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Title: Results Encouraging with Interferon Alpha Plus Iressa (Gefitinib) or Gleevec (imatinib mesylate) in Metastatic Renal Cell Carcinoma: Presented at AACR-NCI-EORTC

"Results Encouraging with Interferon Alpha Plus Iressa (Gefitinib) or Gleevec (imatinib mesylate) in Metastatic Renal Cell Carcinoma: Presented at AACR-NCI-EORTC"

By Maggie Schwarz PHILADELPHIA, PA -- November 22, 2005 -- In a phase 2 study of interferon alpha (IFN) plus either Gleevec (imatinib mesylate) or Iressa (gefitinib) in patients with metastatic renal cell carcinoma, IFN plus Iressa has turned out to be the safer and more effective combination. Lead investigator Robert J. Amato, DO, Director, Genitourinary Oncology Center, Methodist Hospital Research Institute, Houston, Texas, United States, presented these results here on November 16[^th at the International Conference on Molecular Targets and Cancer Therapeutics.

The conference is organized jointly by the American Association for Cancer Research, the National Cancer Institute, and the European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC).

The researchers are applying a non-randomized alternating schedule of subcutaneous IFN plus Gleevec 600 mg/day and IFN plus Iressa 500 mg/day in patients with progressive metastatic renal cell carcinoma. The cycle is 4 weeks in duration and tumor response assessment involves the Response Evaluation Criteria in Solid Tumors performed every 3 cycles. IFN is dosed at 3 million IU 3 times weekly for 1 week followed by 6 million IU weekly.

To date, the researchers have treated 10 men and two women, median age of 51 years (range, 25-66 years). All have progressive metastatic renal cell carcinoma.

Among the eight patients treated with IFN/Iressa, two demonstrated a partial response, one a minor response, and one had stabilization of disease. In four subjects, it is too early to discern a response.

Adverse effects with IFN/Iressa have consisted of skin rash and diarrhea. With IFN/Gleevec, adverse effects have been skin rash, thrombocytopenia and leucopenia. Both combinations are associated with flu-like syndrome and fatigue, Dr. Amato said.

Iressa is an inhibitor of epithelial growth factor receptor (EGFR) tyrosine kinase activity. Gleevec is a potent inhibitor of the Abl tyrosine kinase. IFN is an agent used commonly in renal cell carcinoma.

Dr. Amato concluded that IFN/Iressa can be administered safely with encouraging early anti-tumor activity. IFN/Gleevec can be administered safely with reversible toxicity, with limited anti-tumor activity reported.

The group is continuing with patient enrollment, treatment, analysis of response and progression-free survival and correlative immunohistochemistry.

[Presentation title: A Phase II Study of Interferon-Alpha (IFN), Gleevec or Iressa Patients with Metastatic Renal Cell Carcinoma. Abstract A263]

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