编译：刘畅
来源：桓兴医讯
目的（Purpose）
临床上有淋巴结转移的膀胱癌患者远处转移风险高，但有治愈的可能。新辅助化疗试验将这类患者排除在外，而与远处转移的患者一起参与一线化疗试验，但并不适合评价综合治疗对这类患者的作用。为弥补这种证据缺失，我们进行了一项疗效对比分析。
Patients with bladder cancer with clinical lymph node involvement (cN+) are at high risk for distant metastases, but are potentially curable. Such patients are excluded from neoadjuvant chemotherapy trials and pooled with patients with distant metastases in first-line chemotherapy trials not suited to define the role of combined-modality therapy. To address this evidence void, we performed a comparative effectiveness analysis.
方法（Methods）
我们从“国家癌症数据库（2003-2012）”纳入了化疗和/或膀胱切除术治疗的cTanyN1-3M0膀胱癌患者，允许延迟登记，采用多态生存分析，评估不同治疗策略的总生存率（OS）。对肿瘤层面、患者层面及医疗机构层面进行多变量校正，评价疗效。
We included cTanyN1-3M0 bladder cancer patients from the National Cancer Data Base (2003-2012) treated with chemotherapy and/or cystectomy. We used multistate survival analysis, allowing for delayed entry, to assess overall survival (OS) according to various treatment strategies. Effectiveness was estimated with multivariable adjustment for tumor-, patient-, and facility-level characteristics.
结果（Results）
在1739名患者中（cN1占48%，cN2占45%，cN3占7%），1104名进行了膀胱切除术、635名单行化疗治疗。膀胱切除术患者中，363名接受了术前辅助化疗，328名接受了术后辅助化疗。单行化疗5年总生存率为14%（95%CI11%-17%），单行膀胱切除术5年总生存率19%（95%CI15%-24%），术前化疗后行膀胱切除术5年总生存率31%（95%CI25%-38%），膀胱切除术后辅助化疗5年总生存率26%（95%CI21%-34%）。与单纯膀胱切除术相比，术前化疗与总生存率显著提高相关（风险比0.80，95%CI0.66-0.97）。与单纯膀胱切除术相比，术后辅助化疗也与生存率显著提高相关。单用化疗的患者比单纯手术治疗者生存率更差。
Among 1,739 patients (cN1, 48%; cN2, 45%; cN3, 7%), 1,104 underwent cystectomy and 635 were treated with chemotherapy alone. Of the cystectomy patients, 363 received preoperative and 328 received adjuvant chemotherapy. The crude 5-year OS for chemotherapy alone, cystectomy alone, preoperative chemotherapy followed by cystectomy, and cystectomy followed by adjuvant chemotherapy was 14% (95% CI, 11% to 17%), 19% (95% CI, 15% to 24%), 31% (95% CI, 25% to 38%), and 26% (95% CI, 21% to 34%), respectively. Compared with cystectomy alone, preoperative chemotherapy was associated with a significant improvement in OS (hazard ratio, 0.80; 95% CI, 0.66 to 0.97). Adjuvant chemotherapy was also associated with a significant improvement in survival compared with cystectomy alone. The survival of patients treated with chemotherapy alone was worse than those treated with cystectomy alone.
结论（Conclusion）
临床上有淋巴结转移的一部分膀胱癌患者可获得长期生存。用化疗和膀胱切除术进行综合治疗与最佳转归相关。
A subset of patients with cN+ bladder cancer achieves long-term survival. Combined-modality therapy, with chemotherapy and cystectomy, is associated with the best outcomes.
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