Improved local control of invasive bladder cancer by concurrent cisplatin and preoperative or definitive radiation
Improved local control of invasive bladder cancer by concurrent cisplatin and preoperative or definitive radiation
复制标题
DOI：
10.1200/jco.1996.14.11.2901
复制
发表时间：
1996-11-01
影响因子：
45.3
通讯作者：
Sullivan, LD
中科院分区：
文献类型：
--
作者：
Coppin, CML;Gospodarowicz, MK;Sullivan, LD
目的：进行了一项前瞻性随机试验，以确定在肌肉浸润性膀胱癌患者术前或最终放射治疗中同时添加顺铂是否能改善局部控制或生存率。患者和方法：99例符合条件的T2至T4b移行细胞膀胱癌患者参与研究，其中cT3b或cT4患者占64%。患者及其医生选择明确放疗或膀胱前切除术放疗；然后随机分配患者接受顺铂100 mg/m(2)静脉注射，间隔2周，共3个周期，同时盆腔放疗，或接受放疗而不化疗。根据临床肿瘤分期及放疗方案对患者进行分层。中位随访时间为6.5年。结果：两个研究组中远处转移的发生率相同。然而，48例对照患者中有25例首次骨盆复发，而51例顺铂治疗患者中有15例（P= 0.036）。两组患者同时服用顺铂后盆腔复发率均显著降低（P= 0.038， log-rank检验），且该效果在预后因素逐步Cox回归模型中得以保留（危险比0.50；90%置信区间[CI]， 0.29 ~ 0.86； P= 0.036）。两种辐射方案的危害减少是相似的。在Cox总生存模型中，预处理白细胞增多和临床分期高是独立的不良因素，但顺铂的影响不显著。结论：术前或终期放疗并发顺铂可改善局部晚期膀胱癌的盆腔控制，但未显示其能改善总生存率。同时使用顺铂对远处转移无明显影响。(C)美国临床肿瘤学会1996。
Purpose: A prospective randomized trial was conducted to determine whether the addition of concurrent cisplatin to preoperative or definitive radiation therapy in patients with muscle-invasive bladder cancer improved local control or survival.Patients and Methods: Ninety-nine eligible patients with T2 to T4b transitional cell bladder cancer participated, 64% with cT3b or cT4. Patients and their physicians selected either definitive radiotherapy or precystectomy radiotherapy; patients were then randomly allocated to receive intravenous cisplatin 100 mg/m(2) at 2-week intervals for three cycles concurrent with pelvic radiation, or to receive radiation without chemotherapy. Patients were stratified by clinical tumor stage and by radiation plan. The median follow-up duration is 6.5 years.Results: The occurrence of distant metastases was the same in both study arms. However, 25 of 48 control patients have had a first recurrence in the pelvis, compared with 15 of 51 cisplatin-treated patients (P=.036). The pelvic relapse rate in the two groups was significantly reduced by concurrent cisplatin (P=.038, log-rank test) and this effect was preserved in a stepwise Cox regression model of prognostic factors (hazards ratio, 0.50; 90% confidence interval [CI], 0.29 to 0.86; P=.036). The hazard reduction was similar for both radiation plans. Pretreatment leukocytosis and high clinical stage were independent adverse factors in a Cox model of overall survival, but the effect of cisplatin was not significant.Conclusion: Concurrent cisplatin may improve pelvic control of locally advanced bladder cancer with preoperative or definitive radiation, but has not been shown to improve overall survival. The use of concurrent cisplatin had no detectable effect on distant metastases. (C) 1996 by American Society of Clinical Oncology.