TY - JOUR
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
N1 - Funding Information:
This investigation was supported by the PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA38926, CA32102, CA22433, CA96429, CA68183, CA42777, CA58416, CA37981, CA27057, CA20319, CA35431, CA46282, CA58882, CA13612, CA76447, CA76132, and also supported by The Upjohn Company.
PY - 2005/11
Y1 - 2005/11
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.
KW - Bladder cancer
KW - Bropirimine
KW - Immunotherapy
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U2 - 10.1016/j.urolonc.2005.05.028
DO - 10.1016/j.urolonc.2005.05.028
M3 - Article
C2 - 16301114
AN - SCOPUS:27844432612
SN - 1078-1439
VL - 23
SP - 386
EP - 389
JO - Urologic Oncology: Seminars and Original Investigations
JF - Urologic Oncology: Seminars and Original Investigations
IS - 6
ER -