Tumor biomarkers may help doctors decide on best therapy for lung cancer patients, according to a study conducted by researchers at The University of Texas M.D. Anderson Cancer Center.
Led by Edward Kim, MD, associate professor in M.D. Anderson’s Department of Thoracic/Head and Neck Medical Oncology, the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial involved 255 stage IV patients with advanced non-small cell lung cancer (NSCLC) who had received between one and nine previous treatments. Researchers randomly assigned patients to four treatment groups: erlotinib, vandetanib, erlotinib plus bexarotene, and sorafenib. Biopsy specimens were analyzed for 11 biomarkers associated with four NSCLC molecular pathways.
“Two lung cancer tumors might appear identical under a microscope and have the same staging, but they behave differently,” said Waun Ki Hong, MD, head of M.D. Anderson’s Division of Cancer Medicine and principal investigator on the BATTLE clinical trial. “The name of the game now is to treat based on the molecular defects in the tumor.”
The study found evidence that each of the four drugs targets specific molecular signatures better than the other three. Specifically, patients whose tumors had epidermal growth factor receptor (EGFR) mutations and fluorescence in situ hybridization (FISH) amplification had an 8-week disease control rate of 100% when treated with erlotinib versus 0% with sorafenib. Furthermore, patients with EGFR mutations had the best disease control with erlotinib. Overall, 46% of patients in the trial had disease control at 8 weeks compared with a historical experience of around 30% for late-stage lung cancer patients.
“BATTLE is an important step toward personalized medicine and marks a paradigm shift for clinical trials by demonstrating the feasibility of a biopsy-based, hypothesis-driven biomarker trial,” said Roy Herbst, MD, PhD, professor in the Department of Thoracic/Head and Neck Medical Oncology and co-principal investigator on the BATTLE clinical trials.
The study’s findings were presented at the Annual Meeting of the American Association for Cancer Research.