دورية أكاديمية
Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Primary results from PALOMA-4.
| العنوان: | Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Primary results from PALOMA-4. |
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| المؤلفون: | Xu B; National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: xubinghe@medmail.com.cn., Hu X; Fudan University Shanghai Cancer Center, Shanghai, China., Li W; The First Hospital of Jilin University, Changchun, China., Sun T; Cancer Hospital of China Medical University/Liaoning Cancer Hospital, Shenyang, Liaoning, China., Shen K; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China., Wang S; Sun Yat-Sen University Cancer Center, Guangzhou, China., Cheng Y; Jilin Provincial Cancer Hospital, Changchun, China., Zhang Q; Harbin Medical University Cancer Hospital/Oncology Department, Harbin, China., Cui S; Henan Cancer Hospital, Zhengzhou, China., Tong Z; Tianjin Cancer Hospital/Breast Cancer Department, Tianjin, China., Geng C; Fourth Hospital of Hebei Medical University, Shijiazhuang, China., Song E; Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China., Huang CS; National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan., Sriuranpong V; Faculty of Medicine, Chulalongkorn University and The King Chulalongkorn Memorial Hospital, Bangkok, Thailand., Ngan RKC; Department of Clinical Oncology, The University of Hong Kong, Hong Kong., Chia YH; Tan Tock Seng Hospital, Singapore., Wang X; Pfizer (China) R&D Co., Ltd., Shanghai, China., Zhao H; Pfizer (China) R&D Co., Ltd., Shanghai, China. |
| المصدر: | European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2022 Nov; Vol. 175, pp. 236-245. Date of Electronic Publication: 2022 Sep 22. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Elsevier Science Ltd Original Publication: Oxford ; New York : Pergamon Press, c1990- |
| مواضيع طبية MeSH: | Breast Neoplasms*/pathology , Neutropenia*/drug therapy, Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Cyclin-Dependent Kinase 4 ; Female ; Humans ; Letrozole ; Piperazines ; Postmenopause ; Pyridines ; Receptor, ErbB-2/metabolism ; Receptors, Estrogen/metabolism |
| مستخلص: | Background: The cyclin-dependent kinase 4/6 inhibitor palbociclib has demonstrated efficacy and a manageable safety profile in combination with endocrine therapy in women with oestrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) in international phase 3 trials. The phase 3 PALOMA-4 trial evaluated the efficacy and safety of palbociclib plus letrozole versus placebo plus letrozole in Asian women with ER+/HER2- ABC. Methods: Postmenopausal women (n = 340) with no prior systemic treatment for advanced disease were randomised 1:1 to palbociclib (125 mg/d orally; 3 weeks on, 1 week off) plus letrozole (2.5 mg/d orally; continuously) or placebo plus letrozole. The primary end-point was investigator-assessed progression-free survival (PFS). Secondary end-points included tumour response and safety. Results: Median (95% CI) PFS was 21.5 (16.6-24.9) months with palbociclib plus letrozole and 13.9 (13.7-16.6) months with placebo plus letrozole (hazard ratio, 0.68 [95% CI, 0.53-0.87]; P = 0.0012). Consistent with the established safety profile, the most common adverse events (AEs) with palbociclib plus letrozole were neutropenia, leukopenia, thrombocytopaenia, and anaemia. Grade 3/4 neutropenia was reported in 84.5% of patients in the palbociclib arm versus 1.2% in the placebo arm. One serious AE of febrile neutropenia in the palbociclib group was reported. Conclusions: Findings from PALOMA-4 support the efficacy and safety of first-line palbociclib plus letrozole in postmenopausal Asian women with ER+/HER2- ABC. No new safety concerns of palbociclib plus letrozole were identified. Trial Registration: Clinicaltrials. gov, NCT02297438. Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Binghe Xu has been an advisor for Novartis and Roche, has received research funding from Hengrui, and has served on speakers bureaus for AstraZeneca, Pfizer Inc, Roche, and Eisai. Chiun-Sheng Huang has been an advisor for Amgen, AstraZeneca, Lilly, Novartis, Pfizer Inc, and Roche; has received research funding from Amgen, AstraZeneca, Daiichi Sankyo, EirGenix, Lilly, MSD, Novartis, OBI, Pfizer, and Roche; and has served on a speakers bureau for Roche. Virote Sriuranpong has received research funding from Roche, MSD, Novartis, Pfizer Inc, and AstraZeneca and has been an advisor for Roche, Novartis, Boehringer Ingelheim, MSD, Pfizer Inc, and Amgen. Roger Kai Cheong Ngan has received research funding from Pfizer Inc; has been an advisor for Pfizer Inc, Novartis, Sanofi, AstraZeneca, Lilly, MSD, Zai Lab, Roche, and Eisai; and has served on speakers bureaus for Novartis, AstraZeneca, Sanofi, Pfizer Inc, Zai Lab, Eisai, Lilly, and MSD. Xinwei Wang is an employee of and has stocks or stock options in Pfizer Inc.Huadong Zhao is an employee of Pfizer Inc.Xichun Hu, Wei Li, Tao Sun, Kunwei Shen, Shusen Wang, Ying Cheng, Qingyuan Zhang, Shude Cui, Zhongsheng Tong, Cuizhi Geng, Erwei Song, and Yee Hong Chia have no conflicts of interest to disclose. (Copyright © 2022 Elsevier Ltd. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Advanced breast cancer; Asian; Letrozole; Oestrogen receptor–positive; Palbociclib |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02297438 |
| المشرفين على المادة: | 0 (Piperazines) 0 (Pyridines) 0 (Receptors, Estrogen) 7LKK855W8I (Letrozole) EC 2.7.10.1 (ERBB2 protein, human) EC 2.7.10.1 (Receptor, ErbB-2) EC 2.7.11.22 (Cyclin-Dependent Kinase 4) G9ZF61LE7G (palbociclib) |
| تواريخ الأحداث: | Date Created: 20220926 Date Completed: 20221018 Latest Revision: 20221108 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.ejca.2022.08.012 |
| PMID: | 36155117 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1879-0852 |
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| DOI: | 10.1016/j.ejca.2022.08.012 |