TY - JOUR
T1 - A 95-gene signature stratifies recurrence risk of invasive disease in ER-positive, HER2-negative, node-negative breast cancer with intermediate 21-gene signature recurrence scores
AU - Fujii, Takeo
AU - Masuda, Hiroko
AU - Cheng, Yee Chung
AU - Yang, Fei
AU - Sahin, Aysegul A.
AU - Naoi, Yasuto
AU - Matsunaga, Yuki
AU - Raghavendra, Akshara
AU - Sinha, Arup Kumar
AU - Fernandez, Jose Rodrigo Espinosa
AU - James, Anjali
AU - Yamagishi, Keisuke
AU - Matsushima, Tomoko
AU - Schuetz, Robert
AU - Tripathy, Debu
AU - Tada, Sachiyo
AU - Jackson, Rubie S.
AU - Noguchi, Shinzaburo
AU - Nakamura, Seigo
AU - Acoba, Jared D.
AU - Ueno, Naoto T.
N1 - Funding Information:
K.Y., T.M., and S.T. are employees of Sysmex Corporation (Curebest™ 95GC Breast service provider). Y.N. holds a joint patent on Curebest™ 95GC Breast with Sysmex Corporation, receive research funds from Sysmex and AstraZeneca, and received a lecture fee of 100,000 yen a year from Sysmex Corporation, AstraZeneca and Takeda. S.N. has received honoraria and research grants from Sysmex Corporation and has been an advisor for Sysmex Corporation and holds a joint patent on Curebest™ 95GC Breast with Sysmex. N.T.U. has research grants with Sysmex Corporation and with Genomic Health.
Funding Information:
This work was supported by the Morgan Welch Inflammatory Breast Cancer Research Program; a Grant from the State of Texas Rare and Aggressive Breast Cancer Research Program; the MD Anderson’s Cancer Center Support Grant from the National Cancer Institute (CA016672).
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/9
Y1 - 2021/9
N2 - Purpose: A subset of patients with intermediate 21-gene signature assay recurrence score may benefit from adjuvant chemoendocrine therapy, but a predictive strategy is needed to identify such patients. The 95-gene signature assay was tested to stratify patients with intermediate RS into high (95GC-H) and low (95GC-L) groups that were associated with invasive recurrence risk. Methods: Patients with ER-positive, HER2-negative, node-negative breast cancer and RS 11–25 who underwent definitive surgery and adjuvant endocrine therapy without any cytotoxic agents were included. RNA was extracted from archived formalin-fixed, paraffin-embedded samples, and 95-gene signature was calculated. Results: 206 patients had RS of 11–25 (95GC-L, N = 163; 95GC-H, N = 43). In Cox proportional hazards model, 95GC-H was significantly associated with shorter time to recurrence than was 95GC-L (HR 5.94; 95%CI 1.81–19.53; P = 0.005). The correlation between 95-gene signature and 21-gene signature assay scores was not strong (correlation coefficient r = 0.27), which might suggest that 95-gene signature reflects biological characteristics differing from what 21-gene signature shows. Conclusions: The 95-gene signature stratifies patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS of 11–25 into high and low groups that are associated with recurrence risk of invasive disease. Further retrospective analysis in the prospectively accrued TAILORx population is warranted to confirm that 95-gene signature can identify patients who would benefit from adjuvant chemoendocrine therapy.
AB - Purpose: A subset of patients with intermediate 21-gene signature assay recurrence score may benefit from adjuvant chemoendocrine therapy, but a predictive strategy is needed to identify such patients. The 95-gene signature assay was tested to stratify patients with intermediate RS into high (95GC-H) and low (95GC-L) groups that were associated with invasive recurrence risk. Methods: Patients with ER-positive, HER2-negative, node-negative breast cancer and RS 11–25 who underwent definitive surgery and adjuvant endocrine therapy without any cytotoxic agents were included. RNA was extracted from archived formalin-fixed, paraffin-embedded samples, and 95-gene signature was calculated. Results: 206 patients had RS of 11–25 (95GC-L, N = 163; 95GC-H, N = 43). In Cox proportional hazards model, 95GC-H was significantly associated with shorter time to recurrence than was 95GC-L (HR 5.94; 95%CI 1.81–19.53; P = 0.005). The correlation between 95-gene signature and 21-gene signature assay scores was not strong (correlation coefficient r = 0.27), which might suggest that 95-gene signature reflects biological characteristics differing from what 21-gene signature shows. Conclusions: The 95-gene signature stratifies patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS of 11–25 into high and low groups that are associated with recurrence risk of invasive disease. Further retrospective analysis in the prospectively accrued TAILORx population is warranted to confirm that 95-gene signature can identify patients who would benefit from adjuvant chemoendocrine therapy.
KW - 21-gene signature assay
KW - 95-gene signature assay
KW - Breast cancer
KW - Estrogen receptor-positive
KW - Recurrence Score
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U2 - 10.1007/s10549-021-06276-7
DO - 10.1007/s10549-021-06276-7
M3 - Article
C2 - 34131830
AN - SCOPUS:85108015610
SN - 0167-6806
VL - 189
SP - 455
EP - 461
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
IS - 2
ER -