Breast Cancer Res Treat. 2010 Feb;119(3):717-24. doi: 10.1007/s10549-009-0424-z. Epub 2009 Jun 3.
Docetaxel is an effective therapy for metastatic breast cancer (MBC) and considered a first-line standard of care in many jurisdictions. However, it may be associated with dose-limiting toxicity often requiring dose reductions, delays and in some cases prophylactic hematopoietic growth factors. A nanoparticle albumin-bound (nab) formulation of paclitaxel was developed to overcome the safety drawbacks of solvent-based taxanes and to improve efficacy. A randomized phase II trial comparing nab-paclitaxel 100 or 150 mg/m(2) weekly 3 out of 4 weeks and nab-paclitaxel 300 mg/m(2) every-3-week (q3w) to docetaxel 100 mg/m(2) q3w reported improved progression-free survival (PFS) and reduced toxicity with the former regimens. From resource use captured during the trial, an economic analysis from the perspective of the United Kingdom (UK) National Health Service was conducted. Resource use data contained within the trial database were converted to UK costs. These consisted of costs for chemotherapy, drug delivery, monitoring, supportive care drugs and hospitalization due to toxicity. Univariate and multivariate regression analyses were then conducted to compare the total cost of therapy in patients randomized to each of the four regimens. Growth factor use, hospitalization due to side effects and toxicity-induced protocol discontinuations were higher in the docetaxel group. When all of the cost components were combined for the entire population (N = 300), patients in the nab-paclitaxel 100 mg/m(2) weekly and 300 mg/m(2) q3w groups had comparable average costs to the docetaxel arm ( pound 15,396 vs. pound 15,809 vs. pound 12,923; P = NS). The nab-paclitaxel 150 mg/m(2) weekly arm had significantly higher overall costs of pound 27,222 per patient but had a significant improvement in PFS compared to docetaxel. Relative to docetaxel, the incremental costs per progression-free year gained with nab-paclitaxel 100, 150 mg/m(2) weekly and 300 mg/m(2) q3w were pound 5,600, pound 31,800 and pound 9,900, respectively. Given its improved safety profile, potentially enhanced efficacy and comparable economic impact, nab-paclitaxel (weekly or q3w) can be considered a reasonable alternative to docetaxel as first-line chemotherapy for MBC.
多西他赛是转移性乳腺癌(MBC)的有效治疗药物,在许多司法管辖区被认为是一线标准治疗方法。然而,它可能与剂量限制毒性相关,通常需要减少剂量、延迟治疗,在某些情况下还需要预防性使用造血生长因子。为了克服溶剂型紫杉烷的安全性缺陷并提高疗效,开发了一种纳米白蛋白结合(nab)紫杉醇制剂。一项比较 nab-紫杉醇 100 或 150 mg/m(2)每周 3 次/4 周与 nab-紫杉醇 300 mg/m(2)每 3 周(q3w)和多西他赛 100 mg/m(2)q3w 用于转移性乳腺癌的随机 II 期试验报告称,前两种方案可改善无进展生存期(PFS)并降低毒性。根据试验中捕获的资源使用情况,从英国(UK)国家卫生服务体系的角度进行了经济分析。从试验数据库中转换了资源使用数据为英国成本。这些成本包括化疗、药物输送、监测、支持性护理药物以及因毒性而导致的住院费用。然后进行了单变量和多变量回归分析,以比较随机分配至四种方案的患者的治疗总成本。在多西他赛组中,生长因子的使用、因副作用导致的住院治疗和因毒性导致的方案中断更高。当将整个人群(N = 300)的所有成本组成部分合并时,nab-紫杉醇 100 mg/m(2)每周和 300 mg/m(2)q3w 组的患者与多西他赛组的平均成本相当(英镑 15396 与英镑 15809 与英镑 12923;P = NS)。nab-紫杉醇 150 mg/m(2)每周组的总体成本显着增加,每位患者为 27222 英镑,但与多西他赛相比,PFS 有显着改善。与多西他赛相比,使用 nab-紫杉醇 100、150 mg/m(2)每周和 300 mg/m(2)q3w 可分别获得无进展生存的增量成本为每年 5600 英镑、31800 英镑和 9900 英镑。鉴于其安全性改善、潜在的疗效提高和相当的经济影响,nab-紫杉醇(每周或 q3w)可被视为 MBC 一线化疗的合理替代方案,替代多西他赛。