Berg W J, Schwartz L H, Amsterdam A, Mazumdar M, Vlamis V, Law T M, Nanus D M, Motzer R J
Division of Solid Tumor Oncology, Memorial Sloan-Kettering Cancer Center, New York, USA.
Invest New Drugs. 1997;15(4):353-5. doi: 10.1023/a:1005902022076.
The aim of this study was to determine the antitumor activity of 13-cis-retinoic acid as a single agent in patients with advanced renal cell carcinoma. Eligible patients had advanced renal cell carcinoma with bi-dimensionally measurable disease, a Karnofsky performance status of at least 70, life expectancy of greater than three months, no evidence of brain metastases, and treatment with no more than one chemotherapy regimen. Patients were treated with one mg/kg/day of 13-cis-retinoic acid orally. Twenty-six patients were enrolled in this study and 25 were evaluable for response and toxicity. Of the twenty-five evaluable patients, no major responses were achieved. Toxicity was mild, with no patient requiring a dose reduction. At the dose administered in this trial, 13-cis-retinoic acid is inactive as a single agent in renal cell carcinoma.
本研究的目的是确定13-顺式维甲酸作为单一药物对晚期肾细胞癌患者的抗肿瘤活性。符合条件的患者患有晚期肾细胞癌，具有二维可测量病灶，卡氏评分至少为70，预期寿命超过三个月，无脑转移证据，且接受不超过一种化疗方案的治疗。患者口服13-顺式维甲酸，剂量为每日1mg/kg。26例患者入组本研究，25例可评估疗效和毒性。在这25例可评估的患者中，未取得主要疗效。毒性轻微，无患者需要降低剂量。在本试验所给予的剂量下，13-顺式维甲酸作为单一药物对肾细胞癌无活性。
