title: The BATTLE trial: personalizing therapy for lung cancer.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Edward S
authors.initials: ES
authors.lastname: Kim
authors.forename: Roy S
authors.initials: RS
authors.lastname: Herbst
authors.forename: Ignacio I
authors.initials: II
authors.lastname: Wistuba
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.forename: George R
authors.initials: GR
authors.lastname: Blumenschein
authors.forename: Anne
authors.initials: A
authors.lastname: Tsao
authors.forename: David J
authors.initials: DJ
authors.lastname: Stewart
authors.forename: Marshall E
authors.initials: ME
authors.lastname: Hicks
authors.forename: Jeremy
authors.initials: J
authors.lastname: Erasmus
authors.forename: Sanjay
authors.initials: S
authors.lastname: Gupta
authors.forename: Christine M
authors.initials: CM
authors.lastname: Alden
authors.forename: Suyu
authors.initials: S
authors.lastname: Liu
authors.forename: Ximing
authors.initials: X
authors.lastname: Tang
authors.forename: Fadlo R
authors.initials: FR
authors.lastname: Khuri
authors.forename: Hai T
authors.initials: HT
authors.lastname: Tran
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Johnson
authors.forename: John V
authors.initials: JV
authors.lastname: Heymach
authors.forename: Li
authors.initials: L
authors.lastname: Mao
authors.forename: Frank
authors.initials: F
authors.lastname: Fossella
authors.forename: Merrill S
authors.initials: MS
authors.lastname: Kies
authors.forename: Vassiliki
authors.initials: V
authors.lastname: Papadimitrakopoulou
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Davis
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
authors.forename: Waun K
authors.initials: WK
authors.lastname: Hong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000378:metabolism*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy / Q000379:methods*; D057285:Precision Medicine / Q000379:methods*; D011446:Prospective Studies
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor