Xi'an Jiaotong University, Shaanxi Province, China.
The Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Province, China.
Clin Breast Cancer. 2024 Jun;24(4):e195-e202. doi: 10.1016/j.clbc.2024.01.018. Epub 2024 Mar 8.
The combination of neoadjuvant chemotherapy and anti-angiogenesis therapy for patients with triple-negative breast cancer (TNBC) remains inadequately supported by evidence. We conducted a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and toxicity of anlotinib plus epirubicin and cyclophosphamide followed by paclitaxel in patients with IIB to IIIA stage TNBC.
Newly diagnosed patients received epirubicin at 90 mg/m and cyclophosphamide at 600 mg/m followed by docetaxel at 100 mg/m (21 days per cycle; total of 4 cycles), along with oral anlotinib (12 mg qd, d1-14; 21 days per cycle; total of 4 cycles). Subsequently, patients underwent surgery. The primary endpoint of this study was pathologic complete response (pCR).
Among the 34 included patients, the median age was 46.5 years (range: 27-72); all were female. Pathological assessment revealed that 17 patients achieved RCB 0 response, which is currently defined as pathologic complete response; 3 patients achieved RCB 1; 12 patients achieved RCB 2; and 1 patient achieved RCB 3. The probability of a grade 3 adverse reaction was 17.6%, and no grade 4 adverse reactions occurred. The most common hematological adverse reaction was leukopenia (13/34, 38.2%), of which 5.9% (2/34) were grade 3. The most common non-hematological adverse reactions were oral mucositis (16/34, 58.8%), fatigue (50.0%), hand-foot syndrome (50.0%), hypertension (44.1%), bleeding (44.1%), and alopecia (32.4%).
The combination of anlotinib and EC-T chemotherapy demonstrated tolerable side effects in the neoadjuvant treatment of early TNBC. pCR was higher than what has been reported in previous clinical studies of chemotherapy alone. This study provides additional rationale for using anlotinib plus docetaxel-epirubicin-based chemotherapy regimen in patients with early-stage TNBCs.
新辅助化疗联合抗血管生成治疗三阴性乳腺癌（TNBC）的疗效仍缺乏充分证据支持。我们开展了一项单臂、开放标签、多中心、Ⅱ期临床试验，旨在评估安罗替尼联合表柔比星和环磷酰胺序贯紫杉醇治疗ⅡB 期至ⅢA 期 TNBC 患者的疗效和毒性。
新诊断的患者接受表柔比星 90 mg/m 和环磷酰胺 600 mg/m，随后给予多西他赛 100 mg/m（21 天/周期；共 4 个周期），同时口服安罗替尼 12 mg，qd，d1-14（21 天/周期；共 4 个周期）。随后患者接受手术。本研究的主要终点为病理完全缓解（pCR）。
34 例入组患者的中位年龄为 46.5 岁（范围：27-72 岁）；均为女性。病理评估显示，17 例患者达到 RCB 0 缓解，即目前定义的病理完全缓解；3 例患者达到 RCB 1；12 例患者达到 RCB 2；1 例患者达到 RCB 3。3 级不良反应发生率为 17.6%，无 4 级不良反应发生。最常见的血液学不良反应是白细胞减少（13/34，38.2%），其中 5.9%（2/34）为 3 级。最常见的非血液学不良反应是口腔黏膜炎（16/34，58.8%）、乏力（50.0%）、手足综合征（50.0%）、高血压（44.1%）、出血（44.1%）和脱发（32.4%）。
安罗替尼联合 EC-T 化疗方案在早期 TNBC 的新辅助治疗中显示出可耐受的副作用。pCR 高于既往单纯化疗的临床研究报道。该研究为安罗替尼联合多西他赛-表柔比星化疗方案在早期 TNBC 患者中的应用提供了更多的依据。
