Evidence map›Paper›PMID 33558513›Full record

ArticleNPJ breast cancer2021

Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer.

Julia Foldi, Andrea Silber, Emily Reisenbichler, Kamaljeet Singh, Neal Fischbach, Justin Persico, Kerin Adelson, Anamika Katoch, Nina Horowitz, Donald Lannin and 11 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 45 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 4 pooled it
4.6field-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.

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

45 citing papers in PubMed, 4 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Association of tumor-infiltrating lymphocytes with clinical outcomes in patients with triple-negative breast cancer receiving neoadjuvant chemotherapy: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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  8. Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 3 institutions in 2 countries.

Julia FoldiSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.ORCID http://orcid.org/0000-0002-7504-867X
Andrea SilberSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Emily ReisenbichlerDepartment of Pathology, Yale School of Medicine, New Haven, CT, USA.ORCID http://orcid.org/0000-0002-1570-6538
Kamaljeet SinghDepartment of Pathology, Yale School of Medicine, New Haven, CT, USA.
Neal FischbachSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Justin PersicoSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Kerin AdelsonSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Anamika KatochSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Nina HorowitzDepartment of Surgery, Yale School of Medicine, New Haven, CT, USA.
Donald LanninDepartment of Surgery, Yale School of Medicine, New Haven, CT, USA.
Anees ChagparDepartment of Surgery, Yale School of Medicine, New Haven, CT, USA.
Tristen ParkDepartment of Surgery, Yale School of Medicine, New Haven, CT, USA.
Michal MarczykSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.ORCID http://orcid.org/0000-0003-2508-5736
Courtney FrederickSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Trisha BurrelloSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Eiman IbrahimSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.ORCID http://orcid.org/0000-0002-7445-6540
Tao QingSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
Yalai BaiDepartment of Pathology, Yale School of Medicine, New Haven, CT, USA.
Kim BlenmanSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA.
David L RimmDepartment of Pathology, Yale School of Medicine, New Haven, CT, USA.ORCID http://orcid.org/0000-0001-5820-4397
Lajos PusztaiSection of Medical Oncology, Yale School of Medicine, New Haven, CT, USA. lajos.pusztai@yale.edu.ORCID http://orcid.org/0000-0001-9632-6686
Yale University · USSilesian University of Technology · PLYale Cancer Center · 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
YALE CANCER CENTER CALABRESI IMMUNO-ONCOLOGY TRAINING PROGRAMK12CA215110 · NCI · YALE UNIVERSITY · PI Harriet M. Kluger · 2018 to 2026
$6.1M
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 K12 CA215110NCI NIH HHS R01 CA219647Susan G. Komen (Susan G. Komen Breast Cancer Foundation) SAC160076
6 · The paper itself

Abstract

The goal of this Phase I/II trial is to assess the safety and efficacy of administering durvalumab concurrent with weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide (ddAC) neoadjuvant therapy for stages I-III triple-negative breast cancer. The primary endpoint is pathologic complete response (pCR:ypT0/is, ypN0). The response was correlated with PDL1 expression and stromal tumor-infiltrating lymphocytes (sTILs). Two dose levels of durvalumab (3 and 10 mg/kg) were assessed. PD-L1 was assessed using the SP263 antibody; ≥1% immune and tumor cell staining was considered positive; sTILs were calculated as the area occupied by mononuclear inflammatory cells over the total intratumoral stromal area. 59 patients were evaluable for toxicity and 55 for efficacy in the Phase II study (10 mg/kg dose). No dose-limiting toxicities were observed in Phase I. In Phase II, pCR rate was 44% (95% CI: 30-57%); 18 patients (31%) experienced grade 3/4 treatment-related adverse events (AE), most frequently neutropenia (n = 4) and anemia (n = 4). Immune-related grade 3/4 AEs included Guillain-Barre syndrome (n = 1), colitis (n = 2), and hyperglycemia (n = 2). Of the 50 evaluable patients for PD-L1, 31 (62%) were PD-L1 positive. pCR rates were 55% (95% CI: 0.38-0.71) and 32% (95% CI: 0.12-0.56) in the PD-L1 positive and negative groups (p = 0.15), respectively. sTIL counts were available on 52 patients and were significantly higher in the pCR group (p = 0.0167). Concomitant administration of durvalumab with sequential weekly nab-paclitaxel and ddAC neoadjuvant chemotherapy resulted in a pCR rate of 44%; pCR rates were higher in sTIL-high cancers.

Identifiers

PMID33558513
PMCPMC7870853
OpenAlexW3127886518

What OpenQuestion holds

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Registered trials

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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.