Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer
Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer
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DOI：
10.1056/nejmoa022148
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发表时间：
2003-08-28
影响因子：
158.5
通讯作者：
Crawford, ED
中科院分区：
文献类型：
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作者：
Grossman, HB;Natale, RB;Crawford, ED
背景：尽管进行了积极的局部治疗，局部晚期膀胱癌患者发生转移的风险仍然很高。我们评估了新辅助化疗对接受根治性膀胱切除术的局部晚期膀胱癌患者改善预后的能力。
方法：如果患者患有肌层浸润性膀胱癌（T2至T4a期）且要接受根治性膀胱切除术，则将其纳入研究。根据年龄（小于65岁与65岁及以上）和分期（浅肌层浸润与更广泛病变）进行分层，并随机分配至单独进行根治性膀胱切除术组，或接受三个周期的甲氨蝶呤、长春碱、多柔比星和顺铂治疗后再进行根治性膀胱切除术组。
结果：在11年期间我们招募了317名患者，其中10名被发现不符合条件；因此，154名患者被分配接受单纯手术，153名患者接受联合治疗。根据意向性治疗分析，分配接受单纯手术的患者中位生存期为46个月，而分配接受联合治疗的患者中位生存期为77个月（双侧分层对数秩检验，P = 0.06）。在两组中，生存期的改善都与膀胱切除标本中无残留癌相关。联合治疗组中无残留疾病的患者明显多于膀胱切除组（38%对15%，P<0.001）。联合治疗组的无复发生存期也明显长于膀胱切除组（P = 0.009）。联合治疗组的毒性反应是可接受的，且未导致手术延迟。
结论：对于局部晚期膀胱癌患者，新辅助化疗联合根治性膀胱切除术与单纯根治性膀胱切除术相比，可显著提高无残留疾病率和无复发生存率，并可能提高总体生存率。这些数据支持在这种情况下使用新辅助化疗。
BACKGROUND: Despite aggressive local therapy, patients with locally advanced bladder cancer are at significant risk for metastases. We evaluated the ability of neoadjuvant chemotherapy to improve the outcome in patients with locally advanced bladder cancer who were treated with radical cystectomy.METHODS: Patients were enrolled if they had muscle-invasive bladder cancer (stage T2 to T4a) and were to be treated with radical cystectomy. They were stratified according to age (less than 65 years vs. 65 years or older) and stage (superficial muscle invasion vs. more extensive disease) and were randomly assigned to radical cystectomy alone or three cycles of methotrexate, vinblastine, doxorubicin, and cisplatin followed by radical cystectomy.RESULTS: We enrolled 317 patients over an 11-year period, 10 of whom were found to be ineligible; thus, 154 were assigned to receive surgery alone and 153 to receive combination therapy. According to an intention-to-treat analysis, the median survival among patients assigned to surgery alone was 46 months, as compared with 77 months among patients assigned to combination therapy (P=0.06 by a two-sided stratified log-rank test). In both groups, improved survival was associated with the absence of residual cancer in the cystectomy specimen. Significantly more patients in the combination-therapy group had no residual disease than patients in the cystectomy group (38 percent vs. 15 percent, P