纳布紫杉醇联合曲妥珠单抗新辅助化疗后序贯氟尿嘧啶/表柔比星/环磷酰胺治疗HER2阳性可手术乳腺癌：一项多中心II期试验
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Trastuzumab Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial.
作者信息
Tokunaga Shinya, Takashima Tsutomu, Kashiwagi Shinichiro, Noda Satoru, Kawajiri Hidemi, Tokumoto Mao, Nishimura Shigehiko, Nishimori Takeo, Ikeda Katsumi, Ogawa Yoshinari, Mizuyama Yoko, Sunami Takeshi, Tezuka Kenji, Yamagata Shigehito, Ishikawa Tetsuro, Kudoh Shinzoh, Takada Minoru, Hirakawa Kosei, Ohira Masaichi
机构信息
Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan
出版信息
Anticancer Res. 2019 Apr;39(4):2053-2059. doi: 10.21873/anticanres.13316.
AIM
This study was conducted in order to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus trastuzumab followed by 5-fluorouracil/ epirubicin/cyclophosphamide (FEC) in a neoadjuvant chemotherapy (NAC) setting for patients with human epidermal growth factor receptor 2 (HER2)-positive operable breast cancer.
PATIENTS AND METHODS
Each patient received four cycles of 260 mg/m nab-paclitaxel with 6 mg/kg trastuzumab (8 mg/kg as the loading dose) every 3 weeks (q3w) followed by four cycles of FEC (500/100/500 mg/m) q3w. The primary endpoint was pathological complete response (pCR) rate.
RESULTS
Twenty-nine patients were analyzed for the efficacy and safety of this treatment. All patients completed four cycles of nab-paclitaxel and trastuzumab, and 28 patients completed four cycles of FEC. Twenty-seven patients subsequently underwent surgery. The pCR rate was 74.0%. The most frequent toxicity was sensory neuropathy (96.6%), but grade 3 neuropathy rate was 3.4%.
CONCLUSION
Nab-paclitaxel plus trastuzumab followed by FEC in patients with HER2-positive operable breast cancer is considerably effective and well tolerated.
目的
本研究旨在评估纳米白蛋白结合型紫杉醇（nab-紫杉醇）联合曲妥珠单抗，随后序贯5-氟尿嘧啶/表柔比星/环磷酰胺（FEC）在人表皮生长因子受体2（HER2）阳性可手术乳腺癌患者新辅助化疗（NAC）中的疗效和安全性。
患者与方法
每位患者每3周接受4个周期的260mg/m² nab-紫杉醇联合6mg/kg曲妥珠单抗（8mg/kg为负荷剂量），随后每3周接受4个周期的FEC（500/100/500mg/m²）。主要终点为病理完全缓解（pCR）率。
结果
对29例患者进行了该治疗的疗效和安全性分析。所有患者均完成了4个周期的nab-紫杉醇和曲妥珠单抗治疗，28例患者完成了4个周期的FEC治疗。27例患者随后接受了手术。pCR率为74.0%。最常见的毒性是感觉神经病变（96.6%），但3级神经病变率为3.4%。
结论
HER2阳性可手术乳腺癌患者接受nab-紫杉醇联合曲妥珠单抗，随后序贯FEC治疗具有显著疗效且耐受性良好。
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