Molecular profiling and targeted therapy for advanced thoracic malignancies a biomarker-derived, multiarm, multihistology phase ii basket trial

Journal of Clinical Oncology

Volumn 33, Issue 9, 2015, Pages 1000-1007

  Lopez Chavez, Ariel ^a,c,d   Thomas, Anish ^a   Rajan, Arun ^a   Raffeld, Mark ^a   Morrow, Betsy ^a   Kelly, Ronan ^a   Carter, Corey Allan ^a   Guha, Udayan ^a   Killian, Keith ^a   Lau, Christopher C ^a   Abdullaev, Zied ^a   Xi, Liqiang ^a   Pack, Svetlana ^a   Meltzer, Paul S ^a   Corless, Christopher L ^c   Sandler, Alan ^c   Beadling, Carol ^c   Warrick, Andrea ^c   Liewehr, David J ^a   Steinberg, Seth M ^a   Berman, Arlene ^a   Doyle, Austin ^b   Szabo, Eva ^a   Wang, Yisong ^a,e   Giaccone, Giuseppe ^a,e   more..

^a NATIONAL CANCER INSTITUTE   (United States)

^b Cancer Therapy Evaluation Program   (United States)

^c OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^d UNIVERSITY OF MIAMI   (United States)

^e GEORGETOWN UNIVERSITY   (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; ERLOTINIB; LAPATINIB; SELUMETINIB; SUNITINIB; B RAF KINASE; BENZIMIDAZOLE DERIVATIVE; BRAF PROTEIN, HUMAN; EPIDERMAL GROWTH FACTOR RECEPTOR; INDOLE DERIVATIVE; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHATIDYLINOSITOL 3,4,5 TRISPHOSPHATE 3 PHOSPHATASE; PIK3CA PROTEIN, HUMAN; PROTEIN KINASE INHIBITOR; PTEN PROTEIN, HUMAN; PYRROLE DERIVATIVE; QUINAZOLINE DERIVATIVE; RAS PROTEIN; TUMOR MARKER;

ADULT; ADVANCED CANCER; ARTICLE; CANCER SURVIVAL; CANCER THERAPY; FEMALE; HEALTH CARE QUALITY; HUMAN; MAJOR CLINICAL STUDY; MALE; MUTATION RATE; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; SMALL CELL LUNG CANCER; THYMUS CANCER; TREATMENT OUTCOME; TREATMENT RESPONSE; ADOLESCENT; AGED; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; GENETICS; LUNG NEOPLASMS; METABOLISM; MIDDLE AGED; MOLECULARLY TARGETED THERAPY; MUTATION; ONCOGENE RAS; REPRODUCIBILITY; SMALL CELL LUNG CARCINOMA; THYMUS NEOPLASMS; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BENZIMIDAZOLES; BIOMARKERS, TUMOR; CARCINOMA, NON-SMALL-CELL LUNG; ERLOTINIB HYDROCHLORIDE; FEMALE; GENES, RAS; HUMANS; INDOLES; LUNG NEOPLASMS; MALE; MIDDLE AGED; MOLECULAR TARGETED THERAPY; MUTATION; PHOSPHATIDYLINOSITOL 3-KINASES; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS B-RAF; PTEN PHOSPHOHYDROLASE; PYRROLES; QUINAZOLINES; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR; REPRODUCIBILITY OF RESULTS; SMALL CELL LUNG CARCINOMA; THYMUS NEOPLASMS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84927164071     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.58.2007     Document Type: Article

References (42)

1. Fletcher CD: The evolving classification of soft tissue tumours: An update based on the new 2013WHO classification. Histopathology 64:2-11, 2014
2. NCCN Guidelines Updates. J Natl Compr Canc Netw 11:xxxii-xxxvi, 2013
3. Cancer Genome Atlas Network: Comprehensive molecular portraits of human breast tumours. Nature 490:61-70, 2012
4. Ciriello G, Miller ML, Aksoy BA, et al: Emerging landscape of oncogenic signatures across human cancers. Nat Genet 45:1127-1133, 2013
5. Kandoth C, McLellan MD, Vandin F, et al: Mutational landscape and significance across 12 major cancer types. Nature 502:333-339, 2013
6. Maemondo M, Inoue A, Kobayashi K, et al: Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 362:2380-2388, 2010
7. Kwak EL, Bang YJ, Camidge DR, et al: Anaplastic lymphoma kinase inhibition in non-small- cell lung cancer. N Engl J Med 363:1693-1703, 2010
8. Majewski IJ, Bernards R: Taming the dragon: Genomic biomarkers to individualize the treatment of cancer. Nat Med 17:304-312, 2011
9. Rosell R,Moran T, Queralt C, et al: Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 361:958-967, 2009
10. Sequist LV, Yang JC, Yamamoto N, et al: Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 31:3327-3334, 2013
11. Garraway LA, Verweij J, Ballman KV: Precision oncology: An overview. J Clin Oncol 31:1803-1805, 2013
12. Garraway LA: Genomics-driven oncology: Framework for an emerging paradigm. J Clin Oncol 31:1806-1814, 2013
13. Korn EL, Arbuck SG, Pluda JM, et al: Clinical trial designs for cytostatic agents: Are new approaches needed? J Clin Oncol 19:265-272, 2001
14. Korn EL, McShane LM, Freidlin B: Statistical challenges in the evaluation of treatments for small patient populations. Sci Transl Med 5:178sr3, 2013
15. Seymour L, Ivy SP, Sargent D, et al: The design of phase II clinical trials testing cancer therapeutics: Consensus recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee. Clin Cancer Res 16:1764-1769, 2010
16. Kan Z, Jaiswal BS, Stinson J, et al: Diverse somatic mutation patterns and pathway alterations in human cancers. Nature 466:869-873, 2010
17. Kim Y, Hammerman PS, Kim J, et al: Integrative and comparative genomic analysis of lung squamous cell carcinomas in East Asian patients. J Clin Oncol 32:121-128, 2014
18. Ding L, Getz G, Wheeler DA, et al: Somatic mutations affect key pathways in lung adenocarcinoma. Nature 455:1069-1075, 2008
19. Freidlin B, Korn EL: Biomarker enrichment strategies: Matching trial design to biomarker credentials. Nat Rev Clin Oncol 11:81-90, 2014
20. Seymour LK, Calvert AH, Lobbezoo MW, et al: Design and conduct of early clinical studies of two or more targeted anticancer therapies: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies. Eur J Cancer 49:1808-1814, 2013
21. Kaplan R, Maughan T, Crook A, et al: Evaluating many treatments and biomarkers in oncology: A new design. J Clin Oncol 31:4562-4568, 2013
22. Barker AD, Sigman CC, Kelloff GJ, et al: I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther 86:97-100, 2009
23. Ledford H: Clinical drug tests adapted for speed. Nat News 464:1258, 2010
24. Kim ES, Herbst RS, Wistuba II, et al: The BATTLE trial: Personalizing therapy for lung cancer. Cancer Discov 1:44-53, 2011
25. Sleijfer S, Bogaerts J, Siu LL: Designing transformative clinical trials in the cancer genome era. J Clin Oncol 31:1834-1841, 2013
26. The Clinical Lung Cancer Genome Project (CLCGP), Network Genomic Medicine (NGM): A genomics-based classification of human lung tumors. Sci Transl Med 5:209ra153, 2013
27. Simon R: Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10, 1989
28. Mok TS, Wu YL, Thongprasert S, et al: Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361:947-957, 2009
29. Goldberg SB, Oxnard GR, Digumarthy S, et al: Chemotherapy with erlotinib or chemotherapy alone in advanced non-small cell lung cancer with acquired resistance to EGFR tyrosine kinase inhibitors. Oncologist 18:1214-1220, 2013
30. Mazières J, Peters S, Lepage B, et al: Lung cancer that harbors a HER2 mutation: Epidemiologic characteristics and therapeutic perspectives. J Clin Oncol 31:1997-2003, 2013
31. Tajik P, Zwinderman AH, Mol BW, et al: Trial designs for personalizing cancer care: A systematic review and classification. Clin Cancer Res 19:4578-4588, 2013
32. Kris MG, Johnson BE, Berry LD, et al: Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA 311:1998-2006, 2014
33. Rudin CM, Durinck S, Stawiski EW, et al: Comprehensive genomic analysis identifies SOX2 as a frequently amplified gene in small-cell lung cancer. Nat Genet 44:1111-1116, 2012
34. Peifer M, Fernández-Cuesta L, Sos ML, et al: Integrative genome analyses identify key somatic driver mutations of small-cell lung cancer. Nat Genet 44:1104-1110, 2012
35. Cancer Genome Atlas Research Network: Comprehensive genomic characterization of squamous cell lung cancers. Nature 489:519-525, 2012
36. Carter CA, Rajan A, Szabo E, et al: Two parallel randomized phase II studies of selumetinib (S) and erlotinib (E) in advanced non-small cell lung cancer selected by KRAS mutations. J Clin Oncol 31, 2013 (suppl; abstr 8026)
37. Rosell R, Carcereny E, Gervais R, et al: Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): A multicentre, open-label, randomised phase 3 trial. Lancet Oncol 13:239-246, 2012
38. Bergethon K, Shaw AT, Ou SH, et al: ROS1 rearrangements define a unique molecular class of lung cancers. J Clin Oncol 30:863-870, 2012
39. Davies KD, Le AT, Theodoro MF, et al: Identifying and targeting ROS1 gene fusions in non-small cell lung cancer. Clin Cancer Res 18:4570-4579, 2012
40. Ju YS, Lee WC, Shin JY, et al: A transforming KIF5B and RET gene fusion in lung adenocarcinoma revealed from whole-genome and transcriptome sequencing. Genome Res 22:436-445, 2012
41. Suehara Y, Arcila M, Wang L, et al: Identification of KIF5B-RET and GOPC-ROS1 fusions in lung adenocarcinomas through a comprehensive mRNAbased screen for tyrosine kinase fusions. Clin Cancer Res 18:6599-6608, 2012
42. Kohno T, Ichikawa H, Totoki Y, et al: KIF5BRET fusions in lung adenocarcinoma. Nat Med 18: 375-377, 2012