Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: Quality-of-life results from the randomized KEYNOTE-522 study

Dent R, Cortés J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Haiderali A, Jia L, Nguyen AM, Pan W, O'Shaughnessy J, Schmid P (2024)

Publication Language: English

Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 116

Pages Range: 1654-1663

Journal Issue: 10

DOI: 10.1093/jnci/djae129

Abstract

Background: In 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. Methods: Patients 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). Results: Week 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). Conclusions: No 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.

Authors with CRIS profile

Involved external institutions

Duke-NUS Medical School / 杜克—国大医学研究生院 Singapore (SG) Medica Scientia Innovation Research (MedSIR) Spain (ES) Yale School of Medicine United States (USA) (US) University of Texas Southwestern Medical Center (UT Southwestern) United States (USA) (US) Kliniken Essen-Mitte Germany (DE) Karolinska Institute Sweden (SE) Philipps-Universität Marburg Germany (DE) Sungkyunkwan University (SKKU) Korea, Republic of (KR) Westmead Hospital Australia (AU) Klinikum der Universität München Germany (DE) Hokkaido University Hospital / 北海道大学病院 Japan (JP) HELIOS Kliniken Germany (DE) Champalimaud Foundation / Fundação Champalimaud Portugal (PT) Merck & Co., Inc. / Merck Sharp & Dohme Corp (MSD) United States (USA) (US) Baylor University Medical Center United States (USA) (US) Queen Mary University of London United Kingdom (GB)

How to cite

APA:

Dent, R., Cortés, J., Pusztai, L., McArthur, H., Kümmel, S., Bergh, J.,... Schmid, P. (2024). Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: Quality-of-life results from the randomized KEYNOTE-522 study. Journal of the National Cancer Institute, 116(10), 1654-1663. https://doi.org/10.1093/jnci/djae129

MLA:

Dent, Rebecca, et al. "Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: Quality-of-life results from the randomized KEYNOTE-522 study." Journal of the National Cancer Institute 116.10 (2024): 1654-1663.

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