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Oral tegafur in the treatment of gastrointestinal tract cancers: a phase II study

机译:口服替加福治疗胃肠道癌症:II期研究

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Fifty patients affected by histologically confirmed gastrointestinal tract cancer (GTC) were treated with oral tegafur (TG) 1,000 mg m-2 p.o. on days 1-14 repeated after a 14 day interval. Out of 42 evaluable patients seven patients had a partial response (PR. 17%) with a median duration of 20.5 weeks, three had a minimal response (7%) with a median duration of 23.7 weeks, nine showed a stabilisation which lasted a median of 31.3 weeks, and 23 progressed (55%). No response was obtained in patients affected by carcinoma of the pancreas and the hepatobiliary system. All PRs were achieved in patients with metastatic disease to the liver. No response was seen in patients with bone, lung or nodal metastasis. Three PRs were obtained in patients resistant to 5-fluorouracil. The difference in survival between patients who achieved PR and those who had a stabilisation was not statistically significant. On the other hand the survival of patients with PR was significantly longer than that of patients who progressed. Oral TG was well tolerated by most patients. WHO grade 1-2 gastrointestinal and neurological toxicities were seen respectively in 36% and 25% of cases. Five patients had grade 3 nausea/vomiting and one had grade 3 diarrhoea. Our data suggest that oral TG is effective in the treatment of stomach and colorectal cancers.
机译:接受组织学确认的胃肠道癌(GTC)感染的50名患者口服1,000 mg m-2 pega替加氟(TG)治疗。在14天间隔后重复1-14天。在42例可评估患者中,有7例患者有部分缓解(PR。17%),中位持续时间为20.5周,有3例患者有轻微缓解(7%),中位持续时间为23.7周,其中9例表现稳定,持续了31.3周,其中23进行了(55%)。受胰腺癌和肝胆系统影响的患者没有反应。所有PR均在肝转移性疾病患者中实现。骨,肺或淋巴结转移患者无反应。对5-氟尿嘧啶耐药的患者获得了三个PR。实现PR的患者与稳定的患者之间的生存期差异无统计学意义。另一方面,PR患者的生存期明显长于进展期患者。大多数患者对口服TG的耐受性良好。分别在36%和25%的病例中观察到WHO 1-2级胃肠道和神经系统毒性。 5例3级恶心/呕吐患者,1例3级腹泻。我们的数据表明,口服TG可有效治疗胃癌和大肠癌。

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