International Phase III Trial Assessing Neoadjuvant Cisplatin, Methotrexate, and Vinblastine Chemotherapy for Muscle-Invasive Bladder Cancer: Long-Term Results of the BA06 30894 Trial
International Phase III Trial Assessing Neoadjuvant Cisplatin, Methotrexate, and Vinblastine Chemotherapy for Muscle-Invasive Bladder Cancer: Long-Term Results of the BA06 30894 Trial
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DOI：
10.1200/jco.2010.32.3139
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发表时间：
2011-06-01
影响因子：
45.3
通讯作者：
Griffiths, Gareth
中科院分区：
文献类型：
--
作者：
Griffiths, Gareth
目的
本文呈现了一项国际多中心随机试验的长期结果，该试验研究了在接受膀胱切除术和/或放疗的膀胱肌层浸润性尿路上皮癌患者中使用新辅助顺铂、甲氨蝶呤和长春碱（CMV）化疗的情况。1989年至1995年期间招募了976名患者，目前中位随访时间为8.0年。
患者与方法
这是一项关于不使用新辅助化疗或使用三个周期CMV化疗的随机Ⅲ期试验。
结果
先前报道的CMV可能具有的生存优势现在在5%的水平上具有统计学意义。结果显示，使用CMV后，死亡风险在统计学上显著降低16%（风险比，0.84；95%置信区间，0.72 - 0.99；P = 0.037，相当于10年生存率从30%提高到36%）。
结论
我们得出结论，CMV化疗作为浸润性膀胱癌的一线辅助治疗可改善预后。两项大型随机试验（由医学研究委员会/欧洲癌症研究与治疗组织以及西南肿瘤学组开展）已证实了具有统计学意义且临床相关的生存获益，对于深度浸润性膀胱癌，与单独的膀胱切除术或放疗相比，新辅助化疗后进行确定性的局部治疗应被视为最先进的治疗方法。《临床肿瘤学杂志》29: 2171 - 2177。（2011年，美国临床肿瘤学会）
PurposeThis article presents the long-term results of the international multicenter randomized trial that investigated the use of neoadjuvant cisplatin, methotrexate, and vinblastine (CMV) chemotherapy in patients with muscle-invasive urothelial cancer of the bladder treated by cystectomy and/or radiotherapy. Nine hundred seventy-six patients were recruited between 1989 and 1995, and median follow-up is now 8.0 years.Patients and MethodsThis was a randomized phase III trial of either no neoadjuvant chemotherapy or three cycles of CMV.ResultsThe previously reported possible survival advantage of CMV is now statistically significant at the 5% level. Results show a statistically significant 16% reduction in the risk of death (hazard ratio, 0.84; 95% CI, 0.72 to 0.99; P = .037, corresponding to an increase in 10-year survival from 30% to 36%) after CMV.ConclusionWe conclude that CMV chemotherapy improves outcome as first-line adjunctive treatment for invasive bladder cancer. Two large randomized trials (by the Medical Research Council/European Organisation for Research and Treatment of Cancer and Southwest Oncology Group) have confirmed a statistically significant and clinically relevant survival benefit, and neoadjuvant chemotherapy followed by definitive local therapy should be viewed as state of the art, as compared with cystectomy or radiotherapy alone, for deeply invasive bladder cancer. J Clin Oncol 29: 2171-2177. (C) 2011 by American Society of Clinical Oncology