OnCo
trialsTrialPositive

RxPONDER (SWOG S1007)

Postmenopausal women with a few positive lymph nodes and a low gene-test score can skip chemotherapy; premenopausal women still benefit from it.

Postmenopausal (n=3,350): 5-year iDFS 91.9% vs 91.3%, no chemotherapy benefit. Premenopausal (n=1,665): 5-year iDFS 93.9% vs 89.0% with chemotherapy (HR 0.60), a benefit possibly mediated by chemotherapy-induced ovarian suppression.

Setting
HR+/HER2- breast cancer with 1-3 positive nodes and recurrence score ≤25: endocrine therapy alone vs chemo-endocrine therapy
Phase
Phase 3
Sponsor
SWOG / NCI
Registry
Headline result
No chemo benefit postmenopausal; iDFS HR 0.60 with chemo premenopausal.
Reported
2020
Enrolled
5083
Replication
Consistent with TAILORx age interaction; the OFS-vs-chemotherapy question is being tested prospectively (NRG-BR009 / OFSET).

Outcomes

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In plain words
What these results mean for people, not percentages
5,083 people took part
5-year iDFS, postmenopausalprimarysurrogate endpoint
  • 91.9 vs 91.3 out of 100 alive without the cancer coming back at 5 years with Endocrine alone compared with Chemo-endocrine; 0.6 more per 100.
  • Roughly one extra person helped for every 167 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 2 percent higher chance of the event at any given time (hazard ratio 1.02).
5-year iDFS, premenopausalprimarysurrogate endpoint
  • 89 vs 93.9 out of 100 alive without the cancer coming back at 5 years with Endocrine alone compared with Chemo-endocrine; 4.9 fewer per 100.
  • On this measure the first group did worse, not better.
  • Put another way, the treated group had about 40 percent lower chance of the event at any given time (hazard ratio 0.6, likely range 0.43 to 0.83).
Be careful
  • 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- breast cancer with 1-3 positive nodes and recurrence score ≤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.

5,083 participants enrolled.

5-year iDFS, postmenopausalprimary
HR 1.02
Endocrine alone91.9 of 100
Chemo-endocrine91.3 of 100
Source
5-year iDFS, premenopausalprimary
HR 0.6 (0.43–0.83)
Endocrine alone89 of 100
Chemo-endocrine93.9 of 100
EndpointArmnValueHR (95% CI)pSource
5-year iDFS, postmenopausalprimaryEndocrine alone91.9%1.02link
Chemo-endocrine91.3%
5-year iDFS, premenopausalprimaryEndocrine alone89%0.6 (0.43–0.83)
Chemo-endocrine93.9%
Replication
Consistent with TAILORx age interaction; the OFS-vs-chemotherapy question is being tested prospectively (NRG-BR009 / OFSET).

Connected

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