Abstract 2595
Background
Oncotype DX® (ODX) is a multigene assay allowing physicians to tailor treatment in HR+, HER2- early-stage breast cancer patients. Clinical validation and utility of ODX have been demonstrated across multiple studies in over 63,000 breast cancer patients worldwide. It provides level 1A evidence and has been incorporated in major international clinical guidelines. A market access program was initiated in 2015 in France and 2016 in Italy to assess real-life test utilization and its impact in current clinical practice.
Methods
The program allows for prospective data collection reflecting real life use of ODX by physicians in various clinical practice settings throughout France and Italy. Patient data were collected through an online dedicated platform including classical pathological and clinical parameters (e.g. histology, tumor grade and size, ER, PR, HER2 and Ki67), patient age, ODX Recurrence Score (RS) Results and recommended treatment both before and after the test results have been reported.
Results
A total of 53 and 19 qualified breast cancer centers, in France and Italy respectively, participated in the program and collected 2632 case reports. Study results demonstrated that ODX is used among a wide variety of patient profiles: 24% N1, 7% Nmic & 69% N0, 11% G1, 64% G2 and 25% of G3, 32% pre-, 8% peri- & 59% are post-menopausal, 34% are 35-50, 52% 51-70 and 13% are older than 70, 13% have Ki67%<10%, 35% KI67 10-20%, 30% KI67 21-30% & 18% Ki67>30%, 12% tumor <1cm, 59% 1-2cm and 27% tumor 2.1-5cm. RS distribution is the following: <18 (56%), 18-30 (35%) and >30 (9%). In addition, pre-ODX 60% and 48% patients had a treatment recommendation for chemo-hormonotherapy (CT-HT) in France and Italy respectively. Post-testing, the number of patients recommended CT-HT decreased to 29% and 31% for France and Italy respectively, highlighting that the test reduced unnecessary use of CT and homogenized treatment decisions.
Conclusions
In France and Italy, the use of the ODX test results in an overall reduction in CT recommendations, while also identifying patients more likely to benefit from CT.
Clinical trial identification
Legal entity responsible for the study
Genomic Health SARL.
Funding
Genomic Health SARL.
Editorial Acknowledgement
Disclosure
S. Barni, F. Cognetti: Medical Consultant: Genomic Health. All other authors have declared no conflicts of interest.
Resources from the same session
2343 - Benefit of adjuvant chemotherapy in hormone receptor-positive, HER2-negative, invasive lobular carcinoma of the breast
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2990 - Baseline lymphocyte counts predict distant recurrence in early breast cancer
Presenter: Gun Min Kim
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4532 - A propensity score analysis exploring the impact of the addition of adjuvant chemotherapy (aCT) to hormone therapy (aHT) in a multi-center series of resected luminal early stage pure Invasive Lobular Breast Carcinoma (ILC).
Presenter: Luisa Carbognin
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2344 - Benefit of Adjuvant Systemic Therapies in HR+ HER2- pT1ab Node-Negative Breast Carcinomas
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3525 - Anti-proliferative effect of oral metronomic vinorelbine in PAM50 Luminal/HER2-negative early breast cancer (SOLTI-1501 VENTANA): an open-label, randomized, three-arm, multicenter, window-of-opportunity study
Presenter: Aleix Prat
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3908 - Clinicopathologic significance of androgen receptor expression and discordant receptor status during progression in breast cancer
Presenter: Chan Heun Park
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4075 - The outcomes of early breast cancers utilizing the Oncotype Dx Recurrence score (RS) instead of Clinico-pathological (CP) factors for prognostic risk assessment: A Single Institution Experience
Presenter: Adhar Alsayed
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
738 - Circulating tumor cells as a prognostic marker in non metastatic breast cancer patients.
Presenter: Summar Elmorshidy
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3151 - Molecular subtyping of breast cancer by dedicated breast PET
Presenter: Satoshi Sueoka
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4942 - Analytical validation of OncoMasTR, a multigene test for predicting risk of distant recurrence in hormone receptor-positive early stage breast cancer
Presenter: Tony Loughman
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract