Oncology Unit, Azienda Ospedaliera Treviglio-Caravaggio, Piazzale Ospedale 1, Treviglio (BG), Italy.
Expert Opin Pharmacother. 2010 Jun;11(8):1413-32. doi: 10.1517/14656561003796562.
Taxanes are agents for the treatment of breast cancer. Paclitaxel is hydrophobic, and available formulations require polyoxyethylated castor oil, Cremphor EL (CrEL) and an ethanol vehicle to allow parental administration. Nanoparticle albumin-bound paclitaxel (nab-P) is a CrEL-free formulation of paclitaxel. The human albumin-stabilized paclitaxel particles have a size of approximately 130 nm, which allows intravenous infusion without capillary blockage.
Efficacy and safety of nab-P in breast cancer has been compared with paclitaxel and docetaxel in large Phase III and II trials. Additionally, the efficacy and safety of nab-P have been investigated in other single-arm clinical trials, in early and advanced disease.
Preclinical and clinical development of the drug across all clinical trials published so far, the approved clinical indications, the benefits of this taxane formulation and a look into the future with emphasis on the application in specific subtypes of breast cancer.
nab-P has been approved for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated and represents one of most authoritative and sophisticated applications of nanotechnology in cancer treatment so far.
紫杉醇类药物是治疗乳腺癌的药物。紫杉醇是疏水性的,现有的制剂需要聚氧乙基化蓖麻油、Cremphor EL(CrEL)和乙醇载体才能进行肠胃外给药。白蛋白结合紫杉醇纳米粒(nab-P)是一种不含 CrEL 的紫杉醇制剂。人血白蛋白稳定的紫杉醇颗粒大小约为 130nm,可进行静脉输注而不会发生毛细血管阻塞。
nab-P 在乳腺癌中的疗效和安全性已在大型 III 期和 II 期试验中与紫杉醇和多西紫杉醇进行了比较。此外,nab-P 在早期和晚期疾病的其他单臂临床试验中也研究了其疗效和安全性。
迄今为止发表的所有临床试验中药物的临床前和临床开发情况、已批准的临床适应证、这种紫杉醇制剂的优势以及对未来的展望,重点是在乳腺癌特定亚型中的应用。
nab-P 已被批准用于治疗转移性乳腺癌,适用于一线治疗转移性疾病失败且不适合标准蒽环类药物治疗的患者,是目前癌症治疗中纳米技术最权威和复杂的应用之一。