title: Adverse drug reaction profile of nanoparticle versus conventional formulation of paclitaxel: An observational study.
abstract: OBJECTIVE
  Conventional polyethoxylated castor oil (PCO)-based paclitaxel is associated with major adverse drug reactions (ADRs). Nanoxel, a nanoparticle-based formulation, may improve its tolerability by removing the need for PCO vehicle, and also permit its use in a higher dose. We conducted intensive monitoring of the ADR profile of Nanoxel in comparison with conventional paclitaxel in a public tertiary care set-up.
  
  
  METHODS
  ADR data were collected from 10 patients receiving Nanoxel and 10 age-matched controls receiving conventional paclitaxel in this longitudinal observational study, conducted in a medical oncology ward over 18 months. Severity was graded as per US National Cancer Institute Common Terminology Criteria for Adverse Events.
  
  
  RESULTS
  The groups had comparable demography at baseline. The median disease duration and per cycle median dose of paclitaxel were greater in the Nanoxel arm. Total 119 ADRs were noted with Nanoxel and 123 with conventional paclitaxel. Of these, 25 (21.0%, 95% CI 13.69-28.33%) in the Nanoxel and 20 (16.2%, 95% CI 9.74-22.78%) in paclitaxel group were of grade 3/4 severity. Common events included myalgia, nausea, anemia, paresthesia, alopecia, diarrhea, and vomiting with Nanoxel, and paresthesia, anemia, myalgia, anorexia, alopecia, vomiting, diarrhea, stomatitis, and nausea with paclitaxel. Of the less common events (<5%), grade 2 or 3 arthralgia was seen exclusively with Nanoxel while motor neuropathy with muscular weakness was more frequent and severe with conventional paclitaxel. Hypersensitivity reactions were not encountered in either arm, although no antiallergy premedication was employed for Nanoxel.
  
  
  CONCLUSIONS
  Despite its ADR profile being statistically comparable to conventional paclitaxel, this observational study suggests that Nanoxel tolerability could be better, considering that a significantly higher dose was employed. This hypothesis needs confirmation through an interventional study.
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education & Research (IPGMER), 244B, Acharya J. C. Bose Road, Kolkata, West Bengal, India.
authors.forename: Ballari
authors.initials: B
authors.lastname: Brahmachari
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.forename: Anup
authors.initials: A
authors.lastname: Majumdar