A phase II trial of gefitinib and pegylated IFNα in previously treated renal cell carcinoma View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2011-03-23

AUTHORS

Derek Shek, Jeff Longmate, David I. Quinn, Kim A. Margolin, Przemyslaw Twardowski, David R. Gandara, Paul Frankel, Chong-Xian Pan, Primo N. Lara

ABSTRACT

BackgroundThis study was conducted to evaluate the efficacy of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib with pegylated-IFNα (PEG-IFNα) in patients with advanced renal cell carcinoma.MethodsProgression-free survival (PFS) rate at 6 months >50% was considered promising for further evaluation. Patients with unresectable or metastatic disease, unlimited prior therapies, and adequate performance status and end-organ function were eligible. PEG-IFNα was dosed subcutaneously once weekly (initially 6 μg/kg/week, later reduced to 4 μg/kg/week) for 12 weeks. Gefitinib was given 250 mg orally once daily until progression or intolerance.ResultsTwenty-one patients were accrued. Fourteen patients had a prior nephrectomy, and twelve had prior systemic therapy. The 6-month PFS was 29% (95%CI 15–56%). Best responses by RECIST criteria: complete, partial (1, plus 3 unconfirmed) stable (Uhlman et al. Clin Cancer Res 1:913–920, 1995), and progression (Sirotnak et al. Clin Cancer Res 6:4885–4892, 2000). Response duration: complete response (35+ months) and partial response (2, 3, 3, 37 months). Median PFS and overall survival were 5.3 (95%CI 3–10.1) and 13.6 (95%CI 10.3–NA) months, respectively. Most common toxicities included myelosuppression, rash, and nausea.ConclusionsAlthough generally well tolerated, gefitinib plus PEG-IFNα did not meet the pre-specified 6-month PFS rate >50%. Further evaluation of similar regimens would require appropriate molecular selection of subjects most likely to benefit. Thus, preclinical studies to determine candidate predictive markers for this combination are warranted. More... »

PAGES

494

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10147-011-0212-8

DOI

http://dx.doi.org/10.1007/s10147-011-0212-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1043695726

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21431345


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