Prospective, multicenter study on the economic and clinical impact of gene-expression assays in early-stage breast cancer from a single region: the PREGECAM registry experience

  • S. Pérez Ramírez
  • M. del Monte-Millán
  • S. López-Tarruella
  • N. Martínez Jáñez
  • I. Márquez-Rodas
  • F. Lobo Samper
  • Y. Izarzugaza Perón
  • C. Rubio Terres
  • D. Rubio Rodríguez
  • J. Á. García-Sáenz
  • F. Moreno Antón
  • P. Zamora Auñón
  • M. Arroyo Yustos
  • M. Á. Lara Álvarez
  • E. M. Ciruelos Gil
  • L. Manso Sánchez
  • M. J. Echarri González
  • J. A. Guerra Martínez
  • C. Jara Sánchez
  • C. Bueno Muiño
  • S. García Adrián
  • J. R. Carrión Galindo
  • V. Valentín Maganto
  • M. MartínEmail author
Research Article



The aim of this study is to evaluate the cost-effectiveness and impact of gene-expression assays (GEAs) on treatment decisions in a real-world setting of early-stage breast cancer (ESBC) patients.


This is a regional, prospective study promoted by the Council Health Authorities in Madrid. Enrolment was offered to women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or micrometastatic, stage I or II breast cancer from 21 hospitals in Madrid. Treatment recommendations were recorded before and after knowledge of tests results. An economic model compared the cost-effectiveness of treatment, guided by GEAs or by common prognostic factors.


907 tests (440 Oncotype DX® and 467 MammaPrint®) were performed between February 2012 and November 2014. Treatment recommendation changed in 42.6% of patients. The shift was predominantly from chemohormonal (CHT) to hormonal therapy (HT) alone, in 30.5% of patients. GEAs increased patients’ confidence in treatment decision making. Tumor grade, progesterone receptor positivity and Ki67 expression were associated with the likelihood of change from CHT to HT (P < 0.001) and from HT to CHT (P < 0.001). Compared with current clinical practice genomic testing increased quality-adjusted life years by 0.00787 per patient and was cost-saving from a national health care system (by 13.867€ per patient) and from a societal perspective (by 32.678€ per patient).


Using GEAs to guide adjuvant therapy in ESBC is cost-effective in Spain and has a significant impact on treatment decisions.


Breast cancer Gene-expression profiling Cost analysis Quality-adjusted life years 



We would like to acknowledge all PREGECAM study investigators, the Pharmacoeconomic Company Health value and R. Pla, head of the quality department at Hospital General Universitario Gregorio Marañón, for their contribution, support and advice.


This work was supported by the local health council in Madrid and CIBERONC.

Compliance with ethical standards

Conflict of interest

SPR received consultant/advisory honorarium from Janssen, Novartis, Roche, Pharma-Mar and Bayer; SLTC received consultant/advisory honorarium from Astrazeneca, Novartis, Roche, Pfizer, Gelgene, Pierre-Fabre, Eissai and Lilly; NMJ received consultant/advisory honorarium from Roche, Amgen, Pfizer, Gelgene and Eissai; IMR received consultant/advisory honorarium from BMS, MSD, Novartis, Roche, Pierre-Fabre, Bioncotech and Sanofi; CRT received funding from Hospital General Universitario Gregorio Marañón; DRR received funding from Hospital General Universitario Gregorio Marañón; JAGS received consultant/advisory honorarium from Novartis, Lilly, Celgene and Roche and Funding from AstraZeneca; FMA received consultant/advisory honorarium from Roche, Pfizer, Novartis and AstraZeneca; PZA received consultant/advisory honorarium from Roche and Novartis; MLA received consultant/advisory honorarium from Novartis, Celgene, Roche and Pfizer; EMCG received remuneration from Novartis, Lilly, Pfizer, Roche and consultant/advisory honorarium from Sama; LMS received consultant/advisory honorarium from Tesaro, Astra-Zeneca, Roche, Novartis and Celgene, and funding from Tesaro; SGA reports personal fees from Celgene, Roche, Pierre Fabre, Novartis and Astra Zeneca and non-financial support from Roche, outside the submitted work; MM received remuneration from Pfizer, Lilly; consultant/advisory honorarium from Roche, Novartis, Pfizer, Astrazeneca, Lilly, Glaxo, PharmaMar, Taiho; and funding from Roche and Novartis. MDMM, FLS, YIP, MAY, MJEG, JAGM, CJS, CBM, RCG, VVM declare that they have no conflict of interest.

Research involving human participants and/or animals

This study has been approved by the Ethical Committee (Area 1 CEIm Hospital General Universitario Gregorio Marañón) and it has also been authorised by the local health council in Madrid and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Informed consent

All eligible patients provided written informed consent prior to the inclusion in the study.

Supplementary material

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Supplementary file1 (DOCX 14 kb)
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Supplementary file2 (DOC 118 kb)
12094_2019_2176_MOESM3_ESM.pdf (149 kb)
Supplementary file3 (PDF 149 kb)
12094_2019_2176_MOESM4_ESM.pdf (135 kb)
Supplementary file4 (PDF 135 kb)


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Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2019

Authors and Affiliations

  • S. Pérez Ramírez
    • 1
  • M. del Monte-Millán
    • 2
  • S. López-Tarruella
    • 2
  • N. Martínez Jáñez
    • 3
  • I. Márquez-Rodas
    • 2
  • F. Lobo Samper
    • 4
  • Y. Izarzugaza Perón
    • 4
  • C. Rubio Terres
    • 5
  • D. Rubio Rodríguez
    • 5
  • J. Á. García-Sáenz
    • 6
  • F. Moreno Antón
    • 6
  • P. Zamora Auñón
    • 7
  • M. Arroyo Yustos
    • 8
  • M. Á. Lara Álvarez
    • 9
  • E. M. Ciruelos Gil
    • 10
  • L. Manso Sánchez
    • 10
  • M. J. Echarri González
    • 11
  • J. A. Guerra Martínez
    • 12
  • C. Jara Sánchez
    • 13
  • C. Bueno Muiño
    • 14
  • S. García Adrián
    • 15
  • J. R. Carrión Galindo
    • 16
  • V. Valentín Maganto
    • 17
  • M. Martín
    • 18
    Email author
  1. 1.Medical Oncology ServiceHospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM)MadridSpain
  2. 2.Medical Oncology ServiceHospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CiberOncMadridSpain
  3. 3.Medical Oncology ServiceHospital Universitario Ramón y CajalMadridSpain
  4. 4.Medical Oncology ServiceHospital Universitario Fundación Jiménez DíazMadridSpain
  5. 5.HEALTH VALUE, Health Economics & Research of Outcomes ConsultingMadridSpain
  6. 6.Medical Oncology ServiceHospital Universitario Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)MadridSpain
  7. 7.Medical Oncology ServiceHospital Universitario La PazMadridSpain
  8. 8.Medical Oncology ServiceHospital Universitario Príncipe de AsturiasMadridSpain
  9. 9.Medical Oncology ServiceHospital Universitario Infanta LeonorMadridSpain
  10. 10.Medical Oncology ServiceHospital Universitario 12 de OctubreMadridSpain
  11. 11.Medical Oncology ServiceHospital Universitario Severo OchoaMadridSpain
  12. 12.Medical Oncology ServiceHospital Universitario de FuenlabradaMadridSpain
  13. 13.Medical Oncology ServiceHospital Universitario Fundación Alcorcón, Universidad Rey Juan CarlosMóstolesSpain
  14. 14.Medical Oncology ServiceHospital Universitario Infanta CristinaParlaSpain
  15. 15.Medical Oncology ServiceHospital Universitario de MóstolesMadridSpain
  16. 16.Medical Oncology ServiceHospital del Sureste Arganda del ReyMadridSpain
  17. 17.Regional Oncology CoordinatorMadridSpain
  18. 18.Medical Oncology ServiceHospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERONC, GEICAM (Spanish Breast Cancer Group), Universidad ComplutenseMadridSpain

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