PMID- 35434007
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220830
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 10
IP  - 6
DP  - 2022 Mar
TI  - Efficacy and safety of palbociclib plus endocrine therapy for patients with 
      HR(+)/HER2(-) advanced breast cancer in real-world clinical practice.
PG  - 362
LID - 10.21037/atm-22-1002 [doi]
LID - 362
AB  - BACKGROUND: Palbociclib is the first cyclin dependent kinase 4/6 (CDK4/6) 
      inhibitor approved in China to be combined with endocrine therapy (ET) for 
      patients with hormone receptor-positive (HR(+))/human epidermal growth factor 
      receptor 2-negative (HER2(-)) metastatic breast cancer. However, palbociclib has 
      only been used in China for a short amount of time, and there is limited data on 
      its real-world applications. This study observed the efficacy and safety of 
      palbociclib plus ET in a real-world setting in southwest China and we hope to 
      provide some references for the treatment of patients with breast cancer in 
      China. METHODS: This was an observational study of patients with HR(+)/HER2(-) 
      advanced breast cancer (ABC) who received palbociclib plus ET. The primary 
      endpoint of the study was progression-free survival (PFS) and the 6- and 12-month 
      progression-free rates. The secondary endpoint included the objective response 
      rate (ORR) and the clinical benefit rate (CBR). RESULTS: A total of 64 patients 
      were enrolled in this study, and 54.7% of them received palbociclib plus ET as 
      the first-line treatment for ABC. The median PFS was 21.6 months (95% CI: 
      11.2-32.0 months) after a median follow-up period of 13.8 months (95% CI: 
      11.9-15.7 months). The 6-month progression-free rate was 75.4%, and 48.9% of 
      patients remained progression-free at 12 months. Overall, the ORR was 21.6% and 
      the CBR was 76.5%. Patients with the molecular typing of Luminal A (P=0.035), a 
      lower Ki67 level (P<0.001), sensitivity or acquired resistance to ET (P=0.003), 
      less than 3 visceral metastases lesions (P=0.001), and those who received 
      palbociclib plus ET as first-line or second-line of treatment for ABC (P=0.001) 
      showed longer PFS. A total of 53.1% of patients had grade 3-4 adverse events 
      (AEs), but only 4.7% of patients experienced permanent discontinuation of 
      treatment due to intolerable AEs. CONCLUSIONS: The efficacy of palbociclib plus 
      ET is worthy of recognition and the toxicity was acceptable in this study, which 
      is similar to previously reported data from randomized clinical trials and other 
      real-world evidence. Treatment for ABC using palbociclib plus ET should be 
      recommended more widely in China due to the efficacy and safety.
CI  - 2022 Annals of Translational Medicine. All rights reserved.
FAU - Zhong, Bingqian
AU  - Zhong B
AD  - Department of Oncology, the First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
FAU - Zhang, Jie
AU  - Zhang J
AD  - Department of Oncology, the First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
FAU - Wu, Jing
AU  - Wu J
AD  - Department of Oncology, the First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
AD  - Chongqing Key Laboratory of Translational Research for Cancer Metastasis and 
      Individualized Treatment, Chongqing University Cancer Hospital, Chongqing, China.
FAU - Sun, Langshuang
AU  - Sun L
AD  - Department of Oncology, the First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
FAU - Li, Shuhong
AU  - Li S
AD  - Department of Oncology, the First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
FAU - Zeng, Xiaohua
AU  - Zeng X
AD  - Chongqing Key Laboratory of Translational Research for Cancer Metastasis and 
      Individualized Treatment, Chongqing University Cancer Hospital, Chongqing, China.
FAU - Gan, Lu
AU  - Gan L
AD  - Department of Oncology, the First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
LA  - eng
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC9011297
OTO - NOTNLM
OT  - Palbociclib
OT  - advanced breast cancer (ABC)
OT  - endocrine therapy (ET)
OT  - hormone receptor-positive (HR+)
OT  - human epidermal growth factor receptor 2-negative (HER2-)
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://atm.amegroups.com/article/view/10.21037/atm-22-1002/coif). The authors 
      have no conflicts of interest to declare.
EDAT- 2022/04/19 06:00
MHDA- 2022/04/19 06:01
PMCR- 2022/03/01
CRDT- 2022/04/18 06:40
PHST- 2022/01/19 00:00 [received]
PHST- 2022/03/21 00:00 [accepted]
PHST- 2022/04/18 06:40 [entrez]
PHST- 2022/04/19 06:00 [pubmed]
PHST- 2022/04/19 06:01 [medline]
PHST- 2022/03/01 00:00 [pmc-release]
AID - atm-10-06-362 [pii]
AID - 10.21037/atm-22-1002 [doi]
PST - ppublish
SO  - Ann Transl Med. 2022 Mar;10(6):362. doi: 10.21037/atm-22-1002.