What question did this study set out to answer?

To determine whether combining the 21-gene recurrence score with response to 3-week preoperative endocrine therapy can safely spare chemotherapy in patients with HR+/HER2– early breast cancer.

April 11, 2022Journal of Clinical Oncology

Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2– Early Breast Cancer

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To determine whether combining the 21-gene recurrence score with response to 3-week preoperative endocrine therapy can safely spare chemotherapy in patients with HR+/HER2– early breast cancer.
In this randomized noninferiority trial (WSG-ADAPT-HR+/HER2–, NCT01779206; N=5,625 registered, n=2,290 ITT endocrine trial), patients with pN0-1 HR+/HER2– early breast cancer received 3 weeks of preoperative endocrine therapy (ET).
Patients with recurrence score (RS) ≤ 11 received ET alone (control arm, n=868), while those with RS 12-25 who responded to ET (post-ET Ki67 ≤ 10%) also received ET alone (experimental arm, n=1,422); nonresponders and RS > 25 received dose-dense chemotherapy followed by ET.
Five-year invasive disease-free survival was 92.6% (95% CI, 90.8 to 94.0) in the experimental arm versus 93.9% (95% CI, 91.8 to 95.4) in the control arm, with a one-sided 95% lower confidence limit difference of –3.3%, establishing noninferiority (P = .05).
Five-year distant disease-free survival was 95.6% versus 96.3%, and 5-year overall survival was 97.3% versus 98.0% in the experimental and control arms, respectively.
Endocrine therapy response occurred significantly more often with aromatase inhibitors than tamoxifen (78.1% vs 41.1%, P < .001) and correlated inversely with recurrence score (78.8% in RS 0-11, 62.2% in RS 12-25, and 32.7% in RS > 25; P < .001).

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Implication

Randomized noninferiority trial reveals noninferior 5-year survival with endocrine therapy alone in HR+/HER2– early breast cancer, indicating chemotherapy can be safely omitted.

Cite This Study

A 2022 study studied this question.

synapsesocial.com/papers/6a9f55473ebbb409e69eb2b4 https://doi.org/10.1200/jco.21.02759

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Implication

Randomized noninferiority trial reveals noninferior 5-year survival with endocrine therapy alone in HR+/HER2– early breast cancer, indicating chemotherapy can be safely omitted.

Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2– Early Breast Cancer

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Discussion

Implication

Cite This Study

Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2– Early Breast Cancer

Key Points

Discussion

Implication

Cite This Study

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