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Profesionales de la salud / / / /
Reviewer: Neha Vapiwala, MD
Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 7 de junio del 2004
This presentation discusses the use of erlotinib for the treatment of NSCLC which has not been approved by the FDA.Presenter: U. Gatzemeier
There is a growing body of preclinical data demonstrating the anti-tumor efficacy of erlotinib (OSI-774), a potent oral inhibitor of HER1/EGFR tyrosine kinase phosphorylation. Studies have also established the use of erlotinib (OSI-774) in conjunction with various chemotherapy agents. In light of the non-overlapping toxicity profile of erlotinib and most chemotherapeutic drugs, its applicability in clinical practice seems particularly appealing. The TALENT study was designed as a placebo-controlled trial evaluating the use of cisplatin and gemcitabine chemotherapy with concurrent and continued erlotinib, as compared to placebo, in patients with advanced non-small cell lung cancer.
Materials and Methods
The negative results presented here offer new clinical insight in the management of patients with advanced NSCLC. The lack of a survival benefit with erlotinib in conjunction with chemotherapy in patients with advanced NSCLC raises several questions for further research. Firstly, are these results likely to be reproduced by other similar studies? The results shown here have indeed been echoed in a second abstract presented at this year's ASCO, in the US-based TRIBUTE study. It should be recognized that while the two studies are very similar, the TRIBUTE trial naturally has patient and tumor demographics and a chemotherapy regimen more representative of US practice, compared to the European patients studied in the TALENT trial. Regardless, both trials sought to investigate the use of erlotinib together with NSCLC chemotherapy regimens, and both were negative for a survival benefit. A second issue is whether the concurrent and maintenance regimen of erlotinib might play a role in the underwhelming survival results seen here, rather than the drug itself. Finally, the lack of correlation between EGFR status and survival is a perplexing finding, given the mechanism of erlotinib and its previously documented anti-tumor efficacy as second and third-line therapy. Future studies will likely incorporate some of these remaining questions, but for the present time it does not appear that there is a clear role for the addition of erlotinib to standard chemotherapy doublets in advanced NSCLC.
Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.
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