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Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study

Author

Listed:
  • Filipa Lynce

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Candace Mainor

    (MedStar Georgetown University Hospital)

  • Renee N. Donahue

    (Center for Cancer Research, National Cancer Institute, National Institutes of Health)

  • Xue Geng

    (Georgetown University)

  • Greg Jones

    (NeoGenomics)

  • Ilana Schlam

    (MedStar Washington Hospital Center
    Tufts Medical Center)

  • Hongkun Wang

    (Georgetown University)

  • Nicole J. Toney

    (Center for Cancer Research, National Cancer Institute, National Institutes of Health)

  • Caroline Jochems

    (Center for Cancer Research, National Cancer Institute, National Institutes of Health)

  • Jeffrey Schlom

    (Center for Cancer Research, National Cancer Institute, National Institutes of Health)

  • Jay Zeck

    (MedStar Georgetown University Hospital)

  • Christopher Gallagher

    (MedStar Washington Hospital Center)

  • Rita Nanda

    (University of Chicago)

  • Deena Graham

    (Hackensack University Medical Center)

  • Erica M. Stringer-Reasor

    (University of Alabama at Birmingham)

  • Neelima Denduluri

    (AstraZeneca)

  • Julie Collins

    (MedStar Georgetown University Hospital
    AstraZeneca)

  • Ami Chitalia

    (MedStar Washington Hospital Center)

  • Shruti Tiwari

    (MedStar Washington Hospital Center)

  • Raquel Nunes

    (Johns Hopkins Sidney Kimmel Cancer Center
    AstraZeneca)

  • Rebecca Kaltman

    (Inova)

  • Katia Khoury

    (University of Alabama at Birmingham)

  • Margaret Gatti-Mays

    (The Ohio State University)

  • Paolo Tarantino

    (Dana-Farber Cancer Institute
    Harvard Medical School)

  • Sara M. Tolaney

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Sandra M. Swain

    (Georgetown University)

  • Paula Pohlmann

    (MedStar Georgetown University Hospital)

  • Heather A. Parsons

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Claudine Isaacs

    (Georgetown University)

Abstract

Chemotherapy and immune checkpoint inhibitors have a role in the post-neoadjuvant setting in patients with triple-negative breast cancer (TNBC). However, the effects of nivolumab, a checkpoint inhibitor, capecitabine, or the combination in changing peripheral immunoscore (PIS) remains unclear. This open-label randomized phase II OXEL study (NCT03487666) aimed to assess the immunologic effects of nivolumab, capecitabine, or the combination in terms of the change in PIS (primary endpoint). Secondary endpoints included the presence of ctDNA, toxicity, clinical outcomes at 2-years and association of ctDNA and PIS with clinical outcomes. Forty-five women with TNBC and residual invasive disease after standard neoadjuvant chemotherapy were randomized to nivolumab, capecitabine, or the combination. Here we show that treatment with immunotherapy containing arms (nivolumab or a combination of nivolumab plus capecitabine) leads to an increase in PIS from baseline to week 6 compared with capecitabine alone, meeting the pre-specified primary endpoint. In addition, the presence of circulating tumor DNA (ctDNA) is associated with disease recurrence, with no new safety signals in the combination arm. Our results provide efficacy and safety data on this combination in TNBC and support further development of PIS and ctDNA analyses to identify patients at high risk of recurrence.

Suggested Citation

  • Filipa Lynce & Candace Mainor & Renee N. Donahue & Xue Geng & Greg Jones & Ilana Schlam & Hongkun Wang & Nicole J. Toney & Caroline Jochems & Jeffrey Schlom & Jay Zeck & Christopher Gallagher & Rita N, 2024. "Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study," Nature Communications, Nature, vol. 15(1), pages 1-17, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-46961-x
    DOI: 10.1038/s41467-024-46961-x
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    References listed on IDEAS

    as
    1. N. Jacquelot & M. P. Roberti & D. P. Enot & S. Rusakiewicz & N. Ternès & S. Jegou & D. M. Woods & A. L. Sodré & M. Hansen & Y. Meirow & M. Sade-Feldman & A. Burra & S. S. Kwek & C. Flament & M. Messao, 2017. "Predictors of responses to immune checkpoint blockade in advanced melanoma," Nature Communications, Nature, vol. 8(1), pages 1-13, December.
    2. Norma Rallón & Marcial García & Javier García-Samaniego & Alfonso Cabello & Beatriz Álvarez & Clara Restrepo & Sara Nistal & Miguel Górgolas & José M Benito, 2018. "Expression of PD-1 and Tim-3 markers of T-cell exhaustion is associated with CD4 dynamics during the course of untreated and treated HIV infection," PLOS ONE, Public Library of Science, vol. 13(3), pages 1-14, March.
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