Sallami Sataa, Khouni Hassen, Ben Atta Mahmoud, Abou El Makarim Sana, Zouari Mohamed Bechir, Ben Rhouma Sami
Tunis Med. 2016 Dec;94(12):844.
Data concerning the efficacy of intravesical Bacillus Calmette-Guerin (BCG) on carcinoma in situ (CIS) of the bladder are limited.
We analyzed long-term outcomes of instillation therapy with BCG to treat bladder CIS, evaluated its effectiveness and safety and searched for prognostic factors that could predict disease recurrence and progression.
Between March 1994 and December 2010, 47 patients (male: 40; female: 7) with median age of 59,5 years (range 40-76 years), diagnosed with bladder CIS underwent weekly BCG instillations (75 mg of Pasteur strain) for six weeks followed by 6 monthly instillations. Patients were collected from four different institututions.Proven bladder CIS diagnosis was made through random biopsy (n=19), macroscopic lesion (n=28) and urinary cytology (n=6).Primary, concomitant, and secondary CIS was found in 13 (27,6%), 28 (59,6%) and 6 (12,7%), patients, respectively.
The median follow up period was 67.5 months (range 60-116 months).The recurence rates were 15,4%, 35,7% and 50% respectively in group I,II and III at 5 years follow-up. The overall complete response rate was 68%.The five-year progression-free survival rate was 87.2%.Several factors, such as age (<60 or >60 years), gender, previous transurethral resection and type of CIS, were examined by multivariate analysis to predict recurrence and progression. None of them was an independent prognostic factor.Bladder irritation symptoms were the main BCG adverse effects. There were no severe adverse effects requiring discontinuation of drug administration.Radical cystectomy was performed in 5 patients. Extravesical involvement was identified in only one patient. During follow-up period, none died of bladder cancer.
Therapy with BCG is remarkably effective and safe for primary CIS and concomittent CIS, which might be a prognostic factor. We didn't find any significant risk factor. Recurrence and disease progression including extravesical involvement should be carefully monitored over the long-term after BCG therapy.
关于膀胱内灌注卡介苗（BCG）治疗膀胱原位癌（CIS）疗效的数据有限。
我们分析了BCG灌注治疗膀胱CIS的长期疗效，评估其有效性和安全性，并寻找可预测疾病复发和进展的预后因素。
1994年3月至2010年12月期间，47例诊断为膀胱CIS的患者（男性40例；女性7例），中位年龄59.5岁（范围40 - 76岁），接受每周一次的BCG灌注（巴斯德菌株75mg），共六周，随后每月灌注一次，共6次。患者来自四个不同机构。经随机活检（n = 19）、肉眼病变（n = 28）和尿液细胞学检查（n = 6）确诊为膀胱CIS。原发性、合并性和继发性CIS分别在13例（27.6%）、28例（59.6%）和6例（12.7%）患者中发现。
中位随访期为67.5个月（范围60 - 116个月）。在5年随访时，I组、II组和III组的复发率分别为15.4%、35.7%和50%。总体完全缓解率为68%。五年无进展生存率为87.2%。通过多变量分析检查了几个因素，如年龄（<60或>60岁）、性别、既往经尿道切除术和CIS类型，以预测复发和进展。它们均不是独立的预后因素。膀胱刺激症状是BCG的主要不良反应。没有严重不良反应需要停药。5例患者接受了根治性膀胱切除术。仅1例患者发现膀胱外侵犯。随访期间，无患者死于膀胱癌。
BCG治疗对原发性CIS和合并性CIS非常有效且安全，这可能是一个预后因素。我们未发现任何显著的危险因素。BCG治疗后应长期密切监测复发和疾病进展，包括膀胱外侵犯。
