Sakamoto J, Hamada C, Kodaira S, Nakazato H, Ohashi Y
Department of Surgery, Aichi Prefectural Hospital, Japan.
Jpn J Clin Oncol. 1999 Feb;29(2):78-86. doi: 10.1093/jjco/29.2.78.
Oral 5-fluorouracil and its prodrugs (tegafur, carmofur) is now being studied for adjuvant chemotherapy of curatively resected colorectal cancers. To evaluate the effect of these oral fluoropyrimidines (o-FPs), an individual patient data (IPD) meta-analysis of randomized clinical trials was performed in Japan as an inter-trialist group study.
Data from the three clinical trials in which postoperative adjuvant therapy with o-FPs was compared with surgery alone in patients with colorectal cancer were sought. IPD from a total of 4960 patients with follow-up periods of at least 5 years were analyzed.
The results of the meta-analysis on an 'intention to treat' basis demonstrated a significant benefit of o-FPs in terms of the disease-free survival (DFS) of the total patients [risk ratio (RR) 0.830, 95% confidence interval (CI) 0.742-0.929, P = 0.001]. o-FPs were also demonstrated to be effective for survival in rectal cancer (RR 0.857, 95% CI 0.734-0.999, P = 0.049) and in Dukes'C colorectal cancer (RR 0.828, 95% CI 0.711-0.965, P = 0.016).
The results suggest the advantage of long term o-FPs, possibly with the injection of mitomycin C, for prognosis for curatively resected colorectal cancer patients.
口服5-氟尿嘧啶及其前体药物（替加氟、卡莫氟）目前正用于对已行根治性切除的结直肠癌进行辅助化疗的研究。为评估这些口服氟嘧啶（o-FPs）的疗效，作为一项试验间研究者小组研究，在日本开展了一项针对随机临床试验的个体患者数据（IPD）荟萃分析。
查找三项将结直肠癌患者术后o-FP辅助治疗与单纯手术进行比较的临床试验数据。对总共4960例随访期至少5年的患者的IPD进行了分析。
基于“意向性治疗”的荟萃分析结果显示，o-FPs在全体患者的无病生存期（DFS）方面具有显著益处[风险比（RR）0.830，95%置信区间（CI）0.742 - 0.929，P = 0.001]。o-FPs在直肠癌（RR 0.857，95% CI 0.734 - 0.999，P = 0.049）和杜克氏C期结直肠癌（RR 0.828，95% CI 0.711 - 0.965，P = 0.016）的生存方面也显示出有效性。
结果表明，对于已行根治性切除的结直肠癌患者，长期使用o-FPs（可能联合丝裂霉素C注射）对预后具有优势。
