Evidence map›Paper›PMID 39436619›Full record

ArticleAnnals of surgical oncology2025

Real-World Outcomes with the KEYNOTE-522 Regimen in Early-Stage Triple-Negative Breast Cancer.

Casey Connors, Stephanie A Valente, Ayat ElSherif, Paula Escobar, Anna Chichura, Lauren Kopicky, Erin Roesch, Julie Ritner, Patrick McIntire, Yueqi Wu and 2 more

Abstract read
In one paragraph

Article in Annals of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

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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

12 authors.

Casey ConnorsDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Stephanie A ValenteDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Ayat ElSherifDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Paula EscobarDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Anna ChichuraDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Lauren KopickyDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Erin RoeschDepartment of Medical Oncology, Cleveland Clinic, Cleveland, OH, USA.
Julie RitnerDepartment of Radiology, Cleveland Clinic, Cleveland, OH, USA.
Patrick McIntireDepartment of Pathology, Cleveland Clinic, Cleveland, OH, USA.
Yueqi WuDepartment of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Chao TuDepartment of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Julie E LangDepartment of Breast Surgery, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. langj2@ccf.org.ORCID http://orcid.org/0000-0002-7534-6124

Funding

TUMOR METABOLISM PROGRAMP30CA043703 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Amar Desai · 1987 to 2026
$142.3M
NCI NIH HHS P30 CA043703
6 · The paper itself

Abstract

backgroundThis study aimed to determine if the neoadjuvant (NAT) KEYNOTE-522 regimen was associated with higher rates of pathologic complete response (pCR), corresponding to higher rates of breast conservation therapy (BCT) in early-stage triple-negative breast cancer (TNBC) patients. PATIENTS AND

methodsStage II-III TNBC patients diagnosed between 2019 and 2022 who underwent NAT were analyzed retrospectively. NAT with KEYNOTE-522 versus control NAT were compared for rates of BCT, axillary node dissection (ALND), pCR, and survival outcomes. The prevalence of immune-related adverse events (irAE) from chemoimmunotherapy was recorded.

resultsOf 240 patients identified: 86 received KEYNOTE-522 and 154 received control. The frequency of pCR was significantly higher in KEYNOTE versus the control cohort, 59.3% and 33.1%, respectively (p = 0.001). There was no significant difference in the rate of BCT between the control (33.1%) and the KEYNOTE-522 (32.1%) groups (p = 0.47). Rates of ALND were significantly lower with KEYNOTE-522 (25.6%) as compared with control (39.6%); p = 0.03. The rate of development of grade 2 or higher irAEs was 34.9%. At a median follow-up of 2.4 years, there was no difference in survival outcomes. BRCA1 patients had high rates of pCR regardless of treatment group, KEYNOTE-522: 80.0% (4/5) and control: 75% (9/12), (p = 1).

conclusionThis real-world evidence supports the use of the KEYNOTE-522 regimen in patients with early-stage TNBC given the higher pCR rate and corresponding decrease in the rate of ALND. The majority of patients in both NAT cohorts became BCT eligible, but the rate of BCT did not differ between the two groups.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoadjuvant TherapyTriple Negative Breast NeoplasmsAdultAgedCyclophosphamideFemaleFollow-Up StudiesHumansLymph Node ExcisionMastectomy, SegmentalMiddle AgedNeoplasm StagingPrognosisRetrospective StudiesSurvival RateCyclophosphamidefludarabineVidarabineBreast conservation therapyImmune-related adverse eventsImmunotherapyKEYNOTE-522Pathologic complete responsePembrolizumabTriple-negative breast cancer

Identifiers

PMID39436619
PMCPMC11843215

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.