EORTC Headquarters, Brussels, Belgium.
Eur Urol. 2010 May;57(5):766-73. doi: 10.1016/j.eururo.2009.12.024. Epub 2009 Dec 18.
Intravesical chemotherapy and bacillus Calmette-Guérin (BCG) reduce the recurrence rate in patients with stage Ta T1 urothelial bladder cancer; however, the benefit of BCG relative to chemotherapy for long-term end points is controversial, especially in intermediate-risk patients.
The aim of the study was to compare the long-term efficacy of BCG and epirubicin.
DESIGN, SETTING, AND PARTICIPANTS: From January 1992 to February 1997, 957 patients with intermediate- or high-risk stage Ta T1 urothelial bladder cancer were randomized after transurethral resection to one of three treatment groups in the European Organization for Research and Treatment of Cancer Genito-Urinary Group phase 3 trial 30911.
Patients received six weekly instillations of epirubicin, BCG, or BCG plus isoniazid (INH) followed by three weekly maintenance instillations at months 3, 6, 12, 18, 24, 30, and 36.
End points were time to recurrence, progression, distant metastases, overall survival, and disease-specific survival.
With 837 eligible patients and a median follow-up of 9.2 yr, time to first recurrence (p<0.001), distant metastases (p=0.046), overall survival (p=0.023), and disease-specific survival (p=0.026) were significantly longer in the two BCG arms combined as compared with epirubicin; however, there was no difference for progression. Three hundred twenty-three patients with stage T1 or grade 3 tumors were high risk, and the remaining 497 patients were intermediate risk. The observed treatment benefit was at least as large, if not larger, in the intermediate-risk patients compared with the high-risk patients.
In patients with intermediate- and high-risk stage Ta and T1 urothelial bladder cancer, intravesical BCG with or without INH is superior to intravesical epirubicin not only for time to first recurrence but also for time to distant metastases, overall survival, and disease-specific survival. The benefit of BCG is not limited to just high-risk patients; intermediate-risk patients also benefit from BCG.
This study was registered with the US National Cancer Institute clinical trials database [protocol ID: EORTC-30911]. http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=77075&version=HealthProfessional&protocolsearchid=6540260.
膀胱内化疗和卡介苗（BCG）可降低 Ta、T1 期尿路上皮膀胱癌患者的复发率；然而，BCG 相对于化疗在长期终点方面的益处存在争议，尤其是在中危患者中。
本研究旨在比较 BCG 和表柔比星的长期疗效。
设计、地点和参与者：1992 年 1 月至 1997 年 2 月，欧洲癌症研究与治疗组织（EORTC）泌尿生殖系统癌症研究组 30911 三期临床试验中，957 例中危或高危 Ta、T1 期尿路上皮膀胱癌患者在经尿道切除术（TUR）后随机分为三组，分别接受每周一次的表柔比星、BCG 或 BCG 联合异烟肼（INH）治疗，共 6 周，随后在第 3、6、12、18、24、30 和 36 个月进行每周一次的维持性膀胱内灌注。
终点事件为复发时间、进展、远处转移、总生存期和疾病特异性生存期。
837 例患者符合入组标准，中位随访时间为 9.2 年，首次复发时间（p<0.001）、远处转移（p=0.046）、总生存期（p=0.023）和疾病特异性生存期（p=0.026）在联合 BCG 治疗组显著长于表柔比星组；然而，进展时间无差异。323 例 T1 期或 3 级肿瘤患者为高危，其余 497 例为中危。观察到的治疗益处在中危患者中至少与高危患者一样大，如果不是更大的话。
对于中危和高危 Ta、T1 期尿路上皮膀胱癌患者，BCG 联合或不联合 INH 优于表柔比星，不仅可以降低首次复发时间，还可以降低远处转移时间、总生存期和疾病特异性生存期。BCG 的获益不仅局限于高危患者，中危患者也从 BCG 治疗中获益。
本研究在美国国立癌症研究所临床试验数据库注册[方案 ID：EORTC-30911]。http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=77075&version=HealthProfessional&protocolsearchid=6540260.
