局部阳性淋巴结膀胱癌不同治疗策略的疗效对比研究

Comparative effectiveness of different treatment strategies for bladder cancer of regional lymph nodes involvement

目的 对于临床淋巴结转移（cN＋）膀胱癌患者远距离转移风险高，但存在治愈可能。这类患者被排除在新辅助化疗试验之外，并在一线辅助化疗试验中与远距离转移患者合并，认为不适合定义综合治疗。本研究就其不同治疗策略进行了疗效比较分析。方法 回顾性分析2003年1月至2013年1月间于本院行化疗或膀胱切除术的cTanyN1-3M0期膀胱癌患者522例。通过规避患者及肿瘤相关的混杂因素评估有效性。结果 522例患者中（cN1 47%，cN2 43%，cN3 10%）342例接受了膀胱切除术、180例仅接受化疗。膀胱切除术患者中，116例接受了术前化疗、96例接受了辅助化疗。单独化疗、单独膀胱切除术、膀胱切除术配合术前化疗及膀胱切除术配合术后辅助化疗的5年总生存期（Overall survival,OS）分别为12%（95% CI：9%～14%）、19%（95% CI：13%～23%）、32%（95% CI：26%～37%）、25%（95% CI：20%～32%）。相比于单纯的膀胱切除术，术前化疗的OS显著改善（HR 0.68，95% CI：0.54～0.92）。术后辅助化疗相比于单纯膀胱切除术也显著改善生存期。仅接受化疗患者的生存期低于仅行膀胱切除术的患者。结论 cN＋膀胱癌患者实现长期生存需结合化疗和膀胱切除术等多种疗法以获得最好疗效。

Objective 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 fromneoadjuvant 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 analyze a comparative effectiveness for avoiding invalid evidence. Methods A retrospective study was conducted for 522 patients who underwent chemotherapy and/or cystectomy between January 2003 and January 2013 for cTanyN1-3M0 bladder cancer patients. We used multivariable adjustment for tumor- and patient- characteristics to assess effectiveness. Results Among 522 patients （cN1,47%;cN2, 43%; cN3, 10%）, 342 patients underwent cystectomy and 180 patients were treated with chemotherapy alone. Of the cystectomy patients, 116 patients received preoperative and 96 patients 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 12%（95% CI：9%～14%）, 19%（95% CI：13%～23%）, 32%（95% CI：26%～37%）,25%（95% CI：20%～32%）,respectively. Compared with cystectomy alone, preoperative chemotherapy was associated with a significant improvement in OS （HR 0.68, 95% CI：0.54～0.92）. Adjuvant chemotherapy was also associated with a significant improvement in survival compared with cystectomy alone. The survival in patients were treated with chemotherapy alone was worse than those were treated with cystectomy alone. Conclusions The patients with cN＋ bladder cancer achieves long survival.Combined-modality therapy, with chemotherapy and cystectomy, is associated with the best effect.