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

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 Nanda, Deena Graham, Erica M. Stringer-Reasor, Neelima Denduluri, Julie Collins, Ami Chitalia, Shruti Tiwari, Raquel Nunes, Rebecca Kaltman, Katia Khoury, Margaret Gatti-Mays, Paolo Tarantino, Sara M. Tolaney, Sandra M. Swain, Paula Pohlmann, Heather A. Parsons and Claudine Isaacs
Additional contact information
Filipa Lynce: Dana-Farber Cancer Institute
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
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
Ami Chitalia: MedStar Washington Hospital Center
Shruti Tiwari: MedStar Washington Hospital Center
Raquel Nunes: Johns Hopkins Sidney Kimmel Cancer Center
Rebecca Kaltman: Inova
Katia Khoury: University of Alabama at Birmingham
Margaret Gatti-Mays: The Ohio State University
Paolo Tarantino: Dana-Farber Cancer Institute
Sara M. Tolaney: Dana-Farber Cancer Institute
Sandra M. Swain: Georgetown University
Paula Pohlmann: MedStar Georgetown University Hospital
Heather A. Parsons: Dana-Farber Cancer Institute
Claudine Isaacs: Georgetown University

Nature Communications, 2024, vol. 15, issue 1, 1-17

Abstract: 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.

Date: 2024
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DOI: 10.1038/s41467-024-46961-x

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