Huncharek M, McGarry R, Kupelnick B
Division of Radiation Oncology, Department of Clinical Oncology, Marshfield Clinic Cancer Center, Marshfield, WI, USA.
Anticancer Res. 2001 Jan-Feb;21(1B):765-9.
The impact of in tranvesical chemotherapy on preventing recurrence of superficial transitional cell carcinoma of the bladder is controversial. The objective of this report is to present a meta-analysis of the available clinical trial data to quantify the effect of intravesical chemotherapy on tumor recurrence following trans-urethral resection (TURB) in patients with recurrent superficial bladder cancer.
A prospective study protocol outlining a meta-analysis was developed followed by a thorough search of the existing published literature using strict eligibility criteria. Eight randomized trials were found which met protocol specifications. These studies contained data on 1,609 patients which were statistically combined using a fixed effects model (Peto). The outcome of interest was the proportion of patients with tumor recurrence at one, two and three years post-TURB.
Combining all 8 studies using 1 year recurrence as the outcome measure yielded a Peto odds ratio (ORp) of 0.62, demonstrating a 38% reduction in one year recurrence among patients treated with intravesical chemotherapy versus TURB alone. Using 2 and 3 year recurrence as the outcome measure yielded ORp's of 0.46 and 0.35 respectively, favoring TURB + intravesical chemotherapy versus TURB alone. A statistical test for heterogeneity (Q) showed the 2 and 3 year outcome data to be heterogeneous (i.e. the studies are not measuring an effect of the same magnitude). Sensitivity analyses showed that drug type appeared to account for the observed heterogeneity with a stratified analysis demonstrating that adriamycin is less effective in reducing subsequent tumor recurrences than all other drugs studied.
Intravesical chemotherapy appears to have a major impact on decreasing the chance of recurrence of recurrent superficial bladder cancer. Three year recurrence is decreased by as much as 70% when compared with TURB alone. These data are in contrast to prior analyses suggesting only modest efficacy of such treatment in this clinical setting.
膀胱内化疗对预防浅表性膀胱移行细胞癌复发的影响存在争议。本报告的目的是对现有临床试验数据进行荟萃分析，以量化膀胱内化疗对复发性浅表性膀胱癌患者经尿道膀胱肿瘤切除术（TURB）后肿瘤复发的影响。
制定了一项概述荟萃分析的前瞻性研究方案，随后使用严格的纳入标准对现有已发表文献进行全面检索。发现八项随机试验符合方案规范。这些研究包含1609例患者的数据，使用固定效应模型（Peto）进行统计学合并。感兴趣的结果是TURB后1年、2年和3年肿瘤复发患者的比例。
以1年复发作为结果指标合并所有8项研究，得出Peto比值比（ORp）为0.62，表明膀胱内化疗治疗的患者与单纯TURB相比，1年复发率降低了38%。以2年和3年复发作为结果指标，ORp分别为0.46和0.35，表明TURB联合膀胱内化疗优于单纯TURB。异质性统计检验（Q）显示2年和3年的结果数据存在异质性（即这些研究测量的效应大小不同）。敏感性分析表明，药物类型似乎是观察到的异质性的原因，分层分析表明阿霉素在降低后续肿瘤复发方面比其他所有研究药物的效果更差。
膀胱内化疗似乎对降低复发性浅表性膀胱癌的复发几率有重大影响。与单纯TURB相比，3年复发率降低了70%。这些数据与之前的分析相反，之前的分析表明这种治疗在这种临床情况下的疗效有限。
