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. PATIENTS AND 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. CONCLUSION:NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients.

journal_name

Clin Breast Cancer

journal_title

Clinical breast cancer

authors

Ahmad A,Sheikh S,Taran R,Srivastav SP,Prasad K,Rajappa SJ,Kumar V,Gopichand M,Paithankar M,Sharma M,Rane RC,Ahmad I

doi

10.1016/j.clbc.2013.09.011

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

177-81

issue

3

eissn

1526-8209

issn

1938-0666

pii

S1526-8209(13)00224-3

journal_volume

14

pub_type

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