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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

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Abstract

Introduction

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.

Methods

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.

Results

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).

Conclusion

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

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Acknowledgements

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.

Funding

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

Author information

Authors and Affiliations

  1. Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain

    S. Pérez Ramírez

  2. Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CiberOnc, Madrid, Spain

    M. del Monte-Millán, S. López-Tarruella & I. Márquez-Rodas

  3. Medical Oncology Service, Hospital Universitario Ramón y Cajal, Madrid, Spain

    N. Martínez Jáñez

  4. Medical Oncology Service, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain

    F. Lobo Samper & Y. Izarzugaza Perón

  5. HEALTH VALUE, Health Economics & Research of Outcomes Consulting, Madrid, Spain

    C. Rubio Terres & D. Rubio Rodríguez

  6. Medical Oncology Service, Hospital Universitario Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain

    J. Á. García-Sáenz & F. Moreno Antón

  7. Medical Oncology Service, Hospital Universitario La Paz, Madrid, Spain

    P. Zamora Auñón

  8. Medical Oncology Service, Hospital Universitario Príncipe de Asturias, Madrid, Spain

    M. Arroyo Yustos

  9. Medical Oncology Service, Hospital Universitario Infanta Leonor, Madrid, Spain

    M. Á. Lara Álvarez

  10. Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain

    E. M. Ciruelos Gil & L. Manso Sánchez

  11. Medical Oncology Service, Hospital Universitario Severo Ochoa, Madrid, Spain

    M. J. Echarri González

  12. Medical Oncology Service, Hospital Universitario de Fuenlabrada, Madrid, Spain

    J. A. Guerra Martínez

  13. Medical Oncology Service, Hospital Universitario Fundación Alcorcón, Universidad Rey Juan Carlos, Móstoles, Spain

    C. Jara Sánchez

  14. Medical Oncology Service, Hospital Universitario Infanta Cristina, Parla, Madrid, Spain

    C. Bueno Muiño

  15. Medical Oncology Service, Hospital Universitario de Móstoles, Madrid, Spain

    S. García Adrián

  16. Medical Oncology Service, Hospital del Sureste Arganda del Rey, Madrid, Spain

    J. R. Carrión Galindo

  17. Regional Oncology Coordinator, Madrid, Spain

    V. Valentín Maganto

  18. Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERONC, GEICAM (Spanish Breast Cancer Group), Universidad Complutense, Madrid, Spain

    M. Martín

Authors
  1. S. Pérez Ramírez
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  2. M. del Monte-Millán
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  3. S. López-Tarruella
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  4. N. Martínez Jáñez
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  6. F. Lobo Samper
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  7. Y. Izarzugaza Perón
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  8. C. Rubio Terres
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  9. D. Rubio Rodríguez
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  10. J. Á. García-Sáenz
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  12. P. Zamora Auñón
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  13. M. Arroyo Yustos
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  14. M. Á. Lara Álvarez
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  15. E. M. Ciruelos Gil
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  17. M. J. Echarri González
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  18. J. A. Guerra Martínez
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  19. C. Jara Sánchez
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  20. C. Bueno Muiño
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  21. S. García Adrián
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  22. J. R. Carrión Galindo
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  23. V. Valentín Maganto
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  24. M. Martín
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Corresponding author

Correspondence to M. Martín.

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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.

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Pérez Ramírez, S., del Monte-Millán, M., López-Tarruella, S. et al. 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. Clin Transl Oncol 22, 717–724 (2020). https://doi.org/10.1007/s12094-019-02176-x

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