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Postmenopausal women with a few positive lymph nodes and a low gene-test score can skip chemotherapy; premenopausal women still benefit from it.
RxPONDER, SWOG trial S1007, NCT01272037, sponsored by SWOG and the NCI and reported in 2020, showed that postmenopausal women with one to three positive lymph nodes and a low Oncotype DX recurrence score can skip chemotherapy, while premenopausal women still benefit from it. Among 5,083 women with HR-positive, HER2-negative disease and scores of 25 or below, chemotherapy added nothing to endocrine therapy in the 3,350 postmenopausal women but improved invasive disease-free survival in the 1,665 premenopausal women, a benefit possibly mediated by chemotherapy-induced ovarian suppression. OnCo links it to Oncotype DX, the ovarian function suppression term, the gene-assay-to-chemotherapy-omission pairing, Kathy S. Albain and Kevin Kalinsky. Whether ovarian suppression alone could replace chemotherapy in younger women is being tested in NRG-BR009, known as OFSET.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
5,018 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 5-year iDFS, postmenopausalprimary | Endocrine alone | - | 91.9% | 1.02 | - | link |
| Chemo-endocrine | - | 91.3% | ||||
| 5-year iDFS, premenopausalprimary | Endocrine alone | - | 89% | 0.6 (0.43 to 0.83) | - | link |
| Chemo-endocrine | - | 93.9% |
Shares Kathy S. Albain, Gene-expression assay → chemotherapy omission, A formal regulatory route for validating a biomarker on archived trial samples, Enrichment and biomarker-stratified designs.
Shares Gene-expression assay → chemotherapy omission, Gene-expression prognostic assays, Enrichment and biomarker-stratified designs, Oncotype DX.
Shares Oncotype DX, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.
Shares Enrichment and biomarker-stratified designs, High-risk early HR-positive breast cancer, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.
Shares Oncotype DX, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.
Shares High-risk early HR-positive breast cancer, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, HR-positive / HER2-negative breast cancer.
Shares Ovarian function suppression (OFS), High-risk early HR-positive breast cancer, HR-positive / HER2-negative breast cancer.
Shares Oncotype DX, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.