Iressa Trial Halted, No Benefit Found in Advanced Lung Cancer

By Rachael Myers Lowe, cancerpage.com

(April 19, 2004) - A randomized placebo-controlled clinical trial evaluating the drug Iressa (gefitinib) in advanced non-small cell lung cancer has been halted after preliminary results find no survival advantage for patients given the drug following chemotherapy and radiation therapy. 

The trial was designed to see if taking Iressa would improve progression-free survival in patients whose disease had spread to nearby tissue and lymph nodes. Patients enrolled in the trial had inoperable Stage III disease, which had already been treated with chemotherapy (cisplatin and etoposide) and radiation followed by docetaxel.

As of March, 2005, 276 patients had been blindly randomized to take a daily dose of Iressa or a placebo. Although well short of the total number of patients the trial was designed to include, the researchers decided there would be no point to continue the trial.

"The interim analysis indicates that even with accrual of more patients or with longer follow-up, the gefitinib arm would not improve survival," Laurence Baker, D.O., chairman of South West Oncology Group and a professor of internal medicine and pharmacology at the University of Michigan in Ann Arbor said in a press release.

Scott Saxman, M.D., of the National Cancer Institute said, given these results, Iressa should not be given to patients such as those enrolled in this trial.

Detailed results from the study will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) in May, 2005.

SOURCES:

• Press release (4-18-05) from the National Cancer Institute