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多西他赛为胃肠道癌带来了新的治疗机遇。

Docetaxel delivers new management opportunities for gastrointestinal carcinomas.

作者信息

Rougier P

机构信息

Gastrointestinal Unit, Institut Gustave-Roussy, Villejuif, France.

出版信息

Anticancer Drugs. 1995 Jul;6 Suppl 4:25-9. doi: 10.1097/00001813-199507004-00005.

Abstract

The results of four phase II studies of docetaxel in cancers of the gastrointestinal tract are summarized. No prior chemotherapy was permitted except for adjuvant chemotherapy completed at least 1 year before entering the present study. In all studies, docetaxel was administered at a dose of 100 mg/m2 given by intravenous infusion over 1 h once every 3 weeks, adjusted according to toxicity. Routine premedication for hypersensitivity reactions was given to most patients in the US study in colorectal cancer but not to patients in the three European studies in gastric, pancreatic and colorectal cancers. In a European Organization for Research on Treatment of Cancer--Early Clinical Trials Group (EORTC-ECTG) study in gastric cancer, 8 (24%) of 33 evaluable patients achieved partial remissions lasting for a median of 7.5 months. Responses occurred in a variety of metastatic sites. Forty-two patients were evaluable in a French study of docetaxel in pancreatic cancer. Partial responses were achieved in 6 (20%) of 30 patients with metastatic disease and 3 of 12 patients with loco-regional disease showed some improvement. Two studies in colorectal cancer--one European and one US--found that docetaxel had little or no activity in these patients. Three (9%) of 33 evaluable patients in the European study achieved responses (one complete and two partial) and none of 19 patients in the US study. Hematological toxicity was the dose-limiting adverse effect. Acute hypersensitivity reactions and fluid retention also occurred in some patients. In conclusion, docetaxel appears to be as effective as standard single-agent therapies for gastric and pancreatic cancers but to have minimal effect in colorectal carcinoma. Toxicities were generally manageable; premedication with corticosteroids may reduce the incidence and severity of acute hypersensitivity reactions and delay the onset of fluid retention.

摘要

本文总结了多西他赛用于胃肠道癌的四项II期研究结果。除进入本研究前至少已完成1年的辅助化疗外,不允许进行其他前期化疗。在所有研究中,多西他赛的给药剂量为100mg/m²,静脉输注1小时,每3周1次,并根据毒性进行调整。在美国一项针对结直肠癌的研究中,大多数患者接受了针对过敏反应的常规预处理,但在三项针对胃癌、胰腺癌和结直肠癌的欧洲研究中,患者未接受此类预处理。在欧洲癌症研究与治疗组织-早期临床试验组(EORTC-ECTG)的一项胃癌研究中,33例可评估患者中有8例(24%)实现部分缓解,缓解持续时间中位数为7.5个月。缓解出现在多种转移部位。在一项法国的多西他赛治疗胰腺癌的研究中,42例患者可评估。30例转移性疾病患者中有6例(20%)实现部分缓解,12例局部区域疾病患者中有3例有一定改善。两项针对结直肠癌的研究——一项欧洲研究和一项美国研究——发现多西他赛在这些患者中几乎没有活性或无活性。欧洲研究中33例可评估患者中有3例(9%)实现缓解(1例完全缓解和2例部分缓解),而美国研究中的19例患者均未缓解。血液学毒性是剂量限制性不良反应。一些患者还出现了急性过敏反应和液体潴留。总之,多西他赛似乎与胃癌和胰腺癌的标准单药疗法效果相当,但对结直肠癌的效果甚微。毒性一般可控;使用糖皮质激素进行预处理可能会降低急性过敏反应的发生率和严重程度,并延缓液体潴留的发生。

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