Evidence map›Paper›PMID 41555292›Full record

SynthesisBMC cancer2026

Efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy in breast cancer: a systematic review and meta-analysis with focus on triple-negative subtype and immune-related adverse events.

Aisaide Aikelaimu, Weiwei Li, Mirinsa Kaicaier, Shengjie Liu, Yuhan Zhang, Xueping Hou, Yuying Wang, Liyuan Ma, Weihua Jiang

Abstract readSystematic ReviewMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. 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

9 authors.

Aisaide AikelaimuThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Weiwei LiThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Mirinsa KaicaierThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Shengjie LiuThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Yuhan ZhangThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Xueping HouThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Yuying WangThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Liyuan MaThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China.
Weihua JiangThe Second Department of Breast Surgery, The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi, 841100, China. jsh610@163.com.

Funding

The author(s) declare financial support was received for the research and/or publication of this article. This work was funded by the Outstanding Youth Science Fund of China 2024D01E28
6 · The paper itself

Abstract

objectiveTo systematically evaluate the efficacy and safety of chemotherapy combined with PD-1/PD-L1 inhibitors in breast cancer, thereby informing clinical decision-making.

methodsA comprehensive search was conducted in PubMed, Cochrane Library, Embase, CNKI, Wanfang, and VIP databases from inception to August 2025 for randomized controlled trials (RCTs) comparing chemotherapy plus PD-1/PD-L1 inhibitors versus chemotherapy alone in breast cancer. Two reviewers independently screened studies, extracted data, and assessed quality using the Cochrane risk of bias tool. Meta-analysis was performed using RevMan 5.3. Primary outcomes were progression-free survival (PFS) and pathological complete response (pCR). Secondary outcomes included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AEs).

resultsNineteen RCTs involving 6,546 patients were included. The combination therapy significantly improved pCR(OR = 1.83, 95% CI 1.28–2.62, P < 0.001), PFS (HR = 0.81, 95% CI 0.76–0.87, P < 0.00001), and ORR (OR = 0.62, 95% CI 0.39–0.96, P = 0.03) compared to chemotherapy alone. OS was significantly improved in the combination group (HR = 0.87, 95% CI 0.81–0.94, P = 0.0007). No significant difference was found in CBR (P = 0.07). Safety analysis revealed a higher incidence of grade ≥ 2 AEs (OR = 1.13, P < 0.001), primarily non-hematological toxicities, and a significant increase in immune-related adverse events (irAEs), which were predominantly grade 1–2. Subgroup analyses indicated greater benefit in triple-negative breast cancer (TNBC) and PD-L1-positive populations, with optimal PFS observed with taxane-based regimens.

conclusionsThe addition of PD-1/PD-L1 inhibitors to chemotherapy significantly enhances efficacy in breast cancer, particularly for patients with PD-L1-positive TNBC, at the cost of an increased but manageable risk of low-grade irAEs. Clinical implementation should be guided by biomarker testing and proactive toxicity monitoring.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorTriple Negative Breast NeoplasmsFemaleHumansRandomized Controlled Trials as TopicTreatment OutcomeB7-H1 AntigenCD274 protein, humanImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 ReceptorBreast cancerChemotherapyEfficacyMeta-analysisPD-1 inhibitorPD-L1 inhibitorSafety

Identifiers

PMID41555292
PMCPMC12905840

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.