The BATTLE-2 study: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 34, Issue 30, 2016, Pages 3638-3647

  Papadimitrakopoulou, Vassiliki ^a   Jack Lee, J ^a   Wistuba, Ignacio I ^a   Tsao, Anne S ^a   Fossella, Frank V ^a   Kalhor, Neda ^a   Gupta, Sanjay ^a   Byers, Lauren Averett ^a   Izzo, Julie G ^a   Gettinger, Scott N ^b   Goldberg, Sarah B ^b   Tang, Ximing ^a   Miller, Vincent A ^c   Skoulidis, Ferdinandos ^a   Gibbons, Don L ^a   Shen, Li ^a   Wei, Caimiao ^a   Diao, Lixia ^a   Andrew Peng, S ^a   Wang, Jing ^a   Tam, Alda L ^a   Coombes, Kevin R ^d   Koo, Ja Seok ^b   Mauro, David J ^e   Rubin, Eric H ^e   Heymach, John V ^a   Hong, Waun Ki ^a   Herbst, Roy S ^b   more..

^a UNIVERSITY OF TEXAS   (United States)

^b YALE UNIVERSITY   (United States)

^c FOUNDATION MEDICINE   (United States)

^d THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

8 [4 (1 AMINOCYCLOBUTYL)PHENYL] 9 PHENYL 1,2,4 TRIAZOLO[3,4 F][1,6]NAPHTHYRIDIN 3(2H) ONE; ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; NOTCH1 RECEPTOR; SELUMETINIB; SORAFENIB;

ACNE; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ARAF GENE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER PATIENT; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DRUG EFFICACY; DRUG SENSITIVITY; DRUG TARGETING; DRY SKIN; DYSGEUSIA; DYSPNEA; EPISTAXIS; EPITHELIUM TUMOR; FATIGUE; FBXW7 GENE; FEMALE; GENE; GENE EXPRESSION; GENE MUTATION; HAND FOOT SYNDROME; HOARSENESS; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERPHOSPHATEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOALBUMINEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MESENCHYMOMA; MOLECULARLY TARGETED THERAPY; MULTICENTER STUDY; NAUSEA; NEXT GENERATION SEQUENCING; NON SMALL CELL LUNG CANCER; ONCOGENE K RAS; ORAL MUCOSITIS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; POST TREATMENT SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VERY ELDERLY; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

EID: 84992386844     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.66.0084     Document Type: Article

References (40)

1. Ferlay J, Shin HR, Bray F, et al: Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 127:2893-2917, 2010
2. Siegel RL, Miller KD, Jemal A: Cancer statistics, 2015. CA Cancer J Clin 65:5-29, 2015
3. Le Chevalier T, Scagliotti G, Natale R, et al: Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-small-cell lung cancer: Ameta-analysis of survival outcomes. Lung Cancer 47:69-80, 2005
4. Ding L, Getz G, Wheeler DA, et al: Somatic mutations affect key pathways in lung adenocarcinoma. Nature 455:1069-1075, 2008
5. Toyooka S, Mitsudomi T, Soh J, et al: Molecular oncology of lung cancer. Gen Thorac Cardiovasc Surg 59:527-537, 2011
6. Kim ES, Herbst RS, Wistuba II, et al: The BATTLE trial: Personalizing therapy for lung cancer. Cancer Discov 1:44-53, 2011
7. Zhou X, Liu S, Kim ES, et al: Bayesian adaptive design for targeted therapy development in lung cancer: A step toward personalized medicine. Clin Trials 5:181-193, 2008
8. Tam AL, Kim ES, Lee JJ, et al: Feasibility of image-guided transthoracic core-needle biopsy in the BATTLE lung trial. J Thorac Oncol 8:436-442, 2013
9. Paz-Ares L, Hirsh V, Zhang L, et al: MISSION Trial: A phase III, multi-center, placebo-controlled trial of sorafenib in patients with relapsed or refractory predominantly non-squamous NSCLC after 2 or 3 previous treatment regimens. J Thorac Oncol 10.1097/JTO.0000000000000693 [epub ahead of print on November 6, 2015]
10. Wakelee HA, Lee JW, Hanna NH, et al: A double-blind randomized discontinuation phase-II study of sorafenib (BAY 43-9006) in previously treated non-small-cell lung cancer patients: Eastern Cooperative Oncology Group study E2501. J Thorac Oncol 7:1574-1582, 2012
11. Dingemans AM, Mellema WW, Groen HJ, et al: A phase II study of sorafenib in patients with platinum-pretreated, advanced (Stage IIIb or IV) non-small cell lung cancer with a KRAS mutation. Clin Cancer Res 19:743-751, 2013
12. Yap TA, Yan L, Patnaik A, et al: First-in-man clinical trial of the oral pan-AKT inhibitor MK-2206 in patients with advanced solid tumors. J Clin Oncol 29:4688-4695, 2011
13. Jänne PA, Shaw AT, Pereira JR, et al: Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: A randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol 14:38-47, 2013
14. Engelman JA, Chen L, Tan X, et al: Effective use of PI3K and MEK inhibitors to treat mutant Kras G12D and PIK3CA H1047R murine lung cancers. Nat Med 14:1351-1356, 2008
15. Engelman JA, Jänne PA: Mechanisms of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer. Clin Cancer Res 14:2895-2899, 2008
16. Lara PN Jr, Longmate J, Mack PC, et al: Phase II study of the AKT inhibitor MK-2206 plus erlotinib in patients with advanced non-small cell lung cancer who previously progressed on erlotinib. Clin Cancer Res 21:4321-4326, 2015
17. Camidge DR, Kono SA, Flacco A, et al: Optimizing the detection of lung cancer patients harboring anaplastic lymphoma kinase (ALK) gene rearrangements potentially suitable for ALK inhibitor treatment. Clin Cancer Res 16:5581-5590, 2010
18. Frampton GM, Fichtenholtz A, Otto GA, et al: Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nat Biotechnol 31:1023-1031, 2013
19. Gu X, Chen N, Wei C, et al: Bayesian twostage biomarker-based adaptive design for targeted therapy development. Stat Biosci 7:1-30, 2014
20. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
21. Lara PN Jr, Redman MW, Kelly K, et al: Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: Results from Southwest Oncology Group randomized trials. J Clin Oncol 26:463-467, 2008
22. Blumenschein GR Jr, Saintigny P, Liu S, et al: Comprehensive biomarker analysis and final efficacy results of sorafenib in the BATTLE trial. Clin Cancer Res 19:6967-6975, 2013
23. Byers LA, Diao L, Wang J, et al: An epithelialmesenchymal transition gene signature predicts resistance to EGFR and PI3K inhibitors and identifies Axl as a therapeutic target for overcoming EGFR inhibitor resistance. Clin Cancer Res 19:279-290, 2013
24. Ren H, Koo J, Guan B, et al: The E3 ubiquitin ligases b-TrCP and FBXW7 cooperatively mediates GSK3-dependent Mcl-1 degradation induced by the Akt inhibitor API-1, resulting in apoptosis. Mol Cancer 12:146, 2013
25. Tolcher AW, Patnaik A, Papadopoulos KP, et al: Phase I study of the MEK inhibitor trametinib in combination with the AKT inhibitor afuresertib in patients with solid tumors and multiple myeloma. Cancer Chemother Pharmacol 75:183-189, 2015
26. Mak MP, Tong P, Diao L, et al: A patientderived, pan-cancer EMT signature identifies global molecular alterations and immune target enrichment following epithelial-to-mesenchymal transition. Clin Cancer Res 22:609-620, 2015
27. Zhang J, Chen YL, Ji G, et al: Sorafenib inhibits epithelial-mesenchymal transition through an epigenetic-based mechanism in human lung epithelial cells. PLoS One 8: e64954, 2013
28. Chen YL, Lv J, Ye XL, et al: Sorafenib inhibits transforming growth factor β1-mediated epithelialmesenchymal transition and apoptosis in mouse hepatocytes. Hepatology 53:1708-1718, 2011
29. Buonato JM, Lazzara MJ: ERK1/2 blockade prevents epithelial-mesenchymal transition in lung cancer cells and promotes their sensitivity to EGFR inhibition. Cancer Res 74:309-319, 2014
30. Young A, Lyons J, Miller AL, et al: Ras signaling and therapies. Adv Cancer Res 102:1-17, 2009
31. Ostrem JM, Peters U, Sos ML, et al: K-Ras (G12C) inhibitors allosterically control GTP affinity and effector interactions. Nature 503:548-551, 2013
32. Carracedo A, Pandolfi PP: The PTEN-PI3K pathway: Of feedbacks and cross-talks. Oncogene 27:5527-5541, 2008
33. Banerji U, Camidge DR, Verheul HM, et al: The first-in-human study of the hydrogen sulfate (Hydsulfate) capsule of the MEK1/2 inhibitor AZD6244 (ARRY-142886): A phase I open-label multicenter trial in patients with advanced cancer. Clin Cancer Res 16:1613-1623, 2010
34. Tolcher AW, Khan K, Ong M, et al: Antitumor activity in RAS-driven tumors by blocking AKT and MEK. Clin Cancer Res 21:739-748, 2015
35. Skoulidis F, Byers LA, Diao L, et al: Cooccurring genomic alterations define major subsets of KRAS-mutant lung adenocarcinoma with distinct biology, immune profiles, and therapeutic vulnerabilities. Cancer Discov 5:860-877, 2015
36. Bedard P, Tabernero J, Kurzrock R, et al: A phase lb, open-label, multicenter, dose-escalation study of the oral pan-PI3K inhibitor BKM120 in combination with the oral MEK1/2 inhibitor GSK1120212 in patients (pts) with selected advanced solid tumors. J Clin Oncol 30, 2012 (suppl; abstr 3003)
37. Infante JR, Gandhi L, Shapiro G, et al: Phase lb combination trial of a MEK inhibitor, pimasertib (MSC1936369B), and a PI3K/mTOR inhibitor, SAR245409, in patients with locally advanced or metastatic solid tumors. J Clin Oncol 30, 2012 (suppl; abstr TPS3118)
38. LoRusso P: A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors. J Clin Oncol 30, 2012 (suppl; abstr 2566)
39. Borghaei H, Paz-Ares L, Horn L, et al: Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 373:1627-1639, 2015
40. Garon EB, Rizvi NA, Hui R, et al: Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372:2018-2028, 2015