Pegylated liposomal doxorubicin (Doxil®) for metastatic breast cancer:: The Cancer Research Network, Inc., experience
Pegylated liposomal doxorubicin (Doxil®) for metastatic breast cancer:: The Cancer Research Network, Inc., experience
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DOI：
10.1081/cnv-120014883
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发表时间：
2002-01-01
影响因子：
2.4
通讯作者：
Vogel, CL
中科院分区：
文献类型：
--
作者：
Perez, AT;Domenech, GH;Vogel, CL
为提高阿霉素的安全性，研制了聚乙二醇化阿霉素脂质体(Doxil(R))。主要的毒性反应，粘膜炎和掌底红斑感觉，分别与剂量和时间有关。坊间经验表明，每4周40 mg/m(2)的剂量是很好的耐受性。为了评估该方案在女性转移性乳腺癌患者中的安全性和有效性，我们在一家私人诊所进行了一项回顾图表。40名妇女接受的初始剂量中位数为42.5 mg/m(2)，通常为每4周一次，累积剂量中位数为135 mg/m(2)(范围：40-595 mg/m(2))。在意向治疗分析中，有10名患者部分缓解，7名患者病情稳定超过6个月，临床受益率为43%。所有患者的中位进展时间为4个月，部分缓解患者为6.5个月，病情稳定超过6个月的患者为10个月。未发生4级毒性反应。唯一的3级毒性是7例(18%)患者出现白细胞减少，1例(3%)患者出现粘膜炎，1例(3%)患者出现手掌计划焦油红斑感觉障碍。需要更多的研究来证实我们的发现，这表明聚乙二醇化脂质体阿霉素每4周剂量为40-45 mg/m(2)，在转移性乳腺癌妇女中临床上是有效的，并且耐受性良好。
Pegylated liposomal doxorubicin (Doxil(R)) was formulated to improve the safety, profile of doxorubicin. The major toxicities, mucositis and palmar-plantar erythrodysesthesia, are dose and schedule dependent, respectively. Anecdotal experience suggests that a dosage of 40 mg/m(2) every 4 weeks is well tolerated. To evaluate the safety and efficacy of this regimen in women with metastatic breast cancer; we performed a retrospective chart review at a private practice. Forty women received a median initial dose of 42.5 mg/m(2) usually every 4 weeks and a median cumulative dose of 135 mg/m(2) (range: 40-595 mg/m(2)). There were 10 partial responses and,seven patients with stable disease for more than 6 months resulting in a clinical benefit rate of 43% in the intent-to-treat analysis. The median time to progression was 4 months in all patients, 6.5 months in patients who had partial responses, and 10 months in patients who had stable disease for more than 6 months. There was no grade 4 toxicity. The only grade 3 toxicities were leukopenia in seven (18%) patients, mucositis in one (3%), and palmar-plan tar erythrodysesthesia in one (3%). More studies are warranted to confirm our findings, which suggest that pegylated liposomal doxorubicin at a dosage of 40-45 mg/m(2) every 4 weeks is clinically active in, and well tolerated by, women with metastatic breast cancer.