属于中等风险组的非肌肉浸润性膀胱癌(NMIBC)患者应接受膀胱内滴注治疗,以防止复发和进展。
我们比较了NMIBC患者每月维持卡介苗(BCG)方案与表柔比星(EPI)和干扰素-α2a(IFN)方案的结果。
我们的前瞻性随机多中心研究纳入了1997年至2008年间纳入的229例经常复发的TaT11-2级或低级别NMIBC患者。
四组研究包括围手术期单次灌注EPI加上每周五次灌注BCG或EPI/IFN,随后在1年BCG或EPI/IFN维持组中每月滴注11次,随后又在两个为期两年的维护部门中进行了四次季度灌输。
复发的时间,programming,疾病特异性生存,使用Kaplan-Meier和累积发生率分析以及Cox和比例亚分布风险模型分析总死亡率.
卡介苗和EPI/IFN组的中位随访时间为7.5年和7.4年,分别。BCG组的复发概率明显低于EPI/IFN组。概率为39%,而7.4年为72%,分别(风险比[HR]:0.41;95%置信区间[CI],0.28-0.60;p<0.001)。在进展概率或总生存期方面没有显著差异。然而,BCG组患者的疾病特异性死亡率存在显著差异(HR:0.20;95%CI,0.04-0.91;p=0.04).
与EPI/IFN-α2a的类似方案相比,每月维持BCG方案显示出优异的疗效,并且在预防复发方面明显更好。
与表柔比星和干扰素-α2a的类似方案相比,每月卡介苗(BCG)方案显示出优异的疗效,并且在预防复发方面明显更好。
在随访的这一阶段,注册被认为是没有必要的,因为该研究早在1997年就开始了,当时有关研究注册的要求尚未实施。
Patients with non-muscle-invasive bladder cancer (NMIBC) belonging to the intermediate-risk group should be treated with intravesical instillations to prevent recurrence and progression.
We compared the outcome of a monthly maintenance bacillus Calmette-Guérin (BCG) regimen with that of epirubicin (EPI) and interferon-α2a (IFN) in patients with NMIBC.
Our prospective randomized multicenter study comprised 229 eligible patients with frequently recurrent TaT1 grade 1-2 or low-grade NMIBC enrolled between 1997 and 2008.
The four-arm study involved a single perioperative instillation of EPI plus five weekly instillations of BCG or EPI/IFN, followed by 11 monthly instillations in the 1-yr BCG or EPI/IFN maintenance arms, further followed by four additional quarterly instillations in the two 2-yr maintenance arms.
Time to recurrence, progression, disease-specific survival, and overall mortality were analyzed using the Kaplan-Meier and cumulative incidence analyses plus the Cox and proportional subdistribution hazards models.
The median follow-up time was 7.5 and 7.4 yr in the BCG and EPI/IFN groups, respectively. The probability of recurrence was significantly lower in the BCG group than in the EPI/IFN group. The probability was 39% versus 72% at 7.4 yr, respectively (hazard ratio [HR]: 0.41; 95% confidence interval [CI], 0.28-0.60; p<0.001). There was no significant difference in the probability of progression or in overall survival. However, there was a significant difference in disease-specific mortality in favor of the BCG group (HR: 0.20; 95% CI, 0.04-0.91; p=0.04).
The monthly maintenance BCG regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of EPI/IFN-α2a.
A monthly bacillus Calmette-Guérin (BCG) regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of epirubicin and interferon-α2a.
Registration was not considered necessary at this stage of the follow-up because the study was initiated as early as in 1997, before the current requirements concerning study registrations were implemented.