A phase II trial of continuous low-dose oral cyclophosphamide and celecoxib in patients with renal cell carcinoma
A phase II trial of continuous low-dose oral cyclophosphamide and celecoxib in patients with renal cell carcinoma
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DOI：
10.1007/s00280-006-0347-x
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发表时间：
2007-06-01
影响因子：
3
通讯作者：
Bjarnason, Georg A.
中科院分区：
文献类型：
--
作者：
Krzyzanowska, Monika K.;Tannock, Ian F.;Bjarnason, Georg A.
目的缺乏有效的系统治疗晚期肾细胞癌（RCC）的患者已经刺激了兴趣，在评估新的治疗策略，这种disease.Methods这是一个两个机构，两个阶段，II期临床试验连续低剂量口服环磷酰胺（50毫克，每天）与塞来昔布（400毫克，每天两次）在进行性，局部晚期或转移性肾细胞癌患者。主要终点是疾病控制率（DCR），定义为完全缓解（CR）或部分缓解（PR）或延长（>= 6个月）疾病稳定（SD）的患者数量。次要终点包括进展时间和toxics.Results之间2001年5月和2003年1月，36例患者参加了试验，其中32个是可评价的反应。1例患者PR，3例患者SD超过6个月（DCR 12.5%，95% CI 3.5-29.0%）。中位无进展生存期为3.5个月（95% CI，1.9-4.1个月），中位总生存期为14.5个月（95% CI，8.4-20.8个月）。1例患者发生5级胃肠道出血。否则，治疗耐受性良好。结论虽然一般耐受性良好，连续治疗低剂量环磷酰胺和塞来昔布在肾细胞癌的活性有限。
Purpose The lack of effective systemic therapies for patients with advanced renal cell carcinoma (RCC) has stimulated interest in evaluating novel treatment strategies for this disease.Methods This was a two-institution, two-stage, phase II trial of continuous low-dose oral cyclophosphamide (50 mg daily) in combination with celecoxib (400 mg twice daily) in patients with progressive, locally advanced or metastatic RCC. The primary endpoint was disease control rate (DCR) defined as the number of patients with complete (CR) or partial response (PR) or prolonged (>= 6 months) stable disease (SD). Secondary endpoints included time to progression and toxicity.Results Between May 2001 and January 2003, 36 patients were enrolled onto the trial of which 32 were evaluable for response. One patient had a PR and three others had SD for longer than 6 months (DCR 12.5%, 95% CI 3.5-29.0%). The median progression free survival was 3.5 months (95% CI, 1.9-4.1 months) and the median overall survival was 14.5 months (95% CI, 8.4-20.8 months). One patient experienced grade five gastrointestinal bleeding. Otherwise, the treatment was well tolerated.Conclusions Although generally well tolerated, continuous therapy with low-dose cyclophosphamide and celecoxib had limited activity in RCC.