Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: The eastern cooperative oncology group (ECOG) results of protocol E1293
Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: The eastern cooperative oncology group (ECOG) results of protocol E1293
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DOI：
10.1007/bf02993858
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发表时间：
1996-06-01
期刊：
影响因子：
3.4
通讯作者：
Benson, AB
中科院分区：
文献类型：
--
作者：
Einzig, AI;Neuberg, D;Benson, AB
本研究的目的是评价多西他赛（泰索帝）在既往未接受过细胞毒化疗的上消化道腺癌患者中的临床疗效和安全性。多西他赛100 mg m（-2），每3周1小时静脉（IV）输注给药41例患者。患者在每个疗程前均接受地塞米松、苯海拉明和西咪替丁预处理。测定临床反应和毒性。在41名合格患者中的7名中观察到客观缓解（2名完全缓解[CR]和5名部分缓解[PR]，客观缓解率为17%（90%置信区间[CI]，8%至30%）。最常见的毒性是4级中性粒细胞减少，发生在88%的患者中; 46%的患者在需要抗生素治疗的血小板减少性发热发作后需要减量。另外的患者具有可逆的3-4级毒性，包括恶心、呕吐、口腔炎、腹泻、疲劳和周围神经病变。10例患者发生1-3级超敏反应。大多数患者都有脱发。在患者中观察到1-3级液体潴留。按照该方案给药的多西他赛是上胃肠道腺癌的活性药物。应在多药联合方案中对该药物进行进一步研究。
The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m(-2) was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.