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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer.
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Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer.

机译：尿嘧啶/替加氟联合亚叶酸和塞来昔布联合放疗联合治疗局部晚期胰腺癌的第二阶段试验。

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BACKGROUND AND PURPOSE: To investigate the efficacy and toxicity of a short intensive Uracil/Tegafur (UFT) based chemoradiotherapy scheme combined with celecoxib in locally advanced pancreatic cancer. MATERIAL AND METHODS: The Academic Medical Centre, Amsterdam and the Erasmus Medical Centre, Rotterdam enrolled 83 eligible patients with unresectable pancreatic cancer in a prospective multicentre phase II study. Median age was 62 years, median tumour size 40 mm and the majority of the patients (85%) had pancreatic head cancers. Treatment consisted of 20x2.5 Gy radiotherapy combined with UFT 300 mg/m(2) per day, leucovorin (folinic acid) 30 mg and celecoxib 80 0mg for 28 days concomitant with radiotherapy. Four patients were lost to follow-up. RESULTS: Full treatment compliance was achieved in 55% of patients, 80% received at least 3 weeks of treatment. No partial or complete response was observed. Median survival was 10.6 months and median time to progression 6.9 months. Toxicity was substantial with 28% grades III and IV gastro-intestinal toxicity and two early toxic deaths. CONCLUSIONS: Based on the lack of response, the substantial toxicity of mainly gastro-intestinal origin and the reported mediocre overall and progression free survival, we cannot advise our short intensive chemoradiotherapy schedule combined with celecoxib as the standard treatment.
机译：背景与目的：研究短期基于尿嘧啶/替加氟（UFT）的强化化疗方案联合塞来昔布在局部晚期胰腺癌中的疗效和毒性。材料和方法：阿姆斯特丹的学术医学中心和鹿特丹的伊拉斯姆斯医学中心在一项前瞻性多中心II期研究中招募了83名符合条件的不可切除胰腺癌患者。中位年龄为62岁，中位肿瘤大小为40 mm，大多数患者（85％）患有胰腺癌。治疗包括20x2.5 Gy放疗联合每天300 mg / m（2）的UFT，亚叶酸（亚叶酸）30 mg和塞来昔布80 0mg联合放疗28天。四名患者失去随访。结果：55％的患者达到了完全的治疗依从性，80％的患者接受了至少3周的治疗。没有观察到部分或全部反应。中位生存期为10.6个月，中位进展时间为6.9个月。毒性很大，III级和IV级胃肠道毒性为28％，有2例早期毒性死亡。结论：由于缺乏反应，主要由胃肠道产生的实质性毒性以及所报告的总体和无进展的中等生存，我们不能建议短期短期强化放化疗方案联合塞来昔布作为标准治疗方案。

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