Van Pelt Andrea E, Mohsin Syed, Elledge Richard M, Hilsenbeck Susan G, Gutierrez M Carolina, Lucci Anthony, Kalidas Mamta, Granchi Thomas, Scott Bradford G, Allred D Craig, Chang Jenny C
Department of Surgery, Methodist Hospital, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA.
Clin Breast Cancer. 2003 Dec;4(5):348-53. doi: 10.3816/cbc.2003.n.040.
Trastuzumab/chemotherapy combinations have already shown superior results in metastatic breast cancer patients. The purpose of this study is to determine the clinical efficacy of neoadjuvant trastuzumab and docetaxel in women with locally advanced breast cancer, with or without metastatic disease. Treatment-naive women with HER2-overexpressing locally advanced breast cancer, with or without metastatic disease, were included. Patients received trastuzumab 4 mg/kg loading dose intravenously then 2 mg/kg weekly. On day 22, docetaxel 100 mg/m2 every 3 weeks for 4 cycles was added to weekly trastuzumab. Patients then underwent surgery and subsequent 4 cycles of AC (doxorubicin/cyclophosphamide; 60/600 mg/m2) without trastuzumab. Weekly trastuzumab was resumed 1 month after completion of AC and continued for a year. Preliminary results from the first 22 patients with median follow-up of 15.5 months (range, 2-38 months) are reported. Of these, 9 patients (40.9%) had inflammatory breast cancer, and 6 patients (27.3%) had stage IV breast cancer. Seventeen of 22 patients (77.3%) had objective clinical response, with a clinical complete response in 9 patients (40.9%). Two patients (9.1%) had decline in cardiac function and 7 patients (31.8%) experienced neutropenia, with 2 deaths (9.1%) from neutropenic sepsis. Eight patients (36.4%) have relapsed, 3 with local skin recurrence (13.6%) and 5 with distant recurrence, of whom 1 had liver metastasis (4.5%) and 4 had brain metastasis (18.2%). Combined neoadjuvant trastuzumab and docetaxel induced high clinical response rates for HER2-overexpressing breast cancer, in particular for inflammatory breast cancer. A high rate of brain metastasis was noted, particularly in patients with baseline metastatic disease.
曲妥珠单抗/化疗联合方案已在转移性乳腺癌患者中显示出更好的疗效。本研究的目的是确定新辅助曲妥珠单抗和多西他赛治疗局部晚期乳腺癌女性患者（无论有无转移性疾病）的临床疗效。纳入未经治疗的HER2过表达局部晚期乳腺癌女性患者，无论有无转移性疾病。患者静脉注射曲妥珠单抗4 mg/kg负荷剂量，然后每周2 mg/kg。在第22天，将多西他赛100 mg/m²每3周一次共4个周期加入到每周的曲妥珠单抗治疗中。患者随后接受手术，然后接受4个周期的AC（阿霉素/环磷酰胺；60/600 mg/m²），不使用曲妥珠单抗。在AC完成后1个月恢复每周曲妥珠单抗治疗，并持续1年。报告了前22例患者的初步结果，中位随访时间为15.5个月（范围2 - 38个月）。其中，9例患者（40.9%）患有炎性乳腺癌，6例患者（27.3%）患有IV期乳腺癌。22例患者中有17例（77.3%）有客观临床反应，9例患者（40.9%）达到临床完全缓解。2例患者（9.1%）出现心功能下降，7例患者（31.8%）出现中性粒细胞减少，2例患者（9.1%）死于中性粒细胞减少性败血症。8例患者（36.4%）复发，3例局部皮肤复发（13.6%），5例远处复发，其中1例肝转移（4.5%），4例脑转移（18.2%）。新辅助曲妥珠单抗和多西他赛联合治疗HER2过表达乳腺癌，尤其是炎性乳腺癌，诱导出较高的临床反应率。观察到较高的脑转移率，特别是在基线有转移性疾病的患者中。
