دورية أكاديمية
Health-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355.
| العنوان: | Health-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355. |
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| المؤلفون: | Cescon DW; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada., Schmid P; Centre of Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK., Rugo HS; Department of Medicine, University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA., Im SA; Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea., Md Yusof M; Cancer Center, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia., Gallardo C; Oncology Institute, Arturo Lopez Perez Foundation, Santiago, Chile., Lipatov O; Department of Oncology, Republican Clinical Oncology Dispensary, Republic of Bashkortostan, Ufa, Russian Federation., Barrios CH; Latin American Cooperative Oncology Group (LACOG), Oncology Research Center HSL/PUCRS, Oncoclinicas Group, Porto Alegre, Brazil., Perez-Garcia J; International Breast Cancer Center, Pangaea Oncology, Quirónsalud Group, Barcelona, and Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, NJ, USA., Iwata H; Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan., Masuda N; Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan., Otero MT; Department of Hematology and Oncology, Oncomedica S.A.S, Monteria, Colombia., Gokmen E; Department of Internal Medicine, Ege University Medical Faculty, Izmir, Turkey., Loi S; Division of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.; The Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Australia., Haiderali A; Merck & Co., Inc., Rahway, NJ, USA., Zhou X; Merck & Co., Inc., Rahway, NJ, USA., Guo Z; Merck & Co., Inc., Rahway, NJ, USA., Nguyen AM; Merck & Co., Inc., Rahway, NJ, USA., Cortes J; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Madrid and Barcelona, Spain.; Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain. |
| المصدر: | Journal of the National Cancer Institute [J Natl Cancer Inst] 2024 May 08; Vol. 116 (5), pp. 717-727. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 7503089 Publication Model: Print Cited Medium: Internet ISSN: 1460-2105 (Electronic) Linking ISSN: 00278874 NLM ISO Abbreviation: J Natl Cancer Inst Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2003-> : Cary, NC : Oxford University Press Original Publication: Bethesda, Md., U. S. Dept. of Health, Education, and Welfare, Public Health Service, National Institutes of Health; Washington, for sale by the Supt. of Docs., U. S. Govt. Print. Off. |
| مواضيع طبية MeSH: | Antibodies, Monoclonal, Humanized*/administration & dosage , Antibodies, Monoclonal, Humanized*/therapeutic use , Quality of Life* , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/adverse effects , Triple Negative Breast Neoplasms*/drug therapy , Paclitaxel*/administration & dosage , Patient Reported Outcome Measures*, Humans ; Female ; Middle Aged ; Adult ; Aged ; Carboplatin/administration & dosage ; Gemcitabine ; Deoxycytidine/analogs & derivatives ; Deoxycytidine/administration & dosage ; Double-Blind Method ; B7-H1 Antigen/metabolism ; Albumins |
| مستخلص: | 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). (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.) |
| معلومات مُعتمدة: | Merck Sharp & Dohme LLC; Merck & Co., Inc. |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal, Humanized) DPT0O3T46P (pembrolizumab) P88XT4IS4D (Paclitaxel) BG3F62OND5 (Carboplatin) 0 (Gemcitabine) 0W860991D6 (Deoxycytidine) 0 (130-nm albumin-bound paclitaxel) 0 (B7-H1 Antigen) 0 (Albumins) |
| تواريخ الأحداث: | Date Created: 20231209 Date Completed: 20240508 Latest Revision: 20240617 |
| رمز التحديث: | 20240618 |
| DOI: | 10.1093/jnci/djad240 |
| PMID: | 38070159 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1460-2105 |
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| DOI: | 10.1093/jnci/djad240 |