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

• DOI: 10.1007/s10549-018-4964-y
• Publication Date: 2018-09-21T06:49:52Z
• Authors: 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 Sugiyama; Calvin Chao; Yasuo Ohashi
• Keywords: Letrozole; Neoadjuvant Therapy; Hormonal Therapy; Clinical endpoint

The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether results can clinical response neoadjuvant letrozole.NEOS phase 3 trial hormonal therapy ± chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months letrozole and surgery. TransNEOS had tumors ≥ 2 cm archived core-biopsy samples taken before subsequently sent testing. primary endpoint was evaluate (complete or partial) RS < 18 versus 31. Secondary endpoints included evaluation rate breast-conserving surgery (BCS) by continuous result, ESR1 PGR single-gene scores, ER gene-group score.Of 295 (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% 18, 28.5% RS18-30, 18.3% Clinical rates were 54% (RS 18), 42% (RS18-30), 22% 31). A higher proportion responses (p 0.001 vs. In multivariable analyses, result 0.001), score = 0.049), 0.001) associated response. group significantly BCS treatment 31, p 0.010).The in cancer.