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BATTLE links potential biomarkers to drugs for lung cancer
Date:4/19/2010

ging, but they behave differently," said Waun Ki Hong, M.D., head of M.D. Anderson's Division of Cancer Medicine and principal investigator on the BATTLE grant from the U.S. Department of Defense. "The name of the game now is to treat based on the molecular defects in the tumor."

BATTLE identifies potential biomarkers

The Phase II clinical trial found evidence that each of the four drugs targets specific molecular signatures better than the other three. The drugs used in the trial were erlotinib (Tarceva), sorafenib (Nexavar), vandetanib (Zactima) and erlotinib with bexarotene (Targretin). Each drug is designed to target specific molecular pathways; currently, none has a validated biomarker to guide its use.

BATTLE's end point was disease control at eight weeks, which recent research has found is a good indicator of overall survival. The study found, for example, that 61 percent of patients with a KRAS mutation in their tumors who took sorafenib had disease control at eight weeks, compared with 32 percent for the other three drugs. Erlotinib did best against EGFR mutations, vandetanib for high VEGFR-2 expression and the erlotinib-bexarotene fared best with Cyclin D1 defects or amplified numbers of the EGFR gene. These exploratory analyses raise interesting areas of future research.

Overall, 46 percent of patients on the trial had disease control at 8 weeks, compared with a historical experience of around 30 percent for late-stage lung cancer patients. Median overall survival was nine months, and 38 percent of patients survived to one year. Toxicities from the four drugs were minimal, with only 6.5 percent experiencing a significant side effect.

Kim cautioned that Phase II trial findings of biomarker effectiveness need to be validated in Phase III trials, which are typically sponsored by pharmaceutical companies or performed in cooperative groups.

A model for efficient clinical trials


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Contact: Scott Merville
smerville@mdanderson.org
713-516-4855
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert  

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