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Phase 2 study of neoadjuvant enzalutamide and paclitaxel for luminal androgen receptor-enriched TNBC: Trial results and insights into "ARness".
Lim, Bora; Seth, Sahil; Yam, Clinton; Huo, Lei; Fujii, Takeo; Lee, Jangsoon; Bassett, Roland; Nasser, Sara; Ravenberg, Lisa; White, Jason; Clayborn, Alyson; Guerra, Gil; Litton, Jennifer K; Damodaran, Senthil; Layman, Rachel; Valero, Vicente; Tripathy, Debasish; Lewis, Michael; Dobrolecki, Lacey E; Lei, Jonathan; Candelaria, Rosalind; Arun, Banu; Rauch, Gaiane; Zhao, Li; Zhang, Jianhua; Ding, Qingqing; Symmans, W Fraser; Chang, Jeffrey T; Thompson, Alastair M; Moulder, Stacy L; Ueno, Naoto T.
Affiliation
  • Lim B; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: blim@mdanderson.org.
  • Seth S; Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Yam C; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Huo L; Department of Breast Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Fujii T; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Cold Spring Harbor Laboratory-Northwell Health Cancer Institute, Riverhead, NY, USA.
  • Lee J; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; University of Hawaii Cancer Center, Honolulu, HI, USA.
  • Bassett R; Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Nasser S; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Ravenberg L; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • White J; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Clayborn A; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Guerra G; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Litton JK; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Damodaran S; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Layman R; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Valero V; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Tripathy D; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Lewis M; Lester Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, USA.
  • Dobrolecki LE; Lester Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, USA.
  • Lei J; Lester Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, USA.
  • Candelaria R; Department of Breast Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Arun B; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Rauch G; Department of Breast Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Zhao L; Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Zhang J; Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Ding Q; Department of Breast Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Symmans WF; Department of Breast Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Chang JT; McGovern Medical School, Houston, TX, USA.
  • Thompson AM; Department of Surgical Oncology, Baylor College of Medicine, Houston, TX, USA; Lester Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, USA.
  • Moulder SL; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Ueno NT; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; University of Hawaii Cancer Center, Honolulu, HI, USA. Electronic address: nueno@cc.hawaii.edu.
Cell Rep Med ; 5(6): 101595, 2024 Jun 18.
Article in En | MEDLINE | ID: mdl-38838676
ABSTRACT
Luminal androgen receptor (LAR)-enriched triple-negative breast cancer (TNBC) is a distinct subtype. The efficacy of AR inhibitors and the relevant biomarkers in neoadjuvant therapy (NAT) are yet to be determined. We tested the combination of the AR inhibitor enzalutamide (120 mg daily by mouth) and paclitaxel (80 mg/m2 weekly intravenously) (ZT) for 12 weeks as NAT for LAR-enriched TNBC. Eligibility criteria included a percentage of cells expressing nuclear AR by immunohistochemistry (iAR) of at least 10% and a reduction in sonographic volume of less than 70% after four cycles of doxorubicin and cyclophosphamide. Twenty-four patients were enrolled. Ten achieved a pathologic complete response or residual cancer burden-I. ZT was safe, with no unexpected side effects. An iAR of at least 70% had a positive predictive value of 0.92 and a negative predictive value of 0.97 in predicting LAR-enriched TNBC according to RNA-based assays. Our data support future trials of AR blockade in early-stage LAR-enriched TNBC.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Phenylthiohydantoin / Benzamides / Antineoplastic Combined Chemotherapy Protocols / Receptors, Androgen / Paclitaxel / Neoadjuvant Therapy / Triple Negative Breast Neoplasms / Nitriles Limits: Adult / Aged / Female / Humans / Middle aged Language: En Journal: Cell Rep Med Year: 2024 Document type: Article Country of publication: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Phenylthiohydantoin / Benzamides / Antineoplastic Combined Chemotherapy Protocols / Receptors, Androgen / Paclitaxel / Neoadjuvant Therapy / Triple Negative Breast Neoplasms / Nitriles Limits: Adult / Aged / Female / Humans / Middle aged Language: En Journal: Cell Rep Med Year: 2024 Document type: Article Country of publication: United States