Document Detail

A phase-II study of combination of pegylated interferon alfa-2a and capecitabine in locally advanced or metastatic renal cell cancer.
MedLine Citation:
PMID:  19771431     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Combination of capecitabine and interferon has shown activity in metastatic renal cell carcinoma. Pegylated interferons might have more clinical activity and fewer side effects. This study evaluated the efficacy, tolerability, and safety of the combination of capecitabine and pegylated interferon alfa-2a.
METHODS: In this open label, single institution, non-randomized phase-II first-line study, 26 patients were included. Capecitabine was administered 2,000 mg/m(2) 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 microg. Overall survival, progression-free survival, and response rates were evaluated; safety and tolerability were monitored.
RESULTS: Response rate was 27, with 4% complete responses. Stable disease was achieved in 42%. The treatment discontinued in 4 (15%) patients before first response evaluation because of toxicity. 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.
CONCLUSIONS: The combination had moderate, but manageable toxicity. In the future studies, lower dose for capecitabine is recommended. The combination was active and the response rates seen here were in line with phase-II studies on former combinations of non-pegylated interferons. One complete remission was achieved.
Kaisa Leea Sunela; Sanna Koskinen; Pirkko-Liisa Kellokumpu-Lehtinen
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article     Date:  2009-09-22
Journal Detail:
Title:  Cancer chemotherapy and pharmacology     Volume:  66     ISSN:  1432-0843     ISO Abbreviation:  Cancer Chemother. Pharmacol.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-04-14     Completed Date:  2010-05-06     Revised Date:  2013-05-28    
Medline Journal Info:
Nlm Unique ID:  7806519     Medline TA:  Cancer Chemother Pharmacol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  59-67     Citation Subset:  IM    
Department of Oncology, Tampere University Hospital, P.O. Box 2000, 33521 Tampere, Finland.
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MeSH Terms
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols / adverse effects*,  therapeutic use
Carcinoma, Renal Cell / drug therapy*,  mortality,  pathology
Deoxycytidine / administration & dosage,  adverse effects,  analogs & derivatives*
Disease-Free Survival
Fluorouracil / administration & dosage,  adverse effects,  analogs & derivatives*
Interferon-alpha / administration & dosage*,  adverse effects
Kaplan-Meier Estimate
Kidney Neoplasms / drug therapy*,  mortality,  pathology
Middle Aged
Neoplasm Metastasis
Polyethylene Glycols / administration & dosage*,  adverse effects
Quality of Life
Recombinant Proteins
Treatment Outcome
Reg. No./Substance:
0/Interferon-alpha; 0/Polyethylene Glycols; 0/Recombinant Proteins; 0/peginterferon alfa-2a; 51-21-8/Fluorouracil; 6804DJ8Z9U/capecitabine; 76543-88-9/interferon alfa-2a; 951-77-9/Deoxycytidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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