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

Ramírez, Sara; Monte-Millán, Marı́a del; López-Tarruella, Sara; Jáñez, Noelia Martínez; Márquez-Rodas, Iván; Samper, Francisco Lobo; Perón, Y. Izarzugaza; Terrés, Carlos Rubio; Rodríguez, D. Rubio; Antón, Fernando Moreno; Auñón, Pilar; Yustos, M. Arroyo; Álvarez, María Luz Alonso; Gil, Eva; Manso, Luis; González, M.J. Echarri; Martínez, Juan C. Garro; Sánchez, Carlos Jara; Muíño, Coralia Bueno; Adrián, Silvia García; Galindo, Julio; Maganto, Vicente Valentín; Martín, Miguel

doi:10.1007/s12094-019-02176-x

Cited by 8 publications

(8 citation statements)

References 23 publications

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“…For ER-positive (ER þ ) and HER2-invasive breast cancer, we administered neoadjuvant endocrine therapy prior to surgical intervention. Endocrine responsiveness [4][5][6] was evaluated with the 21-gene RS assay testing in early breast cancer: cT1c-T3 cN0 G2-3 and cT1b cN0 G3 ER þ /HER2-invasive breast cancer.…”

Section: Definitionsmentioning

confidence: 99%

Breast Cancer Management During COVID-19 Pandemic in Madrid: Surgical Strategy

Sánchez

Picado

Crespo

et al. 2021

Clinical Breast Cancer

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Purpose From the first case of SARS-CoV-2 infection in Wuhan (China), the infection spread all around the world causing a pandemic of coronavirus disease-2019 (COVID-19). Spain has been one of the most severely affected countries, and Madrid has reported a high number of cases and deaths. We discuss our strategies for optimal breast cancer management during COVID-19 pandemic. Patients and Methods Retrospective observational study at Clínico San Carlos Hospital to analyze breast cancer patient management during the pandemic outbreak and surgical strategy after the pandemic outbreak. We created a practical and dynamic tool based on a "traffic light" system for prioritizing surgical time. Every patient was contacted by telephone with a preoperative COVID-19 protocol. After surgical procedures, patient satisfaction was assessed using EORTC IN-PATSAT32. Results Breast cancer patients actively treated with surgical procedures were put on a waiting list and received systemic therapy. Telemedicine was used to evaluate any side effects and to avoid unnecessary hospital visits. Surgery was only considered after the pandemic outbreak and then only those procedures designed to minimize surgical complications and therefore reduce hospital stay. We also measured patients´ satisfaction with medical and nursing scales that resulted “very good” evaluation tending to “excellent”. Conclusion It is necessary to adapt the management of oncology treatment and the surgical strategy to optimize resources during the COVID-19 pandemic. Patients´ perception of care quality and the degree of patient’s satisfaction with health services has potential relevance in the absence of outcome data.

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Section: Definitionsmentioning

confidence: 99%

Breast Cancer Management During COVID-19 Pandemic in Madrid: Surgical Strategy

Sánchez

Picado

Crespo

et al. 2021

Clinical Breast Cancer

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“…The population in the study was patients with ER+/HER2-, N0 or micrometastatic stage I or II breast cancer. The study found that using the two genomic tests to assess the benefit of adjuvant chemotherapy in these patients resulted in many patients being spared chemotherapy and overall was cost-effective [ 45 ]. The study reports that when Oncotype DX test was used, adjuvant therapy for 34.5% of patients was changed from chemohormonal therapy to hormonal therapy only [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

“…The study found that using the two genomic tests to assess the benefit of adjuvant chemotherapy in these patients resulted in many patients being spared chemotherapy and overall was cost-effective [ 45 ]. The study reports that when Oncotype DX test was used, adjuvant therapy for 34.5% of patients was changed from chemohormonal therapy to hormonal therapy only [ 45 ]. When MammaPrint was used, adjuvant therapy for 26.8% of patients was changed from chemohormonal therapy to hormonal therapy only [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

Cost and Clinical Benefits Associated with Oncotype DX® Test in Patients with Early-Stage HR+/HER2- Node-Negative Breast Cancer in the Netherlands

Jongh

Efe

Herrmann³

et al. 2022

International Journal of Breast Cancer

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Objectives. Patients with early-stage HR+/HER2- N0 breast cancer may receive adjuvant chemotherapy in combination with surgery. However, chemotherapy does not always lead to improved survival and incurs high healthcare costs and increased adverse events. To support decision-making regarding adjuvant chemotherapy, genomic profile testing performed with tests such as the Oncotype DX® test can help healthcare practitioners decide whether chemotherapy provides any benefit to these patients. As such, a cost-consequence model was developed with the aim to estimate the economic impact of using different gene expression tests or no testing, in patients with node-negative early-stage breast cancer. Methods. A cost-consequence model was developed to estimate the economic impact of three different scenarios in the Dutch setting: (1) Oncotype DX® test, (2) MammaPrint®, and (3) and no genomic profile testing. The model included chemotherapy costs, administration costs, short- and long-term adverse event costs, productivity loss, genomic profiling testing costs, cost of cancer recurrence, and hospitalization costs. Results. A treatment paradigm with Oncotype DX resulted in average savings per patient of €6,768 vs. a paradigm with MammaPrint and €13,125 vs. a paradigm with no genomic testing. Furthermore, due to less patients receiving adjuvant chemotherapy through better targeting by the Oncotype DX test, fewer adverse events, sick days, practice visits, and hospitalizations were required compared to MammaPrint and no genomic profiling. Conclusions. Testing with Oncotype DX test in Dutch clinical practice in patients with early-stage breast cancer proved to be cost-saving versus MammaPrint and no genomic profiling tests. Introducing the Oncotype DX test to the Dutch setting will likely reduce the economic resources that are required.

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“…Other studies suggested that strategies based on gene expression signatures were associated with a higher cost [ 134 , 135 ], especially in an era when taxane-based regimens became cheaper, whereas the cost of genomic assays remained high. However the prospective PREGECAM medico-economic multicenter study recently retrieved favorable outcomes in terms of quality-adjusted life-years and cost-efficacy [ 136 ]. Well-designed prospective cost-efficacy evaluations are still needed to address this controversial debate.…”

Section: Are Gene Expression Signatures Cost-effective?mentioning

confidence: 99%

Using Breast Cancer Gene Expression Signatures in Clinical Practice: Unsolved Issues, Ongoing Trials and Future Perspectives

Varnier

Sajous

Talhouet

et al. 2021

Cancers

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The development of gene expression signatures since the early 2000′s has offered standardized assays to evaluate the prognosis of early breast cancer. Five signatures are currently commercially available and recommended by several international guidelines to individualize adjuvant chemotherapy decisions in hormone receptors-positive/HER2-negative early breast cancer. However, many questions remain unanswered about their predictive ability, reproducibility and external validity in specific populations. They also represent a new hope to tailor (neo)adjuvant systemic treatment, adjuvant radiation therapy, hormone therapy duration and to identify a subset of patients who might benefit from CDK4/6 inhibitor adjuvant treatment. This review will highlight these particular issues, address the remaining questions and discuss the ongoing and future trials.

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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

Cited by 8 publications

References 23 publications

Breast Cancer Management During COVID-19 Pandemic in Madrid: Surgical Strategy

Breast Cancer Management During COVID-19 Pandemic in Madrid: Surgical Strategy

Cost and Clinical Benefits Associated with Oncotype DX® Test in Patients with Early-Stage HR+/HER2- Node-Negative Breast Cancer in the Netherlands

Using Breast Cancer Gene Expression Signatures in Clinical Practice: Unsolved Issues, Ongoing Trials and Future Perspectives

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