Evidence map›Paper›PMID 38538574›Full record

Trial reportNature communications2024

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 and 19 more

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03487666 (OXEL), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03487666 phase2completednot on this map

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy

TypeinterventionalSponsorGeorgetown UniversityRan2018 to 2024Enrolled45ConditionsTriple Negative Breast CancerArmsNivolumab, Capecitabine
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  3. Ultrasound-activated CuJournal of nanobiotechnology · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 12 institutions in 1 country.

Filipa Lynce *Division of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Filipa_Lynce@dfci.harvard.edu.ORCID http://orcid.org/0000-0001-6615-7076
Candace Mainor *MedStar Georgetown University Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0002-4431-7101
Renee N Donahue *Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-6828-3073
Xue GengGeorgetown University, Washington, DC, USA.ORCID http://orcid.org/0000-0003-4100-9899
Greg JonesNeoGenomics, Durham, NC, USA.ORCID http://orcid.org/0000-0001-9652-0294
Ilana SchlamMedStar Washington Hospital Center, Washington, DC, USA.ORCID http://orcid.org/0000-0003-4996-0400
Hongkun WangGeorgetown University, Washington, DC, USA.
Nicole J ToneyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Caroline JochemsCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-9000-9855
Jeffrey SchlomCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0001-7932-4072
Jay ZeckMedStar Georgetown University Hospital, Washington, DC, USA.ORCID http://orcid.org/0009-0007-8847-7223
Christopher GallagherMedStar Washington Hospital Center, Washington, DC, USA.ORCID http://orcid.org/0000-0002-3846-5052
Rita NandaUniversity of Chicago, Chicago, IL, USA.ORCID http://orcid.org/0000-0001-5248-0876
Deena GrahamHackensack University Medical Center, Hackensack, NJ, USA.ORCID http://orcid.org/0000-0003-1111-6984
Erica M Stringer-ReasorUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Neelima DenduluriAstraZeneca, Arlington, VA, USA.ORCID http://orcid.org/0000-0002-6075-6809
Julie CollinsMedStar Georgetown University Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0001-5702-4693
Ami ChitaliaMedStar Washington Hospital Center, Washington, DC, USA.ORCID http://orcid.org/0009-0001-0274-2150
Shruti TiwariMedStar Washington Hospital Center, Washington, DC, USA.
Raquel NunesJohns Hopkins Sidney Kimmel Cancer Center, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-0552-1644
Rebecca KaltmanInova, Fairfax, VA, USA.
Katia KhouryUniversity of Alabama at Birmingham, Birmingham, AL, USA.ORCID http://orcid.org/0000-0003-3899-8649
Margaret Gatti-MaysThe Ohio State University, Columbus, OH, USA.
Paolo TarantinoDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0001-8686-0228
Sara M TolaneyDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-5940-8671
Sandra M SwainGeorgetown University, Washington, DC, USA.ORCID http://orcid.org/0000-0002-1320-3830
Paula PohlmannMedStar Georgetown University Hospital, Washington, DC, USA.
Heather A ParsonsDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0001-8178-6612
Claudine IsaacsGeorgetown University, Washington, DC, USA.ORCID http://orcid.org/0000-0002-9646-1260
Georgetown University · USHarvard University · USMedStar Washington Hospital Center · USNational Institutes of Health · USUniversity of Alabama at Birmingham · USAstraZeneca (United States) · USHackensack University Medical Center · USInova Fairfax Hospital · USJohns Hopkins University · USNeoGenomics (United States) · USThe Ohio State University · USUniversity of Illinois Chicago · US

Funding

XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Omer Jamy · 1985 to 2026
$165.9M
Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI MARCUS S NOEL · 1990 to 2026
$71.5M
Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZIABC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2025
$19.3M
NCI NIH HHS P30 CA013148NCI NIH HHS P30 CA051008
6 · The paper itself

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 a combination of nivolumab plus capecitabine leads to a greater increase in PIS from baseline to week 6 (91%) compared with nivolumab (47%) or capecitabine (53%) alone (log-rank p = 0.08), 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.

Indexed as

NivolumabTriple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineFemaleHumansNeoadjuvant TherapyNeoplasm Recurrence, LocalCapecitabineNivolumab

Identifiers

PMID38538574
PMCPMC10973408
OpenAlexW4393234008

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.