PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy

Cognetti, F.; Masetti, Riccardo; Fabi, Alessandra; Bianchi, Giulia; Santini, Donatella; Rognone, Alessia; Catania, Giovanna; Angelucci, Domenico; Naso, Giuseppe; Giuliano, Mario; Vassalli, Lucia; Vici, Patrizia; Scognamiglio, Giovanni; Generali, Daniele; Zambelli, Alberto; Colleoni, Marco; Tinterri, Corrado; Scanzi, Francesco; Vigna, Leonardo; Scavina, Paola; Gamucci, Teresa; Marrazzo, Emilia; Scinto, Angelo Fedele; Berardi, Rossana; Fabbri, Agnese; Pinotti, Graziella; Franco, Daniela; Terribile, Daniela; Tonini, Giuseppe; Cianniello, Daniela; Barni, Sandro

doi:10.1038/s41523-021-00246-4

Cited by 23 publications

(23 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“… 26 Furthermore, the overall reduction in chemotherapy recommendation of 67% in our study was comparable to the magnitude of reduction of 2 recent studies, 66%-74%, 26 , 27 which is higher than several earlier trials. 23-25 , 28-30 This is suggestive that although the TAILORx study consisted of node-negative patients, the cutpoints and results from this study probably influenced physician treatment recommendations among node-positive patients as well.…”

Section: Discussionmentioning

confidence: 85%

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

et al. 2022

View full text Add to dashboard Cite

Background The 21-gene Breast Recurrence Score (RS) assay, “the assay”, has led to a paradigm shift for patients with hormone receptor-positive, node-negative early breast cancer and is emerging as an important tool to assist physician-patient decisions in foregoing chemotherapy in node-positive patients. We wanted to better understand the impact of the RS assay in node-positive patients upon physician treatment decisions and treatment cost in Quebec, Canada. Patients and Methods We conducted a multicenter, prospective observational trial for Estrogen/Progesterone Receptor (ER/PR)- positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer patients with 1-3 positive lymph nodes. Physicians completed a questionnaire indicating treatment choice prior to and post availability of RS results. The primary endpoint was change in the physician’s recommendation for chemotherapy prior to and post assay results. Secondary endpoints included change in physician’s expressed level of confidence, and changes in estimated cost of recommended treatments prior to and post assay results. Results For the entire cohort, physician recommendation for chemotherapy was reduced by an absolute 67.1% by knowledge of the RS assay result (P < .0001). Physician recommendation of chemotherapy was decreased by 75.9% for patients RS result <14 (P < .0001); and 67.5% for patients with RS result 14-25 (P < .0001). Changes in treatment recommendations were associated with an overall reduction in cost by 73.7% per patient, and after incorporating the cost of the RS test, a cost benefit of $823 CAN at 6-month follow-up. Conclusion Altogether, we established that the assay led to a two-third reduction in the use of chemotherapy, and was a cost-effective approach for hormone receptor-positive, node-positive breast cancer.

show abstract

Section: Discussionmentioning

confidence: 85%

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

et al. 2022

View full text Add to dashboard Cite

show abstract

“…24 , 25 Multiple studies have reported increased uptake of the RS among clinicians as a prognostic and predictive tool in guiding decisions regarding chemo-endocrine therapy and have demonstrated its contribution to reduced adjuvant chemotherapy prescription. 29 – 32 Data from Surveillance, Epidemiology, and End Results (SEER), SEER-Medicare, and SEER-Genomic Health indicate that among patients less than 50 years old, 57.2% received Oncotype DX RS testing from 2010 to 2015 in the period prior to the TAILORx trial. Among all patients with HR-positive HER2-negative early-stage breast cancers, 49.8% received RS testing, with an estimated cost of $115 million annually.…”

Section: Development and Uptake Of Oncotype DX Rsmentioning

confidence: 99%

Oncotype DX Recurrence Score in premenopausal women

2022

View full text Add to dashboard Cite

In the past 20 years, clinicians have shifted away from relying solely on clinicopathologic indicators toward increasing use of multigene expression assays in guiding treatment decisions regarding adjuvant chemotherapy for early-stage hormone receptor (HR)-positive, HER2-negative breast cancer. Oncotype DX Recurrence Score (RS) is one of the most widely used multigene assays when considering indications for adjuvant chemotherapy, and guidelines have recently incorporated its use in women with early HR-positive HER2-negative breast cancer and up to three positive lymph nodes. While multiple retrospective and prospective clinical studies have demonstrated that most women with a low- to mid-range RS (0–25) can safely forgo chemotherapy, premenopausal women remain an important subgroup for which recommendations based on RS are ill-defined. The majority of patients included in clinical trials and retrospective analyses validating the use of RS have been postmenopausal women. In the subgroup of premenopausal women with HR-positive HER2-negative breast cancer, studies indicate that traditional clinicopathologic methods for assessing risk continue to be powerful tools when combined with RS to predict benefit from chemotherapy. This suggests that there is an element of uncaptured risk inherent to the premenopausal state that evades characterization by RS alone. This review describes the evidence that has supported the recommendation of RS in clinical guidelines, specifically focusing on data for its current use in premenopausal women. We review available data regarding the impact of the menstrual cycle on hormonally regulated gene expression, which may drive variations in the RS. Further research on the reliability and interpretation of the RS in the premenopausal subgroup is necessary and represents a gap in knowledge of how the RS should be applied in premenopausal women.

show abstract

“…The increasing understanding of breast cancer biology has led to the development of multigene signatures that provide prognostic information independent of that provided by standard clinicopathologic features and may help clinicians to better identify those patients with low-risk disease who can be safely spared the toxic effects of chemotherapy (2). All the commercially available signatures have been robustly clinically validated (3) and a plethora of studies consistently showed that their use can lead to a decrease of chemotherapy recommendation in up to 50% of cases (4)(5)(6)(7)(8)(9)(10). Accordingly, major Guidelines recommend the use of multigene signatures as a tool to tailor adjuvant chemotherapy decision (11,12).…”

Section: Introductionmentioning

confidence: 99%

Multigene signatures for early breast cancer in clinical practice: A report of the Lombardy genomic assays for breast cancer working group

et al. 2023

Self Cite

View full text Add to dashboard Cite

The increasing understanding of breast cancer biology has provided the basis for the development of multigene signatures aimed to improve the capability of clinicians to assess patients’ prognostication and risk stratification. Incorporating these tools in clinical practice has profoundly impacted on the decision-making process for the adjuvant therapy of patients with ER+/HER2- early breast cancer and the results from prospective adjuvant trials have strengthened the clinical utility of multigene signatures in this setting. In July 2019, Lombardy was the first Region in Italy to reimburse genomic testing for patients with ER+/HER2- early breast cancer. Three years later, a group of investigators from six referral Cancer Centers in Lombardy convened to debate the use of multigene signatures in clinical practice and share their own experience with the tests after reimbursement. Here, we reviewed relevant data on the role of multigene signatures in tailoring adjuvant chemotherapy for patients with ER+/HER2- early breast cancer and discussed about the optimal use of these assays in current clinical practice. As the treatment landscape of early breast cancer evolves and novel questions about the possible additional applications of multigene assays arise, we also provide our viewpoint on the potential implementation of the assays in the evolving scenario ER+/HER2- early breast cancer treatment.

show abstract

PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy

Cited by 23 publications

References 38 publications

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

Oncotype DX Recurrence Score in premenopausal women

Multigene signatures for early breast cancer in clinical practice: A report of the Lombardy genomic assays for breast cancer working group

Contact Info

Product

Resources

About