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.
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.
Authors: M F Sarosdy; L L Pisters; P R Carroll; M C Benson; T D Moon; D L Lamm; M A Hudson; S P Lerner; M O Koch; P F Schellhammer Journal: Urology Date: 1996-07 Impact factor: 2.649
Authors: M F Sarosdy; B A Lowe; P F Schellhammer; D L Lamm; S D Graham; H B Grossman; W A See; J O Peabody; T D Moon; R C Flanigan; E D Crawford; J Morganroth Journal: Urology Date: 1996-07 Impact factor: 2.649
Authors: M F Sarosdy; D L Lamm; R D Williams; T D Moon; R C Flanigan; E D Crawford; N E Wilks; R H Earhart; J A Merritt Journal: J Urol Date: 1992-01 Impact factor: 7.450
Authors: D L Lamm; B A Blumenstein; J D Crissman; J E Montie; J E Gottesman; B A Lowe; M F Sarosdy; R D Bohl; H B Grossman; T M Beck; J T Leimert; E D Crawford Journal: J Urol Date: 2000-04 Impact factor: 7.450
Authors: A L Patterson; R E Greenberg; L Weems; R Bahnson; Z Wajsman; M Israel; T Sweatman; D Webber; J Gulfo Journal: Urology Date: 2000-08-01 Impact factor: 2.649
Authors: D L Lamm; B A Blumenstein; E D Crawford; J E Montie; P Scardino; H B Grossman; T H Stanisic; J A Smith; J Sullivan; M F Sarosdy Journal: N Engl J Med Date: 1991-10-24 Impact factor: 91.245