Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study

Hiroji Iwata, Norikazu Masuda, Yutaka Yamamoto, Tomomi Fujisawa, Tatsuya Toyama, Masahiro Kashiwaba, Shoichiro Ohtani, Naruto Taira, Takehiko Sakai, Yoshie Hasegawa, Rikiya Nakamura, Hiromitsu Akabane, Yukiko Shibahara, Hironobu Sasano, Takuhiro Yamaguchi, Kentaro Sakamaki, Helen Bailey, Diana B. Cherbavaz, Debbie M. Jakubowski, Naoko SugiyamaCalvin Chao, Yasuo Ohashi

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)123-133
Number of pages11
JournalBreast Cancer Research and Treatment
Volume173
Issue number1
DOIs
Publication statusPublished - Jan 15 2019

Keywords

  • Breast cancer
  • Hormonal therapy
  • Neoadjuvant
  • Oncotype DX
  • Recurrence score

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Iwata, H., Masuda, N., Yamamoto, Y., Fujisawa, T., Toyama, T., Kashiwaba, M., Ohtani, S., Taira, N., Sakai, T., Hasegawa, Y., Nakamura, R., Akabane, H., Shibahara, Y., Sasano, H., Yamaguchi, T., Sakamaki, K., Bailey, H., Cherbavaz, D. B., Jakubowski, D. M., ... Ohashi, Y. (2019). Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study. Breast Cancer Research and Treatment, 173(1), 123-133. https://doi.org/10.1007/s10549-018-4964-y