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日本结直肠癌患者口服替加氟/尿嘧啶(UFT)加亚叶酸(LV)方案辅助化疗的临床依从性。

Clinical compliance with an oral uracil/tegafur (UFT) plus leucovorin (LV) regimen as adjuvant chemotherapy in Japanese colorectal cancer patients.

机构信息

Department of Surgical Oncology and Gastroenterological Surgery, Sapporo Medical University School of Medicine, Chuo-ku, Sapporo, Japan.

出版信息

Int J Clin Oncol. 2009 Oct;14(5):402-7. doi: 10.1007/s10147-009-0888-1. Epub 2009 Oct 25.

DOI:10.1007/s10147-009-0888-1
PMID:19856047
Abstract

BACKGROUND

The combination of oral uracil/tegafur (UFT) plus leucovorin (LV) is widely accepted as adjuvant chemotherapy for stages II and III of colorectal cancer. However, the clinical compliance of Japanese patients with this regimen has not been clearly elucidated to date.

METHODS

A total of 40 Japanese outpatients were treated with oral UFT plus LV as adjuvant chemotherapy following colorectal cancer surgery between January 2005 and June 2007. UFT capsules (300-500 mg/body per day) and LV tablets (75 mg/body per day, administered with each dose of UFT) were to be taken for 28 days, followed by 7 days of rest, with this cycle repeated every 35 days for 6 months or until recurrence. The patients were classified into the following three groups based on compliance: the completed group (n = 21), the modified group (n = 12), and the discontinued group (n = 7).

RESULTS

The UFT doses (mean +/- SD) were 267 +/- 35 mg/m(2) in the completed group, 276 +/- 50 mg/m(2) in the modified group, and 288 +/- 22 mg/m(2) in the discontinued group. The UFT dose in the discontinued group tended to be higher than that in the completed group (P = 0.12). The most frequent symptoms of nonhematologic toxicity were appetite loss (45%) and fatigue (45%). There were no hematologic or nonhematologic toxicities of grade 3 or 4.

CONCLUSION

The regimen of oral UFT plus LV produced only low-grade toxicity and was convenient for outpatients. It appears that the initial UFT dose might be associated with the development of toxicity in the oral UFT plus LV regimen.

摘要

背景

口服尿嘧啶/替加氟(UFT)加亚叶酸(LV)联合应用被广泛接受为结直肠癌 II 期和 III 期的辅助化疗。然而,目前尚未明确阐明日本患者对该方案的临床依从性。

方法

2005 年 1 月至 2007 年 6 月期间,40 例日本门诊患者在结直肠癌手术后接受口服 UFT 加 LV 作为辅助化疗。UFT 胶囊(每天 300-500mg/体)和 LV 片(每天 75mg/体,与每次 UFT 剂量一起服用)每天服用 28 天,休息 7 天,每 35 天重复一次,持续 6 个月或直至复发。根据依从性将患者分为以下三组:完成组(n = 21)、修改组(n = 12)和停药组(n = 7)。

结果

完成组 UFT 剂量(平均值 +/- SD)为 267 +/- 35mg/m(2),修改组为 276 +/- 50mg/m(2),停药组为 288 +/- 22mg/m(2)。停药组的 UFT 剂量倾向于高于完成组(P = 0.12)。最常见的非血液学毒性症状是食欲减退(45%)和疲劳(45%)。无 3 级或 4 级血液学或非血液学毒性。

结论

口服 UFT 加 LV 方案仅产生低级别毒性,对门诊患者方便。口服 UFT 加 LV 方案中初始 UFT 剂量可能与毒性的发生有关。

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Phase II study of uracil-tegafur with leucovorin in elderly (> or = 75 years old) patients with colorectal cancer: ECOG 1299.老年(≥75岁)结直肠癌患者使用尿嘧啶替加氟联合亚叶酸钙的II期研究:ECOG 1299
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Quality of life in operable colon cancer patients receiving oral compared with intravenous chemotherapy: results from National Surgical Adjuvant Breast and Bowel Project Trial C-06.
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Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06.口服尿嘧啶、替加氟加亚叶酸与静脉注射氟尿嘧啶加亚叶酸治疗Ⅱ期和Ⅲ期结肠癌的比较:国家外科辅助乳腺和肠道项目C-06方案的结果
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Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer.尿嘧啶/替加氟与口服亚叶酸钙对比氟尿嘧啶与亚叶酸钙用于既往未治疗的转移性结直肠癌患者的多中心III期研究。
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