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Bending the Curve Trial by Trial
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TAILORx

Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer

N = 10,273NCT00310180

Population
Women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer (10,273 enrolled; 6711 of 9719 eligible, 69%, had a recurrence score of 11 to 25 and were randomised)
Design
Prospective trial; women with a midrange recurrence score of 11 to 25 were randomly assigned to chemoendocrine therapy or endocrine therapy alone, designed to show noninferiority of endocrine therapy alone for invasive disease-free survival
Primary endpoint
iDFS
Arms
  • Endocrine therapy alone (experimental): Adjuvant endocrine therapy alone
  • Chemoendocrine therapy (control): Adjuvant chemotherapy plus endocrine therapy
People
Sparano JA
iDFSHR 1.08 (95% CI 0.94–1.24)Δ 108-month iDFS−1 pointsΔ 108-month DRFS−0.5 pointsΔ 108-month OS+0.1 points
Show the numbers
Results reported for TAILORx
EndpointAnalysisEndocrine therapy aloneChemoendocrine therapyEffect
iDFSRandomised patients with recurrence score 11 to 25 (6711)primarySparano 201883.3% at 9 y84.3% at 9 yHR 1.08 (95% CI 0.94–1.24)P=0.26Hazard ratio is endocrine versus chemoendocrine therapy for invasive disease recurrence, second primary cancer or death; noninferiority met. The abstract reports chemotherapy benefit varied with recurrence score and age (P=0.004), with some benefit in women aged 50 years or younger with a recurrence score of 16 to 25.
DRFSRandomised patients with recurrence score 11 to 25Freedom from disease recurrence at a distant site (as worded in the abstract)primarySparano 201894.5% at 9 y95% at 9 y—
OSRandomised patients with recurrence score 11 to 25primarySparano 201893.9% at 9 y93.8% at 9 y—
Results reported for TAILORx
EndpointAnalysisEndocrine therapy aloneChemoendocrine therapyEffect
iDFSRandomised patients with recurrence score 11 to 25 (6711)primarySparano 201883.3% at 9 y84.3% at 9 yHR 1.08 (95% CI 0.94–1.24)P=0.26Hazard ratio is endocrine versus chemoendocrine therapy for invasive disease recurrence, second primary cancer or death; noninferiority met. The abstract reports chemotherapy benefit varied with recurrence score and age (P=0.004), with some benefit in women aged 50 years or younger with a recurrence score of 16 to 25.
DRFSRandomised patients with recurrence score 11 to 25Freedom from disease recurrence at a distant site (as worded in the abstract)primarySparano 201894.5% at 9 y95% at 9 y—
OSRandomised patients with recurrence score 11 to 25primarySparano 201893.9% at 9 y93.8% at 9 y—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
iDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
iDFS1.080.94–1.24
Primary publication: Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2018;379(2):111-121. PubMedDOI

Appears in

Sources

  1. Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2018;379(2):111-121.

    PubMedDOI