Evidence map›Paper›PMID 42372581›Full record

SynthesisBreast (Edinburgh, Scotland)2026

Toxicity profile and tolerability of immune checkpoint inhibitors for the treatment of early-stage breast cancer: a systematic review and meta-analysis.

Maria Inez Dacoregio, Caio Ernesto do Rego Castro, Isadora Mamede, Cainã Gonçalves Rodrigues, João Pedro Thimotheo Batista, Isabella Michelon, Paulo Zattar Ribeiro, José Reinaldo de Oliveira Junior, Renata Colombo Bonadio, Maysa Vilbert and 1 more

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

1 citing paper in PubMed.

  1. 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

11 authors.

Maria Inez DacoregioDepartment of Medical Genetics, University of São Paulo, São Paulo, SP, Brazil. Electronic address: m.dacoregio2707@gmail.com.
Caio Ernesto do Rego CastroDepartment of Internal Medicine, University of São Paulo, SP, Brazil. Electronic address: caioernestorc@gmail.com.
Isadora MamedeDepartment of Medicine, Federal University of São João del Rei, Divinopolis, MG, Brazil. Electronic address: isamamede1@gmail.com.
Cainã Gonçalves RodriguesDepartment of Medicine, Federal University of Ceará, Fortaleza, Brazil. Electronic address: cainagrodrigues@alu.ufc.br.
João Pedro Thimotheo BatistaDepartment of Internal Medicine, MetroWest Medical Center, Framingham, MA, USA. Electronic address: timotio.batista@gmail.com.
Isabella MichelonDivision of Hematology and Oncology, University of Virginia Comprehensive Cancer Center, Charlottesville, VA, USA. Electronic address: isabella.michelon20@gmail.com.
Paulo Zattar RibeiroDepartment of Medical Genetics, University of Sao Paulo of Ribeirão Preto - USP RP, Ribeirão Preto, SP, Brazil. Electronic address: paulovictor.genetica@gmail.com.
José Reinaldo de Oliveira JuniorDepartment of Clinical Oncology, AC Camargo Cancer Center, São Paulo, SP, Brazil. Electronic address: jrooliveirajunior@gmail.com.
Renata Colombo BonadioInstituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, Brazil. Electronic address: rrccbonadio@gmail.com.
Maysa VilbertH. Lee Moffitt Cancer Centre and Research Institute, Morsani College of Medicine, Tampa, FL, USA. Electronic address: msilveiravilbertpereira@mgh.harvard.edu.
Ricardo Lima Barros CostaH. Lee Moffitt Cancer Centre and Research Institute, Morsani College of Medicine, Tampa, FL, USA. Electronic address: ricardo.costa@moffitt.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 axis have demonstrated clinical benefit in early-stage breast cancer (eBC), enhancing antitumor immune responses. However, their incorporation into perioperative polychemotherapy has introduced new concerns regarding safety and immune-related toxicities (irAEs). We conducted a systematic review and meta-analysis to comprehensively evaluate the safety profile and tolerability of ICIs in patients with eBC.

methodsA systematic review was conducted in PubMed, Embase, Cochrane Library, and relevant conference databases (ASCO, ESMO) to identify clinical trials reporting safety outcomes of ICIs in eBC. Data were analyzed using R (v4.2.2), applying random-effects models for both single-arm and comparative (pairwise) analyses.

resultsThirteen studies were included, comprising 3977 patients across all studies, including 3138 treated with ICI-containing regimens and 839 controls. For comparative pairwise analyses, 2715 patients received ICI-based therapy and 2399 received chemotherapy alone. The most frequently reported all-grade AEs in ICI arms were alopecia (AR 86.49%, 95% CI: 59.25-96.57) and leukopenia (AR 52.09%, 95% CI: 15.14-86.89). For grade ≥3 events, decreased neutrophil count (AR 17.88%, 95% CI: 10.65-28.44) and neutropenia (AR 18.19%, 95% CI: 10.81-28.96) were most common. The most common irAE was hypothyroidism (AR 12.70%, 95% CI: 9.27-17.16), while the most frequent severe irAE (grade ≥3) was adrenal insufficiency (AR 1.47%, 95% CI: 0.68-3.12).

conclusionThis meta-analysis provides a comprehensive evaluation of ICI safety in eBC. While most AEs were low-grade and manageable, significant risks of endocrine irAEs-particularly adrenal insufficiency and thyroid dysfunction-were identified. These findings underscore the need for proactive monitoring and highlight the importance of future research to better understand the mechanisms of ICI-related toxicity and to develop strategies for its prevention.

Indexed as

Breast NeoplasmsImmune Checkpoint InhibitorsAlopeciaFemaleHumansHypothyroidismNeoplasm StagingImmune Checkpoint InhibitorsAdverse eventsBreast cancerImmune checkpoint inhibitorsPD-L1Programmed cell death-ligand 1SafetyTolerabilityToxicity

Identifiers

PMID42372581
PMCPMC13330674

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.