Hospital del Mar, Barcelona, Spain.
Anticancer Drugs. 2012 Feb;23(2):239-46. doi: 10.1097/CAD.0b013e32834e2fe4.
Different anthracycline-free regimens have demonstrated activity, without serious cardiac events. This study was conducted to evaluate the activity and toxicity of docetaxel and trastuzumab given every 21 days in patients with metastatic breast cancer (MBC). The primary endpoint was time to progression and the secondary aims included response rate, safety, duration of response, and overall survival. Eligible patients were those with MBC human epidermal growth factor receptor-2+ (HER2+) with no previous chemotherapy for advanced disease. Patients received six cycles of docetaxel (100 mg/m) plus trastuzumab (8 mg/kg loading dose and 6 mg/kg every 21 days thereafter), followed by maintenance treatment with trastuzumab monotherapy every 21 days until disease progression. Forty-nine patients with HER2+ MBC were included. The overall response rate was 44.9% (22/49). With a median follow-up of 16.6 months, the median time to progression was 8.3 months and the median overall survival was 25.7 months. Nineteen patients did not receive treatment continuation with trastuzumab monotherapy. The most common toxicity was febrile neutropenia. A total of 10 patients were taken off the study due to treatment-related toxicity, mainly cardiac events. First-line trastuzumab combined with docetaxel is an effective and well tolerated regimen for HER2+ MBC.
不同的无蒽环类药物方案已经显示出疗效,且无严重心脏事件。本研究旨在评估多西他赛和曲妥珠单抗每 21 天给药在转移性乳腺癌(MBC)患者中的活性和毒性。主要终点是无进展时间,次要目的包括缓解率、安全性、缓解持续时间和总生存期。入组患者为 HER2+ MBC 且无晚期疾病化疗史。患者接受 6 个周期的多西他赛(100 mg/m)加曲妥珠单抗(8 mg/kg 负荷剂量,此后每 21 天 6 mg/kg),随后接受曲妥珠单抗单药维持治疗,每 21 天一次,直至疾病进展。共纳入 49 例 HER2+ MBC 患者。总体缓解率为 44.9%(22/49)。中位随访 16.6 个月,无进展时间为 8.3 个月,总生存期为 25.7 个月。19 例患者未接受曲妥珠单抗单药维持治疗。最常见的毒性是发热性中性粒细胞减少症。共有 10 例患者因治疗相关毒性(主要是心脏事件)退出研究。曲妥珠单抗联合多西他赛作为一线治疗方案,对于 HER2+ MBC 是一种有效且耐受良好的方案。