Purpose
The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Score results can predict clinical response to neoadjuvant letrozole.
Methods
NEOS is a phase 3 clinical trial of hormonal therapy ± adjuvant chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months of neoadjuvant letrozole and breast surgery. TransNEOS patients had tumors ≥ 2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Recurrence Score testing. The primary endpoint was to evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS < 18 versus RS ≥ 31. Secondary endpoints included evaluation of clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score result,
ESR1
and
PGR
single-gene scores, and ER gene-group score.
Results
Of 295 TransNEOS patients (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% had RS < 18, 28.5% had RS18–30, and 18.3% had RS ≥ 31. Clinical response rates were 54% (RS < 18), 42% (RS18–30), and 22% (RS ≥ 31). A higher proportion of patients with RS < 18 had clinical responses (
p
< 0.001 vs. RS ≥ 31). In multivariable analyses, continuous Recurrence Score result (
p
< 0.001),
ESR1
score (
p
= 0.049),
PGR
score (
p
< 0.001), and ER gene-group score (
p
< 0.001) were associated with clinical response. Recurrence Score group was significantly associated with rate of BCS after neoadjuvant treatment (RS < 18 vs. RS ≥ 31,
p
= 0.010).
Conclusion
The Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer.
Electronic supplementary material
The online version of this article (10.1007/s10549-018-4964-y) contains supplementary material, which is available to authorized users.
In order to estimate the stature from the length of the lumbar part of spine (LLPS), studies were made on Japanese males (n = 42) and females (n = 29) autopsied in our laboratory during 1984-1987. Somatometry was performed on the stature and LLPS in centimetres, the latter being measured from the upper edge of the first lumbar vertebral body, to the promonitorium, along the anterior surface of the spine. LLPS were 19.9 +/- 1.19 cm in males and 18.6 +/- 0.84 cm in females (mean +/- S.D.). The regression equations calculated were as follows: stature in males = LLPS x 3.23 + 101.7; stature in females = LLPS x 2.31 + 110.8. The standard errors of estimate were 6.16 cm in males and 4.05 cm in females. This method is useful for estimating the stature of severely burned or mutilated bodies which have no limbs.
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