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A phase-II study of combination of pegylated interferon alfa-2a and capecitabine in locally advanced or metastatic renal cell cancer
Cancer Chemotherapy and Pharmacology, 09/30/09

Sunela KL et al. – The combination of pegylated interferon alfa-2a and capecitabine was active and the response rates seen here were in line with phase-II studies on former combinations of non-pegylated interferons.

Methods

In this open label, single institution, non-randomized phase-II first-line study, 26 patients were included
Capecitabine was administered 2,000 mg/m2 daily for 14 days followed by 1 week rest
Pegylated interferon alfa-2a was given once as weekly injections with a fixed dose of 180 ?g

Results

Response rate was 27, with 4% complete responses
Stable disease was achieved in 42%
The median progression-free survival was 7.5 months; the median overall survival was 17 months
Grades 3–4 toxicity was seen in 46% of patients, but in 93% of cycles no serious toxicity was experienced
Dose reductions had to be done, but in 81% of cycles intensity of 70% or more was possible
Quality of life was better in cycle five than in the base line

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