Treatment patterns, effectiveness, and patient-reported outcomes of palbociclib therapy in Chinese patients with advanced breast cancer: A multicenter ambispective real-world study
机构：[1]Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, Hangzhou, China[2]Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, Hangzhou, China[3]Department of Breast Surgery, Affiliated Hangzhou First People's Hospital of Zhejiang University, Hangzhou, China[4]Department of Breast Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo, China[5]Department of Breast Surgery, First Affiliated Hospital of Zhejiang University, Hangzhou, China浙江大学医学院附属第一医院[6]Department of Breast Surgery, Zhejiang Provincial People's Hospital, Hangzhou, China[7]Department of Breast Surgery, Taizhou Enze Medical Center Enze Hospital, Taizhou, China台州恩泽医疗中心(集团)恩泽医院[8]Department of Breast Surgery, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China[9]Department of Breast Surgery, Hwa Mei Hospital University of Chinese Academy of Sciences, Ningbo, China[10]Department of Breast Surgery, Taizhou Municipal Hospital, Taizhou[11]Quality Management Office, Zhejiang Provincial People's Hospital, Hangzhou, China[12]Department of Breast Surgery, Zhoushan Hospital of Zhejiang University, Zhoushan, China[13]Department of Breast Surgery, Ningbo Hangzhou Bay Hospital, Ningbo, China[14]Department of General Surgery, Affiliated Changhai Hospital of The Second Military Medical University, Shanghai, China[15]Department of Nutrition, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China[16]Department of Clinical Neuroscience, Centre for Molecular Medicine, Karolinska Institute, Stockholm, Sweden
Background Palbociclib was the only available cyclin-dependent kinase 4/6 inhibitor in China until very recently, and its effect has not been systemically evaluated among Chinese patients. This study aims to assess the efficacy, safety and patient-reported outcomes (PROs) of palbociclib plus endocrine therapy (ET) in real-world China. Methods An ambispective cohort study was conducted on patients with advanced HR+HER2- breast cancer who received palbociclib between July 2018, and November 2020 and were enrolled from 12 hospitals. Treatment patterns, survival outcomes, and safety events were documented, and PROs (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items [EORTC QLQ-C30] and EuroQoL 5 dimensions [EQ-5D]) were analyzed. The Kaplan-Meier method was used to visualize and estimate the median progression-free survival (mPFS). Log-rank tests, Cox regressions, t tests, and chi-square tests were performed for comparison. Results A total of 190 patients (median follow-up of 18.0 months) were enrolled. Palbociclib was mostly combined with aromatase inhibitors (66.3%), fulvestrant (32.6%), and tamoxifen (1.1%). The mPFS values were 21.0, 14.0, and 7.0 months with palbociclib administered in first- (n = 83), second- (n = 41) and subsequent-line settings (n = 66), respectively. Endocrine sensitivity was significantly associated with patient prognosis (mPFS: 23.0, 12.0, and 6.0 months for endocrine naive, acquired, and primary resistant patients, respectively, p < 0.01). The outcome was worse for patients who failed to meet the inclusion criteria of PALOMA-3 than for those who met the criteria (later-line: 6.0 months vs. 9.0 months). The most common adverse events (AEs) were neutropenia (74.2%; grade 3/4: 30.0%), fatigue (48.4%), anemia (32.6%), and thrombocytopenia (22.1%). PRO data suggested that palbociclib plus ET significantly improved cognitive and emotional function, pain symptoms, and overall quality of life. Conclusions Palbociclib is effective for front-line use and for treating endocrine-sensitive patients in real-world China and is generally well tolerated. The prevalence of AEs in the Chinese population is different from that reported in the PALOMA-2/3 trials.
基金：
National Natural Science Foundation of China [82073151]; Natural Science Foundation of Zhejiang Province [LR19H160001]; major Project for Medical and Health Science and Technology of Zhejiang Province [WKJ-ZJ-1716]; Project of Application on Public Welfare Technology in Zhejiang Province [LGF18H160022]; Zhejiang Provincial Medical Science and Technology Program [2020KY903]
第一作者机构：[1]Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, Hangzhou, China[2]Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, Hangzhou, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, Hangzhou, China[2]Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, Hangzhou, China[14]Department of General Surgery, Affiliated Changhai Hospital of The Second Military Medical University, Shanghai, China[15]Department of Nutrition, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China[16]Department of Clinical Neuroscience, Centre for Molecular Medicine, Karolinska Institute, Stockholm, Sweden[*1]Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University School, No. 88, Jiefang Road, Hangzhou, Zhejiang 310009, China.[*2]Department of Clinical Neuroscience, Center for Molecular Medicine, Karolinska Institute,Visionsgatan 18, Solna 171 77, Stockholm, Sweden.[*3]Department of General Surgery, Affiliated Changhai Hospital of The Second Military Medical University, No. 168, Changhai Road, Shanghai 200433, China.
推荐引用方式(GB/T 7714)：
Shen Lesang,Zhou Jun,Chen Yiding,et al.Treatment patterns, effectiveness, and patient-reported outcomes of palbociclib therapy in Chinese patients with advanced breast cancer: A multicenter ambispective real-world study[J].CANCER MEDICINE.2022,11(22):4157-4168.doi:10.1002/cam4.4767.
APA：
Shen, Lesang,Zhou, Jun,Chen, Yiding,Ding, Jinhua,Wei, Haiyan...&Ni, Chao.(2022).Treatment patterns, effectiveness, and patient-reported outcomes of palbociclib therapy in Chinese patients with advanced breast cancer: A multicenter ambispective real-world study.CANCER MEDICINE,11,(22)
MLA：
Shen, Lesang,et al."Treatment patterns, effectiveness, and patient-reported outcomes of palbociclib therapy in Chinese patients with advanced breast cancer: A multicenter ambispective real-world study".CANCER MEDICINE 11..22(2022):4157-4168
