Trial reportJournal of the National Cancer Institute2024
Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study.
Trial report in Journal of the National Cancer Institute, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036488 (A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer), which is not on this map. Cited by 28 papers, 8 of them syntheses that pooled 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.
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.
A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Who cites it
28 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Pharmacotherapy for older adults with cancer: a digest of the Japanese clinical practice guidelines (second edition)-breast cancer.International journal of clinical oncology · 2026Guideline
- A Model-Based Meta-Analysis of Pembrolizumab Effects on Patient-Reported Quality of Life: Advancing Patient-Centered Oncology Drug Development.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Potential beneficial effects of PD-1/PD-L1 blockade in Alzheimer's disease: a systematic review and meta-analysis of preclinical and clinical studies.Molecular psychiatry · 2026Pooled it
- Microbiome and Response to Therapy in Triple Negative Breast Cancer: A Systematic Review.Oncology research · 2026Pooled it
- Efficacy and safety of immune checkpoint inhibitors plus chemotherapy in early-stage triple-negative breast cancer: a systematic review and meta-analysis.Frontiers in oncology · 2026Pooled it
- PD-1/PD-L1 inhibitors combined with chemotherapy or as monotherapy versus chemotherapy alone or observation in triple-negative breast cancer: a systematic review and updated meta-analysis incorporating long-term survival data.Frontiers in immunology · 2026Pooled it
- Efficacy, safety, and PD-L1-defined outcomes of neoadjuvant immune checkpoint inhibitors in early-stage triple-negative breast cancer: a systematic review and meta-analysis.Frontiers in immunology · 2026Pooled it
- Immune checkpoint inhibitors plus chemotherapy for early-stage or locally -advanced triple-negative breast cancer: a systematic review and Bayesian network meta-analysis of randomized trials.Frontiers in oncology · 2026Pooled it
- Exploring trop-2-directed ADCs monotherapy and combination therapy in pretreated mTNBC: a real-world study.Breast cancer research and treatment · 2026Article
- Glycosylated extracellular matrix drives immune suppression by modulating macrophage-T cell crosstalk in triple-negative breast cancer.Nature communications · 2026Article
- Identification of a prognostic model using immune related genes combined with tumour mutational burden and T cell infiltration in triple-negative breast cancer.Oncology letters · 2026Article
- When Survival Improves But Quality of Life Does Not: A Model-Based Meta-Analysis of Immune Checkpoint Inhibitors.medRxiv : the preprint server for health sciences · 2026Article
- Real-world outcome of neoadjuvant therapy with or without pembrolizumab for triple-negative breast cancer.Acta oncologica (Stockholm, Sweden) · 2026Article
- Review
- Adjuvant chemotherapy combined with pembrolizumab immunotherapy for primary triple-negative neuroendocrine carcinoma of the breast: a case report and literature review.Frontiers in immunology · 2026Review
- Immune Checkpoint Inhibitors in Breast Cancer: Mechanisms, Biomarkers, and Future Therapeutic Strategies.Therapeutics and clinical risk management · 2026Review
- Immunotherapy in Asia: current insights and prospects in Southeast Asia and Malaysia.Frontiers in oncology · 2026Review
- Immunotherapy innovations in triple-negative breast cancer: targeting checkpoints, combinations, and biomarkers.Oncology reviews · 2026Review
- The Impact of Novel Therapies on Quality-of-Life in Triple-Negative Breast Cancer: A Systematic Review of Clinical Trials.Cancers · 2025Review
- Treatment toxicities and pathological response through the evolution of neoadjuvant regimens in early triple-negative breast cancer.ESMO real world data and digital oncology · 2025Article
Corrections and comments
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Authors and funding
20 authors.
Funding
Abstract
backgroundIn KEYNOTE-522 (NCT03036488), neoadjuvant pembrolizumab plus chemotherapy and then adjuvant pembrolizumab significantly improved pathological complete response and event-free survival vs neoadjuvant chemotherapy in early-stage triple-negative breast cancer (TNBC). We report patient-reported outcomes (PROs) from KEYNOTE-522.
methodsPatients were randomized 2:1 to neoadjuvant pembrolizumab 200 mg or placebo every 3 weeks, plus 4 cycles of paclitaxel plus carboplatin and then 4 cycles of doxorubicin (or epirubicin) plus cyclophosphamide. After surgery, patients received adjuvant pembrolizumab or placebo for up to 9 cycles. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) were prespecified secondary objectives. Between-group differences in least squares (LS) mean change from baseline (day 1 of cycle 1 in both neoadjuvant and adjuvant phases) to the prespecified latest time point with at least 60% completion and at least 80% compliance were assessed using a longitudinal model (no alpha error assigned).
resultsWeek 21 (neoadjuvant phase) and week 24 (adjuvant phase) were the latest time points at which completion/compliance rates were ≥60%/80%. In the neoadjuvant phase, between-group differences (pembrolizumab plus chemotherapy [n = 762] vs placebo plus chemotherapy [n = 383]) in LS mean change from baseline to week 21 in QLQ-C30 global health status/quality of life (GHS/QoL), emotional functioning, and physical functioning were -1.04 (95% confidence interval = -3.46 to 1.38), -0.69 (95% CI = -3.13 to 1.75), and -2.85 (95% CI = -5.11 to -0.60), respectively. In the adjuvant phase, between-group differences (pembrolizumab [n = 539] vs placebo [n = 308]) in LS mean change from baseline to week 24 were -0.41 (95% CI = -2.60 to 1.77), -0.60 (95% CI = -2.99 to 1.79), and -1.57 (95% CI = -3.36 to 0.21).
conclusionsNo substantial differences in PRO assessments were observed between neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab vs neoadjuvant placebo plus chemotherapy in early-stage TNBC.
trial registrationClinicalTrials.gov, NCT03036488.
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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.