Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: A meta-analysis of the published results of randomized clinical trials
Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: A meta-analysis of the published results of randomized clinical trials
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DOI：
10.1016/s0022-5347(05)64273-5
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发表时间：
2002-11-01
影响因子：
6.6
通讯作者：
Lamm, DL
中科院分区：
文献类型：
--
作者：
Sylvester, RJ;van der Meijden, APM;Lamm, DL
目的：我们确定膀胱内卡介苗（BCG）是否能降低浅表性（Ta期、T1期或原位癌）膀胱癌患者经尿道切除后进展到T2期或更高期的风险。材料和方法：对已发表的随机临床试验结果进行荟萃分析，比较经尿道切除加膀胱内卡介苗与单独切除或切除加卡介苗以外的其他治疗。结果：我们在4863例患者中确定了24项具有进展信息的试验。基于中位随访时间为2.5年，最长随访时间为15年，2,658例接受卡介苗治疗的患者中有260例（9.8%）出现进展，而对照组2205例患者中有304例（13.8%）出现进展，卡介苗治疗进展的几率降低了27% （OR 0.73, p = 0.001）。进展患者的百分比很低（2,880例乳头状肿瘤患者中为6.4%，403例原位癌患者中为13.9%），反映了许多试验中随访时间短，患者风险相对较低。乳头状肿瘤患者和原位癌患者的治疗效果大小相似。然而，只有接受维持性BCG治疗的患者受益。对于膀胱癌的总生存率和死亡率，治疗效果没有统计学上的显著差异。结论:膀胱内的。卡介苗显著降低接受维持治疗的浅表性膀胱癌经尿道切除术后进展的风险。因此，它是中、高风险乳头状肿瘤和原位癌患者的首选药物。
Purpose: We determine if intravesical bacillus Calmette-Guerin (BCG) reduces the risk of progression after transurethral resection to stage T2 disease or higher in patients with superficial (stage Ta, T1 or carcinoma in situ) bladder cancer.Materials and Methods: A meta-analysis was performed of the published results of randomized clinical trials comparing transurethral resection plus intravesical BCG to either resection alone or resection plus another treatment other than BCG.Results: We identified 24 trials with progression information on 4,863 patients. Based on a median followup of 2.5 years and a maximum of 15 years, 260 of 2,658 patients on BCG (9.8%) had progression compared to 304 of 2,205 patients in the control groups (13.8%), a reduction of 27% in the odds of progression on BCG (OR 0.73, p = 0.001). The percent of patients with progression was low (6.4% of 2,880 patients with papillary tumors and 13.9% of 403 patients with carcinoma in situ, reflecting the short followup and relatively low risk patients entered in many of the trials. The size of the treatment effect was similar in patients with papillary tumors and in those with carcinoma in situ. However, only patients receiving maintenance BCG benefited. There was no statistically significant difference in treatment effect for either overall survival or death due to bladder cancer.Conclusions: Intravesical. BCG significantly reduces the risk of progression after transurethral resection in patients with superficial bladder cancer who receive maintenance treatment. Thus, it is the agent of choice for patients with intermediate and high risk papillary tumors and those with carcinoma in situ.