Piga A, Giordani P, Quattrone A, Giulioni M, De Signoribus G, Antognoli S, Cellerino R
Medical Oncology, University of Ancona, Ospedale Torrette, Italy.
Cancer Immunol Immunother. 1997 Aug;44(6):348-51. doi: 10.1007/s002620050393.
The activity of the drugs employed in the treatment of metastatic renal cell carcinoma, including biological response modifiers, is limited; one of the aims of clinical research in this area is to maintain the benefits of treatment whilst reducing its toxicity to a minimum level. We have evaluated toxicity and response of the combined administration of recombinant interferon alpha (IFN alpha) and low-dose subcutaneous (s.c.) recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma. A group of 20 previously untreated patients with advanced renal cell carcinoma were included in the study. Treatment consisted of 3 MU/m2 recombinant IFN alpha daily i.m. continuously, and 0.5 MU/m2 recombinant IL-2 twice a day s.c. on days 1-5 for the first week, followed by 1 MU/m2 twice a day for 5 days in the following weeks. For IL-2, a 1-week rest was allowed after 4 weeks of treatment. Response was assessed after 3 months of therapy. Three objective responses were seen, one complete and two partial. Eight patients had stable disease. The median time to progression was 6 months; the median survival for all patients was 14 months. Side-effects were low, limited to grades 1 and 2 in the majority of patients, and included fever, anemia, leukopenia, dyspnea, and abnormalities of liver and renal function tests. Any flu-like syndrome was judged moderate in most patients; however, one-third of the patients refused treatment mostly because of the flu-like syndrome. One of these was the patient experiencing a complete response, who virtually received IFN alpha alone. This regimen, similar to others employed in the treatment of advanced renal cell carcinoma, produced a 15% response rate (95% confidence interval, 0-31%) with 14 months median survival, moderate toxicity and low cost, and required no hospitalization. These data seem to indicate an effectiveness comparable to, and a toxicity lower than, that of regimens employing higher doses of IL-2.
用于治疗转移性肾细胞癌的药物（包括生物反应调节剂）的活性有限；该领域临床研究的目标之一是在将治疗毒性降至最低水平的同时保持治疗效果。我们评估了重组干扰素α（IFNα）和低剂量皮下注射重组白细胞介素-2（IL-2）联合给药对晚期肾细胞癌患者的毒性和反应。一组20名先前未接受过治疗的晚期肾细胞癌患者被纳入研究。治疗方案为每天肌肉注射3 MU/m²重组IFNα，持续给药，第1周的第1 - 5天每天皮下注射0.5 MU/m²重组IL-2，每日2次，随后几周每天皮下注射1 MU/m²，每日2次，持续5天。对于IL-2，治疗4周后允许休息1周。治疗3个月后评估反应。观察到3例客观反应，1例完全缓解，2例部分缓解。8例患者病情稳定。进展的中位时间为6个月；所有患者的中位生存期为14个月。副作用较低，大多数患者限于1级和2级，包括发热、贫血、白细胞减少、呼吸困难以及肝肾功能检查异常。大多数患者的任何流感样综合征被判定为中度；然而，三分之一的患者拒绝治疗，主要原因是流感样综合征。其中1例是完全缓解的患者，实际上几乎仅接受了IFNα治疗。该方案与用于治疗晚期肾细胞癌的其他方案相似，产生了15%的缓解率（95%置信区间，0 - 31%），中位生存期为14个月，毒性中等且成本低，并且无需住院。这些数据似乎表明其有效性与使用更高剂量IL-2的方案相当，但毒性更低。
