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For first-line treatment of patients with hormone receptor (HR)-positive (HR+) and HER2-positive (HER2+) metastatic breast cancer (MBC), there is currently no evidence that endocrine therapy or chemotherapy combined with anti-HER2 therapy is better treatment strategy
.
Therefore, Professor Yuan Zhongyu's team from Sun Yat-Sen University Cancer Center conducted the SYSUCC-002 study to determine whether trastuzumab + endocrine therapy is not inferior to trastuzumab + chemotherapy
breast cancer
The SYSUCC-002 study was an open-label, non-inferiority, phase III randomized controlled trial (NCT01950182) conducted in nine hospitals in China
.
Enrolled patients, stratified by prior adjuvant endocrine therapy and disease status (recurrent disease vs.
A total of 392 patients were included and randomly divided into trastuzumab + endocrine therapy group (ET group, n = 196) and trastuzumab + chemotherapy group (CT group, n = 196)
.
Of these 392 eligible patients, 317 (80.
diagnosis
After a median follow-up of 30.
2 months [interquartile range (IQR) 15.
0-44.
7], the median progression-free survival (PFS) was 19.
2 months in the ET group [95% confidence interval (CI) 16.
7 to 21.
7] in the CT group The median progression-free survival (PFS) was 14.
8 months (12.
8 16.
8) (HR=0.
88; 95% CI, 0.
71 1.
09; P noninferiority <0.
0001)
.
Median OS was 33.
PFS
OS
PFS subgroup analysis
There was no significant difference in ORR between the CT group and the ET group (42.
statistics
The incidence of toxicity was significantly higher in the CT group compared with the ET group
AEs
In conclusion, the SYSUCC-002 study confirmed that first-line trastuzumab + endocrine therapy was non-inferior to trastuzumab + chemotherapy in patients with HR+HER2+ metastatic breast cancer
Original source:
Hua X, Bi XW, Zhao JL, Shi YX, Lin Y, Wu ZY, Zhang YQ, Zhang LH, Zhang AQ, Huang H, Liu XM, Xu F, Guo Y, Xia W, Hong RX, Jiang KK, Xue C , An X, Zhong YY, Wang SS, Huang JJ, Yuan ZY; South China Breast Cancer Group (SCBCG).
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