Phase II trial of branched peginterferon-α 2a (40 kDa) for patients with advanced renal cell carcinoma

R. J. Motzer*, A. Rakhit, J. Thompson, H. Gurney, P. Selby, R. Figlin, S. Negrier, S. Ernst, M. Siebels, M. Ginsberg, K. Rittweger, L. Hooftman

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

49 Citations (Scopus)


Background: Peginterferon-α 2a (40 kDa), PEGASYS™ (PEG-IFN), is a modified form of recombinant human interferon (IFN)-α 2a with sustained absorption and prolonged half-life after subcutaneous administration. A phase II trial was conducted in previously untreated patients with advanced renal cell carcinoma (RCC) to assess efficacy, toxicity and pharmacokinetic profile. Patients and methods: Forty previously untreated patients with advanced RCC were enrolled on this multicenter trial. The median age was 60 years and 63% had prior nephrectomy. PEG-IFN was administered at a dose of 450 μg/week on a weekly basis by subcutaneous injection. Serial venous blood samples were drawn to assess concentrations of PEG-IFN. Results: Five (13%) patients achieved a major response (four partial and one complete). The median time to progression was 3.8 months, and 63% of patients were alive at 1 year. The toxicity profile was mostly mild to moderate in intensity. Toxicity higher than grade 2 included neutropenia (six patients), fatigue/asthenia (four patients), nausea/vomiting (three patients) and elevated hepatic transaminase concentrations (four patients). Serum drug levels were studied in all patients; mean Cmax at week 1 was 19 ng/ml, and levels were sustained at close to peak over 1 week. With chronic dosing, drug concentration was increased 3-fold, and steady state was achieved in 5-9 weeks. Conclusions: The sustained maintenance of serum levels of PEG-IFN allows once-weekly dosing. The efficacy and tolerability profile was qualitatively similar to standard IFN-α, and adverse events were mostly mild to moderate in nature.

Original languageEnglish
Pages (from-to)1799-1805
Number of pages7
JournalAnnals of Oncology
Issue number11
Publication statusPublished - 1 Nov 2002
Externally publishedYes


  • Interferon-α
  • Pegylated
  • Renal cell carcinoma


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