Outpatient subcutaneous interleukin-2 and interferon-alpha for metastatic renal cell cancer: Five-year follow-up of the cytokine working group study

Janice P. Dutcher*, Richard I. Fisher, Geoffrey Weiss, Fred Aronson, Kim Margolin, Arthur Louie, James Mier, Geralyn Caliendo, Jeffrey A. Sosman, John R. Eckardt, MaryLou Ernest, James Doroshow, Michael Atkins

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

75 Scopus citations

Abstract

PURPOSE: A phase II trial of outpatient subcutaneous (SC) interleukin-2 (rIL-2) plus interferon-alpha (IFN-α2B) 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 106 IU/m2/dose q 8 hr x 3, then daily, 5 days per week, and IFN-α2B (Schering- Plough, Kenilworth, NJ), 5 x 106 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 patient). CONCLUSION: SC rIL-2 plus IFN-a2B is tolerated in the outpatient setting with frequent dose adjustments. The overall response rate of this regimen is similar to that seen with high-dose rIL-2 alone; however, the response duration appears to be shorter.

Original languageEnglish (US)
Pages (from-to)157-162
Number of pages6
JournalCancer Journal from Scientific American
Volume3
Issue number3
StatePublished - 1997

Keywords

  • Interleukin-2
  • Renal cell carcinoma
  • interferon-alpha

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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