RÉSUMÉ
Objective:To investigate the effect of trastuzumab deruxtecan (T-DXd) in the treatment of metastatic breast cancer (MBC) patients with different expression levels of human epidermal growth factor receptor 2 (HER2) and the influencing factors of prognosis.Methods:The retrospective case series analysis and cohort study were conducted. Clinical data of 20 MBC patients with different expression levels of HER2 treated with T-DXd at Xi'an International Medical Center Hospital from August 2021 to August 2023 were retrospectively collected to analyze the efficacy and safety of T-DXd. The Cox proportional hazards model was used for multivariate analysis of prognostic factors.Results:All 20 patients were female, with a median age [ M ( Q1, Q3)] of 49 years old (40 years old, 58 years old). Of the 20 cases, 12 had low expression of HER2 [immunohistochemistry HER2+, or immunohistochemistry ++ and fluorescence in situ hybridization (FISH)-negative], and 8 had overexpression of HER2 (immunohistochemistry HER2+++, or immunohistochemistry ++ and FISH-positive); median number of lines of treatment with T-DXd was 6 lines (3 lines, 7 lines); 14 patients had partial remission, 3 patients had stable disease, and 3 patients had disease progression, with an objective remission rate (ORR) of 70% (14/20) and a disease control rate of 85% (17/20). Eight patients with overexpression of HER2 had objective remission in 6 cases, and 12 patients with low expression of HER2 had objective remission in 8 cases, and the ORR difference between the two groups was not statistically significant ( P = 1.000). The main adverse reactions of the patients were nausea (14 cases), vomiting (12 cases), leukopenia (10 cases), elevated aspartate aminotransferase (10 cases), elevated alanine aminotransferase (9 cases), anemia (8 cases), fatigue (8 cases), alopecia (8 cases), neutropenia (6 cases), and thrombocytopenia (5 cases); ≥ grade 3 adverse reactions were bone marrow suppression and gastrointestinal reactions, all with an incidence of ≤10%. The median follow-up time was 7.1 months (1.9 months, 11.5 months). The median progression-free survival (PFS) time was 6.5 months (95% CI: 3.9-9.1 months), and the median PFS time of patients with overexpression of HER2 was longer than that of patients with low expression of HER2 [7.0 months (95% CI: 6.4- 7.6 months) vs. 4.0 months (95% CI: 1.7-6.3 months)], and the difference in PFS between the two groups was statistically significant ( P = 0.025). Multivariate Cox regression analysis showed that overexpression of HER2 was an independent protective factor for PFS in MBC patients treated with T-DXd ( HR = 0.265, 95% CI: 0.075-0.945, P = 0.041). Conclusions:MBC patients with overexpression or low expression of HER2 have a good therapeutic effect and safety profile when treated with T-DXd. The overexpression of HER2 may predict good PFS in MBC patients treated with T-DXd, and may serve as a biomarker for predicting PFS in such patients, but it may not affect the ORR.
RÉSUMÉ
OBJECTIVE:To observe the effectiveness and safety of Jin's three-needle combined with Jiawei wumei pill in the treatment of menopausal insomnia.METHODS:One hundred and sixty-five patients with perimenopausal insomnia were selected from our hospital during Jan.2015-Mar.2016,and then divided into group A (n=41),group B (n=41),group C (n=41) and group D (n=42) according to random number table.Group A was given Estazolam tablet 1 mg,qd;group B was given Jin's three-needle 30 min/time,qd;group C was given Jiawei wumei pill,one pill,after breakfast and supper warm taking;group D was given Jin's three-needle combined with Jiawei wumei pill with same usage as group C.Four groups were treated for 4 weeks.PSQI score,modified Kupperman score,life quality score,serum levels of E2 and FSH were observed in 4 groups before and after treatment,and the occurrence of ADR was recorded.RESULTS:Before treatment,there was no statistical significance in above score (P＞0.05).After treatment,PSQI score and modified Kupperman score of 4 groups were decreased significantly,compared to before treatment;the group B,C,D were significantly lower than the group A;the group D was significantly lower the group B,C,with statistical significance (P＜0.05).The life quality score of 4 groups were increased significantly,and the group B,C,D were significantly higher than the group A;the group D was significantly higher than the group B,C,with statistical signifi cance (P＜0.05).E2 level of group B,C,D were significantly increased,while FSH level was decreased significantly,the improvement of group D was significantly better than group B,C;the improvement of group D was significantly better than that of group B,C,with statistical significance (P＜0.05).The incidence of ADR in group A was significantly higher than group B,C,D,with statistical significance (P＜0.01),and there was no statistical significance in the incidence of ADR among group B,C,D,with statistical significance (P＞0.05).CONCLUSIONS:Jin's three needle combined with Jiawei wumei pill is effective in the treatment of perimenopausal insomnia with good safety.