Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study.
Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study.
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DOI：
10.1038/sj.bjc.6601619
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发表时间：
2004-03-08
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
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作者：
静脉注射氟尿嘧啶和亚叶酸是III期结肠癌的标准辅助治疗。然而，口服辅助化疗是有吸引力的，因为它具有低毒性和更大的方便性。我们研究了口服蛋白结合多糖K（PSK）与替加氟/尿嘧啶（UFT）作为辅助治疗II期和III期结直肠癌的益处。患者被分配到接受3 g PSK加300 mg UFT或300 mg UFT单独口服的两组，在静脉注射丝裂霉素C后持续2年。在207例登记患者中，分析了205例II期（n=123）或III期（n=82）患者。PSK组（n=137）的5年无病生存率为73.0%（95%CI 65.6-80.4%），对照组（n=68）的5年无病生存率为58.8%（95%CI 47.1-70.5%）（P=0.016）。多糖K使复发率降低43.6%（95% CI 4.5-66.7%），死亡率降低40.2%（95% CI −12.5 - 68.3%）。PSK组5年生存率为81.8%（95% CI 75.3-88.2%），对照组为72.1%（95% CI 61.4-82.7%），P=0.056。在III期患者中，接受PSK的患者的无病生存率和总生存率显著增加：60.0%（95% CI 47.1-72.9%）和74.6% PSK组的95%CI为63.0-86.1%，对照组为32.1%（95%CI 14.8-49.4%）和46.4%（95%CI 28.0-64.9%）（分别为P=0.002和0.003）。多糖K可预防复发，尤其是肺转移（P=0.02;比值比0.27; 95% CI 0.09-0.77）。在模型中，区域转移的存在（相对危险度，2.973; 95%CI 1.712-5.165; P<0.001），遗漏PSK（相对危险度，2.106; 95% CI 1.221-3.633; P=0.007）和较高的原发肿瘤（相对危险度，4.398; 95% CI 1.017-19.014; P=0.047）分别是复发的显著指标。不良反应轻微，依从性好。口服PSK联合UFT可降低II期和III期结直肠癌的复发率，并增加III期结直肠癌的生存率。
Intravenous fluorouracil and leucovorin is the standard adjuvant treatment for stage III colon cancer. However, oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience. We investigated the benefits of oral protein-bound polysaccharide K (PSK) with tegafur/uracil (UFT) as an adjuvant in stage II and III colorectal cancer. Patients were assigned to groups that received either 3 g PSK plus 300 mg UFT, or 300 mg UFT alone orally each day for a 2-year period following intravenous mitomycin C. Of 207 registered patients, 205 with stage II (n=123) or III (n=82) were analysed. The 5-year disease-free survival was 73.0% (95% CI 65.6–80.4%) with PSK (n=137) and 58.8% (95% CI 47.1–70.5%) in the controls (n=68) (P=0.016). Polysaccharide K reduced the recurrence by 43.6% (95% CI 4.5–66.7%) and mortality by 40.2% (95% CI −12.5 to 68.3%). The 5-year survival was 81.8% (95% CI 75.3–88.2%) in the PSK group and 72.1% (95% CI 61.4–82.7%) in the control group (P=0.056). In stage III patients, disease-free and overall survivals in patients receiving PSK were increased significantly: 60.0% (95% CI 47.1–72.9%) and 74.6% (95% CI 63.0–86.1%) in the PSK group as compared with 32.1% (95% CI 14.8–49.4%) and 46.4% (95% CI 28.0–64.9%) in the controls (P=0.002 and 0.003, respectively). Polysaccharide K prevented recurrence, particularly lung metastases (P=0.02; odds ratio 0.27; 95% CI 0.09–0.77). In the models, the presence of regional metastases (relative risk, 2.973; 95% CI 1.712–5.165; P<0.001), omission of PSK (relative risk, 2.106; 95% CI 1.221–3.633; P=0.007), and higher primary tumour (relative risk, 4.398; 95% CI 1.017–19.014; P=0.047) were each significant indicators of recurrence. Adverse effects were mild and compliance was good. Oral PSK with UFT reduced recurrence in stage II and III colorectal cancer, and increased survival in stage III.
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影响因子：
39.2
作者：
Goldberg, RM;Fleming, TR;Laurie, JA
通讯作者：
Laurie, JA
DOI：
10.1007/s005990050079
发表时间：
1999-12-01
期刊：
INTERNATIONAL JOURNAL OF CLINICAL & LABORATORY RESEARCH
影响因子：
--
作者：
Pedrinaci, S;Algarra, I;Garrido, F
通讯作者：
Garrido, F
DOI：
10.1111/j.1349-7006.1994.tb02943.x
发表时间：
1994-12-01
期刊：
JAPANESE JOURNAL OF CANCER RESEARCH
影响因子：
--
作者：
MORINAGA, H;TAZAWA, K;FUJIMAKI, M
通讯作者：
FUJIMAKI, M
影响因子：
45.3
作者：
Porschen, R;Bermann, A;Strohmeyer, G
通讯作者：
Strohmeyer, G
DOI：
10.1016/s0022-5223(96)70085-5
发表时间：
1996-10-01
影响因子：
6
作者：
Okumura, S;Kondo, M;Naruke, T
通讯作者：
Naruke, T