The BATTLE Trial: Personalizing Therapy for Lung Cancer

Overview

Journal Cancer Discov

Specialty Oncology

Date 2012 May 16

PMID 22586319

Citations 381

Authors

Edward S Kim

Roy S Herbst

Ignacio I Wistuba

J Jack Lee

George R Blumenschein Jr

Anne Tsao

David J Stewart

Marshall E Hicks

Jeremy Erasmus Jr

Sanjay Gupta

Christine M Alden

Suyu Liu

Ximing Tang

Fadlo R Khuri

Hai T Tran

Bruce E Johnson

John V Heymach

Li Mao

Frank Fossella

Merrill S Kies

Vassiliki Papadimitrakopoulou

Suzanne E Davis

Scott M Lippman

Waun K Hong

Affiliations

Soon will be listed here.

Abstract

Unlabelled: 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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