Lissoni P, Bordin V, Vaghi M, Fumagalli L, Bordoni A, Mengo S, Bucovec R, Fumagalli E, Malugani F, Ardizzoia A, Giani L, Gardani G S, Tancini G
Division of Radiation Oncology, San Gerardo Hospital, Monza, Milan, Italy.
Anticancer Res. 2002 Mar-Apr;22(2B):1061-4.
After more than ten years of clinical investigations, IL-2 immunotherapy appears to constitute the most effective treatment metastatic renal cell carcinoma (RCC),at least in terms of survival time. Moreover, it has been shown that comparable results may be achieved with different schedules of treatment, including intravenous high-dose or subcutaneous (SC) low-dose IL-2. Finally, it has been demonstrated that the association with interferon-alpha does not increase the efficacy of IL-2. Therefore, SC low-dose IL-2 alone may be considered as an adequate therapy for metastatic RCC. In fact, our previous studies with SC low-dose IL-2 alone have shown a 5-year survival time similar to that described with higher and more toxic doses of IL-2. This study was performed to analyze the 10-year survival results with SC low-dose IL-2 in metastatic RCC The study included 44 consecutive metastatic RCC patients, with a minimum follow-up of 120 months. One comlete immunotherapeutic cycle consisted of IL-2 at 3 million IU twice/day SC, 5 days/week for 6 consecutive weeks. In non-progressing patients, a second cycle was planned after a 21-day rest period. Complete response (CR) was achieved in only 2 out of 44 (4%) patients, while partial response (PR) was obtained in 8 out of /44 (18%) patients. Therefore, the response rate (CR + PR) was 10 out of 44 (22%), with a median response duration of 12 months. Stable disease (SD) occurred in 21 out of 44 (48%) patients,whereas the remaining 13 out of 44 (30%) patients had a progressive disease (PD). A 10-year survival was achieved in 2 out of 44 (5%) and the percent of survival at 10 years was significantly higher in patients with response or SD than in those with PD. This study confirms at 10 years the results previously referred to by other authors and by ourselves, in showing that the efficacy of IL-2 immunotherapy in terms of control of cancer growth is associated with a clear prolongation of the overall survival time in metastatic RCC.
经过十多年的临床研究，白细胞介素-2免疫疗法似乎是转移性肾细胞癌（RCC）最有效的治疗方法，至少在生存时间方面是如此。此外，研究表明，不同的治疗方案，包括静脉注射高剂量或皮下（SC）低剂量白细胞介素-2，都能取得类似的效果。最后，已证明与α-干扰素联合使用并不会提高白细胞介素-2的疗效。因此，单独使用皮下低剂量白细胞介素-2可被视为转移性肾细胞癌的一种适当治疗方法。事实上，我们之前单独使用皮下低剂量白细胞介素-2的研究显示，其5年生存率与使用更高剂量且毒性更大的白细胞介素-2所描述的生存率相似。本研究旨在分析皮下低剂量白细胞介素-2治疗转移性肾细胞癌的10年生存结果。该研究纳入了44例连续的转移性肾细胞癌患者，最小随访时间为120个月。一个完整的免疫治疗周期包括皮下注射白细胞介素-2，剂量为300万国际单位，每天两次，每周5天，连续6周。对于病情无进展的患者，计划在休息21天后进行第二个周期的治疗。44例患者中仅有2例（4%）达到完全缓解（CR），而44例中有8例（18%）获得部分缓解（PR）。因此，缓解率（CR + PR）为44例中的10例（22%），中位缓解持续时间为12个月。44例患者中有21例（48%）病情稳定（SD），而其余44例中的13例（30%）病情进展（PD）。44例中有2例（5%）实现了10年生存，缓解或病情稳定患者的10年生存率显著高于病情进展患者。本研究在10年时证实了其他作者以及我们自己之前提到的结果，即白细胞介素-2免疫疗法在控制癌症生长方面的疗效与转移性肾细胞癌总体生存时间的明显延长相关。
