The BATTLE trial: Personalizing Therapy for Lung Cancer

Edward S. Kim; Roy S. Herbst; Ignacio I. Wistuba; J. Jack Lee; George R. Blumenschein; Anne Tsao; David J. Stewart; Marshall E. Hicks; Jeremy Erasmus; 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

doi:10.1158/2159-8274.CD-10-0010

The BATTLE trial: Personalizing Therapy for Lung Cancer

Edward S. Kim, Roy S. Herbst, Ignacio I. Wistuba, J. Jack Lee, George R. Blumenschein, Anne Tsao, David J. Stewart, Marshall E. Hicks, Jeremy Erasmus, 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. KiesVassiliki Papadimitrakopoulou, Suzanne E. Davis, Scott M. Lippman, Waun K. Hong

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735 Scopus citations

Abstract

The Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial represents the first completed prospective, biopsymandated, 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. (ClinicalTrials.gov numbers: NCT00409968, NCT00411671, NCT00411632, NCT00410059, and NCT00410189.) 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.

Original language	English (US)
Pages (from-to)	44-53
Number of pages	10
Journal	Cancer discovery
Volume	1
Issue number	1
DOIs	https://doi.org/10.1158/2159-8274.CD-10-0010
State	Published - Jun 2011

ASJC Scopus subject areas

Oncology

MD Anderson CCSG core facilities

Advanced Technology Genomics Core
Biostatistics Resource Group
Clinical Trials Office

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10.1158/2159-8274.CD-10-0010

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Kim, E. S., Herbst, R. S., Wistuba, I. I., Jack Lee, J., Blumenschein, G. R., Tsao, A., Stewart, D. J., Hicks, M. E., Erasmus, J., Gupta, S., Alden, C. M., Liu, S., Tang, X., Khuri, F. R., Tran, H. T., Johnson, B. E., Heymach, J. V., Mao, L., Fossella, F., ... Hong, W. K. (2011). The BATTLE trial: Personalizing Therapy for Lung Cancer. Cancer discovery, 1(1), 44-53. https://doi.org/10.1158/2159-8274.CD-10-0010

Kim, ES, Herbst, RS, Wistuba, II , Jack Lee, J , Blumenschein, GR , Tsao, A, Stewart, DJ, Hicks, ME , Erasmus, J , Gupta, S, Alden, CM, Liu, S , Tang, X, Khuri, FR, Tran, HT, Johnson, BE, Heymach, JV, Mao, L, Fossella, F, Kies, MS, Papadimitrakopoulou, V, Davis, SE, Lippman, SM & Hong, WK 2011, 'The BATTLE trial: Personalizing Therapy for Lung Cancer', Cancer discovery, vol. 1, no. 1, pp. 44-53. https://doi.org/10.1158/2159-8274.CD-10-0010

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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, biopsymandated, 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. (ClinicalTrials.gov numbers: NCT00409968, NCT00411671, NCT00411632, NCT00410059, and NCT00410189.) 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.",

author = "Kim, {Edward S.} and Herbst, {Roy S.} and Wistuba, {Ignacio I.} and {Jack Lee}, J. and Blumenschein, {George R.} and Anne Tsao and Stewart, {David J.} and Hicks, {Marshall E.} and Jeremy Erasmus and Sanjay Gupta and Alden, {Christine M.} and Suyu Liu and Ximing Tang and Khuri, {Fadlo R.} and Tran, {Hai T.} and Johnson, {Bruce E.} and Heymach, {John V.} and Li Mao and Frank Fossella and Kies, {Merrill S.} and Vassiliki Papadimitrakopoulou and Davis, {Suzanne E.} and Lippman, {Scott M.} and Hong, {Waun K.}",

year = "2011",

month = jun,

doi = "10.1158/2159-8274.CD-10-0010",

language = "English (US)",

volume = "1",

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T1 - The BATTLE trial

T2 - Personalizing Therapy for Lung Cancer

AU - Kim, Edward S.

AU - Herbst, Roy S.

AU - Wistuba, Ignacio I.

AU - Jack Lee, J.

AU - Blumenschein, George R.

AU - Tsao, Anne

AU - Stewart, David J.

AU - Hicks, Marshall E.

AU - Erasmus, Jeremy

AU - Gupta, Sanjay

AU - Alden, Christine M.

AU - Liu, Suyu

AU - Tang, Ximing

AU - Khuri, Fadlo R.

AU - Tran, Hai T.

AU - Johnson, Bruce E.

AU - Heymach, John V.

AU - Mao, Li

AU - Fossella, Frank

AU - Kies, Merrill S.

AU - Papadimitrakopoulou, Vassiliki

AU - Davis, Suzanne E.

AU - Lippman, Scott M.

AU - Hong, Waun K.

PY - 2011/6

Y1 - 2011/6

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The BATTLE trial: Personalizing Therapy for Lung Cancer

Abstract

ASJC Scopus subject areas

MD Anderson CCSG core facilities

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