Lundholm C, Norlén B J, Ekman P, Jahnson S, Lagerkvist M, Lindeborg T, Olsson J L, Tveter K, Wijkstrom H, Westberg R, Malmström P U
Department of Urology, Västerås Central Hospital, Norway.
J Urol. 1996 Aug;156(2 Pt 1):372-6. doi: 10.1016/s0022-5347(01)65853-1.
We compared the efficacy and toxicity of long-term mitomycin C versus bacillus Calmette-Guerin (BCG) instillation in patients at high risk for recurrence and progression of superficial bladder carcinoma.
Our randomized comparison study included 261 patients with primary dysplasia, or stage Tis, stage T1, grade 3 and multiple recurrent stage Ta/T1, grade 1 or 2 disease. Mitomycin C (40 mg.) or Pasteur strain BCG (120 mg.) was instilled weekly for 6 weeks, then monthly for up to 1 year and every 3 months during year 2.
After a median followup of 39 months 49% of the patients given BCG and 34% given mitomycin C were disease-free (p < 0.03), compared to 48 and 35%, respectively, of those with stage Ta or T1 disease, and 54 and 33%, respectively, of those with dysplasia or stage Tis tumor. Tumor progressed in 13% of patients, with no statistically significant difference observed regarding progression between the mitomycin C and BCG groups. Side effects were more common after BCG instillation, with 5 cases of severe side effects compared to 1 in the mitomycin C group. Treatment was stopped due to toxicity in 10% of the patients.
The majority of patients tolerated long-term intravesical therapy well. BCG instillation was hampered by more frequent side effects. BCG was superior regarding recurrence prophylaxis, since patients given BCG had fewer recurrences and a significantly longer time to treatment failure compared to those treated with mitomycin C. No statistically significant difference was observed regarding progression.
我们比较了长期丝裂霉素C与卡介苗（BCG）膀胱灌注对浅表性膀胱癌复发和进展高危患者的疗效和毒性。
我们的随机对照研究纳入了261例原发性发育异常或Tis期、T1期、3级以及多发复发性Ta/T1期、1级或2级疾病的患者。丝裂霉素C（40mg）或巴斯德菌株卡介苗（120mg）每周灌注1次，共6周，然后每月1次，持续1年，第2年每3个月1次。
中位随访39个月后，接受卡介苗灌注的患者中49%无疾病复发，接受丝裂霉素C灌注的患者中这一比例为34%（p<0.03），Ta或T1期疾病患者分别为48%和35%，发育异常或Tis期肿瘤患者分别为54%和33%。13%的患者肿瘤进展，丝裂霉素C组和卡介苗组在进展方面未观察到统计学显著差异。卡介苗灌注后的副作用更常见，严重副作用有5例，而丝裂霉素C组为1例。10%的患者因毒性反应而停止治疗。
大多数患者对长期膀胱内治疗耐受性良好。卡介苗灌注因更频繁的副作用而受到影响。卡介苗在预防复发方面更具优势，因为与接受丝裂霉素C治疗的患者相比，接受卡介苗治疗的患者复发较少，至治疗失败的时间显著更长。在进展方面未观察到统计学显著差异。
