Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T
Department of Surgery, Toho University School of Medicine, Sakura Hospital, 564-1 Shimoshizu, Sakura 285-8741, Japan.
Br J Cancer. 2009 Aug 18;101(4):598-604. doi: 10.1038/sj.bjc.6605218. Epub 2009 Jul 28.
It has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer.
A total of 377 node-positive patients with stage I, II, or IIIA disease were registered from September 1996 through July 2000 and were randomly assigned to either 6 cycles of CMF or 2 years of UFT. In both arms, tamoxifen (TAM) was concurrently administered for 2 years. The primary end point in this study was the non-inferiority of UFT to CMF.
No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF). Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.
UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.
据报道，尿嘧啶替加氟（UFT）治疗在生存率和无复发生存率（RFS）方面显著优于单纯手术治疗。因此，我们在接受了腋窝淋巴结阳性乳腺癌根治性手术的患者中，将UFT与环磷酰胺、甲氨蝶呤和氟尿嘧啶联合疗法（CMF）进行了比较。
1996年9月至2000年7月，共纳入377例I、II或IIIA期淋巴结阳性患者，并随机分为接受6个周期CMF治疗组或2年UFT治疗组。两组均同时给予他莫昔芬（TAM）治疗2年。本研究的主要终点是UFT不劣于CMF。
两组5年RFS率无统计学显著差异（UFT组为72.2%，CMF组为76.3%）。两组不良事件情况不同，UFT组白细胞减少症和贫血的发生率显著较低，还有对生活质量有影响的厌食、恶心/呕吐、口腔炎和脱发。
UFT联合TAM在淋巴结阳性早期乳腺癌治疗中具有前景。分层分析发现，UFT组在雌激素受体（ER）阳性患者中的复发率更好。基于替加氟的治疗应通过在ER阳性患者中进行的前瞻性随机试验进行评估。
