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多西他赛(泰索帝)用于晚期胃癌:一项II期临床试验的结果。欧洲癌症研究与治疗组织早期临床试验小组

Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group.

作者信息

Sulkes A, Smyth J, Sessa C, Dirix L Y, Vermorken J B, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J

机构信息

Institute of Oncology, Beilinson Medical Center, Petah Tiqva, Israel.

出版信息

Br J Cancer. 1994 Aug;70(2):380-3. doi: 10.1038/bjc.1994.310.

DOI:10.1038/bjc.1994.310
PMID:7914428
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2033505/
Abstract

Thirty-seven eligible patients, median age 59 years (range 37-72) and median performance status 1 (0-2), with advanced, untreated, measurable gastric carcinoma were given docetaxel, 100 mg m-2 i.v. over 60 min without premedication, once every 3 weeks. Metastatic sites included the liver in 12 patients and retroperitoneal lymph nodes in 16. Eight of the 33 evaluable patients (24%) achieved a partial remission for a median of 7.5 months (3-11+). An additional 11 patients had stabilisation of disease. The patients received a median of four cycles of docetaxel (range 1-8) for a total of 156 courses. Dose reduction was necessary in 30 cycles; 14 cycles were delayed a mean of 3 days. Haematological toxicity consisted mainly of non-cumulative neutropenia, with a median nadir count of 0.35 x 10(9) l-1 (0.04-1.64) and eight episodes (5%) of leucopenic fever; non-haematological toxicities included alopecia, mild nausea and vomiting and allergic manifestations such as skin rash and pruritus. There were no drug-related deaths. Our data indicate that docetaxel is an active agent in advanced gastric cancer; further clinical investigations seem warranted.

摘要

37例符合条件的患者,中位年龄59岁(范围37 - 72岁),中位体能状态为1(0 - 2),患有晚期、未经治疗且可测量的胃癌,接受多西他赛治疗,剂量为100 mg/m²,静脉滴注60分钟,不进行预处理,每3周一次。转移部位包括12例患者的肝脏和16例患者的腹膜后淋巴结。33例可评估患者中有8例(24%)获得部分缓解,中位缓解持续时间为7.5个月(3 - 11+个月)。另有11例患者病情稳定。患者接受多西他赛治疗的中位周期数为4个周期(范围1 - 8个周期),共156个疗程。30个疗程需要降低剂量;14个疗程平均延迟3天。血液学毒性主要为非累积性中性粒细胞减少,中位最低点计数为0.35×10⁹/L(0.04 - 1.64),有8次(5%)白细胞减少性发热;非血液学毒性包括脱发、轻度恶心和呕吐以及皮疹和瘙痒等过敏表现。无药物相关死亡。我们的数据表明,多西他赛在晚期胃癌中是一种有效的药物;进一步的临床研究似乎是有必要的。

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Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group.多西他赛(泰索帝)用于晚期胃癌:一项II期临床试验的结果。欧洲癌症研究与治疗组织早期临床试验小组
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[A late phase II clinical study of RP56976 (docetaxel) in patients with advanced or recurrent gastric cancer: a cooperative study group trial (group B)].
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J Clin Oncol. 1995 Feb;13(2):314-22. doi: 10.1200/JCO.1995.13.2.314.
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