Breast Cancer Center, The First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Breast Cancer Center, Anhui Provincial Cancer Hospital, Hefei, China.
BMC Cancer. 2024 Oct 7;24(1):1237. doi: 10.1186/s12885-024-12852-z.
Anlotinib, an oral multitarget tyrosine kinase inhibitor, has shown the ability to inhibit tumor angiogenesis. This study aimed to assess the effectiveness and safety of anlotinib plus docetaxel, epirubicin, and cyclophosphamide (TEC) as a neoadjuvant chemotherapy regimen for locally advanced TNBC.
Locally advanced TNBC patients who had received no prior systemic treatment were eligible for this study. The enrolled patients were scheduled to undergo six cycles of anlotinib (12 mg, d1-14, q3w) plus docetaxel (75 mg/m2, d1, q3w), epirubicin (75 mg/m2, d1, q3w) and cyclophosphamide (600 mg/m2, d1, q3w) prior to surgery, unless there was disease progression or severe toxicity. The primary objective of this study was the safety of this therapeutic regimen, and the secondary objective was the tumor response. The safety of this regimen was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and the efficacy of this treatment was measured using the Response Evaluation Criteria in Solid Tumors version 1.1.
A total of 18 patients were included in this study. Participants completed an average of 5.56 neoadjuvant treatment cycles. The objective response rate (ORR) was 83.33%, and the disease control rate was 100%, respectively. The pCR was 55.6%. No patients discontinued therapy because of Adverse effects (AEs). Grade 3 or 4 AEs were observed in 5 cases (27.8%), with neutropenia and palmar-plantar erythrodysesthesia syndrome being the most common.
Anlotinib combined with TEC as neoadjuvant therapy demonstrated manageable toxicity and promising antitumor activity for locally advanced TNBC. Further investigation of this combination regimen is warranted.
安罗替尼是一种口服多靶点酪氨酸激酶抑制剂，具有抑制肿瘤血管生成的能力。本研究旨在评估安罗替尼联合多西他赛、表柔比星和环磷酰胺（TEC）作为局部晚期三阴性乳腺癌（TNBC）新辅助化疗方案的有效性和安全性。
本研究纳入了未经系统治疗的局部晚期 TNBC 患者。患者接受安罗替尼（12mg，d1-14，q3w）联合多西他赛（75mg/m2，d1，q3w）、表柔比星（75mg/m2，d1，q3w）和环磷酰胺（600mg/m2，d1，q3w）治疗 6 个周期，除非疾病进展或出现严重毒性。本研究的主要目的是评估该治疗方案的安全性，次要目的是评估肿瘤反应。该方案的安全性采用不良事件通用术语标准 4.03 版（CTCAE）进行评估，疗效采用实体瘤疗效评价标准 1.1 版进行评估。
本研究共纳入 18 例患者。患者平均完成 5.56 个新辅助治疗周期。客观缓解率（ORR）为 83.33%，疾病控制率为 100%，病理完全缓解（pCR）率为 55.6%。无患者因不良反应（AE）而停止治疗。5 例（27.8%）患者出现 3 级或 4 级 AE，最常见的是中性粒细胞减少和手足综合征。
安罗替尼联合 TEC 作为新辅助治疗方案用于局部晚期 TNBC，具有可管理的毒性和有前景的抗肿瘤活性。有必要进一步研究该联合方案。
