Sakamoto Junichi, Ohashi Yasuo, Hamada Chikuma, Buyse Marc, Burzykowski Tomasz, Piedbois Pascal
Department of Epidemiological and Clinical Research Information Management, Graduate School of Medicine, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501, Japan.
J Clin Oncol. 2004 Feb 1;22(3):484-92. doi: 10.1200/JCO.2004.04.065.
Adjuvant therapy of colorectal cancer with oral fluorinated pyrimidines is attractive because of its ease of administration and good tolerability. The purpose of this meta-analysis is to assess the survival and disease-free survival benefits of treating patients after surgical resection of a primary colorectal tumor with oral fluoropyrimidines for 1 year.
This meta-analysis was performed on individual data from three randomized trials conducted by the Japanese Foundation for Multidisciplinary Treatment for Cancer involving a total of 5,233 patients with stages I to III colorectal cancer.
The overall hazard ratio in favor of oral therapy was 0.89 for survival (95% CI, 0.80 to 0.99; P =.04), and 0.85 for disease-free survival (95% CI, 0.77 to 0.93; P <.001). Thus oral therapy reduced the risk of death by 11% and the risk of recurrence or death by 15%. There was no significant heterogeneity between trials, nor did the benefit of oral therapy depend on tumor stage (I, II, or III), tumor site (rectum or colon), patient age, or patient sex.
Oral fluoropyrimidines improve disease-free survival and survival of patients after resection of early-stage colorectal cancer. These observations support the use of these agents alone after resection of early-stage disease, as well as further testing of oral agents in combination with new drugs that have recently shown antitumor activity in advanced colorectal cancer.
口服氟嘧啶用于结直肠癌的辅助治疗具有给药方便且耐受性良好的特点，因而颇具吸引力。本荟萃分析的目的是评估原发性结直肠癌手术切除后口服氟嘧啶治疗1年对患者生存及无病生存的益处。
本荟萃分析采用了日本多学科癌症治疗基金会开展的三项随机试验的个体数据，共纳入5233例Ⅰ至Ⅲ期结直肠癌患者。
口服治疗组生存的总体风险比为0.89（95%CI，0.80至0.99；P = 0.04），无病生存的总体风险比为0.85（95%CI，0.77至0.93；P < 0.001）。因此，口服治疗可使死亡风险降低11%，复发或死亡风险降低15%。各试验之间无显著异质性，口服治疗的益处也不取决于肿瘤分期（Ⅰ、Ⅱ或Ⅲ期）、肿瘤部位（直肠或结肠）、患者年龄或患者性别。
口服氟嘧啶可改善早期结直肠癌切除术后患者的无病生存和生存情况。这些观察结果支持在早期疾病切除后单独使用这些药物，以及进一步测试口服药物与最近在晚期结直肠癌中显示出抗肿瘤活性的新药联合使用的效果。
