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Title: Worldwide Study Shows No Differences in Sunitinib Effectiveness Outside of Clinical Trial: Presented at ASCO-GI

"Worldwide Study Shows No Differences in Sunitinib Effectiveness Outside of Clinical Trial: Presented at ASCO-GI"

By Ed Susman ORLANDO, FL -- January 25, 2008 -- Researchers said that the safety and efficacy of sunitinib as a second-line treatment for patients with gastrointestinal stromal tumor had been affirmed in a "real world" setting. The effectiveness and safety of the drug seen in phase 3 trials were similar to those seen among 1,091 patients who were excluded because they failed to meet the enrolment criteria for the original trials or lived in countries where the trials were not conducted. "We saw virtually identical results -- such as 73-week median survival -- in this worldwide study," said Jeffery Morgan, MD, Instructor in Medicine, Harvard Medical School and Dana Farber Cancer Institute, Boston, Massachusetts, at the American Society for Clinical Oncology's 2008 Gastrointestinal Cancers Symposium (ASCO-GI)). The symposium is cosponsored by ASCO with the American Gastroenterological Association Institute, the American Society for Therapeutic Radiology and Oncology, and the Society for Surgical Oncology Metastatic or unresectable gastrointestinal stromal tumors are usually treated with imatinib, but 12% to 14% of patients have initial resistance to imatinib, and 40% of patients show secondary resistance to imatinib after 2 years of treatment. In clinical trials, sunitinib was shown to be effective in treating patients with imatinib-resistant disease, Dr. Morgan said at his poster presentation on January 25. His study aimed to determine whether sunitinib would be effective in treating patients who did not fit the strict clinical trial entry criteria or who lived in areas or countries outside the trial area. "We had patients in this trial from Korea, from Poland, from Germany," Dr. Morgan said, "and it showed that it doesn't make any difference where you live -- sunitinib works in all people." The average age of the trial participants was 59 years; about 59% of participants were women. The patients ranged in age from 10 to 92 years. The patients started a median of four cycles of sunitinib and were treated for a median of 181 days. Sunitinib is administrated to patients in repeated 6-week cycles at a starting dose of 50 mg once daily for 4week on treatment followed by 2 weeks off treatment. Median time to progression in the worldwide study was 37 weeks, Dr. Morgan said. "The safety profile observed in this study was similar to that seen with sunitinib in a prior phase 3 gastrointestinal stromal tumor study [Demetri. [Lancet 2006;368;1329-1338], with most adverse events mild to moderate in severity," he said.

Funding for this study was provided by Pfizer.

[Presentation title: Sunitinib in a Worldwide Treatment-Use Trial of Patients With GIST: Safety And Efficacy. Abstract 31]

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