Eur Urol. 2005 Aug;48(2):189-199; discussion 199-201. doi: 10.1016/j.eururo.2005.04.005. Epub 2005 Apr 25.
To evaluate the effect of adjuvant chemotherapy in invasive bladder cancer.
: We conducted a systematic review and meta-analysis of updated individual patient data from all available randomised controlled trials comparing local treatment plus adjuvant chemotherapy versus the same local treatment alone.
Analyses were based on 491 patients from six trials, representing 90% of all patients randomised in cisplatin-based combination chemotherapy trials and 66% of patients from all eligible trials. The power of this meta-analysis is clearly limited. The overall hazard ratio for survival of 0.75 (95% CI 0.60-0.96, p = 0.019) suggests a 25% relative reduction in the risk of death for chemotherapy compared to that on control. Cox regression suggests that small imbalances in patient characteristics do not bias the results in favour of chemotherapy. However, the impact of trials that stopped early, of patients not receiving allocated treatments or not receiving salvage chemotherapy is less clear.
This IPD meta-analysis provides the best evidence currently available on the role of adjuvant chemotherapy for invasive bladder cancer. However, at present there is insufficient evidence on which to reliably base treatment decisions. These results highlight the urgent need for further research into the use of adjuvant chemotherapy. The results of appropriately sized randomised trials, such as the ongoing EORTC-30994 trial are needed before any definitive conclusions can be drawn.
评估辅助化疗在浸润性膀胱癌中的疗效。
我们对所有可用随机对照试验的最新个体患者数据进行了系统评价和荟萃分析，比较局部治疗加辅助化疗与单纯相同局部治疗的效果。
分析基于六项试验中的491名患者，这些患者占以顺铂为基础的联合化疗试验中随机分组患者总数的90%，占所有符合条件试验患者的66%。这项荟萃分析的效能显然有限。总体生存风险比为0.75（95%置信区间0.60 - 0.96，p = 0.019），表明与对照组相比，化疗使死亡风险相对降低了25%。Cox回归分析表明，患者特征的微小差异不会使结果偏向化疗。然而，早期终止试验、未接受分配治疗或未接受挽救性化疗的患者所产生的影响尚不清楚。
这项个体患者数据荟萃分析提供了目前关于辅助化疗在浸润性膀胱癌中作用的最佳证据。然而，目前尚无足够证据可作为可靠的治疗决策依据。这些结果凸显了对辅助化疗应用进行进一步研究的迫切需求。在得出任何明确结论之前，需要如正在进行的欧洲癌症研究与治疗组织（EORTC）-30994试验等规模适当的随机试验结果。
