Raff Joshua P, Rajdev Lakshmi, Malik Umekalsoom, Novik Yelena, Manalo Jane M, Negassa Abdissa, Hopkins Una, Sarta Catherine, Sparano Joseph A
Albert Einstein Cancer Center, Montefiore Medical Center, Bronx, New York, NY 10461-2373, USA.
Clin Breast Cancer. 2004 Feb;4(6):420-7. doi: 10.3816/cbc.2004.n.005.
This study was designed to determine the efficacy and toxicity of weekly docetaxel in metastatic breast cancer when given alone (for HER2/neu negative disease) or with trastuzumab (for HER2/neu overexpressing disease). Patients with metastatic breast carcinoma received docetaxel given on 2 different schedules (group 1A, 33 mg/m2 weekly [n = 21]; group 1B, 40 mg/m2 weekly for 3 weeks with 1 week off [n = 14]). Patients with HER2/neu overexpressing disease also received trastuzumab 4 mg/kg on day 1, then 2 mg/kg on days 8 and 15 of each 28-day cycle (group 2). Fifty-two patients were treated with docetaxel alone (group 1A/B, n = 35) or in combination with trastuzumab (group 2, n = 17). Prior taxane therapy given every 3 weeks had been used for metastatic disease in 19 of 35 patients (54%) in group 1A/B and in 2 of 17 patients (12%) in group 2. The mean delivered dose intensity of docetaxel was 29 mg/m2 per week. Partial response occurred in 7 of 35 patients (21%; 95% exact binomial confidence interval [CI], 9%-38%) treated with docetaxel alone, including 3 of 19 taxane-pretreated patients (16%) and 4 of 16 taxane-naive patients (25%). Partial response occurred in 10 of 17 patients (59%; 95% CI, 34%-82%) treated with docetaxel/trastuzumab. The most common grade 3/4 toxicities, occurring in more than or equal to 10% of patients, included neutropenia (21%), pulmonary toxicity (12%), and hyperglycemia (10%). The median times to disease progression were 4.5 months (95% CI, 2.5-6.5 months) in the docetaxel group and 8.5 months (95% CI, 4.5-12.5 months) in the docetaxel/trastuzumab group. Weekly docetaxel/trastuzumab is an effective regimen for patients with HER2/neu overexpressing metastatic breast cancer. Weekly docetaxel may be effective in as many as 20% of patients who had progressive disease after treatment with taxanes given every 3 weeks.
本研究旨在确定每周使用多西他赛单药治疗（用于HER2/neu阴性疾病）或联合曲妥珠单抗治疗（用于HER2/neu过表达疾病）转移性乳腺癌的疗效和毒性。转移性乳腺癌患者接受两种不同给药方案的多西他赛治疗（1A组，33mg/m²每周一次[n = 21]；1B组，40mg/m²每周一次，共3周，休息1周[n = 14]）。HER2/neu过表达疾病的患者在每个28天周期的第1天还接受4mg/kg的曲妥珠单抗治疗，然后在第8天和第15天接受2mg/kg的曲妥珠单抗治疗（2组）。52例患者接受了多西他赛单药治疗（1A/B组，n = 35）或联合曲妥珠单抗治疗（2组，n = 17）。1A/B组35例患者中有19例（54%）和2组17例患者中有2例（12%）曾接受过每3周一次的紫杉烷类药物治疗转移性疾病。多西他赛的平均给药剂量强度为每周29mg/m²。多西他赛单药治疗的35例患者中有7例（21%；95%确切二项式置信区间[CI]，9%-38%）出现部分缓解，其中包括19例接受过紫杉烷类药物预处理患者中的3例（16%）和16例未接受过紫杉烷类药物治疗患者中的4例（25%）。多西他赛/曲妥珠单抗联合治疗的17例患者中有10例（59%；95%CI，34%-82%）出现部分缓解。最常见的3/4级毒性反应（在≥10%的患者中出现）包括中性粒细胞减少（21%）、肺部毒性（12%）和高血糖（10%）。多西他赛组疾病进展的中位时间为4.5个月（95%CI，2.5 - 6.5个月），多西他赛/曲妥珠单抗组为8.5个月（95%CI，4.5 - 12.5个月）。每周一次的多西他赛/曲妥珠单抗是HER2/neu过表达转移性乳腺癌患者的有效治疗方案。每周一次的多西他赛对多达20%在接受每3周一次的紫杉烷类药物治疗后病情进展的患者可能有效。
