Evidence map›Paper›PMID 38105958›Full record

ArticlemedRxiv : the preprint server for health sciences2023

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

Registry-linked trialOpen access · greenAbstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03487666 (OXEL), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 12 institutions in 1 country.

Filipa LynceDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0001-6615-7076
Candace MainorMedStar Georgetown University Hospital, Washington, DC, USA.
Renee N DonahueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Xue GengGeorgetown University, Washington, DC.
Greg JonesNeoGenomics, Research Triangle Park, NC, USA.
Ilana SchlamMedStar Washington Hospital Center, Washington, DC, USA.
Hongkun WangGeorgetown University, Washington, DC.
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.
Jeffrey SchlomCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Jay ZeckMedStar Georgetown University Hospital, Washington, DC, USA.
Christopher GallagherMedStar Washington Hospital Center, Washington, DC, USA.
Rita NandaUniversity of Chicago, Chicago, IL, USA.
Deena GrahamHackensack University Medical Center, Hackensack, NJ, USA.
Erica M Stringer-ReasorUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Neelima DenduluriAstraZeneca, Arlington, VA, USA.
Julie CollinsMedStar Georgetown University Hospital, Washington, DC, USA.
Ami ChitaliaMedStar Washington Hospital Center, Washington, DC, USA.
Shruti TiwariMedStar Washington Hospital Center, Washington, DC, USA.
Raquel NunesJohns Hopkins Sidney Kimmel Cancer Center, Baltimore, MD, USA.
Rebecca KaltmanInova, Fairfax, VA, USA.
Katia KhouryUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Margaret Gatti-MaysThe Ohio State University, Columbus, OH, USA.
Paolo TarantinoDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Sara M TolaneyDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Sandra M SwainGeorgetown University, Washington, DC.
Paula PohlmannMedStar Georgetown University Hospital, Washington, DC, USA.
Heather A ParsonsDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Claudine IsaacsGeorgetown University, Washington, DC.
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

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI STEPHEN W BYERS · 1990 to 2026
$71.5M
NCI 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 include 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) was 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

breast cancercapecitabinectDNAnivolumabTNBC

Identifiers

PMID38105958
PMCPMC10723519
OpenAlexW4389338963

What OpenQuestion holds

Textmetadata
LicenceCC BY-ND
Read underepoch 390

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.