title: Therapeutic efficacy of a novel nanosomal docetaxel lipid suspension compared with taxotere in locally advanced or metastatic breast cancer patients.
abstract: BACKGROUND
  Nanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate 80 from the currently used docetaxel (Taxotere) drug for treatment of cancer patients. NDLS clinical safety and efficacy was evaluated and compared with Taxotere at 75 mg/m(2) in metastatic breast cancer patients.
  
  
  METHODS
  A total of 72 patients were randomized in a ratio of 2:1 (NDLS:Taxotere). Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere. Disease status and tumor response was assessed after every 2 cycles of treatment using Response Evaluation Criteria in Solid Tumors 1.1 guidelines through cycle 6.
  
  
  RESULTS
  Overall therapeutic response (complete + partial) rate in metastatic breast cancer patients treated with NDLS and Taxotere were 35.5% and 26.3%, respectively, indicating better response in patients treated with NDLS. Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere.
  
  
  CONCLUSIONS
  NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients.
authors.affiliation: Jina Pharmaceuticals, Inc, Libertyville, IL.
authors.forename: Ateeq
authors.initials: A
authors.lastname: Ahmad
authors.affiliation: Jina Pharmaceuticals, Inc, Libertyville, IL.
authors.forename: Saifuddin
authors.initials: S
authors.lastname: Sheikh
authors.affiliation: CHL Apollo Hospital, Indore, India.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Taran
authors.affiliation: Lions Cancer Detection Centre, New Civil Hospital, Surat, India.
authors.forename: Shanti P
authors.initials: SP
authors.lastname: Srivastav
authors.affiliation: Kasturba Medical College and Hospital, Mangalore, India.
authors.forename: Krishna
authors.initials: K
authors.lastname: Prasad
authors.affiliation: Indo-American Cancer Hospital and Research Institute, Hyderabad, India.
authors.forename: Senthil J
authors.initials: SJ
authors.lastname: Rajappa
authors.affiliation: M.V. Hospital and Research Center, Lucknow, India.
authors.forename: Vijay
authors.initials: V
authors.lastname: Kumar
authors.affiliation: City Cancer Center, Vijayawada, India.
authors.forename: Mamillapalli
authors.initials: M
authors.lastname: Gopichand
authors.affiliation: Astron Research, Ltd, Ahmedabad, India.
authors.forename: Mahesh
authors.initials: M
authors.lastname: Paithankar
authors.affiliation: Lambda Therapeutic Research Ltd, Ahmedabad, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Sharma
authors.affiliation: Intas Pharmaceuticals, Ltd, Ahmedabad, India.
authors.forename: Rajendra C
authors.initials: RC
authors.lastname: Rane
authors.affiliation: Jina Pharmaceuticals, Inc, Libertyville, IL. Electronic address: imran@jinapharma.com.
authors.forename: Imran
authors.initials: I
authors.lastname: Ahmad
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008081:Liposomes; D008875:Middle Aged; D036103:Nanotechnology; D043823:Taxoids / Q000008:administration & dosage* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D008081:Liposomes; D043823:Taxoids; D000077143:Docetaxel
keywords: Complete response rate; Computed tomography; Lipid delivery system; Premedication; Safety