The First Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin 300060, People's Republic of China.
The Department of Breast Pathology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin 300060, People's Republic of China.
Oncologist. 2024 Jun 3;29(6):e763-e770. doi: 10.1093/oncolo/oyae033.
To assess the efficacy and safety of tucidinostat plus exemestane as a neoadjuvant strategy in early-stage breast cancer.
This prospective, open-label, single-arm phase II trial enrolled patients with stage II-III breast cancer with hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative. Eligible patients received tucidinostat plus exemestane, and then breast-conserving surgery (BCS) or modified radical mastectomy.
Among 20 enrolled patients, 3 of them achieved preoperative endocrine prognostic index (PEPI) score of 0. Additionally, complete cell cycle arrest was observed in 7, radiologic objective response rate in 10, and disease control rate in 20 patients, pathological complete response in 1 patient, and 5 patients performed BCS. Ki67 suppression from baseline to surgery was observed in 17 of patients, with the Ki67 change ratio of -73.5%. Treatment-emergent adverse event included neutropenia, leukopenia, thrombocytopenia, lymphopenia, hypoalbuminemia, aspartate aminotransferase elevation, glutamyl transpeptidase elevation, anemia, and alanine aminotransferase elevation.
Despite the rate of PEPI score 0 was not high, tucidinostat plus exemestane as a neoadjuvant therapy might be well tolerated and showed promising clinical responses in patients with early hormone receptor-positive, HER2-negative breast cancer. To clarify the safety and efficacy of this strategy, further investigation is warranted.
ChiCTR2100046678.
评估曲昔派他汀联合依西美坦作为新辅助策略在早期乳腺癌中的疗效和安全性。
这是一项前瞻性、开放标签、单臂 II 期临床试验，纳入了激素受体阳性、人表皮生长因子受体 2（HER2）阴性的 II-III 期乳腺癌患者。符合条件的患者接受曲昔派他汀联合依西美坦治疗，然后行保乳手术（BCS）或改良根治性乳房切除术。
在 20 名入组患者中，有 3 名患者术前内分泌预后指数（PEPI）评分达到 0 分。此外，7 例患者完全出现细胞周期停滞，10 例患者影像学客观缓解率，20 例患者疾病控制率，1 例患者病理完全缓解，5 例患者行 BCS。17 例患者的 Ki67 从基线到手术时下降，Ki67 变化率为-73.5%。治疗相关不良事件包括中性粒细胞减少、白细胞减少、血小板减少、淋巴细胞减少、低白蛋白血症、天门冬氨酸氨基转移酶升高、谷氨酰转肽酶升高、贫血和丙氨酸氨基转移酶升高。
尽管 PEPI 评分 0 分的比例不高，但曲昔派他汀联合依西美坦作为新辅助治疗在激素受体阳性、HER2 阴性的早期乳腺癌患者中可能具有良好的耐受性，并显示出有前途的临床反应。为了明确该策略的安全性和有效性，需要进一步的研究。
ChiCTR2100046678。
