Evidence map›Paper›PMID 36463104›Full record

Trial reportBMC cancer2022

Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015-04 (PANGEA-Breast) study.

L de la Cruz-Merino, M Gion, J Cruz, J L Alonso-Romero, V Quiroga, F Moreno, R Andrés, M Santisteban, M Ramos, E Holgado and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03025880 (A Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Pembrolizumab and Gemcitabine in Patients With HER2-negative Advanced Breast Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

NCT03025880 phase2completednot on this map

A Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Pembrolizumab and Gemcitabine in Patients With HER2-negative Advanced Breast Cancer (ABC) "PANGEA-Breast"

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan2017 to 2021Enrolled36ConditionsAdvanced Breast CancerArmsPembrolizumab, Gemcitabine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
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

27 authors at 11 institutions in 1 country.

L de la Cruz-MerinoDepartment of Medical Oncology, Medicine Department, Virgen Macarena University Hospital, University of Seville, Dr. Fedriani St, No. 3, Seville, 41009, Spain. luis.cruz.sspa@juntadeandalucia.es.
M GionGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
J CruzGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
J L Alonso-RomeroGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
V QuirogaGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
F MorenoGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
R AndrésGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
M SantistebanGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
M RamosGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
E HolgadoGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
J CortésGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
E López-MirandaGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
A CortésDepartment of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain.
F HenaoDepartment of Medical Oncology, Medicine Department, Virgen Macarena University Hospital, University of Seville, Dr. Fedriani St, No. 3, Seville, 41009, Spain.
N Palazón-CarriónDepartment of Medical Oncology, Medicine Department, Virgen Macarena University Hospital, University of Seville, Dr. Fedriani St, No. 3, Seville, 41009, Spain.
L M RodriguezGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
I CeballosGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
A SotoDepartment of Medical Oncology, Hospital Clínico Universitario Virgen de La Arrixaca-IMIB, Murcia, Spain.
A PuertesDepartment of Medical Oncology, Hospital Clínico Universitario Virgen de La Arrixaca-IMIB, Murcia, Spain.
M CasasGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
S BenitoGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
M ChiesaGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
S BezaresGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
R CaballeroGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
C Jiménez-CorteganaMedical Biochemistry and Molecular Biology and Immunology Department, Virgen Macarena University Hospital, University of Seville, Seville, Spain.
V Sánchez-MargaletMedical Biochemistry and Molecular Biology and Immunology Department, Virgen Macarena University Hospital, University of Seville, Seville, Spain.
F RojoGEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Madrid, Spain.
GEICAM – Spanish Breast Cancer Group · ESHospital Universitario Virgen de la Arrixaca · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Virgen Macarena · ESHospital Clínico San Carlos · ESHospital La Luz · ESHospital Universitario de Canarias · ESInstitut Català d'Oncologia · ESNavarre Institute of Health Research · ESUniversidad de Sevilla · ESUniversidad Europea de Madrid · ES

Funding

MSD Investigator Initiated Studies Program
6 · The paper itself

Abstract

backgroundWe evaluated a new chemoimmunotherapy combination based on the anti-PD1 monoclonal antibody pembrolizumab and the pyrimidine antimetabolite gemcitabine in HER2- advanced breast cancer (ABC) patients previously treated in the advanced setting, in order to explore a potential synergism that could eventually obtain long term benefit in these patients.

methodsHER2-negative ABC patients received 21-day cycles of pembrolizumab 200 mg (day 1) and gemcitabine (days 1 and 8). A run-in-phase (6 + 6 design) was planned with two dose levels (DL) of gemcitabine (1,250 mg/m

resultsFourteen patients were treated with DL0, resulting in RP2D. Thirty-six patients were evaluated during the first stage of Simon's design. Recruitment was stopped as statistical assumptions were not met. The median age was 52; 21 (58%) patients had triple-negative disease, 28 (78%) visceral involvement, and 27 (75%) ≥ 2 metastatic locations. Progression disease was observed in 29 patients. ORR was 15% (95% CI, 5-32). Eight patients were treated ≥ 6 months before progression. Fourteen patients reported grade ≥ 3 treatment-related adverse events. Due to the small sample size, we did not find any clear association between immune tumor biomarkers and treatment efficacy that could identify a subgroup with higher probability of response or better survival. However, patients that experienced a clinical benefit showed decreased MDSCs levels in peripheral blood along the treatment.

conclusionPembrolizumab 200 mg and gemcitabine 1,250 mg/m

trial registrationClinicalTrials.gov and EudraCT (NCT03025880 and 2016-001,779-54, respectively). Registration dates: 20/01/2017 and 18/11/2016, respectively.

Indexed as

Breast NeoplasmsAntibodies, Monoclonal, HumanizedB7-H1 AntigenBreastFemaleGemcitabineHumansMiddle AgedAntibodies, Monoclonal, HumanizedB7-H1 AntigenGemcitabinepembrolizumabAdvanced breast cancerChemotherapyHER2-negativeMDSCsPD-L1PembrolizumabTILs

Identifiers

PMID36463104
PMCPMC9719636
OpenAlexW4311202775

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.