Akaza H, Hinotsu S, Aso Y, Kakizoe T, Koiso K
Department of Urology, University of Tsukuba, Japan.
Cancer. 1995 Jan 15;75(2):552-9. doi: 10.1002/1097-0142(19950115)75:2<552::aid-cncr2820750219>3.0.co;2-h.
Intravesical instillation therapy of Bacillus Calmette-Guérin (BCG) has become a standard treatment for carcinoma in situ (CIS) of the urinary bladder. However, there have been few reports concerning the direct effect of BCG on existing tumors classified as Ta or T1. In the first stage of this clinical study, 157 patients were treated with BCG intravesical instillation (Tokyo 172 strain [BCG Co. Ltd., Tokyo, Japan]; 80 mg weekly for eight times) by our Study Group. The efficacy on existing tumors was a complete response (CR) rate of 84.4% and 66.4% and a partial response (PR) of 6.3% and 20.8% for 32 cases of CIS and 125 cases of Ta or T1 tumors, respectively.
In the second stage of this study, the authors investigated the outcome of the 138 patients who had achieved CR or PR in the first stage. One hundred twenty (87.0%) of the patients were followed fully. Of those patients, 52 were randomized to receive prophylactic (maintenance) therapy consisting of BCG of 40 mg monthly for 12 times (Group A), whereas 55 were randomized to an untreated control group (Group B). Thirteen other patients refused to be randomized and were followed without prophylactic instillation.
The median follow-up period was 48 months for Group A and 42 months for Group B. In Groups A and B, the beneficial effect of the BCG therapeutic instillation persisted for a long time, and the 3-year nonrecurrence rate was 77.6% in Group A and 74.2% in Group B. Disease progression was observed rarely.
For patients in whom transurethral resection of tumors of the bladder (TUR-Bt) alone is unlikely to eliminate the tumor, intravesical BCG is potentially the treatment of choice.
卡介苗（BCG）膀胱内灌注治疗已成为膀胱原位癌（CIS）的标准治疗方法。然而，关于BCG对已归类为Ta或T1的现有肿瘤的直接作用的报道很少。在本临床研究的第一阶段，我们的研究小组对157例患者进行了BCG膀胱内灌注治疗（东京172株[日本东京BCG有限公司]；每周80mg，共8次）。对于32例CIS和125例Ta或T1肿瘤，现有肿瘤的有效率分别为完全缓解（CR）率84.4%和66.4%，部分缓解（PR）率6.3%和20.8%。
在本研究的第二阶段，作者调查了在第一阶段达到CR或PR的138例患者的结果。其中120例（87.0%）患者得到了充分随访。在这些患者中，52例被随机分配接受预防性（维持性）治疗，即每月40mg BCG，共12次（A组），而55例被随机分配到未治疗的对照组（B组）。另外13例患者拒绝随机分组，未进行预防性灌注而接受随访。
A组的中位随访期为48个月，B组为42个月。在A组和B组中，BCG治疗性灌注的有益效果持续了很长时间，A组的3年无复发率为77.6%，B组为74.2%。很少观察到疾病进展。
对于仅经尿道膀胱肿瘤切除术（TUR-Bt）不太可能消除肿瘤的患者，膀胱内BCG可能是首选治疗方法。
