Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers:: Results of FFCD 9203
Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers:: Results of FFCD 9203
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DOI：
10.1200/jco.2006.06.7629
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发表时间：
2006-10-01
影响因子：
45.3
通讯作者：
Bedenne, Laurent
中科院分区：
文献类型：
--
作者：
Gerard, Jean-Pierre;Conroy, Thierry;Bedenne, Laurent
目的1992年，法国认为术前放疗作为T3-4直肠癌的标准治疗方法。本随机试验比较了术前放疗与放化疗。 患者和方法 如果患者患有可切除的 T3-4、Nx、M0 直肠腺癌且可进行直肠指检，则患者符合资格。术前放疗采用 45 Gy，分 25 次，为期 5 周。实验组在第一周和第五周进行了为期 5 天的氟尿嘧啶 350 mg/m(2)/d 与亚叶酸的同步化疗。手术计划在放疗结束后 3 至 10 周进行。所有患者均应接受相同的氟尿嘧啶/甲酰四氢叶酸方案的辅助化疗。该试验的主要终点是总生存期。结果共有 733 名患者符合资格。放化疗中 3 级或 4 级急性毒性更常见（14.6% vs 2.7%；P
PurposeIn 1992, preoperative radiotherapy was considered in France as the standard treatment for T3-4 rectal cancers. The present randomized trial compares preoperative radiotherapy with chemoradiotherapy.Patients and MethodsPatients were eligible if they presented a resectable T3-4, Nx, M0 rectal adenocarcinoma accessible to digital rectal examination. Preoperative radiotherapy with 45 Gy in 25 fractions during 5 weeks was delivered. Concurrent chemotherapy with fluorouracil 350 mg/m(2)/d during 5 days, together with leucovorin, was administered during the first and fifth week in the experimental arm. Surgery was planned 3 to 10 weeks after the end of radiotherapy. All patients should receive adjuvant chemotherapy with the same fluorouracil/leucovorin regimen. The primary end point of the trial was overall survival.ResultsA total of 733 patients were eligible. Grade 3 or 4 acute toxicity was more frequent with chemoradiotherapy (14.6% v 2.7%; P