Evidence map›Paper›PMID 34026336›Full record

Trial reportOncoimmunology2021

The immune microenvironment and relation to outcome in patients with advanced breast cancer treated with docetaxel with or without gemcitabine.

Elisabeth S Stovgaard, Karama Asleh, Nazia Riaz, Samuel Leung, Dongxia Gao, Lise B Nielsen, Anne-Vibeke Lænkholm, Eva Balslev, Maj-Britt Jensen, Dorte Nielsen and 1 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Oncoimmunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 9% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. The prognostic values of FOXP3Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Pooled it
  2. Review
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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

11 authors at 5 institutions in 3 countries.

Elisabeth S StovgaardDepartment of Pathology, Herlev and Gentofte, University of Copenhagen, Herlev, Denmark.ORCID https://orcid.org/0000-0002-5784-3610
Karama AslehGenetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
Nazia RiazGenetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
Samuel LeungGenetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
Dongxia GaoGenetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
Lise B NielsenDanish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Anne-Vibeke LænkholmDepartment of Surgical Pathology, Zealand University Hospital, Roskilde, Denmark.
Eva BalslevDepartment of Pathology, Herlev and Gentofte, University of Copenhagen, Herlev, Denmark.
Maj-Britt JensenDanish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Dorte NielsenDepartment of Oncology, Herlev and Gentofte, University of Copenhagen, Herlev, Denmark.
T O NielsenGenetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
University of British Columbia · CAUniversity of Copenhagen · DKCopenhagen University Hospital · DKAga Khan University · PKZealand University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Preclinical studies suggest that some effects of conventional chemotherapy, and in particular, gemcitabine, are mediated through enhanced antitumor immune responses. The objective of this study was to use material from a randomized clinical trial to evaluate whether patients with preexisting immune infiltrates responded better to treatment with gemcitabine + docetaxel (GD) compared to docetaxel alone. Formalin fixed, paraffin-embedded breast cancer tissues from SBG0102 phase 3 trial patients randomly assigned to treatment with GD or docetaxel were used. Immunohistochemical staining for CD8, FOXP3, LAG3, PD-1, PD-L1 and CD163 was performed. Tumor infiltrating lymphocytes (TILs) and tumor associated macrophages were evaluated. Prespecified statistical analyses were performed in a formal prospective-retrospective design. Time to progression was primary endpoint and overall survival secondary endpoint. Correlations between biomarker status and endpoints were evaluated using the Kaplan-Meier method and Cox proportional hazards models. Biomarker data was obtained for 237 patients. There was no difference in treatment effect according to biomarker status for the whole cohort. In planned subgroup analysis by PAM50 subtype, in non-luminal (basal-like and HER2E) breast cancers FOXP3 was a significant predictor of treatment effect with GD compared to docetaxel, with a HR of 0.22 (0.09-0.52) for tumors with low FOXP3 compared to HR 0.92 (0.47-1.80) for high FOXP3 TILs (P

Indexed as

Breast NeoplasmsDeoxycytidineDocetaxelFemaleGemcitabineHumansProspective StudiesRetrospective StudiesTumor MicroenvironmentDeoxycytidineDocetaxelGemcitabineBiomarkerclinical trialdocetaxelgemcitabineimmune microenvironmentsurvival

Identifiers

PMID34026336
PMCPMC8118411
OpenAlexW3160437920

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.