The BATTLE trial: personalizing therapy for lung cancer |
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Authors: | Kim Edward S Herbst Roy S Wistuba Ignacio I Lee J Jack Blumenschein George R Tsao Anne Stewart David J Hicks Marshall E Erasmus Jeremy Gupta Sanjay Alden Christine M Liu Suyu Tang Ximing Khuri Fadlo R Tran Hai T Johnson Bruce E Heymach John V Mao Li Fossella Frank Kies Merrill S Papadimitrakopoulou Vassiliki Davis Suzanne E Lippman Scott M Hong Waun K |
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Institution: | Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. |
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Abstract: | The Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial represents the first completed prospective, biopsy-mandated, biomarker-based, adaptively randomized study in 255 pretreated lung cancer patients. Following an initial equal randomization period, chemorefractory non-small cell lung cancer (NSCLC) patients were adaptively randomized to erlotinib, vandetanib, erlotinib plus bexarotene, or sorafenib, based on relevant molecular biomarkers analyzed in fresh core needle biopsy specimens. Overall results include a 46% 8-week disease control rate (primary end point), confirm prespecified hypotheses, and show an impressive benefit from sorafenib among mutant-KRAS patients. BATTLE establishes the feasibility of a new paradigm for a personalized approach to lung cancer clinical trials. SIGNIFICANCE: The BATTLE study is the first completed prospective, adaptively randomized study in heavily pretreated NSCLC patients that mandated tumor profiling with "real-time" biopsies, taking a substantial step toward realizing personalized lung cancer therapy by integrating real-time molecular laboratory findings in delineating specific patient populations for individualized treatment. |
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