PMID- 35470572
OWN - NLM
STAT- MEDLINE
DCOM- 20221123
LR  - 20221217
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 11
IP  - 22
DP  - 2022 Nov
TI  - Treatment patterns, effectiveness, and patient-reported outcomes of palbociclib 
      therapy in Chinese patients with advanced breast cancer: A multicenter 
      ambispective real-world study.
PG  - 4157-4168
LID - 10.1002/cam4.4767 [doi]
AB  - 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.
CI  - (c) 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Shen, Lesang
AU  - Shen L
AD  - Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
AD  - Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, 
      Hangzhou, China.
FAU - Zhou, Jun
AU  - Zhou J
AD  - Department of Breast Surgery, Affiliated Hangzhou First People's Hospital of 
      Zhejiang University, Hangzhou, China.
FAU - Chen, Yiding
AU  - Chen Y
AUID- ORCID: 0000-0002-2263-6275
AD  - Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
FAU - Ding, Jinhua
AU  - Ding J
AD  - Department of Breast Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo, 
      China.
FAU - Wei, Haiyan
AU  - Wei H
AD  - Department of Breast Surgery, First Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
FAU - Liu, Jian
AU  - Liu J
AD  - Department of Breast Surgery, Affiliated Hangzhou First People's Hospital of 
      Zhejiang University, Hangzhou, China.
FAU - Xia, Wenjie
AU  - Xia W
AD  - Department of Breast Surgery, Zhejiang Provincial People's Hospital, Hangzhou, 
      China.
FAU - Xie, Bojian
AU  - Xie B
AD  - Department of Breast Surgery, Taizhou Enze Medical Center Enze Hospital, Taizhou, 
      China.
FAU - Xie, Xiaohong
AU  - Xie X
AD  - Department of Breast Surgery, First Affiliated Hospital of Zhejiang Chinese 
      Medical University, Hangzhou, China.
FAU - Li, Xujun
AU  - Li X
AD  - Department of Breast Surgery, Hwa Mei Hospital University of Chinese Academy of 
      Sciences, Ningbo, China.
FAU - Dai, Yuechu
AU  - Dai Y
AD  - Department of Breast Surgery, Taizhou Municipal Hospital, Taizhou.
FAU - Zhang, Guobing
AU  - Zhang G
AD  - Quality Management Office, Zhejiang Provincial People's Hospital, Hangzhou, 
      China.
FAU - Qiu, Xia
AU  - Qiu X
AD  - Department of Breast Surgery, Zhoushan Hospital of Zhejiang University, Zhoushan, 
      China.
FAU - Li, Chao
AU  - Li C
AD  - Department of Breast Surgery, Hwa Mei Hospital University of Chinese Academy of 
      Sciences, Ningbo, China.
FAU - Sun, Shanshan
AU  - Sun S
AD  - Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
AD  - Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, 
      Hangzhou, China.
FAU - Chen, Wuzhen
AU  - Chen W
AUID- ORCID: 0000-0003-0210-6645
AD  - Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
AD  - Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, 
      Hangzhou, China.
FAU - Gong, Dihe
AU  - Gong D
AD  - Department of Breast Surgery, Ningbo Hangzhou Bay Hospital, Ningbo, China.
FAU - Li, Hengyu
AU  - Li H
AD  - Department of General Surgery, Affiliated Changhai Hospital of The Second 
      Military Medical University, Shanghai, China.
FAU - Huang, Jian
AU  - Huang J
AD  - Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
AD  - Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, 
      Hangzhou, China.
FAU - Jiang, Xia
AU  - Jiang X
AD  - Department of Nutrition, West China School of Public Health and West China Fourth 
      Hospital, Sichuan University, Chengdu, China.
AD  - Department of Clinical Neuroscience, Centre for Molecular Medicine, Karolinska 
      Institute, Stockholm, Sweden.
FAU - Ni, Chao
AU  - Ni C
AD  - Department of Breast Surgery, Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, China.
AD  - Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, 
      Hangzhou, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220425
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - G9ZF61LE7G (palbociclib)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - 0 (Receptors, Estrogen)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Breast Neoplasms
MH  - Receptor, ErbB-2
MH  - Receptors, Estrogen
MH  - Quality of Life
MH  - Cohort Studies
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Patient Reported Outcome Measures
PMC - PMC9678098
OTO - NOTNLM
OT  - adverse events
OT  - endocrine therapy
OT  - metastatic breast cancer
OT  - palbociclib
OT  - patient-reported outcomes
OT  - real-world study
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2022/04/27 06:00
MHDA- 2022/11/24 06:00
PMCR- 2022/04/25
CRDT- 2022/04/26 06:01
PHST- 2022/03/23 00:00 [revised]
PHST- 2021/12/29 00:00 [received]
PHST- 2022/04/10 00:00 [accepted]
PHST- 2022/04/27 06:00 [pubmed]
PHST- 2022/11/24 06:00 [medline]
PHST- 2022/04/26 06:01 [entrez]
PHST- 2022/04/25 00:00 [pmc-release]
AID - CAM44767 [pii]
AID - 10.1002/cam4.4767 [doi]
PST - ppublish
SO  - Cancer Med. 2022 Nov;11(22):4157-4168. doi: 10.1002/cam4.4767. Epub 2022 Apr 25.