Karp S E
Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.
J Immunother. 1998 Jan;21(1):56-61. doi: 10.1097/00002371-199801000-00007.
High-dose therapy with interleukin-2 (IL-2) can produce significant responses in patients with metastatic melanoma (MM) and renal cell carcinoma (RCC). Several studies have shown the benefit of low-dose IL-2 in patients with RCC, but few studies have evaluated low-dose IL-2 in MM. We have used the following regimen: Interferon-alpha 10 million units subcutaneously on days 1, 3, 5, 8, 10, 12, 22, 24, and 26; and IL-2 60,000 IU/kg i.v. every 8 h on days 8-12 and 22-26. Patients had measurable MM or RCC and were excluded for ECOG status > 3, brain metastases, or significant cardiopulmonary or renal dysfunction. Between January 1993 and April 1996, 38 patients with MM and 14 with RCC were treated. In MM, there were six responses (15.7%; 95% confidence interval 4.1-27.3%) (i.e., one complete response and five partial responses). Responses were seen in visceral and nodal disease. Responses were of good duration: 40+, 26+, 13, 6, 4, and 3 months. One response was seen in the 14 RCC patients. Treatment was considerably less toxic than with high-dose IL-2. All treatment was given in a medical or surgical ward with intensive care necessary in only two patients. More than 80% of patients received > 80% of the predicted dose of IL-2. Dose-limiting toxicity consisted mainly of mild confusion or fatigue. In summary, this regimen is better tolerated and produces response rates within the range reported for high-dose IL-2 for patients with MM.
大剂量白细胞介素-2（IL-2）疗法可使转移性黑色素瘤（MM）和肾细胞癌（RCC）患者产生显著反应。多项研究已表明低剂量IL-2对RCC患者有益，但很少有研究评估低剂量IL-2对MM的疗效。我们采用了以下方案：在第1、3、5、8、10、12、22、24和26天皮下注射1000万单位α干扰素；在第8 - 12天和22 - 26天，每8小时静脉注射60,000 IU/kg的IL-2。患者患有可测量的MM或RCC，且因东部肿瘤协作组（ECOG）状态> 3、脑转移或严重心肺或肾功能不全而被排除。在1993年1月至1996年4月期间，38例MM患者和14例RCC患者接受了治疗。在MM患者中，有6例出现反应（15.7%；95%置信区间4.1 - 27.3%）（即1例完全缓解和5例部分缓解）。在内脏和淋巴结疾病中均可见反应。反应持续时间良好：40多个月、26多个月、13个月、6个月、4个月和3个月。14例RCC患者中有1例出现反应。该治疗的毒性比大剂量IL-2治疗小得多。所有治疗均在医疗或外科病房进行，仅2例患者需要重症监护。超过80%的患者接受了> 80%预期剂量的IL-2。剂量限制性毒性主要包括轻度意识模糊或疲劳。总之，该方案耐受性更好，且对于MM患者产生的反应率在大剂量IL-2报道的范围内。
