Br J Urol. 1995 Feb;75(2):206-13. doi: 10.1111/j.1464-410x.1995.tb07313.x.
To assess whether neoadjuvant or concurrent platinum-based chemotherapy improves the survival of patients with locally advanced bladder cancer, and to determine whether there is any evidence that chemotherapy is more or less effective within well-defined subgroups of patients.
A formal meta-analysis (overview) was carried out using updated individual data from 479 patients (301 deaths) from four randomized trials comparing local definitive treatment alone with neoadjuvant or concurrent single-agent cisplatin followed by local definitive treatment. Further summary data were available from a similar randomized trial of cisplatin and doxorubicin in 325 patients (127 deaths).
Combined analysis of the individual patient data gave an overall hazard ratio of 1.02 in favour of local therapy alone (P = 0.845, 95% confidence interval = 0.81-1.26), representing a 2% increase in the relative risk of death with the use of chemotherapy. When this analysis was supplemented by data from the only trial for which individual patient information was not available, the hazard ratio was 0.91 in favour of chemotherapy (P = 0.328, 95% confidence interval = 0.75-1.10), representing a 9% reduction in the relative risk of death. The only prognostic factor for which the evidence suggested a differential treatment effect (interaction) across groups was age (chi-square test for trend = 3.833, P = 0.05), with younger age groups (< 60 years) exhibiting a possible effect in favour of chemotherapy.
Despite a meta-analysis of all known randomized trials, there is still insufficient information to obtain a definitive answer to the question of whether neoadjuvant cisplatin-based chemotherapy improves the survival of patients with locally advanced bladder cancer. Such chemotherapy cannot therefore be currently recommended for routine use and any planned clinical trial should include a 'no chemotherapy' control arm.
评估新辅助或同步铂类化疗是否能提高局部晚期膀胱癌患者的生存率，并确定是否有证据表明化疗在明确界定的患者亚组中效果更好或更差。
采用来自四项随机试验的479例患者（301例死亡）的更新个体数据进行正式的荟萃分析（综述），这些试验比较了单纯局部确定性治疗与新辅助或同步单药顺铂治疗后再进行局部确定性治疗。另外，从一项针对325例患者（127例死亡）的顺铂和阿霉素类似随机试验中可获得进一步的汇总数据。
对个体患者数据的综合分析得出，总体风险比为1.02，支持单纯局部治疗（P = 0.845，95%置信区间 = 0.81 - 1.26），这表明使用化疗后死亡相对风险增加了2%。当该分析补充了唯一一项无法获取个体患者信息的试验数据后，风险比为0.91，支持化疗（P = 0.328，95%置信区间 = 0.75 - 1.10），这表明死亡相对风险降低了9%。唯一有证据表明各亚组间存在差异治疗效果（交互作用）的预后因素是年龄（趋势卡方检验 = 3.833，P = 0.05），较年轻年龄组（< 60岁）可能显示出支持化疗的效果。
尽管对所有已知随机试验进行了荟萃分析，但仍没有足够信息来明确回答基于顺铂的新辅助化疗是否能提高局部晚期膀胱癌患者生存率这一问题。因此，目前不推荐这种化疗常规使用，任何计划中的临床试验都应包括一个“不进行化疗”的对照组。
