PMID- 33046982
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201016
IS  - 1837-9664 (Print)
IS  - 1837-9664 (Electronic)
IS  - 1837-9664 (Linking)
VI  - 11
IP  - 22
DP  - 2020
TI  - Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human 
      Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in 
      China.
PG  - 6612-6622
LID - 10.7150/jca.47960 [doi]
AB  - Background: Fulvestrant 500mg has proved its clinical effectiveness in previous 
      trials as primary or second line treatment of hormone receptor positive, human 
      epidermal receptor 2 negative (HR+/HER2-) post-menopausal advanced breast cancer. 
      This real-world study aimed to investigate the efficacy and safety of Fulvestrant 
      in HR+/HER2- Chinese advanced breast cancer patients. Method: HR+/HER2- advanced 
      breast cancer patients who received Fulvestrant 500mg from January 2015 to 
      December 2018 in Beijing Cancer Hospital were enrolled in this retrospective 
      study. Progression free survival (PFS), objective response rate (ORR), clinical 
      benefit rate (CBR), overall survival (OS) and adverse events (AEs) of Fulvestrant 
      were investigated. Result: In total 303 enrolled patients [median age was 51 
      years (range: 21-82)], 255 (84.2%) patients were at postmenopausal status at the 
      start of Fulvestrant treatment and 264 patients (87.1%) had advanced breast 
      cancer. The median PFS (95% confidence interval) was 14.1 months (10.1-18.0) for 
      the first-line, 11.2 months (2.2-20.3) for the second-line and 6.7 months 
      (4.8-8.5) for >/=third-line of Fulvestrant. The ORR and CBR were 3.8% and 86.8% for 
      the first-line, 5.5% and 75.4% for the second-line, 1.1% and 61.1% for 
      >/=third-line of Fulvestrant. The multivariate subgroup analyses showed, PFS was 
      significantly longer for the patients with light tumor burden, less palliative 
      chemotherapy before Fulvestrant and long disease-free interval. For patients 
      receiving Fulvestrant after palliative chemotherapy, the median PFS was 
      numerically greater in maintenance treatment group than those who progressed 
      after chemotherapy. Only 5.0% of patients (15/303) experienced adverse events and 
      majority were grade 1-2. The most common adverse event was headache and 
      palpitation, with merely one patient had severe adverse event (pulmonary 
      embolism). Conclusion: Fulvestrant is an effective, safe and well-tolerated 
      treatment regimen in endocrine therapy for HR+/HER2- metastatic breast cancer. 
      Light tumor burden, less palliative chemotherapy before Fulvestrant and long 
      disease-free survival (DFS) might be the ideal condition of Fulvestrant 
      treatment. Fulvestrant can be effective for premenopausal patients with 
      drug-induced menopause. Patients of different luminal subtypes can benefit from 
      Fulvestrant. For patients with visceral metastases, presence of liver metastases 
      rather than lung metastases was poor prognostic factor. Fulvestrant may also be 
      considered as a maintenance treatment after first-line palliative chemotherapy.
CI  - (c) The author(s).
FAU - Lei, Wen
AU  - Lei W
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Li, Huiping
AU  - Li H
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Song, Guohong
AU  - Song G
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Zhang, Ruyan
AU  - Zhang R
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Ran, Ran
AU  - Ran R
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Yan, Ying
AU  - Yan Y
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Di, Lijun
AU  - Di L
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
FAU - Jiang, Hanfang
AU  - Jiang H
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education/ Beijing), Department of Breast Oncology, Peking University Cancer 
      Hospital and Institute, Beijing 100142, China.
LA  - eng
PT  - Journal Article
DEP - 20200923
PL  - Australia
TA  - J Cancer
JT  - Journal of Cancer
JID - 101535920
PMC - PMC7545684
OTO - NOTNLM
OT  - Advanced breast cancer
OT  - Endocrine therapy
OT  - Fulvestrant
OT  - hormone-receptor positive
COIS- Competing Interests: The authors have declared that no competing interest exists.
EDAT- 2020/10/14 06:00
MHDA- 2020/10/14 06:01
PMCR- 2020/01/01
CRDT- 2020/10/13 05:39
PHST- 2020/05/09 00:00 [received]
PHST- 2020/09/09 00:00 [accepted]
PHST- 2020/10/13 05:39 [entrez]
PHST- 2020/10/14 06:00 [pubmed]
PHST- 2020/10/14 06:01 [medline]
PHST- 2020/01/01 00:00 [pmc-release]
AID - jcav11p6612 [pii]
AID - 10.7150/jca.47960 [doi]
PST - epublish
SO  - J Cancer. 2020 Sep 23;11(22):6612-6622. doi: 10.7150/jca.47960. eCollection 2020.