Skip to main content
  • 693 Accesses

Abstract

Technological progress in the field of high-throughput technology and the scientific advances in molecular screening have set the ground in the last decades for targeted therapy approaches and precision medicine (PM) in oncology. The utility of molecular profiling in cancer for treatment decision still needs to be proven in well-designed prospective randomized trials, the results of which will be decisive in showing whether or not targeted therapy based on molecular profiling can actually be translated into benefit for patients. For a successful transition toward PM in oncology, several challenges including study designs and biomarkers validation, tissue sampling and tumor heterogeneity, standardization of molecular screening techniques, and bioinformatics in the era of continuous technological progress in addition to financial, regulatory, and ethical aspects need to be addressed.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 39.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 54.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 54.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • Gerlinger M, Rowan AJ, Horswell S et al (2012) Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 366(10):883–892

    Article  CAS  PubMed  Google Scholar 

  • Hodi FS, O’Day SJ, McDermott DF et al (2010) Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363(8):711–723

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  • Hudson TJ et al (2010) International Cancer Genome Consortium. International network of cancer genome projects. Nature 464(7291):993–998. Erratum in: Nature 465(7300):966

    Article  CAS  PubMed  Google Scholar 

  • Jakobsen JN, Sørensen JB (2012) Intratumor heterogeneity and chemotherapy-induced changes in EGFR status in non-small cell lung cancer. Cancer Chemother Pharmacol 69(2):289–299

    Article  CAS  PubMed  Google Scholar 

  • Le Tourneau C, Paoletti X, Servant N et al (2014) 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 111(1):17–24

    Article  PubMed Central  PubMed  Google Scholar 

  • Lebofsky R, Decraene C, Bernard V et al (2015) Circulating tumor DNA as a non-invasive substitute to metastasis biopsy for tumor genotyping and personalized medicine in a prospective trial across all tumor types. Mol Oncol 9(4):783–790. doi:10.1016/j.molonc.2014.12.003

    Article  CAS  PubMed  Google Scholar 

  • McShane LM, Cavenagh MM, Lively TG et al (2013) Criteria for the use of omics-based predictors in clinical trials. Nature 502(7471):317–320

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  • Meacham CE, Morrison SJ (2013) Tumour heterogeneity and cancer cell plasticity. Nature 501(7467):328–337

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  • Sandoval J, Esteller M (2012) Cancer epigenomics: beyond genomics. Curr Opin Genet Dev 22(1):50–55

    Article  CAS  PubMed  Google Scholar 

  • Servant N, Roméjon J, Gestraud P, La Rosa P, Lucotte G, Lair S, Bernard V, Zeitouni B, Coffin F, Jules-Clément G, Yvon F, Lermine A, Poullet P, Liva S, Pook S, Popova T, Barette C, Prud’homme F, Dick JG, Kamal M, Le Tourneau C, Barillot E, (2014) Hupé P.Bioinformatics for precision medicine in oncology: principles and application to the SHIVA clinical trial. Front Genet. 30;5:152. doi:10.3389/fgene.2014.00152. eCollection 2014. Review.

  • Simon R, Roychowdhury S (2013) Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov 12(5):358–369

    Article  CAS  PubMed  Google Scholar 

  • Topalian SL, Hodi FS, Brahmer JR et al (2012) Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 366(26):2443–2454

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  • Topalian SL, Sznol M, McDermott DF et al (2014) Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 32(10):1020–1030

    Article  CAS  PubMed  Google Scholar 

  • Turner NC, Reis-Filho JS (2012) Genetic heterogeneity and cancer drug resistance. Lancet Oncol 13(4):e178–e185

    Article  PubMed  Google Scholar 

  • Vakiani E, Janakiraman M, Shen R et al (2012) Comparative genomic analysis of primary versus metastatic colorectal carcinomas. J Clin Oncol 30(24):2956–2962

    Article  PubMed Central  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Maud Kamal PhD .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2015 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Kamal, M. (2015). Challenges for the Clinical Implementation of Precision Medicine Trials. In: Le Tourneau, C., Kamal, M. (eds) Pan-cancer Integrative Molecular Portrait Towards a New Paradigm in Precision Medicine. Springer, Cham. https://doi.org/10.1007/978-3-319-22189-2_9

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-22189-2_9

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-22188-5

  • Online ISBN: 978-3-319-22189-2

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics