比較口服Tegafur/Uracil(UFUR®)及靜脈注射5-Fluorouracil於直腸癌之術前同步化學及放射線治療

背景：直腸癌的治療，以手術切除為主要治療方式。然而，局部復發是最大的挑戰。透過全直腸係膜切除（total mesorectal excision）和同步化學及放射線治療（concurrent chemoradiotherapy）能有效地降低局部復發率（local recurrent rate）。術前同步化學及放射線治療在肛門保留（sphincter preservation）及完全切除率（complete resection rate）都優於術後同步化學治及放射線治療。口服UFUR比連續靜脈注射5-FU還方便。本研究比較口服UFUR與靜脈注射5-FU於直腸癌患者接受術前同步化學及放射線治療的治療差異。方法：本研究從西元2001一月至西元2010年12月，共有57位患者進入此研究。口服UFUR這組患者，接受放射線治療（4500 cGy平均分成五週）及化學治療（300mg/m2/day UFT and 25mg/day oral LV），於治療前六週給予。靜脈注射5-FU這組患者，接受放射線治療（4500 cGy平均分成五週）及化學治療（每週接受5-FU 3000mg/m2 連續給予 24 hours），於治療前六週給予。使用統計軟體（SPSS 14.0，SPSS Inc.，Chicago，IL，U.S.A）進行統計層次分析。數值變項使用ｔ檢定分析；類別變項使用χ2檢定分析。結果：口服UFUR這組有28位病患，而靜脈注射5-FU這組患者有29位病患。這兩組在腫瘤反應率（response rate）上沒有統計學差異（50.0% vs 38.0%, p=0.171）。腫瘤完全反應率（completeresponse rate）在口服UFUR這組為14.3%，而靜脈注射5-FU這組為13.8%。於接受術前同步化學及放射線治療期間，並沒有患者疾病惡化或是轉移。結論：直腸癌患者接受術前同步化學及放射線治療時，不管是使用口服UFUR 或是靜脈注射5-FU，都有相同的腫瘤反應率和腫瘤完全反應率。

Background：Surgical resection has been the main force of rectal cancer treatment. However, local recurrence has been the most challenge.Total mesorectal excision and concurrent chemo-radiotherapy can effectively reduce the local recurrence rate. Pre-operative concurrent chemo-radiotherapy is superior to post-operative concurrent chemo-radiotherapy in anal sphincter preservation and complete resection. UFUR is more convenient than infusion 5-FU.We compared oral uracil and tegafur plus leucovorin vs. infusion 5-fluorouracil plus leucovorin given concomitantly with preoperative irradiation in patients with low rectal cancer.Materials and Methods：A total of 57 patients were included into this study between Jan 2001 to Dec 2010. Oral UFT group received pelvic radiation（4500 cGy in 5 weeks）and chemotherapy（300mg/m2/day UFT and 25mg/day oral LV）in the first 6 weeks. Infusion group patient received pelvic radiation（4500 cGy in 5 weeks）and chemotherapy （5-FU weekly 3000mg/m2 keep 24 hours）in the first 6 weeks.Statistical analysis was carried out by using the statistical software (SPSS 14.0; SPSS Inc., Chicago, IL, USA). The chi-square test was used to compare categorical data and the Student’s t test was use to compare numerical data.Results：There were 28 patients in oral UFT group and 29 patients in infusion group. There were no differences in response rates （50.0% vs 38.0%, p=0.171） The pCT rate was 14.3% in oral UFT group and 13.8% in infusion group. During pre-OP CCRT period, no patients were suffered from disease progress or metastasis.Conclusion：Oral UFUR and intravenous infusional 5- fluorouracil in preoperative concurrent chemoradiotherapy for rectal cancer are effective in tumor response rate and pathologic complete response.