Utility of the 70-Gene MammaPrint Assay for Prediction of Benefit From Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial-Reference-Cited by-同舟云学术

Utility of the 70-Gene MammaPrint Assay for Prediction of Benefit From Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial

Published:2024-07-24 Issue: Volume: Page:
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Rastogi Priya¹²^ORCID,Bandos Hanna³⁴,Lucas Peter C.¹^ORCID,van ‘t Veer Laura J.⁵^ORCID,Wei Jia-Perng J.⁵,Geyer Charles E.¹^ORCID,Fehrenbacher Louis⁶^ORCID,Chia Stephen K.L.⁷^ORCID,Brufsky Adam M.¹²^ORCID,Walshe Janice M.⁸^ORCID,Soori Gamini S.⁹,Dakhil Shaker R.¹⁰,Paik Soonmyung¹¹¹²^ORCID,Swain Sandra M.¹³^ORCID,Menicucci Andrea R.⁵^ORCID,Audeh M. William⁵^ORCID,Wolmark Norman¹^ORCID,Mamounas Eleftherios P.¹⁴^ORCID

Affiliation:

1. UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA

2. Magee-Women's Hospital, Pittsburgh, PA

3. NRG Oncology SDMC, Pittsburgh, PA

4. University of Pittsburgh, School of Public Health, Pittsburgh, PA

5. Agendia, Inc, Irvine, CA

6. Kaiser Permanente Oncology Clinical Trials Northern CA, Novato, CA

7. British Columbia Cancer Agency, Vancouver, BC, Canada

8. Cancer Trials Ireland, and St Vincent's University Hospital, Dublin, Ireland

9. Florida Cancer Specialists, Fort Myers, FL

10. 0Wichita NCORP, Via Christi Regional Medical Center, and Cancer Center of Kansas, Wichita, KS

11. 1Theragenbio, Inc, Pankyo, Republic of Korea

12. 2Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

13. Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC

14. Advent Health Cancer Center, Orlando, FL

Abstract

PURPOSE MammaPrint (MP) determines distant metastatic risk and may improve patient selection for extended endocrine therapy (EET). This study examined MP in predicting extended letrozole therapy (ELT) benefit in patients with early-stage breast cancer (BC) from the NSABP B-42 trial. PATIENTS AND METHODS MP was tested in 1,866 patients randomly assigned to receive ELT or placebo. The primary end point was distant recurrence (DR). Secondary end points were disease-free survival (DFS) and BC-free interval (BCFI). Tumors were classified as MP high risk (MP-HR) or low risk (MP-LR). MP-LR tumors were further classified as ultralow risk (MP-UL) or low non-ultralow risk (MP-LNUL). RESULTS There was no statistically significant difference in ELT benefit on DR between MP-HR and MP-LR (interaction P = .38). MP-LR tumors (n = 1,160) exhibited a statistically significant 10-year benefit of 3.7% for DR (hazard ratio [HR], 0.43 [95% CI, 0.25 to 0.74]; P = .002), whereas MP-HR tumors (n = 706) exhibited a nonsignificant 2.4% benefit (HR, 0.65 [95% CI, 0.34 to 1.24]; P = .19). The 10-year ELT benefit was significant for DFS (7.8%) and BCFI (7.0%) for MP-LR tumors, whereas MP-HR tumors did not significantly benefit (interaction DFS: P = .015, BCFI: P = .006). In exploratory analysis, the 10-year ELT benefit was significant and more pronounced in MP-LNUL (n = 908) tumors: 4.0% for DR, 9.5% for DFS, and 7.9% for BCFI; the benefit in MP-UL (n = 252) tumors was not significant: 3% for DR, 1.8% for DFS, and 4.1% for BCFI. CONCLUSION The primary hypothesis of predictive ability of MP on DR was not confirmed. However, the secondary outcomes demonstrated MP was predictive of ELT response and identified a subset of patients with early-stage hormone receptor–positive BC (MP-LR) with improved outcomes from ELT. These data could have important clinical implications in patient selection beyond clinical risk assessment for EET.

Publisher

American Society of Clinical Oncology (ASCO)

Link

https://ascopubs.org/doi/pdfdirect/10.1200/JCO.23.01995

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