一项针对老年转移性结直肠癌患者的一线每两周一次卡培他滨和贝伐单抗的II期研究。
A phase II study of first-line biweekly capecitabine and bevacizumab in elderly patients with metastatic colorectal cancer.
作者信息
Puthillath Ajithkumar, Mashtare Terry, Wilding Gregory, Khushalani Nikhil, Steinbrenner Lynn, Ross Mary Ellen, Romano Karen, Wisniewski Michelle, Fakih Marwan G
机构信息
Department of Medicine at Roswell Park Cancer Institute, United States.
出版信息
Crit Rev Oncol Hematol. 2009 Sep;71(3):242-8. doi: 10.1016/j.critrevonc.2008.10.012. Epub 2008 Dec 10.
PURPOSE
This phase II study was conducted to determine the efficacy and safety of capecitabine and bevacizumab in untreated elderly metastatic colorectal cancer patients.
METHODS
Patients received 1500 mg/m(2)/dose of capecitabine twice daily x 7 days and bevacizumab at 5mg/kg on day 1, in 2 week-cycles.
RESULTS
The study was closed early, due to poor accrual, after a total of 16 patients enrolled. Four patients had an objective response and 11 patients had stable disease. The median time to progression and overall survival were 9.5 and 21.2 months, respectively. The most common grade >or= 3 toxicities included diarrhea (13%) and hand and foot syndrome (25%). Three patients had an arterial thrombotic event and one patient developed a bowel perforation.
CONCLUSIONS
In this underpowered phase II study in elderly patients with metastatic colorectal cancer, capecitabine plus bevacizumab was associated with considerable clinical activity but at an increased risk of hand and foot syndrome and arterial thrombotic events.
目的
本II期研究旨在确定卡培他滨和贝伐单抗对未经治疗的老年转移性结直肠癌患者的疗效和安全性。
方法
患者接受卡培他滨1500mg/m²/剂量，每日两次，共7天，第1天接受贝伐单抗5mg/kg，每2周为一个周期。
结果
由于入组情况不佳，该研究在共16例患者入组后提前结束。4例患者有客观缓解，11例患者疾病稳定。中位进展时间和总生存期分别为9.5个月和21.2个月。最常见的≥3级毒性包括腹泻（13%）和手足综合征（25%）。3例患者发生动脉血栓事件，1例患者出现肠穿孔。
结论
在这项针对老年转移性结直肠癌患者的样本量不足的II期研究中，卡培他滨加贝伐单抗具有相当的临床活性，但手足综合征和动脉血栓事件的风险增加。
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