Okuno K, Yasutomi M, Kon M, Hatakeyama K, Muto T, Kitajima M, Koyanagi Y, Hamano K, Ohta H, Aiba K, Arai Y, Sowa M, Kikkawa N, Takayasu Y, Isomoto H
First Department of Surgery, Kinki University School of Medicine, Osaka-sayama, Japan.
Hepatogastroenterology. 1999 Mar-Apr;46(26):1116-21.
BACKGROUND/AIMS: A pilot study of Interleukin-2 (IL-2) with chemotherapy for unresectable colorectal liver metastases revealed a favorable response rate (76%). This prospective, randomized, multicenter study was conducted to evaluate the efficacy of this treatment protocol.
Over a period of 32 months, 46 patients with unresectable liver metastases were randomly assigned to 1 of 3 treatment groups: group A: chemotherapy alone, group B: chemotherapy plus high-dose, intermittent IL-2 (2.1 x 10(6) U twice weekly) or group C: chemotherapy plus low-dose, continuous IL-2 (7 x 10(5) U daily). Treatment continued for 4 weeks in the hospital and on an outpatient basis according to the clinical response. No crossover between treatment arms was permitted.
IL-2 combined with chemotherapy produced a higher complete and partial response rate of 40% in group A, 60% in group B, and 78% in group C. Toxicity related to IL-2 included fever, chills, malaise, and eosinophilia.
Hepatic arterial infusion of chemotherapy plus IL-2 resulted in an increased tumor response when compared with chemotherapy alone. To confirm the efficacy of this treatment protocol, we have started a large-scale, randomized, multi-institution trial.
背景/目的：一项关于白细胞介素-2（IL-2）联合化疗治疗不可切除的结直肠癌肝转移的初步研究显示出良好的缓解率（76%）。本前瞻性、随机、多中心研究旨在评估该治疗方案的疗效。
在32个月的时间里，46例不可切除肝转移患者被随机分配到3个治疗组中的1组：A组：单纯化疗；B组：化疗加高剂量、间歇性IL-2（2.1×10⁶单位，每周两次）；或C组：化疗加低剂量、持续性IL-2（7×10⁵单位，每日）。根据临床反应，治疗在医院持续4周，并在门诊进行。治疗组之间不允许交叉。
IL-2联合化疗产生了更高的完全缓解和部分缓解率，A组为40%，B组为60%，C组为78%。与IL-2相关的毒性包括发热、寒战、不适和嗜酸性粒细胞增多。
与单纯化疗相比，肝动脉灌注化疗加IL-2可提高肿瘤反应率。为了证实该治疗方案的疗效，我们已启动一项大规模、随机、多机构试验。
