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Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial.
Pusztai, Lajos; Yau, Christina; Wolf, Denise M; Han, Hyo S; Du, Lili; Wallace, Anne M; String-Reasor, Erica; Boughey, Judy C; Chien, A Jo; Elias, Anthony D; Beckwith, Heather; Nanda, Rita; Albain, Kathy S; Clark, Amy S; Kemmer, Kathleen; Kalinsky, Kevin; Isaacs, Claudine; Thomas, Alexandra; Shatsky, Rebecca; Helsten, Theresa L; Forero-Torres, Andres; Liu, Minetta C; Brown-Swigart, Lamorna; Petricoin, Emmanuel F; Wulfkuhle, Julia D; Asare, Smita M; Wilson, Amy; Singhrao, Ruby; Sit, Laura; Hirst, Gillian L; Berry, Scott; Sanil, Ashish; Asare, Adam L; Matthews, Jeffrey B; Perlmutter, Jane; Melisko, Michelle; Rugo, Hope S; Schwab, Richard B; Symmans, W Fraser; Yee, Doug; Van't Veer, Laura J; Hylton, Nola M; DeMichele, Angela M; Berry, Donald A; Esserman, Laura J.
Afiliação
  • Pusztai L; Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, 333 Cedar Steet, PO Box 208032, New Haven, CT 06510, USA. Electronic address: lajos.pusztai@yale.edu.
  • Yau C; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Wolf DM; Department of Laboratory Medicine, University of California, San Francisco, CA 94143, USA.
  • Han HS; Medical Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA.
  • Du L; Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
  • Wallace AM; Comprehensive Breast Health Center, University of California San Diego, La Jolla, CA 92037, USA.
  • String-Reasor E; Department of Hematology & Oncology, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
  • Boughey JC; Department of Surgery, Mayo Clinic, Rochester, MN 55905, USA.
  • Chien AJ; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Elias AD; Department of Internal Medicine, University of Colorado, Aurora, CO 80045, USA.
  • Beckwith H; Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA.
  • Nanda R; Department of Medicine, University of Chicago, Chicago, IL 60637, USA.
  • Albain KS; Hematology/Oncology, Loyola University Chicago Stritch School of Medicine, Chicago, IL 60153, USA.
  • Clark AS; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.
  • Kemmer K; Knight Cancer Institute, Oregon Health & Sciences University, Portland, OR 97239, USA.
  • Kalinsky K; Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY 10032, USA.
  • Isaacs C; Lombardi Comprehensive Care Center, Georgetown University, Washington, DC 20007, USA.
  • Thomas A; Medical Oncology and Hematology, Wake Forest University, Winston-Salem, NC 27157, USA.
  • Shatsky R; Comprehensive Breast Health Center, University of California San Diego, La Jolla, CA 92037, USA.
  • Helsten TL; Moores Cancer Center, University of California San Diego, La Jolla, CA 92037, USA.
  • Forero-Torres A; Department of Hematology & Oncology, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
  • Liu MC; Department of Surgery, Mayo Clinic, Rochester, MN 55905, USA.
  • Brown-Swigart L; Department of Laboratory Medicine, University of California, San Francisco, CA 94143, USA.
  • Petricoin EF; Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA 20110, USA.
  • Wulfkuhle JD; Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA 20110, USA.
  • Asare SM; Quantum Leap Healthcare Collaborative, San Francisco, CA 94118, USA.
  • Wilson A; Quantum Leap Healthcare Collaborative, San Francisco, CA 94118, USA.
  • Singhrao R; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Sit L; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Hirst GL; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Berry S; Berry Consultants, LLC, Austin, TX 78746, USA.
  • Sanil A; Berry Consultants, LLC, Austin, TX 78746, USA.
  • Asare AL; Quantum Leap Healthcare Collaborative, San Francisco, CA 94118, USA.
  • Matthews JB; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Perlmutter J; Gemini Group, Ann Arbor, MI 48107, USA.
  • Melisko M; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Rugo HS; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Schwab RB; Moores Cancer Center, University of California San Diego, La Jolla, CA 92037, USA.
  • Symmans WF; Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
  • Yee D; Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA.
  • Van't Veer LJ; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • Hylton NM; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
  • DeMichele AM; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.
  • Berry DA; Berry Consultants, LLC, Austin, TX 78746, USA.
  • Esserman LJ; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Cancer Cell ; 39(7): 989-998.e5, 2021 07 12.
Article em En | MEDLINE | ID: mdl-34143979
The combination of PD-L1 inhibitor durvalumab and PARP inhibitor olaparib added to standard paclitaxel neoadjuvant chemotherapy (durvalumab/olaparib/paclitaxel [DOP]) was investigated in the phase II I-SPY2 trial of stage II/III HER2-negative breast cancer. Seventy-three participants were randomized to DOP and 299 to standard of care (paclitaxel) control. DOP increased pathologic complete response (pCR) rates in all HER2-negative (20%-37%), hormone receptor (HR)-positive/HER2-negative (14%-28%), and triple-negative breast cancer (TNBC) (27%-47%). In HR-positive/HER2-negative cancers, MammaPrint ultra-high (MP2) cases benefited selectively from DOP (pCR 64% versus 22%), no benefit was seen in MP1 cancers (pCR 9% versus 10%). Overall, 12.3% of patients in the DOP arm experienced immune-related grade 3 adverse events versus 1.3% in control. Gene expression signatures associated with immune response were positively associated with pCR in both arms, while a mast cell signature was associated with non-pCR. DOP has superior efficacy over standard neoadjuvant chemotherapy in HER2-negative breast cancer, particularly in a highly sensitive subset of high-risk HR-positive/HER2-negative patients.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Receptor ErbB-2 / Terapia Neoadjuvante Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Receptor ErbB-2 / Terapia Neoadjuvante Idioma: En Ano de publicação: 2021 Tipo de documento: Article