimine immunotherapy of carcinoma in situ of the bladder: results of a phase II trial. Urology 1996 Jul;48(1):21-7

Date

07/01/1996

Pubmed ID

8693646

DOI

10.1016/s0090-4295(96)90059-x

Scopus ID

2-s2.0-0343377307 (requires institutional sign-in at Scopus site)   41 Citations

Abstract

OBJECTIVES: Bropirimine is an orally administered immunostimulant that has been shown to have activity against carcinoma in situ (CIS) of the bladder. To further assess this potential activity, bropirimine was administered to 42 patients for bladder CIS in a Phase II trial.

METHODS: Patients were treated with bropirimine 3.0 g/day by mouth for 3 consecutive days each week up to 1 year. Cystoscopy with biopsies and bladder wash cytology were performed quarterly.

RESULTS: Twenty (61%) of 33 evaluable patients converted malignant biopsies and bladder wash cytology to negative, including 6 (50%) of 12 who failed prior bacillus Calmette-Guérin (BCG) immunotherapy, 14 (67%) of 21 who had not received prior BCG therapy, and 12 (80%) of 15 with primary CIS. Median response duration exceeds 21 months. Four of the 20 responders did have a papillary tumor recurrence at 3 to 15 months, all Stage Ta or T1. Mild toxicity (grade I or II) suggestive to interferon induction or administration occurred in one third of patients. Headache, transient hepatic enzyme elevations, skin rash, and arthralgias each occurred in 5% to 14% of the patients, with nausea or emesis in 21%. Grade 1 tachycardia/palpitations or chest pain each were noted in 5%.

CONCLUSIONS: Oral bropirimine can induce remission of bladder CIS with acceptable toxicity at 3.0 g/day. Bropirimine may be a valuable alternative to cystectomy for some failures of BCG therapy and may have the potential to replace BCG as front-line therapy because of its ease of administration.

Author List

Sarosdy MF, Lowe BA, Schellhammer PF, Lamm DL, Graham SD Jr, Grossman HB, See WA, Peabody JO, Moon TD, Flanigan RC, Crawford ED, Morganroth J

MESH terms used to index this publication - Major topics in bold

Adjuvants, Immunologic
Administration, Oral
Adult
Aged
Aged, 80 and over
Carcinoma in Situ
Cytosine
Female
Humans
Male
Middle Aged
Urinary Bladder Neoplasms