Mlineritsch Brigitte, Schabel-Moser Renate, Andel Johannes, Fridrik Michael, Moik Martin, Mayer Peter, Russ Gudrun, Rass Christof, Greil Richard
Paracelsus Medical University Salzburg, 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectious Disease and Laboratory of Immunological and Molecular Cancer Research, Müllner Hauptstrasse 48, Salzburg, Austria.
Onkologie. 2009 Feb;32(1-2):18-24. doi: 10.1159/000180915. Epub 2009 Jan 20.
This multicenter phase II trial was conducted to analyze the clinical activity and toxicity of the combination of pegylated liposomal doxorubicin and vinorelbine as first-line treatment in elderly patients with metastatic breast cancer.
From August 2002 to August 2004, 42 patients with metastatic breast cancer were recruited for treatment with pegylated liposomal doxorubicin 40 mg/m(2) intravenously (i.v.) on day 1 and vinorelbine 30 mg/m(2) i.v. on days 1 and 15 every 4 weeks.
The median age of the patients in this trial was 68 years (range 60-82). 40% of patients had 2 or more sites of metastasis, 33 (78%) had predominantly visceral metastasis, and 7 (16%) mostly bone metastasis. Just 2 (5%) patients had only lymphogenous or soft tissue metastasis. All patients had an ECOG performance status of 0-1, but 70% of the patients had relevant comorbidities. In an intention-to-treat analysis, the overall clinical response rate was 36%, the complete response rate was 2%, and the rate of partial remissions was 34%; stable disease occurred in 30%, and progressive disease was observed in 36%. Median duration of response was 10 months. Median time to progression was 4 months, and median overall survival time was 24 months.
The combination of pegylated liposomal doxorubicin and vinorelbine is an active and well tolerated regimen in elderly patients with metastatic breast cancer in first-line treatment.
本多中心II期试验旨在分析聚乙二醇化脂质体阿霉素与长春瑞滨联合用药作为老年转移性乳腺癌患者一线治疗方案的临床活性和毒性。
2002年8月至2004年8月，招募了42例转移性乳腺癌患者，接受每4周一次的治疗，第1天静脉注射聚乙二醇化脂质体阿霉素40mg/m²，第1天和第15天静脉注射长春瑞滨30mg/m²。
本试验患者的中位年龄为68岁（范围60 - 82岁）。40%的患者有2个或更多转移部位，33例（78%）主要为内脏转移，7例（16%）主要为骨转移。仅2例（5%）患者仅有淋巴或软组织转移。所有患者的东部肿瘤协作组（ECOG）体能状态为0 - 1，但70%的患者有相关合并症。在意向性分析中，总体临床缓解率为36%，完全缓解率为2%，部分缓解率为34%；疾病稳定率为30%，疾病进展率为36%。中位缓解持续时间为10个月。中位疾病进展时间为4个月，中位总生存时间为24个月。
聚乙二醇化脂质体阿霉素与长春瑞滨联合用药对老年转移性乳腺癌患者一线治疗而言是一种活性良好且耐受性佳的方案。
