Annals of Oncology 13:1799-1805, 2002
© 2002 European Society for Medical Oncology
Original Paper |
Phase II trial of branched peginterferon-
2a (40 kDa) for patients with advanced renal cell carcinoma
1 Memorial Sloan-Kettering Cancer Center, New York, NY; 2 Hoffmann-La Roche Inc., Nutley, NJ; 3 University of Washington Medical Center, Seattle, WA, USA; 4 Westmead Hospital, NSW, Australia; 5 St James University Hospital, Leeds, UK; 6 UCLA Medical Center, Los Angeles, CA, USA; 7 Centre Leon Berard, Lyon, France; 8 Tom Baker Cancer Center, Calgary, Alberta, Canada; 9 Universitaetsklinikum Grosshadern, Munich, Germany
Received 29 January 2002; revised 18 March 2002; accepted 10 April 2002
Background:
Peginterferon-
2a (40 kDa), PEGASYSTM (PEG-IFN), is a modified form of recombinant human interferon (IFN)- 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-, and adverse events were mostly mild to moderate in nature.
Key words: interferon-, pegylated, renal cell carcinoma
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