Eng Cathy, Ramanathan Ramesh K, Wong Michael K, Remick Scot C, Dai Lanting, Wade-Oliver Kurombi T, Mani Sridhar, Kindler Hedy L
Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Am J Clin Oncol. 2004 Dec;27(6):565-9. doi: 10.1097/01.coc.0000135924.94955.16.
Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10% to 60%. Preclinical studies indicate that fixed dose rate infusion optimizes accumulation of gemcitabine triphosphate and may enhance the clinical activity of gemcitabine. We conducted a phase II study of fixed dose rate gemcitabine in 15 chemotherapy-naive patients with advanced cholangiocarcinoma and gallbladder carcinoma. Gemcitabine was administered at a dose of 1500 mg/m2 over 150 minutes weekly for 3 weeks every 28 days. Fourteen patients were evaluable for response. No complete or partial responses were observed. Two patients (13%) had stable disease lasting a median of 9 weeks. The median time to progression was 9 weeks; median survival was 20 weeks. There was considerable grade 3/4 hematologic toxicity, including neutropenia in 49% of patients, leukopenia in 40%, anemia in 27%, and thrombocytopenia in 27%. Grade 3/4 nonhematologic toxicities were minimal. We conclude that fixed dose rate gemcitabine results in significant myelosuppression and has minimal activity in patients with biliary tree carcinoma.
吉西他滨是一种常用于治疗胆管癌的化疗药物，有效率为10%至60%。临床前研究表明，固定剂量率输注可优化三磷酸吉西他滨的蓄积，并可能增强吉西他滨的临床活性。我们对15例初治的晚期胆管癌和胆囊癌患者进行了固定剂量率吉西他滨的II期研究。吉西他滨剂量为1500mg/m²，每28天内每周1次，每次150分钟，共3周。14例患者可评估疗效。未观察到完全缓解或部分缓解。2例患者（13%）病情稳定，中位持续时间为9周。中位疾病进展时间为9周；中位生存期为20周。有相当多的3/4级血液学毒性，包括49%的患者出现中性粒细胞减少、40%的患者出现白细胞减少、27%的患者出现贫血、27%的患者出现血小板减少。3/4级非血液学毒性轻微。我们得出结论，固定剂量率吉西他滨会导致显著的骨髓抑制，对胆管癌患者的活性极小。
