Vuky Jacqueline, Yu Richard, Schwartz Lawrence, Motzer Robert J
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Invest New Drugs. 2002 Aug;20(3):327-30. doi: 10.1023/a:1016270206374.
Fourteen patients with metastatic renal cell carcinoma (RCC) were treated on a Phase II trial with arsenic trioxide (As2O3). Eligible patients had metastatic renal cell carcinoma with bidimensionally measurable disease, a Karnofsky performance status of at least 70%, life expectancy of greater than three months, and no evidence of brain metastases. Arsenic trioxide was given intravenously at a dose of 0.3 mg/kg/day for five consecutive days every four weeks. The most common toxicity observed was grade II elevation in liver function tests (36%), anemia (21%), renal insufficiency (14%), rash (7%), and diarrhea (7%). Best response was stable disease in 3 patients with one patient remaining on study at 8+ months At the dose and schedule used in this trial, arsenic trioxide did not achieve a complete or partial response in metastatic renal cell carcinoma.
14例转移性肾细胞癌（RCC）患者在一项二期试验中接受了三氧化二砷（As2O3）治疗。符合条件的患者患有二维可测量疾病的转移性肾细胞癌，卡诺夫斯基表现状态至少为70%，预期寿命大于3个月，且无脑转移证据。三氧化二砷以0.3mg/kg/天的剂量静脉给药，每四周连续给药五天。观察到的最常见毒性是肝功能试验二级升高（36%）、贫血（21%）、肾功能不全（14%）、皮疹（7%）和腹泻（7%）。最佳反应是3例患者病情稳定，1例患者在8个多月时仍在研究中。在本试验使用的剂量和方案下，三氧化二砷在转移性肾细胞癌中未实现完全或部分缓解。
