A RANDOMIZED TRIAL OF FLUOROURACIL AND FOLINIC ACID IN PATIENTS WITH METASTATIC COLORECTAL-CARCINOMA
A RANDOMIZED TRIAL OF FLUOROURACIL AND FOLINIC ACID IN PATIENTS WITH METASTATIC COLORECTAL-CARCINOMA
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DOI：
10.1200/jco.1988.6.3.469
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发表时间：
1988-03-01
影响因子：
45.3
通讯作者：
ELHAKIM, T
中科院分区：
文献类型：
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作者：
ERLICHMAN, C;FINE, S;ELHAKIM, T
我们在一项前瞻性对照试验中，通过与标准5-FU疗法的比较，确定了氟尿嘧啶(5-FU)联合亚叶酸(FA)对可测量的复发或转移性结直肠癌患者的疗效。患者随机接受FA，200 mg/m2/d，连续5天，或不接受任何治疗。所有患者在第一个疗程中接受5-FU，370 mg/m2/d，连续5天，随后调整剂量以维持两个手臂的同等毒性。130名患者参加了试验，只有5名患者因不符合资格标准或随机后拒绝治疗而被排除在分析之外。两个治疗臂针对11个临床特征进行了平衡。在每两个疗程结束时评估患者的反应，并在每个疗程结束后评估毒性。中位随访期为1.45年。剂量限制毒性为粘膜炎和腹泻，尽管有明显的中性粒细胞减少。5-FU+FA组有效率为33%(21/63)，5-FU组有效率为7%(4/61)(P<；0.0005)。与单一用药组相比，联合用药组的疾病进展时间有显著差异(P=.023)。与单独使用5-FU的患者相比，接受5-FU和FA治疗的患者总生存期显著延长(P=0.05)。联合用药的中位生存期为12.6个月，单用5-FU的中位生存期为9.6个月。我们的结果表明，5-FU和FA联合治疗未接受过化疗的转移性或复发性直肠癌患者是有效的。
We determined the therapeutic effect of fluorouracil (5-FU) in combination with folinic acid (FA) in patients with measurable recurrent or metastatic carcinoma of the colon or rectum by comparing it to standard 5-FU therapy in a prospective controlled trial. Patients were randomized to receive either FA, 200 mg/m2/d for five consecutive days, or nothing. All patients received 5-FU, 370 mg/m2/d for five days on the first course, with subsequent dose modifications to maintain equal toxicity in the two arms. One hundred thirty patients were entered on trial and only five were excluded from the from the analysis because they did not meet the eligibility criteria or they refused therapy after randomization. The two treatment arms were balanced for 11 clinical characteristics. Patients were evaluated for response at the end of every two treatment courses and toxicity after every course of therapy. Median follow-up was 1.45 years. Dose-limiting toxicity was mucositis and diarrhea on this treatment schedule, although neutropenia was appparent. The response rate was 33% (21 of 63 patients) in the 5-FU and FA arm and was 7% (four of 61 patients) in the 5-FU arm (P < .0005). Time to disease progression was significantly different in the combination arm as compared with the single-agent arm (P = .023). Overall survival was significantly longer for patients treated with 5-FU and FA as compared with those receiving 5-FU alone (P = .05). The median survival was 12.6 months for patients receiving the combination, and 9.6 months for those receiving 5-FU alone. Our results indicate that the combination of 5-FU and FA is effective treatment for patients with metastatic or recurrent carcinoma of the rectum and colon who have not received prior chemotherapy.