Clinical and economic implications of the use of nanoparticle paclitaxel (Nanoxel) in India

Abstract

Paclitaxel (Taxol), one of the most commonly used chemotherapeutic agents, is poorly soluble in water and requires cremophor, which often causes infusion reactions, as a solvent. Nanoxel, a nanoparticle formulation of the taxane, has been approved by the Indian regulatory authority. In the present article, we aim to describe the experience with the use of Nanoxel in India and its clinical and economic implications. We present three retrospective series in a common practice environment and an economic model. The first series shows no reactions in 596 Nanoxel infusions; the second series shows comparable adverse events other than infusion reactions between 83 patients who received Nanoxel and 32 treated with conventional paclitaxel. The third reveals comparable clinical outcomes for 51 patients treated with Nanoxel or conventional paclitaxel for gastroesophageal tumors. Finally, we describe an economic model which estimates savings of 21 580 Indian rupees per cycle with Nanoxel vis-à-vis conventional paclitaxel in the treatment of solid tumors in India. In conclusion, in an era in which the greatest challenge we face as medical oncologists is how to conciliate hard-won and incremental--but small--improvements in survival with exponentially rising drugs costs, it is refreshing to see a potential new formulation of a commonly used drug that may actually generate cost-savings while improving clinical outcomes and patient well-being. Further studies are clearly warranted to determine the optimal dose and schedule for Nanoxel as well as its comparative effectiveness to cremophor-based paclitaxel.

Mitotic Poisons in Research and Medicine

“…Another way to enhance the water solubility of compound 9 , is the use of liposomes, as in the case of Lipusu ® agent, or encapsulation into polymer micelles as, for example, in the Nanoxel ® agent [ 50 , 51 ]. A major limitation of broader clinical use of compound 9 is also the fact that despite a successful outcome after the first series of chemotherapy with this drug, most patients experience a relapse of the disease and an increase in cancer cell resistance to the drug.…”

Nanopharmaceuticals: Characteristics of importance for pharmaceutical practice

“…U poređenju sa Taxol ® rastvorom za infuziju pokazano je da su neželjeni efekti smanjeni upotrebom nanofarmaceutskih preparata sa paklitakselom. Takođe, postignuta je veća ili slična efikasnost u slučaju primjene Genexol ® -PM (koji će vjerovatno biti odobren u EU pod imenom Cynvilog ® ) i Nanoxel ® -a, respektivno, kao jedina dva odobrena preparata zasnovana na polimernim micelama (10,35,(38)(39)(40). Abraxane ® je zasad jedini odobreni lijek u kojem su polimerne nanočestice nosači paklitaksela.…”

The Application of Nanotechnology to Drug Delivery in Medicine

“…The breakdown of the different nanomaterial types is very similar to those in phase II trials, with 44.2% of the nanomedicine options being liposomes/solid lipid nanoparticles, 32.6% are polymer therapeutics, 9.3% are polymer micelles, 7.0% are metal nanoparticles, and 7.0% are SDNs. Nanoxel-PM, like other docetaxel-/pacitaxel-based nanomedicines, has been designed to avoid the need for delivery with solubilizing agents, such as Cremophor which can cause serious side effects [211]. The conjugated PEG molecules are designed to increase the half-life and decrease the immunogenicity of uricase.…”