Background: Intravesical bacillus Calmette-Guèrin (BCG) and mitomycin C (MMC) are a theoretically attractive combination for the treatment of high risk superficial bladder cancer. We conducted a prospective, controlled study comparing BCG with sequential BCG + electromotive delivery MMC in patients with T1 bladder cancer. Methods: Following transurethral resection and multiple biopsies we randomized 175 patients with T1 bladder cancer into 2 groups. Group I received BCG 81 mg; 6 weekly instillations. Group II received sequential BCG and electromotive (intravesical electric current; 20 mA for 30 min.) MMC at weekly intervals thus: (BCG, BCG, MMC) x 3, totaling 6 BCG and 3 MMC instillations. Non responders received repeat courses at 3 months. All complete responders underwent maintenance regimens of monthly instillations. Group I: 10 BCG treatments. Group II: (MMC, MMC, BCG) x 3, treatments. Results: Group I vs Group II: median (IQR or 95% CI). Follow up (months): 64 (38–82) vs 71 (49–87); p = 0.054 Recurrence: 47% (36–58) vs 28% (19–39); p = 0.013 Months to Recurrence: 11 (6–19) vs 20 (16–33); p = 0.001 Progression: 20% (12–30) vs 14% (7–22); p = 0.312 Months to Progression: 17 (10–21) vs 46 (21–58); p = 0.002 % 5-years mortality by any cause: 11.6 (5.7–20.3) vs 4.5 (1.2–11.1); p = 0.099 % 5-years mortality by bladder cancer: 9.3 (4.1–17.5) vs 1.1 (0.02–6.1); p = 0.017 Side effects were numerous but mainly localized to the bladder. There were no treatment related deaths nor episodes of serious illness nor bladder contractures. Conclusions: Intravesical sequential BCG/electromotive MMC is superior to BCG alone in the treatment of high risk bladder cancer.
Di Stasi, S.M., Giannantoni, A., Stephen, R., Capelli, G., Giurioli, A., Zampa, G., et al. (2004). Sequential Bacillus Calmette Guerin and electromotive mitomycin-C versus Bacillus Calmette Guerin alone for high-risk superficial bladder cancer: a prospective controlled study. JOURNAL OF CLINICAL ONCOLOGY, Vol 22, No 14S (July 15 Supplement), 5439.
Sequential Bacillus Calmette Guerin and electromotive mitomycin-C versus Bacillus Calmette Guerin alone for high-risk superficial bladder cancer: a prospective controlled study.
Giannantoni A.;
2004-01-01
Abstract
Background: Intravesical bacillus Calmette-Guèrin (BCG) and mitomycin C (MMC) are a theoretically attractive combination for the treatment of high risk superficial bladder cancer. We conducted a prospective, controlled study comparing BCG with sequential BCG + electromotive delivery MMC in patients with T1 bladder cancer. Methods: Following transurethral resection and multiple biopsies we randomized 175 patients with T1 bladder cancer into 2 groups. Group I received BCG 81 mg; 6 weekly instillations. Group II received sequential BCG and electromotive (intravesical electric current; 20 mA for 30 min.) MMC at weekly intervals thus: (BCG, BCG, MMC) x 3, totaling 6 BCG and 3 MMC instillations. Non responders received repeat courses at 3 months. All complete responders underwent maintenance regimens of monthly instillations. Group I: 10 BCG treatments. Group II: (MMC, MMC, BCG) x 3, treatments. Results: Group I vs Group II: median (IQR or 95% CI). Follow up (months): 64 (38–82) vs 71 (49–87); p = 0.054 Recurrence: 47% (36–58) vs 28% (19–39); p = 0.013 Months to Recurrence: 11 (6–19) vs 20 (16–33); p = 0.001 Progression: 20% (12–30) vs 14% (7–22); p = 0.312 Months to Progression: 17 (10–21) vs 46 (21–58); p = 0.002 % 5-years mortality by any cause: 11.6 (5.7–20.3) vs 4.5 (1.2–11.1); p = 0.099 % 5-years mortality by bladder cancer: 9.3 (4.1–17.5) vs 1.1 (0.02–6.1); p = 0.017 Side effects were numerous but mainly localized to the bladder. There were no treatment related deaths nor episodes of serious illness nor bladder contractures. Conclusions: Intravesical sequential BCG/electromotive MMC is superior to BCG alone in the treatment of high risk bladder cancer.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
https://hdl.handle.net/11365/1065740
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