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

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

Research output: Contribution to journalArticlepeer-review

9 Scopus citations


Background: This 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. Methods: Progression-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 endorgan 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. Results: Twenty-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. Conclusions: Although 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.

Original languageEnglish (US)
Pages (from-to)494-499
Number of pages6
JournalInternational Journal of Clinical Oncology
Issue number5
StatePublished - Oct 2011


  • Cytokine therapy
  • Epidermal growth factor receptor (EGFR) inhibitor
  • Renal cell cancer

ASJC Scopus subject areas

  • Oncology
  • Surgery
  • Hematology
  • Medicine(all)


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