Hurle R, Losa A, Ranieri A, Graziotti P, Lembo A
Division of Urology, Ospedali Riuniti di Bergamo, Italy.
J Urol. 1996 Nov;156(5):1602-5.
We assessed the effectiveness of intravesical bacillus Calmette-Guerin (BCG) for high risk transitional cell carcinoma of the bladder.
A total of 51 patients with stage T1, grade 3 disease was treated with weekly instillations of 75 mg. Pasteur strain BCG for 6 weeks after transurethral resection for bladder cancer. An additional induction course was given to patients with relapse. Tumor-free patients followed a maintenance course with monthly instillations for 12 months.
After the initial induction course 37 of 51 patients (72.5%) remained tumor-free. A second induction course was necessary in 13 patients. After 1 or 2 induction courses 44 of 51 patients (86.3%) were tumor-free. The maintenance course was administered to 44 patients, with 41 remaining tumor-free. After a median followup of 33 months (range 3 to 63) 28 patients (54.9%) were disease-free, 12 (23.5%) had recurrent tumors and 7 (13.7%) had progression. The risk of treatment failure was significantly greater for solid than papillary tumors (p = 0.0006), recurrent than primary tumors (p = 0.0052) and coexisting carcinoma in situ (p = 0.124) in multivariate analysis, and for early recurrence (p = 0.0001) in univariate analysis only. The drug was well tolerated with few side effects.
Our data suggest that this low dose Pasteur BCG regimen is effective in the treatment of high risk superficial bladder cancer. Some tumor characteristics, such as solid appearance, coexisting carcinoma in situ, history of superficial transitional cell carcinoma and early relapse after the initial induction course, seem to be negative prognostic factors.
我们评估了膀胱内灌注卡介苗（BCG）治疗高危膀胱移行细胞癌的有效性。
共有51例T1期3级疾病患者在经尿道膀胱肿瘤切除术后接受每周一次75mg卡介苗巴斯德菌株灌注，共6周。复发患者给予额外的诱导疗程。无瘤患者接受维持疗程，每月灌注一次，共12个月。
初始诱导疗程后，51例患者中有37例（72.5%）无瘤。13例患者需要进行第二个诱导疗程。经过1或2个诱导疗程后，51例患者中有44例（86.3%）无瘤。44例患者接受了维持疗程，其中41例仍无瘤。中位随访33个月（范围3至63个月）后，28例患者（54.9%）无疾病，12例（23.5%）有复发性肿瘤，7例（13.7%）有进展。多因素分析显示，实体瘤比乳头状瘤（p = 0.0006）、复发性肿瘤比原发性肿瘤（p = 0.0052）以及并存原位癌（p = 0.124）的治疗失败风险显著更高，单因素分析仅显示早期复发（p = 0.0001）的治疗失败风险显著更高。该药物耐受性良好，副作用较少。
我们的数据表明，这种低剂量卡介苗巴斯德菌株方案对高危浅表性膀胱癌的治疗有效。一些肿瘤特征，如实性外观、并存原位癌、浅表性移行细胞癌病史以及初始诱导疗程后早期复发，似乎是不良预后因素。
