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

Michael F. Sarosdy, Catherine M. Tangen, Geoffrey R. Weiss, Blake R. Nestok, Mitchell C. Benson, Paul F. Schellhammer, Arthur I Sagalowsky, David P. Wood, E. David Crawford

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Objectives: 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.

Original languageEnglish (US)
Pages (from-to)386-389
Number of pages4
JournalUrologic Oncology: Seminars and Original Investigations
Volume23
Issue number6
DOIs
StatePublished - Nov 2005

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Phase II Clinical Trials
Carcinoma in Situ
Bacillus
Urinary Bladder
Cystoscopy
Disease-Free Survival
Cell Biology
bropirimine
Confidence Intervals
Biopsy
Survival
Therapeutics

Keywords

  • Bladder cancer
  • Bropirimine
  • Immunotherapy

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

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. / Sarosdy, Michael F.; Tangen, Catherine M.; Weiss, Geoffrey R.; Nestok, Blake R.; Benson, Mitchell C.; Schellhammer, Paul F.; Sagalowsky, Arthur I; Wood, David P.; Crawford, E. David.

In: Urologic Oncology: Seminars and Original Investigations, Vol. 23, No. 6, 11.2005, p. 386-389.

Research output: Contribution to journalArticle

Sarosdy, Michael F. ; Tangen, Catherine M. ; Weiss, Geoffrey R. ; Nestok, Blake R. ; Benson, Mitchell C. ; Schellhammer, Paul F. ; Sagalowsky, Arthur I ; Wood, David P. ; Crawford, E. David. / 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. In: Urologic Oncology: Seminars and Original Investigations. 2005 ; Vol. 23, No. 6. pp. 386-389.
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abstract = "Objectives: To estimate the probability of response when intravesical bacille Calmette-Gu{\'e}rin (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.",
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T1 - A phase II clinical trial of oral bropirimine in combination with intravesical bacillus Calmette-Guérin for carcinoma in situ of the bladder

T2 - A Southwest Oncology Group Study

AU - Sarosdy, Michael F.

AU - Tangen, Catherine M.

AU - Weiss, Geoffrey R.

AU - Nestok, Blake R.

AU - Benson, Mitchell C.

AU - Schellhammer, Paul F.

AU - Sagalowsky, Arthur I

AU - Wood, David P.

AU - Crawford, E. David

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N2 - Objectives: 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.

AB - Objectives: 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.

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