Scheithauer W, Rosen H, Schiessel R, Schüller J, Karall M, Ernst F, Sebesta C, Kornek G, Hentschel E, Marczell A
Department of Gastroenterology II, Vienna University School of Medicine, Austria.
Cancer. 1991 Mar 1;67(5):1294-8. doi: 10.1002/1097-0142(19910301)67:5<1294::aid-cncr2820670504>3.0.co;2-m.
Based on in vitro studies that have demonstrated synergy between 5-fluorouracil (5-FU), leucovorin (LV), and cisplatin (CDDP) against human colon cancer cell lines, a clinical trial was initiated to determine the effects of this combination in patients with advanced unresectable colorectal carcinoma. Fifty-nine patients were enrolled in the study and 12 of them had received prior conventional 5-FU chemotherapy. Treatment consisted of 4 weekly courses of high-dose LV (200 mg/m2) administered by intravenous (IV) bolus, followed by 5-FU (550 mg/m2) and CDDP (20 mg/m2) each administered as a 2-hour infusion on 4 consecutive days. After a median of 5.5 treatment cycles, objective tumor response was seen in 20 of 59 patients (34%) (this included 3 complete remissions). The response rate in the 47 previously untreated patients was 38% (95% confidence limits, 26% to 53%). Stable disease occurred in 16 (27%) patients, whereas the tumor progressed in 23 (39%) patients. The median survival time was 11.5 months, with 15% of the patients alive at 2 years. The regimen was well tolerated and the primary side effects were mild and reversible gastrointestinal symptoms and myelosuppression. There was no episode of life-threatening toxicity. Eastern Cooperative Oncology Group (ECOG) Grade III adverse reactions that required 25% dose reductions occurred in only 14% of the patients. The results of this trial suggest that 5-FU, LV, and CDDP is an active, safe, and well-tolerated combination regimen in patients with advanced colorectal cancer.
基于体外研究已证明5-氟尿嘧啶（5-FU）、亚叶酸（LV）和顺铂（CDDP）联合对人结肠癌细胞系具有协同作用，开展了一项临床试验以确定该联合方案对晚期不可切除结直肠癌患者的疗效。59例患者入组该研究，其中12例患者此前接受过传统的5-FU化疗。治疗包括4个每周疗程的大剂量LV（200mg/m²）静脉推注，随后5-FU（550mg/m²）和CDDP（20mg/m²）均连续4天进行2小时静脉滴注。经过中位5.5个治疗周期后，59例患者中有20例（34%）出现客观肿瘤反应（其中包括3例完全缓解）。47例既往未接受过治疗的患者的缓解率为38%（95%置信区间，26%至53%）。16例（27%）患者病情稳定，而23例（39%）患者肿瘤进展。中位生存时间为11.5个月，2年时15%的患者仍存活。该方案耐受性良好，主要副作用为轻度且可逆的胃肠道症状和骨髓抑制。未发生危及生命的毒性反应。仅14%的患者出现需要降低25%剂量的东部肿瘤协作组（ECOG）III级不良反应。该试验结果表明，5-FU、LV和CDDP联合方案对晚期结直肠癌患者是一种有效、安全且耐受性良好的治疗方案。
