To systematically evaluate the efficacy and safety of histone deacetylase inhibitors (HDACi) combined with exemestane compared with exemestane alone in the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
Electronic databases including PubMed, Cochrane Library, Embase, Wanfang Data, CNKI, and VIP were searched for randomized controlled trials (RCTs) comparing HDACi combined with exemestane versus exemestane alone in the treatment of HR+/HER2- breast cancer. The search period began from database inception to July 10, 2025. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias in the included studies. Meta-analysis was performed using RevMan 5.4.1 software.
Five RCTs involving 1 588 patients were included. The meta-analysis showed that HDACi plus exemestane group had significantly better progression-free survival [HR=0.77, 95%CI (0.67, 0.89), P=0.000 2], objective response rate [OR=1.69, 95%CI (1.15, 2.50), P=0.008], and clinical benefit rate [OR=1.39, 95%CI (1.05, 1.85), P=0.02] than the exemestane alone group. However, there was no significant difference in overall survival between the two groups [HR=0.91, 95%CI (0.63, 1.30), P=0.60]. Regarding safety, the meta-analysis showed that the overall incidence of ≥grade 3 adverse events was significantly higher in the HDACi plus exemestane group compared to the monotherapy group [OR=7.16, 95% CI (4.37, 11.74), P<0.000 01].
Current evidence suggests that in HR+/HER2- breast cancer patients, HDACi combined with exemestane significantly prolongs progression-free survival and improves objective response rate and clinical benefit compared to exemestane alone, but also significantly increases the risk of ≥grade 3 adverse events, particularly hematological toxicity and fatigue. Clinicians should carefully weigh the benefits of efficacy against the risks of adverse events when making decisions.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |