A phase II clinical trial of oral bropirimine in combination with intravesical bacillus Calmette-Guérin for carcinoma in situ of the bladder: a Southwest Oncology Group Study.
OBJECTIVE
To estimate the probability of response when intravesical bacille Calmette-Guérin (BCG) is given in combination with oral bropirimine for bladder carcinoma in situ, and to evaluate toxicity when the 2 agents are combined.


METHODS
A total of 51 patients with histologic evidence of carcinoma in situ and no prior treatment with BCG or bropirimine were enrolled in a cooperative group multicenter phase II trial. Initial treatment included Tice BCG 50 mg weekly for 6 weeks and oral bropirimine 3.0 g/day for 3 consecutive days each week for 12 weeks. Response was assessed after 12 weeks by cystoscopy, biopsy, and barbotage cytology. Most patients received a second course followed by an identical assessment. Toxicity was recorded according to the Southwest Oncology Group toxicity criteria.


RESULTS
A total of 51 patients were enrolled and treated. There were 42 patients who were eligible and valuable for response and toxicity. There were 28 complete responders (67%, 50% to 80% 95% confidence interval). The 5-year progression-free survival estimate is 53%, and the 5-year survival estimate is 80%. There were no deaths, 2 patients had grade 4 toxicity, 14 grade 3 toxicity, 17 grade 2 toxicity, 6 grade 1 toxicity, and only 3 had no toxicity reported as their worst toxicity grade.


CONCLUSIONS
The combination failed to show an estimated response higher than 80%. It is not recommended that further evaluation of this combination be conducted.
Sarosdy
Michael F
MF
South Texas Urology and Urologic Oncology, San Antonio, TX 78229, USA. urodoc@satx.rr.com
Tangen
Catherine M
CM
Weiss
Geoffrey R
GR
Nestok
Blake R
BR
Benson
Mitchell C
MC
Schellhammer
Paul F
PF
Sagalowsky
Arthur I
AI
Wood
David P
DP
Crawford
E David
ED
D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D003596:Cytosine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D018450:Disease Progression; D006801:Humans; D008495:Medical Oncology; D008875:Middle Aged; D015996:Survival Rate; D014481:United States; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
D001500:BCG Vaccine; D003596:Cytosine; C033560:bropirimine