Department of Thyroid Breast and Vascular Surgery, Xijing Hospital of Air Force Military Medical University, Xi'an 710032, People's Republic of China.
Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, People's Republic of China.
Oncologist. 2024 Jan 5;29(1):e15-e24. doi: 10.1093/oncolo/oyad160.
Neoadjuvant trastuzumab/pertuzumab (HP) plus chemotherapy for HER2-positive breast cancer (BC) achieved promising efficacy. The additional cardiotoxicity still existed. Brecan study evaluated the efficacy and safety of neoadjuvant pegylated liposomal doxorubicin (PLD)/cyclophosphamide and sequential nab-paclitaxel based on HP (PLD/C/HP-nabP/HP).
Brecan was a single-arm phase II study. Eligible patients with stages IIA-IIIC HER2-positive BC received 4 cycles of PLD, cyclophosphamide, and HP, followed by 4 cycles of nab-paclitaxel and HP. Definitive surgery was scheduled after 21 days for patients completing treatment or experiencing intolerable toxicity. The primary endpoint was the pathological complete response (pCR).
Between January 2020 and December 2021, 96 patients were enrolled. Ninety-five (99.0%) patients received 8 cycles of neoadjuvant therapy and all underwent surgery with 45 (46.9%) breast-conserving surgery and 51 (53.1%) mastectomy. The pCR was 80.2% (95%CI, 71.2%-87.0%). Four (4.2%) experienced left ventricular insufficiency with an absolute decline in LVEF (43%-49%). No congestive heart failure and ≥grade 3 cardiac toxicity occurred. The objective response rate was 85.4% (95%CI, 77.0%-91.1%), including 57 (59.4%) complete responses and 25 (26.0%) partial responses. The disease control rate was 99.0% (95%CI, 94.3%-99.8%). For overall safety, ≥grade 3 AEs occurred in 30 (31.3%) and mainly included neutropenia (30.2%) and asthenia (8.3%). No treatment-related deaths occurred. Notably, age of >30 (P = .01; OR = 5.086; 95%CI, 1.44-17.965) and HER2 IHC 3+ (P = .02; OR = 4.398; 95%CI, 1.286-15.002) were independent predictors for superior pCR (ClinicalTrials.gov Identifier NCT05346107).
Brecan study demonstrated the encouraging safety and efficacy of neoadjuvant PLD/C/HP-nabP/HP, suggesting a potential therapeutic option in HER2-positive BC.
曲妥珠单抗/帕妥珠单抗（HP）联合新辅助化疗治疗人表皮生长因子受体 2（HER2）阳性乳腺癌（BC）取得了有前景的疗效。但仍存在额外的心脏毒性。Brecan 研究评估了基于 HP 的新型载多柔比星脂质体（PLD）/环磷酰胺和序贯 nab-紫杉醇（PLD/C/HP-nabP/HP）新辅助治疗的疗效和安全性。
Brecan 是一项单臂、Ⅱ期研究。ⅡA-ⅢC 期 HER2 阳性 BC 患者接受 4 个周期的 PLD、环磷酰胺和 HP，随后接受 4 个周期的 nab-紫杉醇和 HP。对于完成治疗或出现无法耐受毒性的患者，在 21 天后安排确定性手术。主要终点是病理完全缓解（pCR）。
2020 年 1 月至 2021 年 12 月，共纳入 96 例患者。95（99.0%）例患者接受了 8 个周期的新辅助治疗，所有患者均接受了手术，其中 45（46.9%）例患者接受了保乳手术，51（53.1%）例患者接受了乳房切除术。pCR 率为 80.2%（95%CI，71.2%-87.0%）。4（4.2%）例患者发生左心室功能不全，LVEF（左心室射血分数）绝对下降 43%-49%。无充血性心力衰竭和≥3 级心脏毒性发生。客观缓解率为 85.4%（95%CI，77.0%-91.1%），包括 57（59.4%）例完全缓解和 25（26.0%）例部分缓解。疾病控制率为 99.0%（95%CI，94.3%-99.8%）。在总体安全性方面，≥3 级不良事件发生在 30（31.3%）例患者中，主要包括中性粒细胞减少症（30.2%）和乏力（8.3%）。无治疗相关死亡发生。值得注意的是，年龄>30 岁（P=0.01；OR=5.086；95%CI，1.44-17.965）和 HER2 IHC 3+（P=0.02；OR=4.398；95%CI，1.286-15.002）是 pCR 更好的独立预测因素（ClinicalTrials.gov 标识符 NCT05346107）。
Brecan 研究表明，新型 PLD/C/HP-nabP/HP 新辅助治疗具有令人鼓舞的安全性和疗效，为 HER2 阳性 BC 提供了一种潜在的治疗选择。
