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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.

AbstractOBJECTIVES:
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.
AuthorsMichael F Sarosdy, Catherine M Tangen, Geoffrey R Weiss, Blake R Nestok, Mitchell C Benson, Paul F Schellhammer, Arthur I Sagalowsky, David P Wood Jr, E David Crawford
JournalUrologic oncology (Urol Oncol) 2005 Nov-Dec Vol. 23 Issue 6 Pg. 386-9 ISSN: 1078-1439 [Print] United States
PMID16301114 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • BCG Vaccine
  • Cytosine
  • bropirimine
Topics
  • Aged
  • Aged, 80 and over
  • BCG Vaccine (therapeutic use)
  • Carcinoma in Situ (drug therapy, pathology)
  • Cytosine (administration & dosage, analogs & derivatives, pharmacology)
  • Disease Progression
  • Humans
  • Medical Oncology
  • Middle Aged
  • Survival Rate
  • United States
  • Urinary Bladder Neoplasms (drug therapy, pathology)

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