TY - JOUR
T1 - Therapeutic efficacy of a novel Nanosomal Docetaxel lipid suspension compared with Taxotere in locally advanced or Metastatic breast cancer patients
AU - Ahmad, Ateeq
AU - Sheikh, Saifuddin
AU - Taran, Rakesh
AU - Srivastav, Shanti P.
AU - Prasad, Krishna
AU - Rajappa, Senthil J.
AU - Kumar, Vijay
AU - Gopichand, Mamillapalli
AU - Paithankar, Mahesh
AU - Sharma, Manish
AU - Rane, Rajendra C.
AU - Ahmad, Imran
PY - 2014/1/1
Y1 - 2014/1/1
N2 - 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/m2 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.
AB - 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/m2 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.
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U2 - 10.1016/j.clbc.2013.09.011
DO - 10.1016/j.clbc.2013.09.011
M3 - Article
C2 - 24287370
AN - SCOPUS:84899918655
SN - 1526-8209
VL - 14
SP - 177
EP - 181
JO - Clinical Breast Cancer
JF - Clinical Breast Cancer
IS - 3
ER -
