Merz V W, Marth D, Kraft R, Ackermann D K, Zingg E J, Studer U E
Department of Urology, University of Berne, Switzerland.
Br J Urol. 1995 Feb;75(2):180-4. doi: 10.1111/j.1464-410x.1995.tb07307.x.
To analyse the clinical and therapeutic consequences of early treatment failure after bacille Calmette-Guérin (BCG) instillation therapy for carcinoma in situ of the bladder.
A total of 115 patients with carcinoma in situ (Tis) of the bladder were treated by intravesical instillation of living BCG vaccine (Immun BCG Pasteur F). Twenty five patients had primary Tis and 90 had secondary Tis with synchronous or prior superficial papillary tumours. All papillary tumours were resected before instillation of BCG. All patients completed one series of 6 weekly instillations of 120 mg BCG.
Twenty-two of 25 patients (88%) with primary Tis responded completely, with negative cytology and cystoscopy findings within a median follow-up period of 44 months. Three of the 25 (12%) had cytological evidence of disease within 9 months of therapy and were considered to be early treatment failures. One patient had muscle-invasive bladder cancer, one had Tis and invasive cancer of the prostatic urethra, and the last, in whom a second BCG course also failed, had Tis of both ureters. Seventy of 90 patients (78%) with secondary Tis had a complete response after treatment with BCG, with repeated negative cytology and cystoscopy examinations within a median follow-up time of 40 months. Twenty of the 90 (22%) with secondary Tis had positive cytology within 9 months after BCG therapy and were considered early treatment failures. Five of these 20 had a cystectomy, three for persistent Tis of the bladder and two for a solid urothelial carcinoma of the prostate. The remaining 15 early failures received a second course of BCG. Four of these 15 patients responded and the remaining 11 failed the second course. The 11 failures included two patients with multifocal T1 G3 bladder cancers. four with invasive bladder cancer, two with solid urothelial carcinomas of the prostatic urethra, and three with Tis of the upper urinary tract.
According to these data, early treatment failure after 6 weekly instillations of 120 mg Immun BCG Pasteur F is an alarming signal which requires immediate re-assessment of the patient to exclude a muscle-invasive bladder cancer or an extravesical carcinoma in situ, either in the upper urinary tract or in the prostatic urethra.
分析膀胱原位癌卡介苗（BCG）灌注治疗后早期治疗失败的临床及治疗后果。
115例膀胱原位癌（Tis）患者接受了膀胱内灌注活卡介苗疫苗（免疫卡介苗巴斯德F）治疗。25例为原发性Tis，90例为继发性Tis，伴有同步或既往浅表乳头状肿瘤。所有乳头状肿瘤在卡介苗灌注前均已切除。所有患者均完成了6周1次、每次120mg卡介苗的一系列灌注。
25例原发性Tis患者中，22例（88%）完全缓解，中位随访44个月时细胞学和膀胱镜检查结果均为阴性。25例中有3例（12%）在治疗9个月内有疾病的细胞学证据，被视为早期治疗失败。1例发生肌层浸润性膀胱癌，1例有Tis及前列腺尿道浸润癌，最后1例第二次卡介苗疗程也失败，双侧输尿管均有Tis。90例继发性Tis患者中，70例（78%）卡介苗治疗后完全缓解，中位随访40个月时细胞学和膀胱镜检查反复阴性。90例继发性Tis患者中有20例（22%）在卡介苗治疗9个月内细胞学阳性，被视为早期治疗失败。这20例中有5例行膀胱切除术，3例因膀胱Tis持续存在，2例因前列腺实性尿路上皮癌。其余15例早期治疗失败者接受了第二个卡介苗疗程。这15例患者中有4例缓解，其余11例第二个疗程失败。这11例失败者包括2例多灶性T1 G3膀胱癌患者、4例浸润性膀胱癌患者、2例前列腺尿道实性尿路上皮癌患者和3例上尿路Tis患者。
根据这些数据，每周1次、每次120mg免疫卡介苗巴斯德F灌注6周后早期治疗失败是一个警示信号，需要立即对患者进行重新评估，以排除肌层浸润性膀胱癌或上尿路或前列腺尿道的膀胱外原位癌。
