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
4023 - The accuracy of sentinel lymph node biopsy following neoadjuvant chemotherapy in clinically node positive breast cancer patients: A single institution experience
Presenter: Narges Sistany Allahabadi
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
4707 - Index BRCA1/2 testing under a multidisciplinary program
Presenter: Duarte Machado
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
3393 - BRCA1/BRCA2 germline mutations and chemotherapy-related hematological toxicity in breast cancer patients
Presenter: Alex Friedlaender
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
3175 - PALB2 germ-line mutations in Russian breast cancer patients: identification of recurrent alleles and analysis of phenotypic characteristics of the tumors
Presenter: Evgeny Imyanitov
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
3027 - Landscape of germline mutations in hereditary breast and ovarian cancer (HBOC) patients in Russia revealed by target panel sequencing
Presenter: Elena Shagimardanova
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
4963 - Lynch syndrome-associated hereditary mutations cause breast and ovarian cancer: results from Russian Heredetary Oncogenomics project
Presenter: Marat Gordiev
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
2916 - Impact of deleterious germline BRCA mutations, addition of taxanes and use of adjuvant endocrine therapy (ET) on anti-müllerian hormone (AMH) levels in early breast cancer (EBC) patients treated by adjuvant chemotherapy (CT)
Presenter: Nathalie OLYMPIOS
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
2400 - Germline mutation status and therapy response in patients with triple-negative breast cancer (TNBC): Results of the GeparOcto study
Presenter: Esther Pohl
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
1345 - BRCA1/BRCA2 Predictive Genetic Testing in an Irish Population: A Missed Opportunity
Presenter: David O Reilly
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
1959 - Incidence and Survival among Young Women with Stage I-III Breast Cancer
Presenter: Alexandra Thomas
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