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

Cescon, DW; Schmid, P; Rugo, HS; Im, SA; Md Yusof, M; Gallardo, C; Lipatov, O; Barrios, CH; Perez-Garcia, J; Iwata, H; Masuda, N; Otero, MT; Gokmen, E; Loi, S; Haiderali, A; Zhou, X; Guo, Z; Nguyen, AM; Cortes, J

Author(s): Cescon, DW; Schmid, P; Rugo, HS; Im, SA; Md Yusof, M; Gallardo, C; Lipatov, O; Barrios, CH; Perez-Garcia, J; Iwata, H; Masuda, N; Otero, MT; Gokmen, E; Loi, S; Haiderali, A; Zhou, X; Guo, Z; Nguyen, AM; Cortes, J;
Details: Publication Year 2024-05-08,Volume 116,Issue #5,Page 717-727
Journal Title: Journal of the National Cancer Institute
Publication Type: Research article
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).
Publisher: Oxford University Press
Keywords: Humans; *Antibodies, Monoclonal, Humanized/administration & dosage/therapeutic use; *Quality of Life; Female; *Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse effects; *Triple Negative Breast Neoplasms/drug therapy; *Paclitaxel/administration & dosage; Middle Aged; *Patient Reported Outcome Measures; Adult; Aged; Carboplatin/administration & dosage; Gemcitabine; Deoxycytidine/analogs & derivatives/administration & dosage; Double-Blind Method; B7-H1 Antigen/metabolism; Albumins
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.1093/jnci/djad240
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-07-04 12:38:03

Last Modified: 2024-07-04 12:38:35