Although a Phase III clinical trial of Tarceva combined with chemotherapy to treat advanced lung cancer did not show a survival advantage, the study hints that young non-smokers did benefit from the targeted therapy.
In the 1,059-patient trial, known as TRIBUTE, Tarceva used with chemotherapy was compared to treatment with chemotherapy and a placebo. The trial showed the safety of Tarceva but did not show an overall benefit in survival or response between the groups.
A "bright spot" in the study was a sub-analysis that showed 69 young non-smokers treated with Tarceva survived 23 months versus 10 months for a group of 44 similar patients who used chemotherapy and a placebo drug, says Roy Herbst, M.D., Ph.D., an associate professor in M. D. Anderson's Department of Thoracic/Head and Neck Medical Oncology, who led the trial. The sub-analysis was performed by researchers at the Memorial Sloan-Kettering Cancer Center.
"There seemed to be a maintenance effect of Tarceva in patients who responded or had stable disease after chemotherapy," Herbst says. "Tarceva deserves further study in those patients whose disease stabilizes or responds after chemotherapy treatment for non-small cell lung cancer," he adds.
Tarceva (also known as OSI-774 or Erlotinib) inhibits a receptor on cancer cells for the epidermal growth factor (EGF), a protein that helps spur cells to divide. Many types of cancer cells tend to produce too much EGF.
Similar to Iressa results
The TRIBUTE results are similar to a clinical trial that tested Iressa, a targeted therapy that is nearly identical in structure and function. Iressa was approved for use in 2003 based on evidence that the drug was best used for some non-smokers who developed lung cancer, says Herbst, who has tested both drugs.
"I think we know now that this class of drug does not function well when combined with chemotherapy," Herbst says. "That may be because the drug stops cells from growing, but that also makes them less sensitive to chemotherapy."
© 2007 The University of Texas M. D. Anderson Cancer Center. All rights reserved.
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