Bartsch Rupert, Wenzel Catharina, Altorjai Gabriela, Pluschnig Ursula, Bachleitner-Hoffmann Thomas, Locker Gottfried J, Rudas Margaretha, Mader Robert, Zielinski Christoph C, Steger Guenther G
Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, A-1090, Vienna, Austria.
Breast Cancer Res Treat. 2007 May;102(3):375-81. doi: 10.1007/s10549-006-9342-5. Epub 2006 Sep 21.
We evaluated the efficacy and tolerability of oral vinorelbine plus trastuzumab (OV + T) in Her2 positive advanced breast cancer as first line chemotherapy or after progressing on earlier treatment.
Thirty consecutive patients (median age: 59 years) were included. Patients received OV in a dose of 60 mg/m(2) on day 1 and 8, q=21, without dose escalation. Trastuzumab was administered every 3 weeks at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Response was evaluated every three cycles using UICC criteria. Time to progression (TTP) and overall survival (OS) were estimated using the Kaplan-Meier product limit method. A multivariate analysis was performed to evaluate factors potentially influencing response rate and TTP.
Median time of observation was 20 months. We observed a complete response in 18% of patients, partial remission in 50%, stable disease >or= 6 months in 21%, and progressive disease in 11%. TTP was median 9 months. OS was not reached. Response rate and TTP were influenced by line of treatment only. The main toxicities consisted of neutropenia and nausea.
OV + T appears to be an effective and safe treatment option in advanced breast cancer at the dose and schedule chosen.
我们评估了口服长春瑞滨联合曲妥珠单抗（OV + T）用于人表皮生长因子受体2（Her2）阳性晚期乳腺癌一线化疗或早期治疗进展后的疗效和耐受性。
纳入30例连续患者（中位年龄：59岁）。患者在第1天和第8天接受剂量为60mg/m²的OV，每21天一次，不进行剂量递增。曲妥珠单抗在8mg/kg负荷剂量后，每3周以6mg/kg体重的剂量给药。每三个周期使用国际抗癌联盟（UICC）标准评估反应。使用Kaplan-Meier乘积限界法估计疾病进展时间（TTP）和总生存期（OS）。进行多因素分析以评估可能影响缓解率和TTP的因素。
中位观察时间为20个月。我们观察到18%的患者完全缓解，50%部分缓解，21%疾病稳定≥6个月，11%疾病进展。TTP中位值为9个月。OS未达到。缓解率和TTP仅受治疗线数影响。主要毒性包括中性粒细胞减少和恶心。
在所选择的剂量和方案下，OV + T似乎是晚期乳腺癌一种有效且安全的治疗选择。
