一项在IIB期、III期结直肠癌中比较优福定+PSK与优福定+亚叶酸钙的III期试验（MCSGO-CCTG）。
Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG).
作者信息
Miyake Yasuhiro, Nishimura Junichi, Kato Takeshi, Ikeda Masataka, Tsujie Masaki, Hata Taishi, Takemasa Ichiro, Mizushima Tsunekazu, Yamamoto Hirofumi, Sekimoto Mitsugu, Nezu Riichiro, Doki Yuichiro, Mori Masaki
机构信息
Department of Surgery, Nishinomiya Municipal Hospital, Hayashidacho 8-24, Nishinomiya, Hyogo, 6638014, Japan.
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, 5650871, Japan.
出版信息
Surg Today. 2018 Jan;48(1):66-72. doi: 10.1007/s00595-017-1555-1. Epub 2017 Jun 20.
PURPOSE
Oral adjuvant uracil and tegafur plus leucovorin (UFT/LV) is not inferior to standard weekly fluorouracil and folinate for stage II/III colon cancer. However, protein-bound polysaccharide K (PSK) has been evaluated as postoperative adjuvant therapy for colorectal cancer. This report is the first of MCSGO-CCTG, which compared UFT/LV to UFT/PSK as adjuvant chemotherapy for stage IIB or III colorectal cancer in patients who had undergone Japanese D2/D3 lymph node dissection.
METHODS
The primary endpoint was the 3-year disease-free survival (DFS). A randomized non-inferiority study compared UFT/LV to UFT/PSK. The overall survival, adverse events, compliance, and quality of life were also investigated as the secondary endpoints.
RESULTS
Between March 2006 and December 2010, 357 patients were randomized to UFT/PSK (n = 178) or UFT/LV (n = 179) (median age 65 years, colon/rectum 67.4/32.6%, stage IIB/IIIA/IIIB/IIIC 11.1/15.7/55.0/18.2%). The 3-year DFS rate was 82.3% in those receiving UFT/LV and 72.1% in those receiving UFT/PSK. The non-inferiority of UFT/PSK adjuvant therapy to UFT/LV therapy was not verified (-9.06%, 90% confidence interval -17.06 to -1.06%). The 3-year overall survival rate was 95.4% in those receiving UFT/LV and 90.7% in those receiving UFT/PSK.
CONCLUSIONS
As adjuvant chemotherapy for stage IIB and III colorectal cancer patients, UFT/PSK adjuvant therapy was not non-inferior to UFT/LV therapy with respect to the DFS.
目的
口服辅助药物尿嘧啶替加氟加亚叶酸钙（UFT/LV）在治疗II/III期结肠癌方面并不逊色于标准的每周氟尿嘧啶和亚叶酸钙治疗。然而，蛋白结合多糖K（PSK）已被评估用于结直肠癌的术后辅助治疗。本报告是MCSGO-CCTG的首份报告，该研究比较了UFT/LV与UFT/PSK作为接受日本D2/D3淋巴结清扫术的IIB期或III期结直肠癌患者辅助化疗的疗效。
方法
主要终点为3年无病生存率（DFS）。一项随机非劣效性研究比较了UFT/LV与UFT/PSK。总生存率、不良事件、依从性和生活质量也作为次要终点进行了调查。
结果
2006年3月至2010年12月期间，357例患者被随机分为UFT/PSK组（n = 178）或UFT/LV组（n = 179）（中位年龄65岁，结肠癌/直肠癌占67.4/32.6%，IIB/IIIA/IIIB/IIIC期占11.1/15.7/55.0/18.2%）。接受UFT/LV治疗的患者3年DFS率为82.3%，接受UFT/PSK治疗的患者为72.1%。未证实UFT/PSK辅助治疗相对于UFT/LV治疗的非劣效性（-9.06%，90%置信区间为-17.06至-1.06%）。接受UFT/LV治疗的患者3年总生存率为95.4%，接受UFT/PSK治疗的患者为90.7%。
结论
对于IIB期和III期结直肠癌患者，作为辅助化疗，UFT/PSK辅助治疗在DFS方面并不非劣于UFT/LV治疗。
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