Personalized oncology: Genomic screening in phase 1

APMIS

Volumn 122, Issue 8, 2014, Pages 723-733

  Tuxen, Ida Viller ^a   Jønson, Lars ^a   Santoni Rugiu, Eric ^a   Hasselby, Jane Preuss ^a   Nielsen, Finn Cilius ^a   Lassen, Ulrik ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Cancer; Next generation sequencing; Personalized medicine; Phase 1; Targeted treatment

Indexed keywords

B RAF KINASE; CETUXIMAB; CRIZOTINIB; DOVITINIB; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; FOXY 5; FOXY5; GSK 3052230; LAPATINIB; LY 3039; LY 3039478; OLAPARIB; PANITUMUMAB; PROTEIN TYROSINE KINASE INHIBITOR; RO 6895882; SELINEXOR; TRASTUZUMAB; UNCLASSIFIED DRUG;

BREAST CANCER; CANCER GENETICS; CANCER SURVIVAL; CELL PROLIFERATION; CHROMOSOME TRANSLOCATION; CLINICAL GENETICS; COLORECTAL CANCER; GENE EXPRESSION ASSAY; GENE MAPPING; GENE MUTATION; GENETIC COUNSELING; GENETIC SCREENING; GERMLINE MUTATION; HUMAN; METASTATIC MELANOMA; MOLECULAR MEDICINE; MOLECULARLY TARGETED THERAPY; NEOPLASM; OUTCOME ASSESSMENT; PERSONALIZED MEDICINE; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REVIEW; RNA SEQUENCE; SOMATIC MUTATION;

CANCER; NEXT GENERATION SEQUENCING; PERSONALIZED MEDICINE; PHASE 1; TARGETED TREATMENT;

CHROMOSOME MAPPING; CLINICAL TRIALS, PHASE I AS TOPIC; DNA MUTATIONAL ANALYSIS; GENETIC TESTING; GENETIC VARIATION; GENOMICS; HUMANS; INDIVIDUALIZED MEDICINE; MOLECULAR TARGETED THERAPY; NEOPLASMS; PATIENT SELECTION; TUMOR MARKERS, BIOLOGICAL;

EID: 84904566704     PISSN: 09034641     EISSN: 16000463     Source Type: Journal    
DOI: 10.1111/apm.12293     Document Type: Review

References (55)

1. Dancey JE, Bedard PL, Onetto N, Hudson TJ. The genetic basis for cancer treatment decisions. Cell 2012;148:409-20.
2. Garnett MJ, Edelman EJ, Heidorn SJ, Greenman CD, Dastur A, Lau KW, et al. Systematic identification of genomic markers of drug sensitivity in cancer cells. Nature 2012;483:570-5.
3. Stratton MR, Campbell PJ, Futreal PA. The cancer genome. Nature 2009;458:719-24.
4. Vogelstein B, Kinzler KW. Cancer genes and the pathways they control. Nat Med 2004;10:789-99.
5. Tsimberidou A-M, Iskander NG, Hong DS, Wheler JJ, Falchook GS, Fu S, et al. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res 2012;18:6373-83.
6. King CR, Kraus MH, Aaronson SA. Amplification of a novel v-erbB-related gene in a human mammary carcinoma. Science 1985;229:974-6.
7. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92.
8. Thomson A. Proof of concept review Lapatinib: the evidence for its therapeutic value in metastatic breast cancer. Core Evid 2005;1:77-87.
9. Bokemeyer C, Van Cutsem E, Rougier P, Ciardiello F, Heeger S, Schlichting M, et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer 2012;48:1466-75.
10. Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129-39.
11. Paz-Ares L, Soulières D, Melezínek I, Moecks J, Keil L, Mok T, et al. Clinical outcomes in non-small-cell lung cancer patients with EGFR mutations: pooled analysis. J Cell Mol Med 2010;14:51-69.
12. Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010;11:121-8.
13. Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-8.
14. Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 2007;448:561-6.
15. Amin HM, Lai R. Pathobiology of ALK+ anaplastic large-cell lymphoma. Blood 2007;110:2259-67.
16. Shaw AT, Yeap BY, Mino-Kenudson M, Digumarthy SR, Costa DB, Heist RS, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27:4247-53.
17. Kwak EL, Bang Y-J, Camidge DR, Shaw AT, Solomon B, Maki RG, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-703.
18. Shaw AT, Kim D-W, Nakagawa K, Seto T, Crinó L, Ahn M-J, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-94.
19. Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, et al. Mutations of the BRAF gene in human cancer. Nature 2002;417:949-54.
20. Gray-Schopfer V, Wellbrock C, Marais R. Melanoma biology and new targeted therapy. Nature 2007;445:851-7.
21. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 2010;363:809-19.
22. Gainor JF, Shaw AT. Emerging paradigms in the development of resistance to tyrosine kinase inhibitors in lung cancer. J Clin Oncol 2013;31:3987-96.
23. Friboulet L, Li N, Katayama R, Lee CC, Gainor JF, Crystal AS, et al. The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov 2014;4:662-73
24. Shaw AT, Kim D-W, Mehra R, Tan DSW, Felip E, Chow LQM, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014;370:1189-97.
25. Menzies AM, Long GV. Dabrafenib and Trametinib, alone and in combination for BRAF-mutant metastatic melanoma. Clin Cancer Res 2014;20:2035-43
26. Von Hoff DD, Stephenson JJ, Rosen P, Loesch DM, Borad MJ, Anthony S, et al. Pilot study using molecular profiling of patients' tumors to find potential targets and select treatments for their refractory cancers. J Clin Oncol 2010;28:4877-83.
27. Mick R, Crowley JJ, Carroll RJ. Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. Control Clin Trials 2000;21:343-59.
28. Soria JC. Molecular Screening for Cancer Treatment Optimization (MOSCATO 01). http://clinicaltrials.gov/show/NCT01566019.
29. Hollebecque A, Massard C, De Baere T, Auger N, Lacroix L, Koubi-Pick V, et al. Molecular screening for cancer treatment optimization (MOSCATO 01): a prospective molecular triage trial-interim results. J Clin Oncol 2013; 31(Suppl; abstr 2512).
30. Soria JC, Tsimberidou A, Kurzrock R, Tabernero J, Rodon J, Berger R, et al. L04.04 * Winther: a study to select rational therapeutics based on the analysis of tumor and matched normal tissue biopsies in subjects with advanced malignancies. Ann Oncol 2013;24:i10-1.
31. Soria JC. A study to select rational therapeutics based on the analysis of matched tumor and normal biopsies in subjects with advanced malignancies (WINTHER). http://clinicaltrials.gov/ct2/show/NCT01856296.
32. Roychowdhury S, Iyer MK, Robinson DR, Lonigro RJ, Wu Y-M, Cao X, et al. Personalized oncology through integrative high-throughput sequencing: a pilot study. Sci Transl Med 2011;3:111ra121.
33. Robinson DR, Wu Y-M, Vats P, Su F, Lonigro RJ, Cao X, et al. Activating ESR1 mutations in hormone-resistant metastatic breast cancer. Nat Genet 2013;45:1446-51.
34. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-47.
35. Everett JN, Gustafson SL, Raymond VM. Traditional roles in a non-traditional setting: genetic counseling in precision oncology. J Genet Couns 2014 [Epub ahead of print].
36. Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer 2011;47:1490-7.
37. Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA, Kinzler KW. Cancer genome landscapes. Science 2013;339:1546-58.
38. Vignot S, Frampton GM, Soria J-C, Yelensky R, Commo F, Brambilla C, et al. Next-generation sequencing reveals high concordance of recurrent somatic alterations between primary tumor and metastases from patients with non-small-cell lung cancer. J Clin Oncol 2013;31:2167-72.
39. Knijn N, Mekenkamp LJM, Klomp M, Vink-Börger ME, Tol J, Teerenstra S, et al. KRAS mutation analysis: a comparison between primary tumours and matched liver metastases in 305 colorectal cancer patients. Br J Cancer 2011;104:1020-6.
40. Tran B, Brown AMK, Bedard PL, Winquist E, Goss GD, Hotte SJ, et al. Feasibility of real time next generation sequencing of cancer genes linked to drug response: results from a clinical trial. Int J Cancer 2013;132:1547-55.
41. Dupont Jensen J, Laenkholm A-V, Knoop A, Ewertz M, Bandaru R, Liu W, et al. PIK3CA mutations may be discordant between primary and corresponding metastatic disease in breast cancer. Clin Cancer Res 2011;17:667-77.
42. El-Osta H, Hong D, Wheler J, Fu S, Naing A, Falchook G, et al. Outcomes of research biopsies in phase I clinical trials: the MD anderson cancer center experience. Oncologist 2011;16:1292-8.
43. Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011;144:646-74.
44. Shah SP, Roth A, Goya R, Oloumi A, Ha G, Zhao Y, et al. The clonal and mutational evolution spectrum of primary triple-negative breast cancers. Nature 2012;486:395-9.
45. Dienstmann R, Rodon J, Barretina J, Tabernero J. Genomic medicine frontier in human solid tumors: prospects and challenges. J Clin Oncol 2013;31:1874-84.
46. Gerlinger M, Rowan AJ, Horswell S, Larkin J, Endesfelder D, Gronroos E, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 2012;366:883-92.
47. Yap TA, Gerlinger M, Futreal PA, Pusztai L, Swanton C. Intratumor heterogeneity: seeing the wood for the trees. Sci Transl Med 2012;4:127 ps10.
48. Garraway LA, Jänne PA. Circumventing cancer drug resistance in the era of personalized medicine. Cancer Discov 2012;2:214-26.
49. Sequist LV, Waltman BA, Dias-Santagata D, Digumarthy S, Turke AB, Fidias P, et al. Genotypic and histological evolution of lung cancers acquiring resistance to EGFR inhibitors. Sci Transl Med 2011;3:75ra26.
50. Pantel K, Alix-Panabières C. Real-time liquid biopsy in cancer patients: fact or fiction? Cancer Res 2013;73:6384-8.
51. Diaz LA, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol 2014;32:579-86.
52. Dawson S-J, Tsui DWY, Murtaza M, Biggs H, Rueda OM, Chin S-F, et al. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med 2013;368:1199-209.
53. Miller MC, Doyle GV, Terstappen LWMM. Significance of circulating tumor cells detected by the cell search system in patients with metastatic breast colorectal and prostate cancer. J Oncol 2010;2010:617421.
54. Diaz LA, Williams RT, Wu J, Kinde I, Hecht JR, Berlin J, et al. The molecular evolution of acquired resistance to targeted EGFR blockade in colorectal cancers. Nature 2012;486:537-40.
55. Iyer G, Hanrahan AJ, Milowsky MI, Al-Ahmadie H, Scott SN, Janakiraman M, et al. Genome sequencing identifies a basis for everolimus sensitivity. Science 2012;338:221.