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Utility of the 70-Gene MammaPrint Assay for Prediction of Benefit From Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial.
Rastogi, Priya; Bandos, Hanna; Lucas, Peter C; van 't Veer, Laura J; Wei, Jia-Perng J; Geyer, Charles E; Fehrenbacher, Louis; Chia, Stephen K L; Brufsky, Adam M; Walshe, Janice M; Soori, Gamini S; Dakhil, Shaker R; Paik, Soonmyung; Swain, Sandra M; Menicucci, Andrea R; Audeh, M William; Wolmark, Norman; Mamounas, Eleftherios P.
Afiliação
  • Rastogi P; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.
  • Bandos H; Magee-Women's Hospital, Pittsburgh, PA.
  • Lucas PC; NRG Oncology SDMC, Pittsburgh, PA.
  • van 't Veer LJ; University of Pittsburgh, School of Public Health, Pittsburgh, PA.
  • Wei JJ; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.
  • Geyer CE; Agendia, Inc, Irvine, CA.
  • Fehrenbacher L; Agendia, Inc, Irvine, CA.
  • Chia SKL; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.
  • Brufsky AM; Kaiser Permanente Oncology Clinical Trials Northern CA, Novato, CA.
  • Walshe JM; British Columbia Cancer Agency, Vancouver, BC, Canada.
  • Soori GS; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.
  • Dakhil SR; Magee-Women's Hospital, Pittsburgh, PA.
  • Paik S; Cancer Trials Ireland, and St Vincent's University Hospital, Dublin, Ireland.
  • Swain SM; Florida Cancer Specialists, Fort Myers, FL.
  • Menicucci AR; 0Wichita NCORP, Via Christi Regional Medical Center, and Cancer Center of Kansas, Wichita, KS.
  • Audeh MW; 1Theragenbio, Inc, Pankyo, Republic of Korea.
  • Wolmark N; 2Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
  • Mamounas EP; Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.
J Clin Oncol ; 42(30): 3561-3569, 2024 Oct 20.
Article em En | MEDLINE | ID: mdl-39047219
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Triazóis / Neoplasias da Mama / Letrozol / Nitrilas Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: J Clin Oncol Ano de publicação: 2024 Tipo de documento: Article País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Triazóis / Neoplasias da Mama / Letrozol / Nitrilas Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: J Clin Oncol Ano de publicação: 2024 Tipo de documento: Article País de publicação: Estados Unidos