Clinical and Translational Oncology

, Volume 20, Issue 5, pp 630–638 | Cite as

PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system

  • L. Alonso-Alconada
  • J. Barbazan
  • S. Candamio
  • J. L. Falco
  • C. Anton
  • C. Martin-Saborido
  • G. Fuster
  • M. Sampedro
  • C. Grande
  • R. Lado
  • L. Sampietro-Colom
  • E. Crego
  • S. Figueiras
  • L. Leon-Mateos
  • R. Lopez-Lopez
  • M. Abal
Research Article

Abstract

Purpose

Management of metastatic disease in oncology includes monitoring of therapy response principally by imaging techniques like CT scan. In addition to some limitations, the irruption of liquid biopsy and its application in personalized medicine has encouraged the development of more efficient technologies for prognosis and follow-up of patients in advanced disease.

Methods

PrediCTC constitutes a panel of genes for the assessment of circulating tumor cells (CTC) in metastatic colorectal cancer patients, with demonstrated improved efficiency compared to CT scan for the evaluation of early therapy response in a multicenter prospective study. In this work, we designed and developed a technology transfer strategy to define the market opportunity for an eventual implementation of PrediCTC in the clinical practice.

Results

This included the definition of the regulatory framework, the analysis of the regulatory roadmap needed for CE mark, a benchmarking study, the design of a product development strategy, a revision of intellectual property, a cost-effectiveness study and an expert panel consultation.

Conclusion

The definition and analysis of an appropriate technology transfer strategy and the correct balance among regulatory, financial and technical determinants are critical for the transformation of a promising technology into a viable technology, and for the decision of implementing liquid biopsy in the monitoring of therapy response in advanced disease.

Keywords

Liquid biopsy Metastatic colorectal cancer Regulatory roadmap Benchmarking Product development Intellectual property Cost-effectiveness Expert panel 

Notes

Compliance with ethical standards

Financial support

Pre-commercial Development of Research Results Program (PRIS), from the Galician Health System (SERGAS); “la Caixa” Banking Foundation call CaixaImpulse 2015.

Conflict of interest

The authors declare no conflict of interest.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was signed by all patients.

References

  1. 1.
    Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7–30.CrossRefPubMedGoogle Scholar
  2. 2.
    Sargent D, Sobrero A, Grothey A, O’Connell MJ, Buyse M, Andre T, et al. Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol. 2009;27(6):872–7.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Brandi G, De Lorenzo S, Nannini M, Curti S, Ottone M, Dall’Olio FG, et al. Adjuvant chemotherapy for resected colorectal cancer metastases: literature review and meta-analysis. World J Gastroenterol. 2016;22(2):519–33.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Van Cutsem E, Verheul HM, Flamen P, Rougier P, Beets-Tan R, Glynne-Jones R, et al. Imaging in colorectal cancer: progress and challenges for the clinicians. Cancers (Basel). 2016;8(9):81.CrossRefGoogle Scholar
  5. 5.
    Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011;144(5):646–74.CrossRefPubMedGoogle Scholar
  6. 6.
    Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail GY, et al. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Ann Oncol. 2009;20(7):1223–9.CrossRefPubMedGoogle Scholar
  7. 7.
    Negin BP, Cohen SJ. Circulating tumor cells in colorectal cancer: past, present, and future challenges. Curr Treat Options Oncol. 2010;11(1–2):1–13.CrossRefPubMedGoogle Scholar
  8. 8.
    Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail GY, et al. Relationship of circulating tumor cells to tumor response, progression-free survival, and overall survival in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(19):3213–21.CrossRefPubMedGoogle Scholar
  9. 9.
    Alix-Panabières C, Pantel K. Circulating tumor cells: liquid biopsy of cancer. Clin Chem. 2013;59(1):110–8.CrossRefPubMedGoogle Scholar
  10. 10.
    Barbazan J, Muinelo-Romay L, Vieito M, Candamio S, Diaz-Lopez A, Cano A, et al. A multimarker panel for circulating tumor cells detection predicts patient outcome and therapy response in metastatic colorectal cancer. Int J Cancer. 2014;135(11):2633–43.CrossRefPubMedGoogle Scholar
  11. 11.
    Vidal Insua Y, Camara J, Vazquez EB, Fernandez A, Rivera F, Silva MJVV, et al. Predicting outcome and therapy response in mCRC patients using an indirect method for CTCs detection by a multigene expression panel: a multicentric prospective validation study. Int J Mol Sci. 2017;18(6):1265.CrossRefPubMedCentralGoogle Scholar
  12. 12.
    Hayes DF, Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Miller MC, et al. 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;12(14):4218–24.CrossRefPubMedGoogle Scholar
  13. 13.
    de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, et al. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008;14(19):6302–9.CrossRefPubMedGoogle Scholar
  14. 14.
    Lankiewicz S, Zimmermann S, Hollmann C, Hillemann T, Greten TF. Circulating tumour cells as a predictive factor for response to systemic chemotherapy in patients with advanced colorectal cancer. Mol Oncol. 2008;2(4):349–55.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Anton C, Abal M, Alonso-Alconada L, Candamio S, Lopez-Lopez R, Martin-Saborido C. Monitoring treatment response in metastatic colorectal cancer: economic evaluation of PrediCTC® versus CT scan (submitted).Google Scholar
  16. 16.
    Tan CRC, Zhou L, El-Deiry WS. Circulating tumor cells versus circulating tumor dna in colorectal cancer: pros and cons. Curr Colorectal Cancer Rep. 2016;12(3):151–61.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2017

Authors and Affiliations

  • L. Alonso-Alconada
    • 1
  • J. Barbazan
    • 1
  • S. Candamio
    • 1
  • J. L. Falco
    • 2
  • C. Anton
    • 3
  • C. Martin-Saborido
    • 3
  • G. Fuster
    • 4
  • M. Sampedro
    • 5
  • C. Grande
    • 6
  • R. Lado
    • 6
  • L. Sampietro-Colom
    • 7
  • E. Crego
    • 8
  • S. Figueiras
    • 9
  • L. Leon-Mateos
    • 9
  • R. Lopez-Lopez
    • 1
  • M. Abal
    • 1
  1. 1.Translational Medical Oncology, CIBERONC, Health Research Institute of Santiago (IDIS)University Hospital of Santiago (SERGAS)Santiago de CompostelaSpain
  2. 2.Antares ConsultingBarcelonaSpain
  3. 3.UETeS, Universidad Francisco de VitoriaMadridSpain
  4. 4.Hoffmann EitleMadridSpain
  5. 5.Department of Innovation and TransferRamon Dominguez FoundationSantiago de CompostelaSpain
  6. 6.Medical and Health Technology Innovation Platform (ITEMAS), Galician NetworkSantiago de CompostelaSpain
  7. 7.Health Technology Assessment UnitClinic HospitalBarcelonaSpain
  8. 8.EFT ConsultingSantiago de CompostelaSpain
  9. 9.Health Knowledge Agency (ACIS), Galician Health System (SERGAS)Santiago de CompostelaSpain

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