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PMID: 25277503 Published · epublish English Journal Article Research Support, Non-U.S. Gov't Review

Strategies for modern biomarker and drug development in oncology.

Journal of hematology & oncology ·Vol. 7 ·2014-10-03 ·Pages 70

Smith AD, Roda D, Yap TA

Abstract

Technological advancements in the molecular characterization of cancers have enabled researchers to identify an increasing number of key molecular drivers of cancer progression. These discoveries have led to multiple novel anticancer therapeutics, and clinical benefit in selected patient populations. Despite this, the identification of clinically relevant predictive biomarkers of response continues to lag behind. In this review, we discuss strategies for the molecular characterization of cancers and the importance of biomarkers for the development of novel antitumor therapeutics. We also review critical successes and failures in oncology, and detail the lessons learnt, which may aid in the acceleration of anticancer drug development and biomarker discovery.

MeSH Terms
Animals Antineoplastic Agents/pharmacology Biomarkers, Tumor/metabolism Drug Discovery Humans Neoplasms/drug therapy,metabolism
Chemicals
Antineoplastic Agents Biomarkers, Tumor
Authors & Affiliations
3 authors, click to expand affiliations / ORCID
Smith Alan D
Drug Development Unit, Royal Marsden NHS Foundation Trust, Division of Clinical Studies, The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK. alan.smith@icr.ac.uk.
Roda Desam
Drug Development Unit, Royal Marsden NHS Foundation Trust, Division of Clinical Studies, The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK. desam.roda-perez@icr.ac.uk.
Yap Timothy A
Drug Development Unit, Royal Marsden NHS Foundation Trust, Division of Clinical Studies, The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK. timothy.yap@icr.ac.uk.
References (179)
179 references, click to expand
  1. Gastric GI stromal tumors (GISTs): the role of surgery in the era of targeted therapy.
    J Surg Oncol. 2005 Jun 1;90(3):195-207; discussion 207 PMID: 15895440
  2. Exploiting the cancer genome: strategies for the discovery and clinical development of targeted molecular therapeutics.
    Annu Rev Pharmacol Toxicol. 2012;52:549-73 PMID: 22235862
  3. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma.
    N Engl J Med. 2009 Sep 3;361(10):947-57 PMID: 19692680
  4. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial.
    Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34 PMID: 15451219
  5. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer.
    Clin Cancer Res. 2008 Oct 1;14(19):6302-9 PMID: 18829513
  6. Diffusion and diffusion tensor imaging in brain cancer.
    Semin Radiat Oncol. 2011 Apr;21(2):141-6 PMID: 21356481
  7. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial.
    Lancet Oncol. 2013 Jul;14(8):697-710 PMID: 23746666
  8. ALK in lung cancer: past, present, and future.
    J Clin Oncol. 2013 Mar 10;31(8):1105-11 PMID: 23401436
  9. A single nucleotide polymorphism based approach for the identification and characterization of gene expression modulation using MassARRAY.
    Mutat Res. 2005 Jun 3;573(1-2):83-95 PMID: 15829239
  10. Personalized ovarian cancer disease surveillance and detection of candidate therapeutic drug target in circulating tumor DNA.
    Neoplasia. 2014 Jan;16(1):97-103 PMID: 24563622
  11. Deep proteome and transcriptome mapping of a human cancer cell line.
    Mol Syst Biol. 2011 Nov 08;7:548 PMID: 22068331
  12. Epidermal growth factor receptor inhibition in lung cancer: status 2012.
    J Thorac Oncol. 2013 Mar;8(3):373-84 PMID: 23370315
  13. Escaping ALK inhibition: mechanisms of and strategies to overcome resistance.
    Sci Transl Med. 2012 Feb 8;4(120):120ps2 PMID: 22323827
  14. Inhibition of mutated, activated BRAF in metastatic melanoma.
    N Engl J Med. 2010 Aug 26;363(9):809-19 PMID: 20818844
  15. The role of the human homologue of Drosophila patched in sporadic basal cell carcinomas.
    Nat Genet. 1996 Sep;14(1):78-81 PMID: 8782823
  16. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial.
    Lancet Oncol. 2013 Sep;14(10):933-42 PMID: 23932548
  17. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer.
    Cancer Discov. 2014 Sep;4(9):1046-61 PMID: 24893891
  18. Dual targeting of the epidermal growth factor receptor using the combination of cetuximab and erlotinib: preclinical evaluation and results of the phase II DUX study in chemotherapy-refractory, advanced colorectal cancer.
    J Clin Oncol. 2012 May 1;30(13):1505-12 PMID: 22412142
  19. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene.
    Science. 1987 Jan 9;235(4785):177-82 PMID: 3798106
  20. Analysis of circulating tumor DNA to monitor metastatic breast cancer.
    N Engl J Med. 2013 Mar 28;368(13):1199-209 PMID: 23484797
  21. Improved survival with MEK inhibition in BRAF-mutated melanoma.
    N Engl J Med. 2012 Jul 12;367(2):107-14 PMID: 22663011
  22. Antibody-drug conjugates for the treatment of cancer.
    Chem Biol Drug Des. 2013 Jan;81(1):113-21 PMID: 23253133
  23. LUX-Lung 4: a phase II trial of afatinib in patients with advanced non-small-cell lung cancer who progressed during prior treatment with erlotinib, gefitinib, or both.
    J Clin Oncol. 2013 Sep 20;31(27):3335-41 PMID: 23816963
  24. Role of epidermal growth factor receptor inhibitors in epidermal growth factor receptor wild-type non-small-cell lung cancer.
    J Clin Oncol. 2013 Mar 10;31(8):1061-9 PMID: 23401452
  25. Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy.
    Am J Pathol. 2009 Aug;175(2):808-16 PMID: 19628770
  26. Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor.
    J Clin Oncol. 2008 Nov 20;26(33):5352-9 PMID: 18955458
  27. Efficacy of HER2-targeted therapy in metastatic breast cancer. Monoclonal antibodies and tyrosine kinase inhibitors.
    Breast. 2013 Feb;22(1):1-12 PMID: 23084121
  28. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer.
    N Engl J Med. 2006 Dec 14;355(24):2542-50 PMID: 17167137
  29. Imatinib mesylate (STI-571 Glivec, Gleevec) is an active agent for gastrointestinal stromal tumours, but does not yield responses in other soft-tissue sarcomas that are unselected for a molecular target. Results from an EORTC Soft Tissue and Bone Sarcoma Group phase II study.
    Eur J Cancer. 2003 Sep;39(14):2006-11 PMID: 12957454
  30. New technologies and directed agents for applications of cancer imaging.
    J Clin Oncol. 2006 Jul 10;24(20):3299-308 PMID: 16829654
  31. Improved survival with ipilimumab in patients with metastatic melanoma.
    N Engl J Med. 2010 Aug 19;363(8):711-23 PMID: 20525992
  32. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors.
    Clin Cancer Res. 2011 Apr 15;17(8):2502-11 PMID: 21300762
  33. Adjuvant bevacizumab: positive data from a negative trial.
    Lancet Oncol. 2013 Sep;14(10):910-1 PMID: 23932547
  34. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial.
    Lancet. 2010 Jul 24;376(9737):235-44 PMID: 20609467
  35. Integrative genomic profiling of human prostate cancer.
    Cancer Cell. 2010 Jul 13;18(1):11-22 PMID: 20579941
  36. Metabolomic profiles delineate potential role for sarcosine in prostate cancer progression.
    Nature. 2009 Feb 12;457(7231):910-4 PMID: 19212411
  37. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer.
    J Clin Oncol. 2005 May 20;23(15):3502-8 PMID: 15908660
  38. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer.
    J Clin Oncol. 2008 May 10;26(14):2311-9 PMID: 18390971
  39. Monitoring the clinical outcomes in advanced prostate cancer: what imaging modalities and other markers are reliable?
    Semin Oncol. 2013 Jun;40(3):375-92 PMID: 23806501
  40. Phase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitor.
    J Clin Oncol. 2013 Feb 1;31(4):482-9 PMID: 23248257
  41. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer.
    J Clin Oncol. 2008 Apr 1;26(10):1626-34 PMID: 18316791
  42. Can the pharmaceutical industry reduce attrition rates?
    Nat Rev Drug Discov. 2004 Aug;3(8):711-5 PMID: 15286737
  43. Study of the biologic effects of lapatinib, a reversible inhibitor of ErbB1 and ErbB2 tyrosine kinases, on tumor growth and survival pathways in patients with advanced malignancies.
    J Clin Oncol. 2005 Apr 10;23(11):2502-12 PMID: 15684311
  44. Efficacy and safety of vismodegib in advanced basal-cell carcinoma.
    N Engl J Med. 2012 Jun 7;366(23):2171-9 PMID: 22670903
  45. Randomized phase II study of maintenance irinotecan therapy versus observation following induction chemotherapy with irinotecan and cisplatin in extensive disease small cell lung cancer.
    J Thorac Oncol. 2008 Sep;3(9):1039-45 PMID: 18758308
  46. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers.
    N Engl J Med. 2009 Jul 9;361(2):123-34 PMID: 19553641
  47. Identification of mutations in the human PATCHED gene in sporadic basal cell carcinomas and in patients with the basal cell nevus syndrome.
    J Invest Dermatol. 1998 Jun;110(6):885-8 PMID: 9620294
  48. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.
    N Engl J Med. 2012 Jun 28;366(26):2443-54 PMID: 22658127
  49. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study.
    Ann Oncol. 2011 Jul;22(7):1535-1546 PMID: 21228335
  50. A phase I study of AST1306, a novel irreversible EGFR and HER2 kinase inhibitor, in patients with advanced solid tumors.
    J Hematol Oncol. 2014 Mar 11;7:22 PMID: 24612546
  51. Therapeutic strategies to overcome crizotinib resistance in non-small cell lung cancers harboring the fusion oncogene EML4-ALK.
    Proc Natl Acad Sci U S A. 2011 May 3;108(18):7535-40 PMID: 21502504
  52. Progression-free survival in advanced ovarian cancer: a Canadian review and expert panel perspective.
    Curr Oncol. 2011 Oct;18 Suppl 2:S20-7 PMID: 21969808
  53. Circulating tumour cells as prognostic markers in progressive, castration-resistant prostate cancer: a reanalysis of IMMC38 trial data.
    Lancet Oncol. 2009 Mar;10(3):233-9 PMID: 19213602
  54. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study.
    Blood. 2002 Mar 15;99(6):1928-37 PMID: 11877262
  55. Cancer. Awakening immunity.
    Science. 2010 Nov 5;330(6005):761-2 PMID: 21051618
  56. A novel ALK secondary mutation and EGFR signaling cause resistance to ALK kinase inhibitors.
    Cancer Res. 2011 Sep 15;71(18):6051-60 PMID: 21791641
  57. Minimally invasive pharmacokinetic and pharmacodynamic technologies in hypothesis-testing clinical trials of innovative therapies.
    J Natl Cancer Inst. 2006 May 3;98(9):580-98 PMID: 16670384
  58. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial.
    Clin Cancer Res. 2010 Oct 1;16(19):4853-63 PMID: 20651059
  59. RAF inhibitor resistance is mediated by dimerization of aberrantly spliced BRAF(V600E).
    Nature. 2011 Nov 23;480(7377):387-90 PMID: 22113612
  60. Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer.
    Breast Cancer Res Treat. 2007 Mar;101(3):355-65 PMID: 16850247
  61. Novel mutant-selective EGFR kinase inhibitors against EGFR T790M.
    Nature. 2009 Dec 24;462(7276):1070-4 PMID: 20033049
  62. VEGFA genomic amplification tailors treatment of HCCs with sorafenib.
    Cancer Discov. 2014 Jun;4(6):640-1 PMID: 24891362
  63. Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival.
    Clin Cancer Res. 2006 Jul 15;12(14 Pt 1):4218-24 PMID: 16857794
  64. Combined antiangiogenesis and antiepidermal growth factor receptor targeting in the treatment of cancer: hold back, we are not there yet.
    J Clin Oncol. 2007 Oct 10;25(29):4516-8 PMID: 17876011
  65. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer.
    J Clin Oncol. 2004 Jun 1;22(11):2184-91 PMID: 15169807
  66. Biomarkers characterization of circulating tumour cells in breast cancer patients.
    Breast Cancer Res. 2012 May 03;14(3):R71 PMID: 22554015
  67. Leukopenia as a biomarker of sunitinib outcome in advanced renal cell carcinoma.
    Anticancer Res. 2014 Jul;34(7):3781-7 PMID: 24982402
  68. Improved survival with vemurafenib in melanoma with BRAF V600E mutation.
    N Engl J Med. 2011 Jun 30;364(26):2507-16 PMID: 21639808
  69. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT.
    J Clin Oncol. 2008 Feb 1;26(4):620-5 PMID: 18235121
  70. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study.
    Lancet Oncol. 2011 Aug;12(8):735-42 PMID: 21783417
  71. Effect of simvastatin on cetuximab resistance in human colorectal cancer with KRAS mutations.
    J Natl Cancer Inst. 2011 Apr 20;103(8):674-88 PMID: 21398618
  72. Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer.
    J Clin Oncol. 2005 Apr 10;23(11):2534-43 PMID: 15699478
  73. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate.
    Cancer Res. 2008 Nov 15;68(22):9280-90 PMID: 19010901
  74. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer.
    Clin Cancer Res. 2012 Mar 1;18(5):1472-82 PMID: 22235099
  75. Abiraterone and increased survival in metastatic prostate cancer.
    N Engl J Med. 2011 May 26;364(21):1995-2005 PMID: 21612468
  76. Metabolomic profiling identifies biochemical pathways associated with castration-resistant prostate cancer.
    J Proteome Res. 2014 Feb 7;13(2):1088-100 PMID: 24359151
  77. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer.
    N Engl J Med. 2012 Apr 12;366(15):1382-92 PMID: 22452356
  78. Dual targeting of HER2-positive cancer with trastuzumab emtansine and pertuzumab: critical role for neuregulin blockade in antitumor response to combination therapy.
    Clin Cancer Res. 2014 Jan 15;20(2):456-68 PMID: 24097864
  79. Combinatorial treatments that overcome PDGFRβ-driven resistance of melanoma cells to V600EB-RAF inhibition.
    Cancer Res. 2011 Aug 1;71(15):5067-74 PMID: 21803746
  80. Impact of EGFR inhibitor in non-small cell lung cancer on progression-free and overall survival: a meta-analysis.
    J Natl Cancer Inst. 2013 May 1;105(9):595-605 PMID: 23594426
  81. Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature.
    Ann Oncol. 2010 Jan;21(1):7-12 PMID: 19901012
  82. Synergistic activity of the new ABL-specific tyrosine kinase inhibitor STI571 and chemotherapeutic drugs on BCR-ABL-positive chronic myelogenous leukemia cells.
    Leukemia. 2001 Mar;15(3):342-7 PMID: 11237055
  83. Adjuvant therapy in primary GIST: state-of-the-art.
    Ann Oncol. 2012 Nov;23(11):2776-2781 PMID: 22831984
  84. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer.
    J Clin Oncol. 2005 Sep 1;23(25):5892-9 PMID: 16043829
  85. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage.
    Nat Med. 2014 May;20(5):548-54 PMID: 24705333
  86. Markers of response for the antiangiogenic agent bevacizumab.
    J Clin Oncol. 2013 Mar 20;31(9):1219-30 PMID: 23401453
  87. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors.
    N Engl J Med. 2010 Oct 28;363(18):1734-9 PMID: 20979473
  88. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial.
    Lancet Oncol. 2012 May;13(5):528-38 PMID: 22452896
  89. EGFR-directed treatments in SCCHN.
    Lancet Oncol. 2013 Jul;14(8):672-3 PMID: 23746667
  90. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer.
    J Clin Oncol. 2007 May 1;25(13):1658-64 PMID: 17470858
  91. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil.
    J Clin Oncol. 2009 Mar 10;27(8):1227-34 PMID: 19188680
  92. The role of aberrant VHL/HIF pathway elements in predicting clinical outcome to pazopanib therapy in patients with metastatic clear-cell renal cell carcinoma.
    Clin Cancer Res. 2013 Sep 15;19(18):5218-26 PMID: 23881929
  93. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies.
    Cancer Res. 2005 Feb 1;65(3):671-80 PMID: 15705858
  94. Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors.
    J Hematol Oncol. 2014 Jan 03;7:1 PMID: 24387695
  95. Fundamentals of quantitative dynamic contrast-enhanced MR imaging.
    Magn Reson Imaging Clin N Am. 2009 May;17(2):277-89 PMID: 19406359
  96. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group.
    J Clin Oncol. 2005 Jul 1;23(19):4265-74 PMID: 15911866
  97. Detection of circulating tumor DNA in early- and late-stage human malignancies.
    Sci Transl Med. 2014 Feb 19;6(224):224ra24 PMID: 24553385
  98. Novel strategies to test biological hypotheses in early drug development for advanced prostate cancer.
    Clin Chem. 2013 Jan;59(1):75-84 PMID: 23204221
  99. Molecular markers to predict outcome to antiangiogenic therapies in colorectal cancer: current evidence and future perspectives.
    Cancer Treat Rev. 2013 Dec;39(8):908-24 PMID: 23510598
  100. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial.
    Lancet. 2010 Jul 24;376(9737):245-51 PMID: 20609468
  101. Gastrointestinal stromal tumours (GISTs) negative for KIT (CD117 antigen) immunoreactivity.
    J Pathol. 2004 Apr;202(4):430-8 PMID: 15095270
  102. Antibody therapeutics in cancer.
    Science. 2013 Sep 13;341(6151):1192-8 PMID: 24031011
  103. The role of functional and molecular imaging in cancer drug discovery and development.
    Br J Radiol. 2003;76 Spec No 2:S128-38 PMID: 15572335
  104. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status.
    J Clin Oncol. 2011 May 20;29(15):2011-9 PMID: 21502544
  105. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer.
    N Engl J Med. 2006 Feb 23;354(8):809-20 PMID: 16495393
  106. Translating metastasis-related biomarkers to the clinic--progress and pitfalls.
    Nat Rev Clin Oncol. 2013 Mar;10(3):169-79 PMID: 23381003
  107. 18F-FDG-PET/CT Imaging as an early survival predictor in patients with primary high-grade soft tissue sarcomas undergoing neoadjuvant therapy.
    Clin Cancer Res. 2012 Apr 1;18(7):2024-31 PMID: 22338012
  108. PF00299804, an irreversible pan-ERBB inhibitor, is effective in lung cancer models with EGFR and ERBB2 mutations that are resistant to gefitinib.
    Cancer Res. 2007 Dec 15;67(24):11924-32 PMID: 18089823
  109. How much gets there and what does it do?: The need for better pharmacokinetic and pharmacodynamic endpoints in contemporary drug discovery and development.
    Curr Pharm Des. 2003;9(11):891-902 PMID: 12678873
  110. Envisioning the future of early anticancer drug development.
    Nat Rev Cancer. 2010 Jul;10(7):514-23 PMID: 20535131
  111. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer.
    N Engl J Med. 2009 Apr 2;360(14):1408-17 PMID: 19339720
  112. Targeted therapy by combined inhibition of the RAF and mTOR kinases in malignant spindle cell neoplasm harboring the KIAA1549-BRAF fusion protein.
    J Hematol Oncol. 2014 Jan 14;7:8 PMID: 24422672
  113. Imaging readouts as biomarkers or surrogate parameters for the assessment of therapeutic interventions.
    Eur Radiol. 2007 Oct;17(10):2441-57 PMID: 17340100
  114. Relationship of circulating tumor cells to tumor response, progression-free survival, and overall survival in patients with metastatic colorectal cancer.
    J Clin Oncol. 2008 Jul 1;26(19):3213-21 PMID: 18591556
  115. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models.
    Oncogene. 2008 Aug 7;27(34):4702-11 PMID: 18408761
  116. Clinical benefit assessment of vismodegib therapy in patients with advanced basal cell carcinoma.
    Oncologist. 2014 Aug;19(8):790-6 PMID: 25001266
  117. Mutant V599EB-Raf regulates growth and vascular development of malignant melanoma tumors.
    Cancer Res. 2005 Mar 15;65(6):2412-21 PMID: 15781657
  118. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer.
    N Engl J Med. 2012 Jan 12;366(2):109-19 PMID: 22149875
  119. Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.
    Clin Cancer Res. 2013 Jul 15;19(14):3722-31 PMID: 23665737
  120. Evaluation and prognostic significance of circulating tumor cells in patients with non-small-cell lung cancer.
    J Clin Oncol. 2011 Apr 20;29(12):1556-63 PMID: 21422424
  121. Gastrointestinal stromal tumors: review on morphology, molecular pathology, prognosis, and differential diagnosis.
    Arch Pathol Lab Med. 2006 Oct;130(10):1466-78 PMID: 17090188
  122. Progression-free survival as a surrogate endpoint for median overall survival in metastatic colorectal cancer: literature-based analysis from 50 randomized first-line trials.
    Clin Cancer Res. 2013 Jan 1;19(1):225-35 PMID: 23149819
  123. Tissue-based approaches to study pharmacodynamic endpoints in early phase oncology clinical trials.
    Curr Drug Targets. 2012 Nov;13(12):1525-34 PMID: 22974395
  124. Advances in patient-derived tumor xenografts: from target identification to predicting clinical response rates in oncology.
    Biochem Pharmacol. 2014 Sep 15;91(2):135-43 PMID: 24950467
  125. Promise and pitfalls of quantitative imaging in oncology clinical trials.
    Magn Reson Imaging. 2012 Nov;30(9):1301-12 PMID: 22898682
  126. A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group.
    Lancet Oncol. 2014 Apr;15(4):e184-93 PMID: 24694642
  127. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer.
    J Clin Oncol. 2007 Jan 1;25(1):118-45 PMID: 17159189
  128. Cancer immunotherapy comes of age.
    Nature. 2011 Dec 21;480(7378):480-9 PMID: 22193102
  129. Nivolumab plus ipilimumab in advanced melanoma.
    N Engl J Med. 2013 Jul 11;369(2):122-33 PMID: 23724867
  130. Surgical management of advanced gastrointestinal stromal tumors after treatment with targeted systemic therapy using kinase inhibitors.
    J Clin Oncol. 2006 May 20;24(15):2325-31 PMID: 16710031
  131. State-of-the art therapy for gastrointestinal stromal tumors.
    Cancer Invest. 2005;23(3):274-80 PMID: 15945512
  132. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma.
    N Engl J Med. 2011 Jun 30;364(26):2517-26 PMID: 21639810
  133. Proteomics for discovery of candidate colorectal cancer biomarkers.
    World J Gastroenterol. 2014 Apr 14;20(14):3804-24 PMID: 24744574
  134. Implementing personalized cancer genomics in clinical trials.
    Nat Rev Drug Discov. 2013 May;12(5):358-69 PMID: 23629504
  135. Microarray technology and applications in the arena of genome-wide association.
    Clin Chem. 2008 Jul;54(7):1116-24 PMID: 18499899
  136. A window into third-generation sequencing.
    Hum Mol Genet. 2010 Oct 15;19(R2):R227-40 PMID: 20858600
  137. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033.
    J Clin Oncol. 2008 Feb 1;26(4):626-32 PMID: 18235122
  138. Targeted comparative genomic hybridization array for the detection of single- and multiexon gene deletions and duplications.
    Genet Med. 2009 Apr;11(4):232-40 PMID: 19282776
  139. The hallmarks of cancer.
    Cell. 2000 Jan 7;100(1):57-70 PMID: 10647931
  140. Targeted high throughput sequencing of a cancer-related exome subset by specific sequence capture with a fully automated microarray platform.
    Genomics. 2010 Apr;95(4):241-6 PMID: 20138981
  141. Detection of mutant free circulating tumor DNA in the plasma of patients with gastrointestinal stromal tumor harboring activating mutations of CKIT or PDGFRA.
    Clin Cancer Res. 2013 Sep 1;19(17):4854-67 PMID: 23833305
  142. Trastuzumab emtansine for HER2-positive advanced breast cancer.
    N Engl J Med. 2012 Nov 8;367(19):1783-91 PMID: 23020162
  143. Clinical evaluation of continuous daily dosing of sunitinib malate in patients with advanced gastrointestinal stromal tumour after imatinib failure.
    Eur J Cancer. 2009 Jul;45(11):1959-68 PMID: 19282169
  144. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840.
    J Clin Oncol. 2008 Apr 1;26(10):1642-9 PMID: 18375893
  145. The impact of whole-genome sequencing on the reconstruction of human population history.
    Nat Rev Genet. 2014 Mar;15(3):149-62 PMID: 24492235
  146. Breast cancer biomarkers: proteomic discovery and translation to clinically relevant assays.
    Expert Rev Proteomics. 2012 Dec;9(6):599-614 PMID: 23256671
  147. Acquired resistance to BRAF inhibitors mediated by a RAF kinase switch in melanoma can be overcome by cotargeting MEK and IGF-1R/PI3K.
    Cancer Cell. 2010 Dec 14;18(6):683-95 PMID: 21156289
  148. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.
    N Engl J Med. 2005 Oct 20;353(16):1659-72 PMID: 16236737
  149. Carbonic anhydrase IX as a potential biomarker of efficacy in metastatic clear-cell renal cell carcinoma patients receiving sorafenib or placebo: analysis from the treatment approaches in renal cancer global evaluation trial (TARGET).
    Urol Oncol. 2013 Nov;31(8):1788-93 PMID: 23141780
  150. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy.
    J Clin Oncol. 2011 Feb 1;29(4):398-405 PMID: 21172893
  151. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.
    N Engl J Med. 2001 Mar 15;344(11):783-92 PMID: 11248153
  152. Development of therapeutic combinations targeting major cancer signaling pathways.
    J Clin Oncol. 2013 Apr 20;31(12):1592-605 PMID: 23509311
  153. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma.
    N Engl J Med. 2009 Sep 17;361(12):1164-72 PMID: 19726763
  154. Mass spectrometry-based proteomics: the road to lung cancer biomarker discovery.
    Mass Spectrom Rev. 2013 Mar-Apr;32(2):129-42 PMID: 22829143
  155. Melanoma whole-exome sequencing identifies (V600E)B-RAF amplification-mediated acquired B-RAF inhibitor resistance.
    Nat Commun. 2012 Mar 06;3:724 PMID: 22395615
  156. Cancer genomics: technology, discovery, and translation.
    J Clin Oncol. 2012 Feb 20;30(6):647-60 PMID: 22271477
  157. Molecular genetic testing and the future of clinical genomics.
    Nat Rev Genet. 2013 Jun;14(6):415-26 PMID: 23681062
  158. Investigation of novel circulating proteins, germ line single-nucleotide polymorphisms, and molecular tumor markers as potential efficacy biomarkers of first-line sunitinib therapy for advanced renal cell carcinoma.
    Cancer Chemother Pharmacol. 2014 Oct;74(4):739-50 PMID: 25100134
  159. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer.
    J Clin Oncol. 2009 Feb 10;27(5):663-71 PMID: 19114683
  160. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer.
    J Clin Oncol. 2010 Jun 1;28(16):2698-704 PMID: 20421541
  161. Basic principles and technologies for deciphering the genetic map of cancer.
    World J Surg. 2009 Apr;33(4):615-29 PMID: 19115029
  162. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.
    J Clin Oncol. 2010 Nov 1;28(31):4697-705 PMID: 20921465
  163. Adjuvant therapy for high-risk gastrointestinal stromal tumour: considerations for optimal management.
    Drugs. 2012 Oct 22;72(15):1953-63 PMID: 22994537
  164. Novel methylated biomarkers and a robust assay to detect circulating tumor DNA in metastatic breast cancer.
    Cancer Res. 2014 Apr 15;74(8):2160-70 PMID: 24737128
  165. 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. 2012 Mar;13(3):239-46 PMID: 22285168
  166. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung Cancers.
    Sci Transl Med. 2012 Feb 8;4(120):120ra17 PMID: 22277784
  167. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer.
    N Engl J Med. 2010 Oct 28;363(18):1693-703 PMID: 20979469
  168. HER2 status and benefit from adjuvant trastuzumab in breast cancer.
    N Engl J Med. 2008 Mar 27;358(13):1409-11 PMID: 18367751
  169. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial.
    Lancet. 2012 Jul 28;380(9839):358-65 PMID: 22735384
  170. Discovery of a mutant-selective covalent inhibitor of EGFR that overcomes T790M-mediated resistance in NSCLC.
    Cancer Discov. 2013 Dec;3(12):1404-15 PMID: 24065731
  171. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma.
    N Engl J Med. 2013 Jul 11;369(2):134-44 PMID: 23724846
  172. Next-generation sequencing analysis of lung and colon carcinomas reveals a variety of genetic alterations.
    Int J Oncol. 2014 Sep;45(3):1167-74 PMID: 24990411
  173. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.
    N Engl J Med. 2006 Feb 9;354(6):567-78 PMID: 16467544
  174. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group.
    J Clin Oncol. 2007 Mar 20;25(9):1107-13 PMID: 17369574
  175. Association of KRAS G13D tumor mutations with outcome in patients with metastatic colorectal cancer treated with first-line chemotherapy with or without cetuximab.
    J Clin Oncol. 2012 Oct 10;30(29):3570-7 PMID: 22734028
  176. Quantitative assessment of dynamic PET imaging data in cancer imaging.
    Magn Reson Imaging. 2012 Nov;30(9):1203-15 PMID: 22819579
  177. Molecular pathobiology of gastrointestinal stromal sarcomas.
    Annu Rev Pathol. 2008;3:557-86 PMID: 18039140
  178. Evolution: Cancer drivers everywhere?
    Nat Rev Genet. 2014 May;15(5):289 PMID: 24662218
  179. A phase I dose escalation study of BIBW 2992, an irreversible dual inhibitor of epidermal growth factor receptor 1 (EGFR) and 2 (HER2) tyrosine kinase in a 2-week on, 2-week off schedule in patients with advanced solid tumours.
    Br J Cancer. 2008 Jan 15;98(1):80-5 PMID: 18026190
Article Info
Journal
Journal of hematology & oncology
Abbr.
J Hematol Oncol
ISSN
1756-8722
DOI
10.1186/s13045-014-0070-8
Email
alan.smith@icr.ac.uk
desam.roda-perez@icr.ac.uk
timothy.yap@icr.ac.uk
Published
2014-10-03
Epub
2014-00-03
Pages
70
Language
English
Region
England
NLM ID
101468937
PMCID
PMC4189730
Subset
IM
Grants
Cancer Research UK · United Kingdom
External Links
PubMed source DOI: 10.1186/s13045-014-0070-8 PMC Full Text View journal details
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