Nanoparticle Albumin-bound Paclitaxel: a Novel Cremphor-EL®-free Formulation of Paclitaxel

Thomas E Stinchcombe


Nanomedicine. 2007;2(4):415-423. 

In This Article


The extensive preclinical data indicated that the CrEL vehicle used in the standard formulation of paclitaxel may contribute to the toxicity of paclitaxel therapy. The nab technology has allowed the development of a novel formulation of paclitaxel, nab-paclitaxel, which eliminates the need for premedication for hypersensitivity reactions, reduces the infusion time and allows paclitaxel to be administered with standard infusion equipment. Preclinical data have indicated that nab-paclitaxel has less toxicity and greater antitumor activity than CrEL-paclitaxel. Preclinical studies have also demonstrated that the nab-paclitaxel formulation results in higher intratumoral levels of paclitaxel through the mechanisms of albumin transportations into malignant cells and, potentially, sequestration of the nab-paclitaxel by SPARC. A Phase III clinical trial in patients with metastatic breast cancer compared nab-paclitaxel (260 mg/m2) with CrEL-paclitaxel (175 mg/m2) every 3 weeks, and patients treated with nab-paclitaxel had a higher response rate and time to tumor progression. Patients on the nab-paclitaxel arm had a statistically significantly lower rate of grade 4 neutropenia (9 vs 22%, respectively; p < 0.001) and a higher rate of grade 3 sensory neuropathy (10 vs 2%, respectively; p < 0.001). Nab-paclitaxel is currently approved for the treatment of metastatic breast cancer and has shown activity in advanced NSCLC. Ongoing trials are investigating the activity and toxicity of nab-paclitaxel in combination with other agents (e.g., carboplatin, bevacizumab, cyclophosphamide, epirubicin or gemcitabine) in different diseases (e.g., ovarian, small-cell lung cancer) and in adjuvant breast cancer. The nab technology may be used to develop new formulations of different cytotoxic agents, in the development of drug-eluting cardiac stents and in combination with radiotherapy.[44,45]


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