BATTLE Advances Cause of Personalized Medicine

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A trail-blazing lung cancer clinical trial that matched drugs to patients based on a molecular analysis of their tumors took center stage today at the opening session of the American Association for Cancer Research 101st Annual Meeting 2010

The Phase II clinical trial known as BATTLE demonstrates the potential of using drugs that target specific genetic networks or other molecular defects to tailor personal therapy for patients. That's not done now in lung cancer, as it can be to the benefit of some breast and colon cancer patients, because there are no established molecular signatures to predict who would benefit from each drug, says clinical trial leader Edward Kim, M.D., associate professor in M. D. Anderson's Department of Thoracic/Head and Neck Medical Oncology.

BATTLE -- short for Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination -- evaluated four drugs in 255 stage IV non-small cell lung cancer patients who had received between one and nine previous treatments.

"We know that new targeted therapies help a fraction of lung cancer patients, but we haven't been able to identify who those people are," Kim says. "BATTLE demonstrates the feasibility of a more personalized approach by taking a new biopsy of each patient's tumor, swiftly evaluating that tumor tissue for specific biomarkers, then assigning drugs to patients based on that analysis." 

For example, the researchers found one of the four drugs in the trial, sorafenib, didn't work at all against tumors with one common, more easily treated mutation. However, sorafenib had good effect controlling tumors that featured a KRAS mutation, which has no proven treatment.

By using an innovative statistical approach to identify patients in Phase II clinical trials who are most likely to benefit from a targeted drug, BATTLE points the way toward focused Phase III trials that will require fewer patients, take less time and will be more likely to succeed.

Lung cancer research, Kim says, is littered with large Phase III trials that enrolled hundreds or thousands of patients, then showed no or only minor effects. Many failed to enroll enough patients to finish.

The BATTLE abstract at AACR can be viewed here.

Read the news release from M. D. Anderson - BATTLE Links Potential Biomarkers to Drugs for Lung Cancer

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