TAILORx
Showed that most women with the commonest breast cancer can safely skip chemotherapy if a gene test says their risk is low or intermediate.
Among 6,711 women with mid-range recurrence scores, endocrine therapy alone was non-inferior to chemo-endocrine therapy (9-year iDFS 83.3% vs 84.3%; HR 1.08). Women ≤50 with scores 16-25 derived some chemotherapy benefit. Spared chemotherapy for roughly 70% of eligible patients worldwide.
Setting
HR+/HER2-, node-negative early breast cancer with Oncotype DX recurrence score 11-25: endocrine therapy alone vs chemo-endocrine therapy
Phase
Phase 3
Sponsor
ECOG-ACRIN / NCI
Registry
Headline result
9-year iDFS 83.3% vs 84.3%; non-inferior.
Reported
2018
Enrolled
10273
Replication
RxPONDER extended the finding to 1-3 positive nodes in postmenopausal women; MINDACT (MammaPrint) reached a similar conclusion with a different assay.
In plain words
What these results mean for people, not percentages
Invasive disease-free survival at 9 years (RS 11-25)primarysurrogate endpoint
- 83.3 vs 84.3 out of 100 alive without the cancer coming back at 9 years with Endocrine therapy alone compared with Chemo-endocrine therapy; 1 fewer per 100.
- On this measure the first group did worse, not better.
- Put another way, the treated group had about 8 percent higher chance of the event at any given time (hazard ratio 1.08, likely range 0.94 to 1.24).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: HR+/HER2-, node-negative early breast cancer with Oncotype DX recurrence score 11-25: endocrine therapy alone vs chemo-endocrine therapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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.
10,273 participants enrolled.
Invasive disease-free survival at 9 years (RS 11-25)primary
HR 1.08 (0.94–1.24)
Endocrine therapy alone83.3 of 100
n = 3,399
Chemo-endocrine therapy84.3 of 100
n = 3,312
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survival at 9 years (RS 11-25)primary | Endocrine therapy alone | 3,399 | 83.3% | 1.08 (0.94–1.24) | — | link |
| Chemo-endocrine therapy | 3,312 | 84.3% |
Replication
RxPONDER extended the finding to 1-3 positive nodes in postmenopausal women; MINDACT (MammaPrint) reached a similar conclusion with a different assay.