Metastatic renal cell carcinoma treated with Peg-interferon alfa-2b.
BACKGROUND
Peginterferon has an increased plasma half-life and enables a constant exposure to interferon. This modification might increase the antiangiogenic effect of the treatment and influence the efficacy. We report the results of a phase II open-label study with Peginterferon alfa-2b (Pegintron Schering-Plough) on efficacy and tolerability in patients with advanced renal cell carcinoma (MRCC).


METHODS
Twenty eight patients with MRCC were treated with Peginterferon in escalating doses of 0.5 microg/kg once weekly until 2 microg/kg was reached or prohibited toxicity occurred. Lesions were evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).


RESULTS
Thirteen patients tolerated a dose of 2 microg/kg/week. At 6 months 16 patients (57%) had disease control of which four had partial response (PR) and 12 stable disease whereas 12 (43%) had progressed. PR was only seen in the lung parenchyma or mediastinum. Median time to progression (TTP) was 8 months in all patients and 13 months for PR and SD patients. Correspondingly, median survival was 19.5 months and 28 months, respectively (seven patients received second-line treatment with tyrosine kinase inhibitor). The mean dose during long-term treatment was 1.5 and at the end of treatment 1.2 microg/kg/week. Most side effects were grade 1-2 and only two patients stopped treatment for that reason. VEGF levels in serum before and during treatment did not correlate to the therapeutic response.


CONCLUSIONS
Peginterferon was well tolerated in MRCC albeit with dose modification during long-term treatment. Response pattern seems to be the same as with nonpegylated interferon. Peginterferon may be used as monotherapy in selected patients and in trials of combinations with targeted drugs.
Lyrdal
David
D
Department of Urology, Sahlgrenska University Hospital, Göteborg, Sweden.
Stierner
Ulrika
U
Lundstam
Sven
S
D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011379:Prognosis; D011994:Recombinant Proteins; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000378:metabolism
D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b