Outpatient subcutaneous interleukin-2 and interferon-alpha for metastatic renal cell cancer: five-year follow-up of the Cytokine Working Group Study.

作者：Janice P. Dutcher, Richard I. Fisher, Geoffrey R. Weiss, Frederick R. Aronson, Kim Margolin, Arthur C. Louie, J W Mier, Geralyn Caliendo, J. A. Sosman, John R. Eckardt, Mary Lou Ernest, James H. Doroshow, Michael B. Atkins · 发表于：PubMed · 年份：1997 · 被引用次数：78 · 研究领域：Renal cell carcinoma treatment、Cancer Immunotherapy and Biomarkers、Multiple and Secondary Primary Cancers

PURPOSE: A phase II trial of outpatient subcutaneous (SC) interleukin-2 (rIL-2) plus interferon-alpha (IFN-alpha 2B) was performed in patients with metastatic renal cell cancer. A 5-year follow-up of that Cytokine Working Group study is presented. PATIENTS AND METHODS: Forty-seven patients meeting eligibility criteria of previous Cytokine Working Group studies were treated on an outpatient basis with SC rIL-2 (Chiron, Emeryville, CA), 5 x 10(6) IU/m2/dose q 8 hr x 3, then daily, 5 days per week, and IFN-alpha 2B (Schering-Plough, Kenilworth, NJ), 5 x 10(6) IU/m2/dose three times weekly for 4 weeks. After a 2- to 4-week break, patients were scheduled to continue treatment for up to six cycles. RESULTS: There were two complete and six partial responders (17% response rate, 95% CI: 8%-31%). Median duration of response was 12 months (range 1-49+ months), with complete responses of 15 and 49+ months. Responding sites of disease included lung, nodes, soft tissue, bone, and liver. Dose and schedule were adjusted to control toxicity at grade 2/3 levels, with 50% requiring dosage alterations. Grade 2/3 toxicity included fatigue, nausea/vomiting, diarrhea, anorexia, fluid overload, rash, CNS, injection site pain, chest pain/palpitations (including atrial fibrillation requiring treatment, two patients), and hypotension. Grade 4 toxicity included dehydration (seven patients), vomiting (one patient), and irreversible renal failure with crescentic glomerulonephritis requiring dialysis (one...