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多中心观察性试验:聚乙二醇脂质体阿霉素治疗转移性乳腺癌。

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer.

机构信息

Breast Center Kantonsspital, St Gallen, Switzerland.

出版信息

BMC Cancer. 2010 Jan 5;10:2. doi: 10.1186/1471-2407-10-2.

DOI:10.1186/1471-2407-10-2
PMID:20047698
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2806246/
Abstract

BACKGROUND

Pegylated liposomal doxorubicin (PLD) is active in metastatic breast cancer. This observational study evaluated the efficacy and safety of PLD in patients treated during routine clinical practice.

METHODS

Eligible patients had metastatic breast cancer and were treated with PLD according to the dose and schedule determined by their physician as part of routine practice. The primary objectives were to analyze the efficacy and toxicity of PLD therapy.

RESULTS

125 patients were assessable. Median age was 62 years, 78% had performance status 0-1, and 60% had estrogen-receptor-positive disease. PLD treatment was second- or third-line in 69% of patients. Prior anthracyclines (adjuvant or metastatic) had been used in 56% of patients. The majority of patients (79%) received PLD every 4 weeks at a median dose of 40 mg/m2. Overall response rate was 43% in all patients and 34% in those previously treated with anthracyclines. The most common grade 3/4 adverse events were skin toxicity/hand-foot syndrome (6%), and leukopenia (3%).

CONCLUSIONS

This observational study supports the activity and tolerability of PLD in metastatic breast cancer as demonstrated in PLD clinical trials.

摘要

背景

多柔比星脂质体(PLD)在转移性乳腺癌中具有活性。本观察性研究评估了 PLD 在常规临床实践中治疗的转移性乳腺癌患者中的疗效和安全性。

方法

符合条件的患者患有转移性乳腺癌,根据医生确定的剂量和方案使用 PLD 进行治疗,这是常规实践的一部分。主要目的是分析 PLD 治疗的疗效和毒性。

结果

125 名患者可评估。中位年龄为 62 岁,78%的患者体能状态为 0-1 级,60%的患者雌激素受体阳性疾病。69%的患者接受 PLD 二线或三线治疗。56%的患者既往接受过辅助或转移性蒽环类药物治疗。大多数患者(79%)以 40mg/m2 的中位数剂量每 4 周接受 PLD 治疗。所有患者的总体缓解率为 43%,既往接受过蒽环类药物治疗的患者为 34%。最常见的 3/4 级不良事件是皮肤毒性/手足综合征(6%)和白细胞减少(3%)。

结论

这项观察性研究支持 PLD 在转移性乳腺癌中的活性和可耐受性,与 PLD 临床试验中的结果一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd0/2806246/6299312768cc/1471-2407-10-2-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd0/2806246/6299312768cc/1471-2407-10-2-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd0/2806246/6299312768cc/1471-2407-10-2-1.jpg

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