Yang J C, Topalian S L, Parkinson D, Schwartzentruber D J, Weber J S, Ettinghausen S E, White D E, Steinberg S M, Cole D J, Kim H I
Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
J Clin Oncol. 1994 Aug;12(8):1572-6. doi: 10.1200/JCO.1994.12.8.1572.
A randomized prospective study was performed to compare the efficacy and toxicity of high-dose intravenous bolus interleukin-2 (IL-2) and a lower-dose intravenous bolus regimen for the treatment of metastatic renal cell carcinoma (RCC).
Between March 1991 and April 1993, 125 patients with metastatic RCC were randomized to receive IL-2 by intravenous bolus every 8 hours at either 720,000 IU/kg (high-dose) or 72,000 IU/kg (low-dose) to the maximum-tolerated number of doses (or a maximum of 15 doses). After approximately 7 to 10 days, both treatment groups were re-treated with a second identical cycle of therapy. Those patients who were stable or responding to treatment 5 to 6 weeks later went on to receive re-treatment with another course (two cycles) of therapy. Response rates and toxicity were determined for the two treatment arms.
One hundred twenty-five patients received a total of 208 courses of therapy. Sixty patients were randomized to receive low-dose, and 65 to receive high-dose IL-2. There were no treatment-related deaths in either arm. There was a greater incidence of grade III or IV thrombocytopenia, malaise, and hypotension in patients who received high-dose IL-2, while patients who received low-dose IL-2 had significantly more infections. Three percent of treatment courses with low-dose IL-2 required vasopressor support, compared with 52% of courses with high-dose IL-2. Patients who received low-dose IL-2 had a 7% complete response (CR) and an 8% partial response (PR) rate, and patients who received high-dose IL-2 had a 3% CR and a 17% PR rate.
Low-dose intravenous bolus IL-2 represents an effective regimen for the treatment of metastatic RCC, with preliminary results comparable to those observed with high-dose IL-2. Low-dose IL-2 can be administered with significantly fewer complications, reduced use of vasopressor support, and fewer admissions to an intensive care unit (ICU).
进行一项随机前瞻性研究，比较大剂量静脉推注白细胞介素-2（IL-2）与小剂量静脉推注方案治疗转移性肾细胞癌（RCC）的疗效和毒性。
1991年3月至1993年4月期间，125例转移性RCC患者被随机分组，每8小时静脉推注IL-2，剂量为720,000 IU/kg（大剂量）或72,000 IU/kg（小剂量），直至最大耐受剂量数（或最多15剂）。大约7至10天后，两个治疗组均接受第二个相同疗程的再治疗。5至6周后病情稳定或对治疗有反应的患者继续接受另一个疗程（两个周期）的再治疗。确定两个治疗组的缓解率和毒性。
125例患者共接受了208个疗程的治疗。60例患者被随机分配接受小剂量治疗，65例接受大剂量IL-2治疗。两组均无与治疗相关的死亡病例。接受大剂量IL-2治疗的患者中，III级或IV级血小板减少、不适和低血压的发生率更高，而接受小剂量IL-2治疗的患者感染明显更多。小剂量IL-2治疗疗程中有3%需要血管升压药支持，而大剂量IL-2治疗疗程中这一比例为52%。接受小剂量IL-2治疗的患者完全缓解（CR）率为7%，部分缓解（PR）率为8%，接受大剂量IL-2治疗的患者CR率为3%，PR率为17%。
小剂量静脉推注IL-2是治疗转移性RCC的有效方案，初步结果与大剂量IL-2相当。小剂量IL-2给药时并发症明显较少，血管升压药支持使用减少，入住重症监护病房（ICU）的次数也较少。
