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