Pazdur R, Ajani J A, Patt Y Z, Gomez J, Bready B, Levin B
Section of Gastrointestinal Oncology and Digestive Diseases, University of Texas M. D. Anderson Cancer Center, Houston 77030.
Cancer. 1993 Feb 15;71(4):1214-8. doi: 10.1002/1097-0142(19930215)71:4<1214::aid-cncr2820710407>3.0.co;2-t.
Thirty-nine patients with advanced measurable metastatic colorectal carcinoma were entered in a clinical trial of recombinant alpha-2a-interferon (r alpha-2a-IFN) and continuous-infusion 5-fluorouracil (5-FU). Patients had not been treated previously with chemotherapy and had bidimensionally measurable disease.
A course of therapy consisted of a 5-day continuous infusion of 5-FU, 750 mg/m2/day, with r alpha-2a-IFN, 9 x 10(6) IU, subcutaneously, on days 1, 3 and 5 of the 5-FU infusion. A course of therapy was repeated every 15 days, and patients were examined for response after receiving four courses of therapy.
One patient had a complete response, and 11 patients experienced partial responses, for an overall response rate of 31% (95% confidence interval [CI], 17-48%). The median duration of response was 7.5 months (range, 2-13 months). Fifty-two percent of the patients entered in this trial are alive at time of this writing, with a median follow-up duration of 12.2 months (range, 6-24 months). Grade 3-4 toxicities included mucositis (nine patients), diarrhea (two patients), granulocytopenia (two patients), and fatigue (three patients).
This regimen of 5-FU with r alpha-2a-IFN administration does not appear to be superior to previously published schedules of 5-FU with r alpha-2a-IFN or to other methods that modulate 5-FU.
39例晚期可测量转移性结直肠癌患者进入重组α-2a干扰素（rα-2a-IFN）与持续输注5-氟尿嘧啶（5-FU）的临床试验。患者此前未接受过化疗，且有二维可测量疾病。
一个疗程的治疗包括5天持续输注5-FU，750mg/m²/天，在5-FU输注的第1、3和5天皮下注射rα-2a-IFN，9×10⁶IU。每15天重复一个疗程的治疗，患者在接受四个疗程的治疗后检查疗效。
1例患者完全缓解，11例患者部分缓解，总缓解率为31%（95%置信区间[CI]，17-48%）。缓解的中位持续时间为7.5个月（范围，2-13个月）。在撰写本文时，该试验中52%的患者存活，中位随访时间为12.2个月（范围，6-24个月）。3-4级毒性包括粘膜炎（9例患者）、腹泻（2例患者）、粒细胞减少（2例患者）和疲劳（3例患者）。
这种5-FU联合rα-2a-IFN给药方案似乎并不优于先前发表的5-FU联合rα-2a-IFN方案或其他调节5-FU的方法。
