Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced biliary carcinoma.
Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced biliary carcinoma.
复制标题
尿嘧啶/替加氟 (UFT) 加亚叶酸治疗晚期胆管癌患者的 II 期试验。
DOI：
10.1023/a:1006268018519
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发表时间：
1999
影响因子：
3.4
通讯作者：
Benner,S
中科院分区：
文献类型：
--
作者：
Mani,S;Sciortino,D;Samuels,B;Arrietta,R;Schilsky,RL;Vokes,EE;Benner,S
精确度：UFT 300 mg/m2/d和甲酰四氢叶酸90 mg/d可安全地用于晚期胆道癌患者，患者的体能状态良好;然而，这种联合用药和28天给药方案对这种疾病没有活性。（UFT; Bristol-Myers Squibb，Wallingford，CT）加口服醛氢叶酸钙治疗晚期胆道（胆囊和胆管）癌患者。所有患者的Karnofsky体力状态≥ 60%，血小板计数≥ 75，000/μL，总胆红素≤ 2.0×机构正常上限，但其他肝功能和肾功能正常，通过CT扫描或超声检查发现二维可测量疾病。这些患者既往均未因晚期疾病接受过细胞毒性化疗或放疗。患者接受300 mg/m2/d UFT加90 mg/d甲酰四氢叶酸口服给药，每日分次给药，每8小时一次，共28天，每35天重复一次。在两个疗程后评价客观肿瘤反应，即本试验的主要终点。其他终点包括毒性，进展时间，和总survival.Results：所有患者的反应和毒性评价。在本试验中未观察到完全或部分缓解。4例患者病情稳定，分别持续17、30、33和35周。中位（范围）进展时间和生存期分别为9（1-35）周和28（1-61）周。治疗相关毒性为轻度，2例（15%）患者出现重度（3级或4级）腹泻。观察到3-4级高胆红素血症（31%）和恶心/呕吐（31%），可能与基础疾病相关。结论：UFT 300 mg/m2/d联合亚叶酸钙90 mg/d口服治疗中晚期胆管癌，每35 d重复1次，连续28 d，疗效不佳。
Precis: UFT 300 mg/m2/day and leucovorin 90 mg/day could be administered safely to patients with advanced biliary cancer with good performance status; however, this combination and schedule of 28-day administration has no activity in this disease.Purpose: To determine the activity and evaluate the toxicity of uracil and tegafur in a 4:1 molar concentration ratio (UFT; Bristol-Myers Squibb, Wallingford, CT) plus oral calcium leucovorin in the treatment of patients with advanced biliary (gallbladder and bile duct) carcinoma.Patients and methods: Thirteen patients with advanced measurable biliary carcinoma were enrolled onto the trial. All patients had a Karnofsky performance status ≥ 60%, platelet count ≥ 75,000/μL, total bilirubin ≤ 2.0× institutional upper limit of normal but otherwise normal liver and kidney function profile and bidimensionally measurable disease by CT scan or ultrasound examination. None of these patients previously received cytotoxic chemotherapy or radiation therapy for advanced disease. Patients received 300 mg/m2/d UFT plus 90 mg/d leucovorin administered orally in divided daily doses every 8 hours for 28 days repeated every 35 days. Objective tumor response, the primary endpoint of this trial, was evaluated after two courses of therapy. Other endpoints included toxicity, time to progression, and overall survival.Results: All patients were evaluable for response and toxicity. No complete or partial responses were observed in this trial. Four patients had stable disease lasting 17, 30, 33, and 35 weeks, respectively. The median (range) time to progression and survival were 9 (1–35) and 28 (1–61) weeks, respectively. Treatment-related toxicity was mild with severe (grade 3 or 4) diarrhea seen in 2 (15%). Grade 3–4 hyperbilirubinemia (31%) and nausea/vomiting (31%) were observed and likely related to the underlying disease. Grade 1 and 2 toxic effects included mainly anorexia and fatigue.Conclusion: UFT 300 mg/m2/d plus oral leucovorin 90 mg/d administered for 28 days repeated every 35 days is ineffective in the treatment of advanced biliary carcinoma.