Lee K H, Lee J S, Suh C, Lee Y S, Min Y I, Ahn S H, Park K C, Kim S K, Kim S H
Section of Medical Oncology, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, Korea.
Am J Clin Oncol. 1992 Apr;15(2):141-5. doi: 10.1097/00000421-199204000-00009.
Based on recent preclinical data suggesting synergism between 5-fluorouracil (5-FU) and interferon alpha (IFN-alpha) and clinical activity of the combination therapy in colon cancer, 14 patients with advanced gastric cancer were treated with combination therapy of 5-FU and recombinant interferon alpha-2b (rIFN alpha-2b) (Intron A, Schering, Kenilworth, NJ, U.S.A.). The maximum tolerated dose was 5-FU 750 mg/m2/day given as a continuous infusion daily for 5 days followed by weekly bolus injection of the same initial daily dose, plus rIFN alpha-2b 5 X 10(6) U given subcutaneously 3 times weekly starting day 1 of 5-FU infusion. The dose-limiting toxicities were fatigue/weakness, diarrhea, and neurologic toxicities such as somnolence and confusion. The other common side effects were nausea, fever, leukocytopenia, thrombocytopenia, and the darkening of the skin. Of 13 evaluable patients, 4 had a partial response (duration 6, 14, 24, and 28 weeks). These data suggest that combination therapy of 5-FU plus rIFN alpha-2b is tolerable and has manageable side effects in patients with advanced gastric cancer. Further Phase II study will be needed to define the antitumor activity of this combination.
基于近期临床前数据表明5-氟尿嘧啶（5-FU）与α干扰素（IFN-α）之间存在协同作用，以及联合疗法在结肠癌中的临床活性，14例晚期胃癌患者接受了5-FU与重组α-2b干扰素（rIFNα-2b）（美国新泽西州肯尼沃思先灵公司的Intron A）的联合治疗。最大耐受剂量为5-FU 750mg/m²/天，持续静脉输注5天，随后每周推注相同的初始日剂量，加rIFNα-2b 5×10⁶U，从5-FU输注第1天开始每周皮下注射3次。剂量限制性毒性为疲劳/虚弱、腹泻以及诸如嗜睡和意识模糊等神经毒性。其他常见副作用为恶心、发热、白细胞减少、血小板减少和皮肤变黑。在13例可评估患者中，4例出现部分缓解（持续时间为6、14、24和28周）。这些数据表明，5-FU加rIFNα-2b联合疗法在晚期胃癌患者中是可耐受的，且副作用可控。需要进一步开展II期研究来明确该联合疗法的抗肿瘤活性。
