Therapeutic efficacy of a novel Nanosomal Docetaxel lipid suspension compared with Taxotere in locally advanced or Metastatic breast cancer patients

Ateeq Ahmad, Saifuddin Sheikh, Rakesh Taran, Shanti P. Srivastav, Krishna Prasad, Senthil J. Rajappa, Vijay Kumar, Mamillapalli Gopichand, Mahesh Paithankar, Manish Sharma, Rajendra C. Rane, Imran Ahmad

Research output: Contribution to journalArticle

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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/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.

Original languageEnglish
Pages (from-to)177-181
Number of pages5
JournalClinical Breast Cancer
Volume14
Issue number3
DOIs
Publication statusPublished - 01-01-2014
Externally publishedYes

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docetaxel
Suspensions
Breast Neoplasms
Lipids
Therapeutics
Safety
Premedication
Polysorbates

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Ahmad, Ateeq ; Sheikh, Saifuddin ; Taran, Rakesh ; Srivastav, Shanti P. ; Prasad, Krishna ; Rajappa, Senthil J. ; Kumar, Vijay ; Gopichand, Mamillapalli ; Paithankar, Mahesh ; Sharma, Manish ; Rane, Rajendra C. ; Ahmad, Imran. / Therapeutic efficacy of a novel Nanosomal Docetaxel lipid suspension compared with Taxotere in locally advanced or Metastatic breast cancer patients. In: Clinical Breast Cancer. 2014 ; Vol. 14, No. 3. pp. 177-181.
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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/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.",
author = "Ateeq Ahmad and Saifuddin Sheikh and Rakesh Taran and Srivastav, {Shanti P.} and Krishna Prasad and Rajappa, {Senthil J.} and Vijay Kumar and Mamillapalli Gopichand and Mahesh Paithankar and Manish Sharma and Rane, {Rajendra C.} and Imran Ahmad",
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Ahmad, A, Sheikh, S, Taran, R, Srivastav, SP, Prasad, K, Rajappa, SJ, Kumar, V, Gopichand, M, Paithankar, M, Sharma, M, Rane, RC & Ahmad, I 2014, 'Therapeutic efficacy of a novel Nanosomal Docetaxel lipid suspension compared with Taxotere in locally advanced or Metastatic breast cancer patients', Clinical Breast Cancer, vol. 14, no. 3, pp. 177-181. https://doi.org/10.1016/j.clbc.2013.09.011

Therapeutic efficacy of a novel Nanosomal Docetaxel lipid suspension compared with Taxotere in locally advanced or Metastatic breast cancer patients. / Ahmad, Ateeq; Sheikh, Saifuddin; Taran, Rakesh; Srivastav, Shanti P.; Prasad, Krishna; Rajappa, Senthil J.; Kumar, Vijay; Gopichand, Mamillapalli; Paithankar, Mahesh; Sharma, Manish; Rane, Rajendra C.; Ahmad, Imran.

In: Clinical Breast Cancer, Vol. 14, No. 3, 01.01.2014, p. 177-181.

Research output: Contribution to journalArticle

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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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DO - 10.1016/j.clbc.2013.09.011

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