Scheithauer W, Depisch D, Schiessel R, Ludwig H
Department of Gastroenterology and Hepatology II, Vienna University School of Medicine, Austria.
Oncology. 1989;46(4):217-21. doi: 10.1159/000226719.
Twenty-seven patients with advanced measurable colorectal carcinoma were treated with a combination protocol consisting of folinic acid (FA) 200 mg/m2 i.v. bolus followed by 5-fluorouracil (5-FU) 550 mg/m2, and cisplatin (CIS) 20 mg/m2 each administered as a 2-hour i.v. infusion. Treatment was given on 4 consecutive days at 3- to 4-weekly intervals. Of 25 evaluable patients, 1 achieved complete remission and 5 partial remission for an overall response rate of 24%, while 9 patients (36%) had stable disease. Two out of 6 responders had previously progressed on 5-FU-containing regimens. The 95% confidence interval for response is 7-41%. Median survival time for all 27 patients enrolled in the study is 27+ weeks. Tolerance was remarkable and consisted primarily of mild and reversible gastrointestinal symptoms and myelosuppression. This 3-drug-regimen had significant palliative activity in our patient population. Its definitive role in the treatment of metastatic colorectal cancer as well as the potential improvement of the therapeutic index of 5-FU/FA by addition of CIS, require further evaluation in a randomized phase III trial.
27例晚期可测量的结直肠癌患者接受了一种联合方案治疗，该方案包括静脉推注亚叶酸（FA）200mg/m²，随后静脉输注5-氟尿嘧啶（5-FU）550mg/m²和顺铂（CIS）20mg/m²，每次输注2小时。每3至4周连续4天进行治疗。在25例可评估的患者中，1例获得完全缓解，5例部分缓解，总缓解率为24%，而9例患者（36%）病情稳定。6例缓解者中有2例先前在含5-FU方案中病情进展。缓解的95%置信区间为7%-41%。纳入研究的所有27例患者的中位生存时间为27+周。耐受性良好，主要表现为轻度且可逆的胃肠道症状和骨髓抑制。这种三药方案在我们的患者群体中具有显著的姑息治疗活性。其在转移性结直肠癌治疗中的明确作用以及通过添加顺铂提高5-FU/FA治疗指数的潜力，需要在随机III期试验中进一步评估。
