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Bending the Curve Trial by Trial
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RxPONDER

21-gene assay to inform chemotherapy benefit in node-positive breast cancer

N = 5,083NCT01272037

Population
Women with hormone-receptor-positive, HER2-negative breast cancer, one to three positive axillary lymph nodes and a recurrence score of 25 or lower (5083 randomised; 5018 participated)
Design
Prospective randomised trial of endocrine therapy only versus chemotherapy plus endocrine (chemoendocrine) therapy; separate prespecified analyses by menopausal status after a significant interaction at the third interim analysis
Arms
  • Endocrine therapy only (experimental): Endocrine therapy only
  • Chemoendocrine therapy (control): Chemotherapy plus endocrine therapy
People
Kalinsky K
iDFSHR 1.02 (95% CI 0.82–1.26)Δ 60-month iDFS+0.6 pointsiDFSHR 0.60 (95% CI 0.43–0.83)Δ 60-month iDFS−4.9 pointsDRFSHR 0.58 (95% CI 0.39–0.87)
Show the numbers
Results reported for RxPONDER
EndpointAnalysisEndocrine therapy onlyChemoendocrine therapyEffect
iDFSPostmenopausal womeninterimKalinsky 202191.9% at 5 y91.3% at 5 yHR 1.02 (95% CI 0.82–1.26)P=0.89Prespecified third interim analysis.
iDFSPremenopausal womeninterimKalinsky 202189% at 5 y93.9% at 5 yHR 0.60 (95% CI 0.43–0.83)P=0.002Prespecified third interim analysis. Hazard ratios in this trial compare chemoendocrine therapy with endocrine therapy only: the abstract does not spell out the direction, but it follows from the 5-year iDFS percentages in the same abstract (premenopausal 93.9% chemoendocrine vs 89.0% endocrine only with HR 0.60; postmenopausal 91.3% chemoendocrine vs 91.9% endocrine only with HR 1.02).
DRFSPremenopausal womeninterimKalinsky 2021——HR 0.58 (95% CI 0.39–0.87)P=0.009Prespecified third interim analysis.
Results reported for RxPONDER
EndpointAnalysisEndocrine therapy onlyChemoendocrine therapyEffect
iDFSPostmenopausal womeninterimKalinsky 202191.9% at 5 y91.3% at 5 yHR 1.02 (95% CI 0.82–1.26)P=0.89Prespecified third interim analysis.
iDFSPremenopausal womeninterimKalinsky 202189% at 5 y93.9% at 5 yHR 0.60 (95% CI 0.43–0.83)P=0.002Prespecified third interim analysis. Hazard ratios in this trial compare chemoendocrine therapy with endocrine therapy only: the abstract does not spell out the direction, but it follows from the 5-year iDFS percentages in the same abstract (premenopausal 93.9% chemoendocrine vs 89.0% endocrine only with HR 0.60; postmenopausal 91.3% chemoendocrine vs 91.9% endocrine only with HR 1.02).
DRFSPremenopausal womeninterimKalinsky 2021——HR 0.58 (95% CI 0.39–0.87)P=0.009Prespecified third interim analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
iDFSiDFSDRFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
iDFS1.020.82–1.26
iDFS0.60.43–0.83
DRFS0.580.39–0.87
Primary publication: Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, et al. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 2021;385(25):2336-2347. PubMedDOI

Appears in

Sources

  1. Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, et al. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 2021;385(25):2336-2347.

    PubMedDOI