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紫杉醇与脂质体阿霉素(凯素灵)联合用于晚期乳腺癌患者:一项II期研究。

Paclitaxel and liposomal doxorubicin (Caelyx) combination in advanced breast cancer patients: a phase II study.

作者信息

Rigatos Sotiris K, Tsavdaridis Dimitrios, Athanasiadis Athanasios, Stathopoulos John G, Stathopoulos George P

机构信息

Oncology Department, Errikos Dynan Hospital, Athens, Greece.

出版信息

Oncol Rep. 2003 Nov-Dec;10(6):1817-9.

PMID:14534702
Abstract

Due to the cumulative cardiotoxicity of doxorubicin in cancer treatment, the tendency of the physician to find a substitute has led to the use of liposomal encapsulated doxorubicin, as well as other similar compounds. Doxorubicin and paclitaxel, two of the most active agents for breast cancer, have often been used in combination for this condition. In the present study we combined liposomal doxorubicin with paclitaxel with the intention of diminishing the toxicity of the cardiac muscle. Twenty-three patients were evaluated for response rate, survival and toxicity. All patients had metastatic disease and were chemotherapy-naïve after generalization of the disease. Liposomal doxorubicin was infused at a dose of 30 mg/m(2) and paclitaxel at a dose of 175 mg/m(2) once every 3 weeks. The response rate was complete in 2 patients (8.70%) and partial in 14 patients (60.87%) totalling 69.57%. The median duration of response was 6 months (range 2-13+) and median survival was 10 months (range 4-20+). Cardiotoxicity, myelotoxicity and gastrointestinal toxicity were well-tolerated. The high hand-foot adverse reaction (47.83%) inhibited the continuation of treatment in half of the patients and due to this toxicity the trial was terminated after the 23rd patient.

摘要

由于阿霉素在癌症治疗中具有累积性心脏毒性,医生寻找替代药物的趋势促使脂质体包裹的阿霉素以及其他类似化合物得以应用。阿霉素和紫杉醇是乳腺癌最有效的两种药物,常联合用于治疗这种疾病。在本研究中,我们将脂质体阿霉素与紫杉醇联合使用,目的是降低对心肌的毒性。对23例患者进行了缓解率、生存率和毒性评估。所有患者均患有转移性疾病,在疾病播散后均未接受过化疗。脂质体阿霉素以30mg/m²的剂量静脉输注,紫杉醇以175mg/m²的剂量静脉输注,每3周一次。2例患者完全缓解(8.70%),14例患者部分缓解(60.87%),总缓解率为69.57%。中位缓解持续时间为6个月(范围2 - 13 +),中位生存期为10个月(范围4 - 20 +)。心脏毒性、骨髓毒性和胃肠道毒性耐受性良好。手足不良反应发生率较高(47.83%),导致一半患者停止治疗,由于这种毒性,在第23例患者之后试验终止。

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