Liposomal pegylated doxorubicin plus vinorelbine combination as first-line chemotherapy for metastatic breast cancer in elderly women ≥65 years of age
Liposomal pegylated doxorubicin plus vinorelbine combination as first-line chemotherapy for metastatic breast cancer in elderly women ≥65 years of age
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DOI：
10.1007/s00280-007-0605-6
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发表时间：
2008-07-01
影响因子：
3
通讯作者：
Del Prete, Salvatore
中科院分区：
文献类型：
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作者：
Addeo, Raffaele;Faiola, Vincenzo;Del Prete, Salvatore
目的老年转移性乳腺癌（MBC）的标准化疗方案尚未确定。为了确定一个方案具有可接受的疗效和低负担的非重叠的毒性作用，脂质体聚乙二醇化阿霉素（PLD）与交替口服和静脉注射长春瑞滨（NVB）组成的组合进行了研究，在第二阶段study.Methods三十四个连续的患者（中位年龄71岁;范围65-82）与MBC已被招募。基于4周周期，PLD 40 mg/m（2）+NVB 25 mg/m（2）静脉注射，第1天静脉滴注，第15天口服诺维本60 mg/m2。总共记录了17例缓解，其中3例完全缓解（CR），14例部分缓解，总缓解率为50%（95%CI 36-66）。中位总生存时间为13个月，中位进展时间为8个月。有趣的是，所有CR患者仍然存活，无病生存期超过1年。主要毒性为中性粒细胞减少症：分别为15%的3级和11%的4级患者。3例患者记录了发热性中性粒细胞减少，无需减量。其他经常报告的不良事件包括：贫血、恶心、呕吐、口腔炎，均为罕见的重度不良事件。生活质量（QoL）的评价并没有显示出任何显着的变化在study.Conclusions我们的数据表明，这种组合是积极的，耐受性良好的MBC老年患者，并可能代表另一个有效的机会，为管理这个人口。
Purpose No standard chemotherapy has been so far definitely settled for elderly patients with metastatic breast cancer (MBC). In order to identify a regimen with acceptable efficacy and low burden of non-overlapping toxic effects, a combination consisting of liposomal pegilated doxorubicin (PLD) with alternating oral and intravenous vinorelbine (NVB) has been investigated in a phase II study.Methods Thirty-four consecutive patients (median age 71 years; range 65-82) with MBC have been enrolled. Based on 4-weekly cycles, PLD 40 mg/m(2) plus NVB 25 mg/m(2) i.v., have been administered intravenously on day 1 and oral NVB 60 mg/m(2) on day 15.Results All patients were assessable for safety and efficacy. In all, 17 responses were documented with three complete responses (CR) and 14 partial responses, with an overall response rate of 50% (95% CI 36-66). Median overall survival time was 13 months and the median time to progression 8 months. Interestingly, all the patients with CR are still alive with a disease-free survival of more than 1 year. The main toxicity was neutropenia: grade 3 in 15% and grade 4 in 11% of patients, respectively. Febrile neutropenia was recorded in three patients not requiring dose reduction. Other frequently reported adverse events included: anemia, nausea, vomiting, stomatitis, all rarely severe. The evaluation of quality of life (QoL) did not show any significant change during the study.Conclusions Our data suggest that this combination is active and well tolerated in elderly patients with MBC and could represent another efficacious chance for the management of this population.