一项关于肾细胞癌患者连续低剂量口服环磷酰胺和塞来昔布的II期试验。

A phase II trial of continuous low-dose oral cyclophosphamide and celecoxib in patients with renal cell carcinoma.

作者信息

Krzyzanowska Monika K, Tannock Ian F, Lockwood Gina, Knox Jennifer, Moore Malcolm, Bjarnason Georg A

机构信息

Department of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada.

出版信息

Cancer Chemother Pharmacol. 2007 Jun;60(1):135-41. doi: 10.1007/s00280-006-0347-x. Epub 2006 Sep 29.

DOI:10.1007/s00280-006-0347-x

PMID:17009033

Abstract

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 (> or =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.

摘要

目的

晚期肾细胞癌（RCC）患者缺乏有效的全身治疗方法，这激发了人们对评估该疾病新治疗策略的兴趣。

方法

这是一项在两个机构进行的两阶段II期试验，对进展性、局部晚期或转移性RCC患者连续低剂量口服环磷酰胺（每日50毫克）联合塞来昔布（每日两次，每次400毫克）进行研究。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）或疾病稳定延长（≥6个月）的患者数量。次要终点包括进展时间和毒性。

结果

在2001年5月至2003年1月期间，36名患者入组该试验，其中32名可评估疗效。1名患者达到PR，另外3名患者疾病稳定超过6个月（DCR为12.5%，95%CI为3.5 - 29.0%）。无进展生存期的中位数为3.5个月（95%CI，1.9 - 4.1个月），总生存期的中位数为14.5个月（95%CI，8.4 - 20.8个月）。1名患者发生5级胃肠道出血。除此之外，该治疗耐受性良好。