Health-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355

Cescon DW 1 , Schmid P 2 , Rugo HS 3 , Im SA 4 , Md Yusof M 5 , Gallardo C 6 Show all authors , Lipatov O 7 , Barrios CH 8 , Perez-Garcia J 9 , Iwata H 10 , Masuda N 11 , Otero MT 12 , Gokmen E 13 , Loi S 14 , Haiderali A 15 , Zhou X 15 , Guo Z 15 , Nguyen AM 15 , Cortes J 16

Affiliations 

  • 1 Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada
  • 2 Centre of Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK
  • 3 Department of Medicine, University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA
  • 4 Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea
  • 5 Cancer Center, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
  • 6 Oncology Institute, Arturo Lopez Perez Foundation, Santiago, Chile
  • 7 Department of Oncology, Republican Clinical Oncology Dispensary, Republic of Bashkortostan, Ufa, Russian Federation
  • 8 Latin American Cooperative Oncology Group (LACOG), Oncology Research Center HSL/PUCRS, Oncoclinicas Group, Porto Alegre, Brazil
  • 9 International Breast Cancer Center, Pangaea Oncology, Quirónsalud Group, Barcelona, and Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, NJ, USA
  • 10 Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
  • 11 Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • 12 Department of Hematology and Oncology, Oncomedica S.A.S, Monteria, Colombia
  • 13 Department of Internal Medicine, Ege University Medical Faculty, Izmir, Turkey
  • 14 Division of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia
  • 15 Merck & Co., Inc., Rahway, NJ, USA
  • 16 International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Madrid and Barcelona, Spain
J Natl Cancer Inst, 2024 May 08;116(5):717-727.
PMID: 38070159 DOI: 10.1093/jnci/djad240

Abstract

BACKGROUND: In KEYNOTE-355 (NCT02819518), the addition of pembrolizumab to chemotherapy led to statistically significant improvements in progression-free survival and overall survival in patients with advanced triple-negative breast cancer with tumor programmed cell death ligand 1 (PD-L1) combined positive score of at least 10. We report patient-reported outcomes from KEYNOTE-355.

METHODS: Patients were randomly assigned 2:1 to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus investigator's choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Breast Cancer-Specific Quality of Life Questionnaire, and EuroQol 5-Dimension questionnaire visual analog scale were prespecified. Patient-reported outcomes were analyzed for patients who received at least 1 dose of study treatment and completed at least 1 patient-reported outcome assessment. Changes in patient-reported outcome scores from baseline were assessed at week 15 (latest time point at which completion and compliance rates were at least 60% and at least 80%, respectively). Time to deterioration in patient-reported outcomes was defined as time to first onset of at least a 10-point worsening in score from baseline.

RESULTS: Patient-reported outcome analyses included 317 patients with tumor PD-L1 combined positive score of at least 10 (pembrolizumab plus chemotherapy: n = 217; placebo plus chemotherapy: n = 100). There were no between-group differences in change from baseline to week 15 in QLQ-C30 global health status/quality of life (QOL; least-squares mean difference = -1.81, 95% confidence interval [CI] = -6.92 to 3.30), emotional functioning (least-squares mean difference = -1.43, 95% CI = -7.03 to 4.16), physical functioning (least-squares mean difference = -1.05, 95% CI = -6.59 to 4.50), or EuroQol 5-Dimension questionnaire visual analog scale (least-squares mean difference = 0.18, 95% CI = -5.04 to 5.39) and no between-group difference in time to deterioration in QLQ-C30 global health status/QOL, emotional functioning, or physical functioning.

CONCLUSIONS: Together with the efficacy and safety findings, patient-reported outcome results from KEYNOTE-355 support pembrolizumab plus chemotherapy as a standard of care for patients with advanced triple-negative breast cancer with tumor PD-L1 expression (combined positive score ≥10).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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