Cytoreductive nephrectomy in patients with metastatic renal cancer: A combined analysis
Cytoreductive nephrectomy in patients with metastatic renal cancer: A combined analysis
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DOI：
10.1097/01.ju.0000110610.61545.ae
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发表时间：
2004-03-01
影响因子：
6.6
通讯作者：
Crawford, ED
中科院分区：
文献类型：
--
作者：
Flanigan, RC;Mickisch, G;Crawford, ED
目的：转移性肾癌预后差。免疫治疗的最新进展使肿瘤细胞减少性肾切除术重新引起人们的兴趣。我们报告的2个前瞻性随机试验，使用相同的研究protocol.Materials和方法：共331例患者被随机分配到2个相同的协议比较细胞减灭性肾切除术加干扰素α-2b与干扰素α-2b单独在转移性肾癌患者，其中原发性肿瘤存在，并认为是可切除的。每项试验的主要终点是总生存率，次要终点是反应率。患者在随机化前按体能状态（0或1）、转移部位（仅肺vs其他）和疾病可测量性分层。所有结果均按意向治疗标准进行分析。假设单用干扰素治疗的中位生存期为1年，西南肿瘤组试验设计用于检测中位生存期改善50%和应答率改善15%，功效为0.85。欧洲组织的研究和治疗癌症积累了额外的80名患者在该study.Results：这2项试验的综合分析得出的中位生存期为13.6个月的肾切除术加干扰素与7.8个月的干扰素单独。这一差异代表死亡风险降低31%（p = 0.002）。有没有证据表明，在治疗效果的大小差异，根据预随机化分层factors.Conclusions：细胞减灭性肾切除术似乎显着改善与干扰素免疫治疗的转移性肾癌患者的总生存率独立于患者的性能状态，转移的网站和存在可测量的疾病。尽管具有高度统计学意义，但整个组的总体生存优势仅为5.8个月。这些数据强调，需要确定这种生存优势是否可以进一步提高使用更积极的免疫治疗或其他新的药物在细胞减少性肾切除术的设置。
Purpose: Metastatic renal cancer is associated with a poor prognosis. Recent advances in immunotherapy for this problem have rekindled interest in cytoreductive nephrectomy. We report a combined analysis of 2 prospective randomized trials that used an identical study protocol.Materials and Methods: A total of 331 patients were randomized to 2 identical protocols comparing cytoreductive nephrectomy plus interferon alpha-2b vs interferon alpha-2b alone in patients with metastatic renal cancer, in whom the primary tumor was present and believed to be resectable. The primary end point for each trial was overall survival with a secondary end point of the response rate. Patients were stratified at pre-randomization by performance status (0 or 1), site of metastases (lung only vs other) and disease measurability. All results were analyzed by intent to treat criteria. Assuming a median survival of I year for interferon only, the Southwest Oncology Group trial was designed to detect a 50% improvement in median survival duration and a 15% improvement in response rate with a power of 0.85. The European Organization for the Research and Treatment of Cancer accrued an additional 80 patients in that study.Results: The combined analysis of these 2 trials yielded a median survival of 13.6 months for nephrectomy plus interferon vs 7.8 months for interferon alone. This difference represents a 31% decrease in the risk of death (p = 0.002). There was no evidence of a difference in the size of the treatment effect according to pre-randomization stratification factors.Conclusions: Cytoreductive nephrectomy appears to improve significantly overall survival in patients with metastatic renal cancer treated with interferon immunotherapy independent of patient performance status, the site of metastases and the presence of measurable disease. Although it is highly statistically significant, the overall survival advantage is only 5.8 months for the entire group. These data emphasize the need to determine if this survival advantage can be further improved using more aggressive immunotherapy or other novel agents in the setting of cytoreductive nephrectomy.