van Ramshorst Mette S, van Werkhoven Erik, Mandjes Ingrid A M, Schot Margaret, Wesseling Jelle, Vrancken Peeters Marie-Jeanne T F D, Meerum Terwogt Jetske M, Bos Monique E M, Oosterkamp Hendrika M, Rodenhuis Sjoerd, Linn Sabine C, Sonke Gabe S
Department of Medical Oncology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.
Department of Biometrics, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.
Eur J Cancer. 2017 Mar;74:47-54. doi: 10.1016/j.ejca.2016.12.023. Epub 2017 Feb 10.
To determine the efficacy and safety of an anthracycline-free neo-adjuvant regimen consisting of weekly paclitaxel, carboplatin and trastuzumab in HER2-positive breast cancer.
Patients with stage II or III HER2-positive breast cancer received weekly paclitaxel ([P], 70 mg/m), trastuzumab ([T], 2 mg/kg, loading dose 4 mg/kg) and carboplatin ([C], AUC = 3 mg ml min) for 24 weeks. In weeks 7, 8, 15, 16, 23 and 24, trastuzumab was administered without chemotherapy. The primary end-point was pathologic complete response in the surgical resection specimen, defined as the absence of invasive tumour cells in breast and axilla.
One hundred and eleven patients were included in the study, and 108 were evaluable for the primary end-point. The pathologic complete response rate was 43% (95% confidence interval [CI]: 33-52). Median follow-up was 52 months, and the 3-year event-free survival was 88% (95% CI: 82-94), and the 3-year overall survival was 92% (95% CI: 88-98). The most common grade 3-4 adverse events were neutropenia (67%) and thrombocytopenia (43%). Less than five percent of patients experienced febrile neutropenia. No symptomatic left ventricular systolic dysfunction was observed during neo-adjuvant treatment.
An anthracycline-free neo-adjuvant regimen of weekly paclitaxel, trastuzumab and carboplatin is highly effective in HER2-positive breast cancer with manageable toxicity.
确定由每周一次的紫杉醇、卡铂和曲妥珠单抗组成的无蒽环类新辅助方案在人表皮生长因子受体2（HER2）阳性乳腺癌中的疗效和安全性。
II期或III期HER2阳性乳腺癌患者接受每周一次的紫杉醇（[P]，70mg/m²）、曲妥珠单抗（[T]，2mg/kg，负荷剂量4mg/kg）和卡铂（[C]，曲线下面积[AUC]=3mg·ml⁻¹·min⁻¹）治疗24周。在第7、8、15、16、23和24周，仅给予曲妥珠单抗，不进行化疗。主要终点是手术切除标本中的病理完全缓解，定义为乳腺和腋窝无浸润性肿瘤细胞。
111例患者纳入本研究，108例可评估主要终点。病理完全缓解率为43%（95%置信区间[CI]：33%-52%）。中位随访时间为52个月，3年无事件生存率为88%（95%CI：82%-94%），3年总生存率为92%（95%CI：88%-98%）。最常见的3-4级不良事件是中性粒细胞减少（67%）和血小板减少（43%）。不到5%的患者发生发热性中性粒细胞减少。新辅助治疗期间未观察到有症状的左心室收缩功能障碍。
由每周一次的紫杉醇、曲妥珠单抗和卡铂组成的无蒽环类新辅助方案在HER2阳性乳腺癌中疗效显著，毒性可控。
