Evidence map›Paper›PMID 35903931›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC.

Julia Foldi, Adriana Kahn, Andrea Silber, Tao Qing, Emily Reisenbichler, Neal Fischbach, Justin Persico, Kerin Adelson, Anamika Katoch, Anees Chagpar and 5 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  11. Associations of Immune Checkpoint Predictive Biomarkers (MHC-I and MHC-II) with Clinical and Molecular Features in a Diverse Breast Cancer Cohort.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Julia FoldiSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.ORCID 0000-0002-7504-867X
Adriana KahnSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.ORCID 0000-0002-5306-0571
Andrea SilberSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.ORCID 0000-0002-3339-6959
Tao QingSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.
Emily ReisenbichlerDepartment of Pathology, Saint Louis University, St. Louis, Missouri.
Neal FischbachSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.
Justin PersicoSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.
Kerin AdelsonSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.
Anamika KatochSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.
Anees ChagparDepartment of Surgery, Yale School of Medicine, New Haven, Connecticut.
Tristen ParkDepartment of Surgery, Yale School of Medicine, New Haven, Connecticut.
Adam BlanchardSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.
Kim BlenmanSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.ORCID 0000-0001-6070-0728
David L RimmDepartment of Pathology, Yale School of Medicine, New Haven, Connecticut.ORCID 0000-0001-5820-4397
Lajos PusztaiSection of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.ORCID 0000-0001-9632-6686
Yale Cancer Center · USYale University · USUniversity of Missouri–St. Louis · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Immune biological differences between Triple Negative Breast Cancer in African American and non-African American women and potential immunotherapy opportunities to improve treatment outcomeR01CA219647 · NCI · YALE UNIVERSITY · PI PUSZTAI, LAJOS · 2017 to 2020
$2.0M
NCATS NIH HHS UL1 TR001863NCI NIH HHS R01 CA219647
6 · The paper itself

Abstract

purposeThe incidence of triple-negative breast cancer (TNBC) is higher among Black or African American (AA) women, yet they are underrepresented in clinical trials. To evaluate safety and efficacy of durvalumab concurrent with neoadjuvant chemotherapy for stage I-III TNBC by race, we enrolled additional AA patients to a Phase I/II clinical trial. PATIENTS AND

methodsOur study population included 67 patients. The primary efficacy endpoint was pathologic complete response (pCR; ypT0/is, N0) rate. χ2 tests were used to evaluate associations between race and baseline characteristics. Cox proportional hazards models were used to assess association between race and overall survival (OS) and event-free survival (EFS). Multivariate logistic regression analyses were used to evaluate associations between race and pCR, immune-related adverse events (irAE) and recurrence.

resultsTwenty-one patients (31%) self-identified as AA. No significant associations between race and baseline tumor stage (P = 0.40), PD-L1 status (0.92), and stromal tumor-infiltrating lymphocyte (sTIL) count (P = 0.57) were observed. pCR rates were similar between AA (43%) and non-AA patients (48%; P = 0.71). Three-year EFS rates were 78.3% and 71.4% in non-AA and AA patients, respectively [HR, 1.451; 95% confidence interval (CI), 0.524-4.017; P = 0.474]; 3-year OS was 87% and 81%, respectively (HR, 1.72; 95% CI, 0.481-6.136; P = 0.405). The incidence of irAEs was similar between AA and non-AA patients and no significant associations were found between irAEs and pathologic response.

conclusionspCR rates, 3-year OS and EFS after neoadjuvant immunotherapy and chemotherapy were similar in AA and non-AA patients. Toxicities, including the frequency of irAEs, were also similar.

Indexed as

Breast NeoplasmsTriple Negative Breast NeoplasmsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkersFemaleHumansNeoadjuvant TherapyAntibodies, MonoclonalBiomarkersdurvalumab

Identifiers

PMID35903931
PMCPMC9444984
OpenAlexW4288489119

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.