Progress Using Cancer Genotyping, Biomarkers and Adaptive Clinical Trials against Cancer

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Wall Street Journal – An unusual clinical trial involving four different drugs offered promise that guiding treatment based on the molecular traits of a tumor can improve survival from lung cancer.

Doctors don't know which patients are likely to respond to which treatments, resulting in hit-or-miss use of high-cost medicines.

Researchers at the University of Texas M.D. Anderson Cancer Center mounted the Battle trial to see whether matching tumor characteristics called biomarkers with specific drugs would lead to better results. Lung cancer is the leading cancer killer, accounting for 28% of all cancer deaths in the U.S.

Tumor Biopsies were taken at the start and biomarkers were identified. Patients were placed into five marker groups. A first subset of patients was assigned to one of four drugs without regard to their biomarkers. Then patients in a second wave were assigned to drugs based on their particular tumor biomarkers, taking into consideration how people in the first group with similar biomarkers were faring. 

Eight weeks after the start of therapy, doctors used imaging to assess whether disease in each patient was under control. Researchers said absence of progression at eight weeks is considered a reliable predictor of overall survival benefit. 

After about 40% of the patients were enrolled, researchers looked at the first imaging results to see which combinations of drug and biomarkers were more likely to result in disease control. Then, in a strategy called adaptive trial design, the randomization of the remaining patients was weighted to steer patients toward therapies they were likely to benefit from based on their biomarkers.

The adaptive design is gaining interest among researchers and drug companies because it could help identify drugs that don't work sooner, and identify biomarkers that would be used to enroll patients in late-stage studies required for market approval.

The study is too small to call for immediate new treatment strategies. But researchers believe it sets a path for bringing personalized medicine into the care of lung-cancer patients, just as it is already playing a critical role in breast, colon and other tumors

We need to get to the point where biomarkers can be used to identify cancer just as it is first starting. Before the current phase 1 of the disease, where treatments would be most effective.

Overall disease control -- defined as “non-progression” of the cancer -- among all participants was 46 percent after eight weeks,  Kim said. However, about 71 percent of patients with mutations involving EGFR who were given Roche’s Tarceva, a treatment designed to inhibit EGFR, had disease control at eight weeks. Among those with KRAS gene mutations, 61 percent had non- progression of their cancer when given Nexavar, Kim said. 

Nexavar, which is not approved to treat lung cancer, also showed the highest overall disease control of all the treatments in the study at 58 percent of patients

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