6.1.2 Endocrine Therapy for Premenopausal Breast C...
the determination of the state of menopause：（1）After double ovary removal.（2）Age：60 years old.（3）Age 60 years old，natural menopause of 12 months，in the nearly 1 year without chemotherapy，tamoxifen，torimyfen or ovary deposition，FSH and estradiol levels in the postmenopausal range.（4）In patients aged 60 who were taking tamoxifen or torimefen，FSH and estradiol levels were in the postmenopausal range twice in a row.
treatment strategy：
Fig.1
According to the latest CSCO guidelines，patients at low risk of recurrence：lymph node negative，histological grade 1，T＜2cm，and non-assisted chemotherapy refers to patients with tamoxifen for 5 years of treatment.For young patients，the following risk factors are considered：hetology grade 2-3，lymph nodes 1-3 positive，T≥2cm or with auxiliary chemotherapy signs but do not want to receive chemotherapy.It is recommended that ovarian function inhibition at the same time with 5 years of tamoxifen treatment.After five years of treatment，good tolerance may be considered for extended endocrine therapy（five years for nonmenopausal patients to continue to use tamoxifen treatment and 5 years for menopausal patients using aromatase inhibitors）.For patients with 4 or more positive lymph nodes or histology grade 3，ovarian function inhibition was treated with 5 years of aromatase inhibitors.After five years of treatment，good tolerance may be considered for extended endocrine therapy（nonmenopausal patients continue to use ovarian dysfunction while using five years of aromatase inhibitor therapy，menopausal patients treated with aromatase inhibitors for five years）（see Fig.1）.
The 2014 SOFT Study and the joint analysis of SOFT/TEXT established a landmark ovarian function inhibition of standard treatment status in patients with high-risk breast cancer in premenopausal hormone receptor-positive breast cancer treatment.Age 35 in soft study subgroup reaps significant 5-year BCFI benefit from auxiliary OFS（OFS+AI：OFS+TAM：TAM=83.4%：78.9%：67.7%）［soft］.However，any benefits must be balanced and evaluated for the accompanying adverse reactions.In young（35-yearold）patients with very strong ovarian function，the rapid decrease in estrogen levels after ovary function is inhibited，which is bound to lead to more serious endocrine therapy-related adverse reactions.The study in，June，2017 by JCO named“TEXT/SOFT Study assessment of the therapeutic efficacy，therapeutic compliance，and quality of life of young women aged 35”reaffirms that HR-HER2-early breast cancer at age 35 receives a longer BC FI than OFS-TAM/AI；(https://www.daowen.com)
The analysis data are all derived from Phase Ⅲ Clinical Research：TEXT and SOFT Research.The study was conducted from November 2003 to March 2011 in patients with estrogen receptors and/or progesterone receptors who were 10%positive for early leaching breast cancer and were randomly grouped.TEXT studied 2,660 patients，randomly assigned to the ovarian function inhibition combined aromatase inhibitor group（OFS-AI）and ovarian function inhibition in the combined tamoxifen group（OFS-TAM）.The soft study enrolled 3,047 patients，randomly assigned to the OFS-AI，OFS-TAM，and tamoxifen（tam）groups.The end indicators of the study were：DFS，BCFI，DRFI，and OS（6 years in TEXT study and 5.6 years in SOFT study）.
The SOFT and TEXT studies included 5,707 patients，including 582 patients aged 35.Patients aged 35 had a higher risk of recurrence，mainly in lymph nodes（39.6%：55.5%），histology level 3（21.6%：41.8%）and vein thrombosis（27.8%：43.5%）.The risk of breast cancer events was compared to patients at 35 years of randomage（HR，1.53；95%CI，1.24 to 1.88），distance transfer risk（HR，1.52；95%CI，1.21 to 1.91），and DFS event risk（HR，1.43；95%CI，1.18 to 1.74）were all increased，and age 35 was an independent adverse prognosis.
In the SOFT study，there were 240 patients aged 35 and have HER2 negative，and 5-yearBCFI in 3 treatment groups was：67.1%（95%CI，54.6%～76.9%），OFS-TAM group 75.9%（95%CI，64.0%-84.4%），OFS-AI group 83.2%（95%CI，72.70%～90.0%）.There were 145 patients aged 35 years and have HER2 negative in the text study，with 5-year BCFI being 79.2%（95%CI，66.2%～87.7%）and OFS-AI group 81.6%（95%CI，69.8%～89.2%）respectively.the OFS-AI/TAM increased more BCFI benefits by 5 years compared to tam.
In the SOFT/TEXT study，94%and 82%of patients aged 35 and below 35 received complementary chemotherapy，so QoL analysis was only available for patients who received assisted chemotherapy.Vascular dissation symptoms were the most common adverse reactions of patients aged 35 when treated with OFS，most notably from baseline to June，after which these symptoms gradually improved and approached baseline levels.Despite this，the global QoL score was similar in patients aged 35 and above 35 who received chemotherapy.A total of 19.8%（115/582）of patients aged 35 in the text and SOFT studies were discontinued with TAM or OFS+TAM/AI.The proportion of patients aged 35 and above 35 years of age without interruption of oral endocrine therapy increased significantly（P=0.01）.The incidence of interruption of oral endocrine therapy in 1 year，2 years，3 years and 4 years was（＜35 years old：≥35 years old）：11%：9%，17%：14%，23%：18%，25%：21%.The interruption rate of drug-basedovarian suppression therapy was observed higher in patients not aged 35 years old（P=0.009），while those aged 35 opted for more permanent ovary de-seamounts such as surgery or radiotherapy.
To sum up，HR+HER2-premenopausal early breast cancer at age below 35 can benefit more from BCFI than patients above the age of 35.Adverse reactions to assisted endocrine therapy in patients not aged 35 were no more severe than patients above 35.