Aapro M S, Martin C, Hatty S
Oncology Service, Clinique de Genolier, Geneva, Switzerland.
Anticancer Drugs. 1998 Mar;9(3):191-201. doi: 10.1097/00001813-199803000-00001.
Gemcitabine is a novel nucleoside analog with demonstrated efficacy across a range of solid tumors. This paper reviews the single-agent safety profiles of 979 patients in 22 completed clinical studies using a day 1, 8, 15 q 28 day, 800-1250 mg/m2 dose schedule. Hematological toxicity was mild with WHO grade 3 and 4 toxicities recorded for hemoglobin (6.8 and 1.3% of patients), leukocytes (8.6 and 0.7%), neutrophils (19.3 and 6.0%) and platelets (4.1 and 1.1%). Myelosuppression was short lived and rarely of clinical significance. Mucositis and alopecia were rare, and nausea and vomiting mild. Transient rises in transaminases, mild proteinuria and hematuria were common, but rarely clinically significant. Renal failure of uncertain etiology was reported in seven instances. Some patients (18.9%) experienced transient flu-like symptoms and mild fever was reported in 37.3% of flu patients. Peripheral edema was reported in 20.3% of patients in the absence of cardiac, hepatic or renal failure. Thus, gemcitabine is well tolerated and has a mild toxicity profile. Of nearly 11,000 protocol-defined injections, 94% were administered and only 14% were reduced. Grade 3 or 4 non-laboratory toxicities with a frequency of more than 1% were only seen for infection (1.2%), nausea and vomiting (18.4%), and pulmonary toxicity (1.4%).
吉西他滨是一种新型核苷类似物，已证明对多种实体瘤有效。本文回顾了22项完成的临床研究中979例患者使用第1、8、15天，每28天一次，800 - 1250mg/m²剂量方案的单药安全性。血液学毒性较轻，血红蛋白（患者的6.8%和1.3%）、白细胞（8.6%和0.7%）、中性粒细胞（19.3%和6.0%）和血小板（4.1%和1.1%）出现WHO 3级和4级毒性。骨髓抑制持续时间短且很少具有临床意义。粘膜炎和脱发罕见，恶心和呕吐较轻。转氨酶短暂升高、轻度蛋白尿和血尿常见，但很少具有临床意义。7例报告了病因不明的肾衰竭。一些患者（18.9%）出现短暂的流感样症状，37.3%的流感患者报告有轻度发热。20.3%的患者在无心脏、肝脏或肾衰竭的情况下出现外周水肿。因此，吉西他滨耐受性良好，毒性较轻。在近11000次方案规定的注射中，94%进行了给药，仅14%进行了减量。发生率超过1%的3级或4级非实验室毒性仅见于感染（1.2%）、恶心和呕吐（18.4%）以及肺部毒性（1.4%）。
