Rolevich A I, Evmenenko A A
Division of Oncourology, Department of Surgery.
Department of Cancer Control N.N. Alexandrov National Cancer Centre, Minsk, Belarus.
Urologiia. 2016 Aug(4):137-146.
We conducted a meta-analysis assessing the effect of photodynamic diagnosis (PDD) -guided transurethral resection of the bladder tumor (TURB) on the recurrence-free survival in patients with non-muscle invasive bladder cancer within prospective randomised trials that used 5-aminolevulinic acid as a photosensitizer.
Medical literature search was performed up to February 2016. Recurrence hazard ratios (HRs) and its 95% confidence intervals (CI) were calculated for each selected study with direct and indirect methods and the pooled estimates were obtained with random-effects model.
Data from 5 prospective randomized trials with inclusion of 1089 patients were selected. Pooled estimate of recurrence HR was 0.71 (95% CI 0.48-1.04, p=0.08) with significant heterogeneity across selected publications: p=0,001; I2=78%. The subgroup analysis substantially reduced the heterogeneity: in subgroup comprising single/two-center studies or with moderate to high risk of bias or with long follow-up there was significant benefit of PDD-assisted TURBT (HR 0.51, 95% CI 0.38-0.69; p<0.0001), while in multicenter studies or those with low risk of bias or short follow-up the effect size was within the statistical error limits (HR 1.04, 95% CI 0.77-1.42, p=0.78).
Statistically significant benefit of PDD-guided TURBT over the white-light TURBT was limited to single/two-center studies or with moderate to high risk of bias or with long follow-up. True meaning of these finding it is not clear due to possibility of alternative explanations of identified differences. Generally there was low quality of evidence from significant proportion of studies and risk of publication bias.
我们进行了一项荟萃分析,在使用5-氨基乙酰丙酸作为光敏剂的前瞻性随机试验中,评估光动力诊断(PDD)引导下的经尿道膀胱肿瘤切除术(TURB)对非肌层浸润性膀胱癌患者无复发生存率的影响。
截至2016年2月进行医学文献检索。使用直接和间接方法为每项选定研究计算复发风险比(HRs)及其95%置信区间(CI),并采用随机效应模型获得合并估计值。
选取了5项纳入1089例患者的前瞻性随机试验数据。复发HR的合并估计值为0.71(95%CI 0.48 - 1.04,p = 0.08),所选出版物之间存在显著异质性:p = 0.001;I² = 78%。亚组分析显著降低了异质性:在包括单中心/双中心研究或偏倚风险为中度至高度或随访时间长的亚组中,PDD辅助TURBT有显著益处(HR 0.51,95%CI 0.38 - 0.69;p < 0.0001),而在多中心研究或偏倚风险低或随访时间短的研究中,效应大小在统计误差范围内(HR 1.04,95%CI 0.77 - 1.42,p = 0.78)。
PDD引导下的TURBT相对于白光TURBT的统计学显著益处仅限于单中心/双中心研究或偏倚风险为中度至高度或随访时间长的研究。由于对已识别差异可能存在其他解释,这些发现的真正意义尚不清楚。总体而言,相当比例的研究证据质量较低,存在发表偏倚风险。