Treatment algorithms based on tumor molecular profiling: The essence of precision medicine trials

Journal of the National Cancer Institute

Volumn 108, Issue 4, 2016, Pages

  Tourneau, Christophe Le ^a,b   Kamal, Maud ^a   Tsimberidou, Apostolia Maria ^c   Bedard, Philippe ^d   Pierron, Gaëlle ^a   Callens, Céline ^a   Rouleau, Etienne ^a   Vincent Salomon, Anne ^a   Servant, Nicolas ^a   Alt, Marie ^a   Rouzier, Roman ^a,b   Paoletti, Xavier ^a   Delattre, Olivier ^a   Bièche, Ivan ^e  

^a INSTITUT CURIE   (France)

^b LABORATOIRE DES SCIENCES DU CLIMAT ET DE L ENVIRONNEMENT   (France)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d PRINCESS MARGARET HOSPITAL   (Canada)

^e UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; DNA; PANITUMUMAB; RNA; TUMOR MARKER; VEMURAFENIB;

BIOINFORMATICS; CANCER GROWTH; CANCER THERAPY; COMPARATIVE GENOMIC HYBRIDIZATION; DNA SEQUENCE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE DOSAGE; HUMAN; IMMUNOHISTOCHEMISTRY; INDEL MUTATION; MISSENSE MUTATION; MOLECULAR DIAGNOSIS; MOLECULARLY TARGETED THERAPY; NEOPLASM; NEXT GENERATION SEQUENCING; NONHUMAN; ONCOGENE; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PROTEIN MICROARRAY; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; REVIEW; SINGLE NUCLEOTIDE POLYMORPHISM; TUMOR SUPPRESSOR GENE; ALGORITHM; CLINICAL TRIAL (TOPIC); COPY NUMBER VARIATION; DRUG EFFECTS; DRUG RESISTANCE; GENE EXPRESSION PROFILING; GENE EXPRESSION REGULATION; GENE SILENCING; GENETICS; HIGH THROUGHPUT SCREENING; HIGH THROUGHPUT SEQUENCING; NEOPLASMS; PROCEDURES; SIGNAL TRANSDUCTION; TRENDS;

ALGORITHMS; BIOMARKERS, TUMOR; CLINICAL TRIALS AS TOPIC; DNA COPY NUMBER VARIATIONS; DRUG RESISTANCE, NEOPLASM; GENE DOSAGE; GENE EXPRESSION PROFILING; GENE EXPRESSION REGULATION, NEOPLASTIC; GENE SILENCING; GENES, TUMOR SUPPRESSOR; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HIGH-THROUGHPUT SCREENING ASSAYS; HUMANS; MOLECULAR TARGETED THERAPY; NEOPLASMS; PRECISION MEDICINE; SIGNAL TRANSDUCTION;

EID: 84964798583     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djv362     Document Type: Review

References (44)

1. Ciriello G, Miller ML, Aksoy BA, et al. Emerging landscape of oncogenic signatures across human cancers. Nat Genet. 2013;45(10):1127-1133.
2. Sleijfer S, Ballman K, Verweij J. The future of drug development? Seeking evidence of activity of novel drugs in small groups of patients. J Clin Oncol. 2013;31(18):2246-2248.
3. Le Tourneau C, Kamal M, Alt M, et al. The spectrum of clinical trials aiming at personalizing medicine. Chin Clin Oncol. 2014;3(2):13.
4. Le Tourneau C, Paoletti X, Servant N, et al. Randomised proof-of-concept phase II trial comparing targeted therapy based on tumour molecular profiling vs conventional therapy in patients with refractory cancer: Results of the feasibility part of the SHIVA trial. Br J Cancer. 2014;111(1):17-24.
5. Tsimberidou AM, Wen S, Hong DS, et al. Personalized medicine for patients with advanced cancer in the phase I program at MD Anderson: validation and landmark analyses. Clin Cancer Res. 2014;20(18):4827-4836.
6. Rodon J, Soria JC, Berger R, et al. Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial. Ann Oncol. 2015;26(8):1791-1798.
7. Andre F, Bachelot T, Commo F, et al. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: A multicentre, prospective trial (SAFIR01/UNICANCER). Lancet Oncol. 2014;15(3):267-274.
8. Le Tourneau C, Delord JP, Goncalves A, et al. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): A multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015;16(13):1324-1334.
9. Greaves M, Maley CC. Clonal evolution in cancer. Nature. 2012;481(7381):306- 313.
10. Hudson TJ, Anderson W, Artez A et al. International Cancer Genome Consortium. International network of cancer genome projects. Nature. 2010;464(7291):993-998.
11. McShane LM, Cavenagh MM, Lively TG, et al. Criteria for the use of omicsbased predictors in clinical trials. Nature. 2013;502(7471):317-320.
12. Bourdeaut F, Grison C, Maurage CA, et al. MYC and MYCN amplification can be reliably assessed by aCGH in medulloblastoma. Cancer Genet. 2013;206(4):124-129.
13. Vincent-Salomon A, Lucchesi C, Gruel N, et al. Integrated genomic and transcriptomic analysis of ductal carcinoma in situ of the breast. Clin Cancer Res. 2008;14(7):1956-1965.
14. Sims D, Sudbery I, Ilott NE, et al. Sequencing depth and coverage: key considerations in genomic analyses. Nat Rev Genet 2014;5(2):121-132.
15. Carter SL, Cibulskis K, Helman E, et al. Absolute quantification of somatic DNA alterations in human cancer. Nat Biotechnol. 2012;30(5):413-421.
16. Berger AH, Pandolfi PP. Haplo-insufficiency: A driving force in cancer. J Pathol. 2011; 223(2):137-146.
17. Kwon CH, Zhao D, Chen J, et al. Pten haploin sufficiency accelerates formation of high-grade astrocytomas. Cancer Res. 2008;68(9):3286-3294.
18. Hayes DF, Bast RC, Desch CE, et al. Tumor marker utility grading system: A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst. 1996;16;88(20):1456-1466.
19. Meric-Bernstam F, Johnson A, Holla V, et al. Decision Support Framework for Genomically Informed Investigational Cancer Therapy. Natl Cancer Inst. 2015;107(7):djv098 doi:10.1093/jnci/djv098.
20. Pegram MD, Lipton A, Hayes DF, et al. Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-over expressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol. 1998;16(8):2659-2671.
21. Kantarjian H, Sawyers C, Hochhaus A, et al. International STI571 CML Study Group. Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med. 2002;346(9):645-652.
22. Lievre A, Bachet JB, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 2008;66(8):3992-3995.
23. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008;359(17):1757-1765.
24. Meacham CE, Morrison SJ. Tumour heterogeneity and cancer cell plasticity. Nature. 2013;501(7467):328-337.
25. Gerlinger M, Rowan AJ, Horswell S, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med. 2012;366(10):883-892.
26. Turner NC, Reis-Filho JS. Genetic heterogeneity and cancer drug resistance. Lancet Oncol. 2012;13(4):e178-e185.
27. Jamal-Hanjani M, Hackshaw A, Ngai Y, et al. Tracking genomic cancer evolution for precision medicine: The lung TRACER x study PLoS Biol. 2014;8;12(7):e1001906.
28. Zardavas D, Maetens M, Irrthum A, et al. The AURORA initiative for metastatic breast cancer. Br J Cancer. 2014;11;111(10):1881-1887.
29. Pestrin M, Salvianti F, Galardi F, et al. Heterogeneity of PIK3CA mutational status at the single cell level in circulating tumor cells from metastatic breast cancer patients. Mol Oncol. 2015;9(4):749-757.
30. Lebofsky R, Decraene C, Bernard V, et al. Circulating tumor DNA as a noninvasive substitute to metastasis biopsy for tumor genotyping and personalized medicine in a prospective trial across all tumor types. Mol Oncol. 2015;9(4):783-790.
31. Boeva V, Popova T, Lienard M, et al. Multi-factor data normalization enables the detection of copy number aberrations in amplicon sequencing data. Bioinformatics. 2014;30(24):3443-3450.
32. Bennett NC, Farah CS. Next-generation sequencing in clinical oncology: next steps towards clinical validation. Cancers (Basel). 2014;6(4):2296-2312.
33. Cree IA, Deans Z, Ligtenberg MJ, et al. Quality Assurance in Molecular Pathology; Royal College of Pathologists. J Clin Pathol. 2014;67(11):923-931.
34. Collins FS, Hamburg MA. First FDA authorization for next-generation sequencer. N Engl J Med. 2013;19;369(25):2369-2371.
35. Dubbink HJ, Deans ZC, Tops BB, et al. Next generation diagnostic molecular pathology: critical appraisal of quality assurance in Europe. Mol Oncol. 2014;8(4):830-839.
36. Simon R, Roychowdhury S. Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov. 2013;12(5):358-369.
37. Servant N, Romejon J, Gestraud P, et al. Bioinformatics for precision medicine in oncology: principles and application to the SHIVA clinical trial. Front Genet. 2014;5:152.
38. Sosman JA, Kim KB, Schuchter L, et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med. 2012;366(8):707-714.
39. Prahallad A, Sun C, Huang S, et al. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature. 2012;483(7387):100-103.
40. Everett JN, Gustafson SL, Raymond VM. Traditional roles in a non-traditional setting: genetic counseling in precision oncology. J Genet Couns. 2014;23(4):655-660.
41. Soria JC, Massard C, Izzedine H. From theoretical synergy to clinical supraadditive toxicity. J Clin Oncol. 2009;27(9):1359-1361.
42. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723.
43. Topalian SL, Sznol M, McDermott DF, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014;32(10):1020-1030.
44. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366(26):2443-2454.