Rosenberg S A, Yang J C, Topalian S L, Schwartzentruber D J, Weber J S, Parkinson D R, Seipp C A, Einhorn J H, White D E
Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
JAMA. 1994;271(12):907-13.
To determine the efficacy of treatment using high-dose bolus interleukin 2 (IL-2) in patients with metastatic melanoma or renal cell cancer.
Consecutive series of all patients treated with high-dose IL-2 in the Surgery Branch of the National Cancer Institute from September 1985 through December 1992.
Two hundred eighty-three patients with metastatic melanoma or metastatic renal cell cancer who had failed standard treatment for their cancers.
Patients received IL-2 at a dose of 720,000 IU/kg intravenously every 8 hours for a maximum of 15 doses per cycle. Two cycles constituted a treatment course, and patients with stable or responding disease received additional treatment courses. A total of 447 courses of treatment were administered.
Regression of measurable tumor, durability of response to treatment, and survival.
Nine patients (7%) with metastatic melanoma achieved complete regression of all disease and 14 patients (10%) had partial regression. Ten patients (7%) with metastatic renal cell cancer experienced complete regression and 20 patients (13%) had partial regression. Of the 19 patients with complete regression, 15 have remained in complete remission from 7 to 91 months after treatment. Three treatment-related deaths (1.1%) occurred early in this series, but as experience with the administration of this IL-2 regimen increased, no treatment-related deaths occurred in 214 patients treated during the last 5 years of the study.
Biologic therapy with IL-2 can cause significant antitumor effects in patients with advanced metastatic melanoma or renal cell cancer. Because IL-2 does not have a direct effect on cancer cells but rather mediates its antitumor activity by altering host immune reactions, these data represent the best available evidence that immunologic therapy for cancer can be effective in selected patients.
确定大剂量推注白细胞介素2（IL-2）治疗转移性黑色素瘤或肾细胞癌患者的疗效。
1985年9月至1992年12月在美国国立癌症研究所外科分部接受大剂量IL-2治疗的所有患者的连续系列研究。
283例转移性黑色素瘤或转移性肾细胞癌患者，这些患者的癌症标准治疗均告失败。
患者每8小时静脉注射720,000 IU/kg的IL-2，每个周期最多15剂。两个周期构成一个疗程，疾病稳定或有反应的患者接受额外疗程。共进行了447个疗程的治疗。
可测量肿瘤的消退、治疗反应的持久性和生存率。
9例（7%）转移性黑色素瘤患者所有病灶完全消退，14例（10%）部分消退。10例（7%）转移性肾细胞癌患者完全消退，20例（13%）部分消退。在19例完全消退的患者中，15例在治疗后7至91个月仍处于完全缓解状态。本系列研究早期发生了3例与治疗相关的死亡（1.1%），但随着该IL-2治疗方案给药经验的增加，在研究的最后5年中接受治疗的214例患者未发生与治疗相关的死亡。
IL-2生物治疗可使晚期转移性黑色素瘤或肾细胞癌患者产生显著的抗肿瘤作用。由于IL-2对癌细胞没有直接作用，而是通过改变宿主免疫反应来介导其抗肿瘤活性，因此这些数据是癌症免疫治疗对特定患者有效的最佳现有证据。
