Younes A, Ayoub J P, Hagemeister F B, McLaughlin P, Sarris A, Rodriguez M A, Swan F, Romaguera J E, Martin J, Cabanillas F
Department of Hematology, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
J Clin Oncol. 1996 Feb;14(2):543-8. doi: 10.1200/JCO.1996.14.2.543.
Preclinical data suggest that the efficacy of paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ) is schedule-dependent. Schedule dependency is currently under investigation in ongoing randomized trials.
Twelve patients with relapsed non-Hodgkin's lymphoma (NHL) refractory to a 3-hour infusion of 200 mg/m2 Taxol were crossed over to receive a 96-hour infusion of 140 mg/m2 Taxol every 3 weeks in an outpatient setting. Premedication with corticosteroids and antihistamines was not used. Patients who did not achieve at least a partial remission (PR) after two courses or whose disease progressed after one course were removed from the study.
All 12 patients were assessable for response. Eleven patients received at least two courses and one patient received one course of 96-hour Taxol infusion. None of the 12 patients crossed over to receive 96-hour Taxol infusion achieved a PR or complete response (CR). Eight patients (67%) developed progressive lymphoma, three (25%) had stable disease, and only one (8%) had a minor response. No major hypersensitivity reactions or life-threatening toxicities were observed.
Ninety-six-hour Taxol infusion does not produce significant responses in patients with NHL refractory to 3-hour Taxol infusion. Until the results of an ongoing multicenter trial comparing a 3- with a 96-hour infusion are published, the use of 96-hour Taxol infusion in NHL patients should be restricted to investigational programs. Because 48- to 72-hour infusions can produce higher plasma concentrations of Taxol than a 96-hour infusion, these schedules should be investigated to determine if they can induce better clinical responses.
临床前数据表明，紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）的疗效具有给药方案依赖性。给药方案依赖性目前正在正在进行的随机试验中进行研究。
12例对200mg/m²紫杉醇3小时输注难治的复发非霍奇金淋巴瘤（NHL）患者，在门诊环境中改为每3周接受140mg/m²紫杉醇96小时输注。未使用皮质类固醇和抗组胺药进行预处理。在两个疗程后未达到至少部分缓解（PR）或在一个疗程后疾病进展的患者被排除在研究之外。
所有12例患者均可评估反应。11例患者接受了至少两个疗程，1例患者接受了一个疗程的96小时紫杉醇输注。改为接受96小时紫杉醇输注的12例患者中，无1例达到PR或完全缓解（CR）。8例患者（67%）出现淋巴瘤进展，3例（25%）病情稳定，仅1例（8%）有轻微反应。未观察到严重过敏反应或危及生命的毒性反应。
96小时紫杉醇输注对3小时紫杉醇输注难治的NHL患者无显著反应。在正在进行的比较3小时与96小时输注的多中心试验结果公布之前，NHL患者中96小时紫杉醇输注的使用应限于研究项目。由于48至72小时输注可产生比96小时输注更高的紫杉醇血浆浓度，应研究这些给药方案以确定它们是否能诱导更好的临床反应。
