|
|
|
|
|
|
TABLE OF CONTENTS
|
October 26, 2007 NEW YORK (Reuters Health) - The preliminary results of a phase I study suggest that combined treatment with sorafenib (Nexavar) and interleukin-21 is superior to sorafenib alone in patients with metastatic renal cell carcinoma. "The advent of the tyrosine kinase inhibitors and MTOR inhibitors has revolutionized the therapy of metastatic kidney cancer; however, responses to these agents usually last less than one year," lead author Dr. John A. Thompson, from the University of Washington in Seattle, told Reuters Health. The present findings suggest that IL-21, an immunotherapeutic molecule, may enhance the benefits of Serafini, a tyrosine kinase inhibitor, he added. Dr. Thompson presented his team's findings Tuesday at the AACR-NCI-EORTC International Conference in San Francisco. The study involved 13 patients who were treated with sorafenib in combination with recombinant IL-21. Escalating doses of IL-21 were given, while the sorafenib dose remained fixed. All 10 patients who could be evaluated for an antitumor response showed some degree of tumor shrinkage, ranging from a 20% to 40% drop in tumor size, Dr. Thompson said. In addition, 4 of the 10 patients achieved a partial response based on standard criteria. The efficacy findings are encouraging given that the overall response rate seen with sorafenib alone in the studies that led to the drug's approval was just 2%, he noted. In general, the drug combination was well tolerated with only mild to moderate adverse effects, the report indicates. Dr. Thompson said that the study "will be completed by year's end and will allow us to identify the maximum tolerated dose of IL-21 to be used in combination with Serafini. Phase II will be conducted at multiple sites in up to 40 patients with renal cell carcinoma to determine the objective response rate, time to progression, and safety of the combination regimen in patients with renal cell carcinoma." The study was supported by Zymogenetics, which developed recombinant IL-21. Copyright 2008 Reuters. Click for Restrictions.
|
