Abstract
PurposeThe 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.MethodsNEOS 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.ResultsOf 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).ConclusionThe Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer.
Highlights
Neoadjuvant therapy for locally advanced breast cancer has the potential to improve rates of breast-conserving surgery (BCS), permit the assessment of patients’ primary tumor response to systemic therapy, and reduce rates of distant metastases by as much as that observed with adjuvant approaches [1,2,3,4,5,6]
With the RS18–30 group included, Recurrence Score group remained significantly associated with the rate of clinical response (Cochran–Armitage trend test, p < 0.001)
We report the findings of TransNEOS, the largest study to date to evaluate the relationship between Recurrence Score results and clinical response to neoadjuvant hormonal therapy
Summary
Neoadjuvant therapy for locally advanced breast cancer has the potential to improve rates of breast-conserving surgery (BCS), permit the assessment of patients’ primary tumor response to systemic therapy, and reduce rates of distant metastases by as much as that observed with adjuvant approaches [1,2,3,4,5,6]. Studies conducted since 2001, have demonstrated that neoadjuvant hormonal therapy can yield clinically meaningful response rates in more general populations of patients with ER + breast cancer [10,11,12,13,14,15,16]. Many patients with locally advanced ER + breast cancer may be considered for neoadjuvant hormonal therapy, as a viable means to achieve clinical response and improve rates of BCS [12,13,14,15,16,17,18,19]. As in the adjuvant setting, response to neoadjuvant hormonal therapy can vary across patients with ER + breast cancer [20]. The capacity to select patients who are more likely to benefit from neoadjuvant hormonal therapy would represent an advance in the clinical management of breast cancer
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