Oncology Department, Medical Oncology Unit, Azienda Ospedaliera Treviglio, Treviglio (BG), Italy.
Oncology Department, Medical Oncology Unit, Azienda Ospedaliera Treviglio, Treviglio (BG), Italy.
Eur Urol. 2014 Feb;65(2):350-7. doi: 10.1016/j.eururo.2013.06.049. Epub 2013 Jul 3.
Neoadjuvant chemotherapy before radical cystectomy (RC) is the preferred initial option for muscle-invasive bladder cancer (BCa). As in rectal and breast cancer, pathologic downstaging is associated with increased overall survival (OS).
We conducted a meta-analysis to determine whether pathologic complete response (pCR) (pT0N0M0) after neoadjuvant chemotherapy is associated with a better outcome in muscle-invasive BCa.
A systematic search was conducted in PubMed, Web of Science, Cochrane Collaboration's Central register of controlled trials, and Embase for publications reporting outcomes of patients with and without pCR. All patients underwent neoadjuvant cisplatin-based polychemotherapy and RC. The primary outcome reported as relative risk (RR) was OS. Secondary end points were recurrence-free survival (RFS) and cancer-specific survival other than distant and locoregional RFS. A meta-analysis was performed using the fixed effects model or random effects model. Overall heterogeneity for RFS and OS was assessed with forest plots and the Q test.
A total of 13 trials were included, for a total of 886 patients analysed after neoadjuvant chemotherapy and RC, without any postoperative treatment. The pCR rate was 28.6%. Patients who achieved pCR in the primary tumour and the lymph nodes presented an RR for OS of 0.45 (95% confidence interval [CI], 0.36-0.56; p<0.00001). The number needed to treat to prevent 1 death was 3.7 (absolute risk difference: -26%). The summary RR for RFS was 0.19 (95% CI, 0.09-0.39; p<0.00001).
Patients with BCa who achieved pCR (pT0N0M0 stage) after neoadjuvant chemotherapy have a better OS and RFS than do patients without pCR.
新辅助化疗（NAC）后行根治性膀胱切除术（RC）是肌层浸润性膀胱癌（BCa）的首选初始治疗方案。与直肠癌和乳腺癌一样，病理降期与总生存（OS）的增加相关。
我们进行了一项荟萃分析，以确定新辅助化疗后是否达到病理完全缓解（pCR）（pT0N0M0）与肌层浸润性 BCa 患者的更好结局相关。
在 PubMed、Web of Science、Cochrane 协作组对照试验中心注册库和 Embase 中进行了系统搜索，以查找报告有或无 pCR 的患者结局的出版物。所有患者均接受了基于顺铂的新辅助化疗联合 RC。报告的主要结局是相对风险（RR），即 OS。次要终点是无复发生存率（RFS）和癌症特异性生存（除远处和局部区域 RFS 外）。使用固定效应模型或随机效应模型进行荟萃分析。使用森林图和 Q 检验评估 RFS 和 OS 的总体异质性。
共纳入 13 项试验，共纳入 886 例患者，在新辅助化疗和 RC 后未行任何术后治疗。pCR 率为 28.6%。原发肿瘤和淋巴结达到 pCR 的患者 OS 的 RR 为 0.45（95%置信区间 [CI]，0.36-0.56；p<0.00001）。预防 1 例死亡所需的治疗人数为 3.7（绝对风险差异：-26%）。RFS 的汇总 RR 为 0.19（95% CI，0.09-0.39；p<0.00001）。
新辅助化疗后达到 pCR（pT0N0M0 期）的 BCa 患者的 OS 和 RFS 优于未达到 pCR 的患者。
