TY - JOUR
T1 - Ten-year follow-up of the observational RASTER study, prospective evaluation of the 70-gene signature in ER-positive, HER2-negative, node-negative, early breast cancer
AU - Vliek, Sonja B.
AU - Hilbers, Florentine S.
AU - Jager, Agnes
AU - Retèl, Valesca P.
AU - Bueno de Mesquita, Jolien M.
AU - Drukker, Caroline A.
AU - Veltkamp, Sanne C.
AU - Zeillemaker, Anneke M.
AU - Rutgers, Emiel J.
AU - van Tinteren, Harm
AU - van Harten, Wim H.
AU - van 't Veer, Laura J.
AU - van de Vijver, Marc J.
AU - Linn, Sabine C.
N1 - Funding Information: The RASTER study was financially supported by the Dutch Health Care Insurance Board (ZINL). The study was funded by The Netherlands Organisation for Health Research and Development ( ZonMw ). Publisher Copyright: © 2022 The Author(s)
PY - 2022/11/1
Y1 - 2022/11/1
N2 - Introduction: Prognostic gene expression signatures can be used in combination with classical clinicopathological factors to guide adjuvant chemotherapy decisions in ER-positive, HER2-negative breast cancer. However, long-term outcome data after introduction of genomic testing in the treatment decision-making process are limited. Methods: In the prospective RASTER study, the tumours of 427 patients with cTanyN0M0 breast cancer were tested to assess the 70-gene signature (MammaPrint). The results were provided to their treating physician to be incorporated in the decision-making on adjuvant systemic therapy. Here, we report the long-term outcome of the 310 patients with ER-positive, HER2-negative tumours by clinical and genomic risk categories at a median follow-up of 10.3 years. Results: Among the clinically high-risk patients, 45 (49%) were classified as genomically low risk. In this subgroup, at 10 years, distant recurrence free interval (DRFI) was similar between patients treated with (95.7% [95% CI 87.7–100]) and without (95.5% [95% CI 87.1–100]) chemotherapy. Within the group of clinically low-risk patients, 56 (26%) were classified as genomically high risk. Within the clinically low-risk group, beyond 5 years, a difference emerged between the genomically high- and low-risk subgroup resulting in a 10-year DRFI of 84.3% (95% CI 74.8–95.0) and 93.4% (95% CI 89.5–97.5), respectively. Interestingly, genomic ultralow-risk patients have a 10-year DRFI of 96.7% (95% CI 90.5–100), largely (79%) without systemic therapy. Conclusions: These data confirm that clinically high-risk, genomically low-risk tumours have an excellent outcome in the real-world setting of shared decision-making. Together with the updated results of the MINDACT trial, these data support the use of the MammaPrint, in ER-positive, HER2-negative, node-negative, clinically high-risk breast cancer patients. Registry: ISRCTN71917916
AB - Introduction: Prognostic gene expression signatures can be used in combination with classical clinicopathological factors to guide adjuvant chemotherapy decisions in ER-positive, HER2-negative breast cancer. However, long-term outcome data after introduction of genomic testing in the treatment decision-making process are limited. Methods: In the prospective RASTER study, the tumours of 427 patients with cTanyN0M0 breast cancer were tested to assess the 70-gene signature (MammaPrint). The results were provided to their treating physician to be incorporated in the decision-making on adjuvant systemic therapy. Here, we report the long-term outcome of the 310 patients with ER-positive, HER2-negative tumours by clinical and genomic risk categories at a median follow-up of 10.3 years. Results: Among the clinically high-risk patients, 45 (49%) were classified as genomically low risk. In this subgroup, at 10 years, distant recurrence free interval (DRFI) was similar between patients treated with (95.7% [95% CI 87.7–100]) and without (95.5% [95% CI 87.1–100]) chemotherapy. Within the group of clinically low-risk patients, 56 (26%) were classified as genomically high risk. Within the clinically low-risk group, beyond 5 years, a difference emerged between the genomically high- and low-risk subgroup resulting in a 10-year DRFI of 84.3% (95% CI 74.8–95.0) and 93.4% (95% CI 89.5–97.5), respectively. Interestingly, genomic ultralow-risk patients have a 10-year DRFI of 96.7% (95% CI 90.5–100), largely (79%) without systemic therapy. Conclusions: These data confirm that clinically high-risk, genomically low-risk tumours have an excellent outcome in the real-world setting of shared decision-making. Together with the updated results of the MINDACT trial, these data support the use of the MammaPrint, in ER-positive, HER2-negative, node-negative, clinically high-risk breast cancer patients. Registry: ISRCTN71917916
KW - 70-gene signature
KW - ER-positive
KW - Early breast cancer
KW - Gene expression profile
KW - HER2-negative
KW - MammaPrint
KW - Node-negative
KW - Observational
KW - Prognostic
KW - Prospective
UR - http://www.scopus.com/inward/record.url?scp=85138040656&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ejca.2022.07.036
DO - https://doi.org/10.1016/j.ejca.2022.07.036
M3 - Article
C2 - 36126477
SN - 0959-8049
VL - 175
SP - 169
EP - 179
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -