Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study

Sundaram Subramanian,1 Rammohan Prasanna,2 Ghanashyam Biswas,3 Saroj Kumar Das Majumdar,4 Nisarg Joshi,5 Deepak Bunger,5 Mujtaba A Khan,5 Imran Ahmad6 1VS Hospital, Madras Cancer Institute, Advanced Cancer Care, Chennai, Tamil Nadu 600031, India; 2Department of Medical Oncology, CBCC-GVN Cancer Cent...

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Autores principales:	Subramanian S, Prasanna R, Biswas G, Das Majumdar SK, Joshi N, Bunger D, Khan MA, Ahmad I
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	doceaqualip ndls nanosomal docetaxel lipid suspension breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/358d8fccbb8844ecbeece7205ae7f687
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spelling	oai:doaj.org-article:358d8fccbb8844ecbeece7205ae7f6872021-12-02T12:35:11ZNanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study1179-1314https://doaj.org/article/358d8fccbb8844ecbeece7205ae7f6872020-05-01T00:00:00Zhttps://www.dovepress.com/nanosomal-docetaxel-lipid-suspension-based-chemotherapy-in-breast-canc-peer-reviewed-article-BCTThttps://doaj.org/toc/1179-1314Sundaram Subramanian,1 Rammohan Prasanna,2 Ghanashyam Biswas,3 Saroj Kumar Das Majumdar,4 Nisarg Joshi,5 Deepak Bunger,5 Mujtaba A Khan,5 Imran Ahmad6 1VS Hospital, Madras Cancer Institute, Advanced Cancer Care, Chennai, Tamil Nadu 600031, India; 2Department of Medical Oncology, CBCC-GVN Cancer Center, Tiruchirappalli, Tamil Nadu 620005, India; 3Department of Medical Oncology, Sparsh Hospital, Bhubaneswar, Odisha 751007, India; 4Department of Radiotherapy, All India Institute of Medical Sciences, Bhubaneswar, Odisha 751019, India; 5Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat 380054, India; 6Jina Pharmaceuticals Inc., Libertyville, Illinois, USACorrespondence: Imran AhmadJina Pharmaceuticals Inc., Libertyville, IL, USAEmail imran@jinapharma.comPurpose: The purpose of this study was to evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip)-based chemotherapy in breast cancer.Methods: Medical charts of patients with breast cancer, who were treated and followed up with NDLS (75– 100 mg/m2; 3-week cycle)-based chemotherapy from August 2014 to September 2018, were analyzed in this multicenter, retrospective study. The study endpoints were overall response rate (ORR: complete response [CR]+partial response [PR]) and disease control rate (DCR: CR+PR+stable disease [SD]) in neoadjuvant and metastatic settings. Overall survival (OS) and safety were evaluated for all settings.Results: Of 91 patients (neoadjuvant: 12, adjuvant: 61, metastatic: 18), efficacy evaluation in 29 patients (neoadjuvant: 12/12, metastatic: 17/18) demonstrated an ORR and DCR of 100%, respectively, in the neoadjuvant setting, and an ORR of 64.7% and DCR of 70.6%, respectively, in the metastatic setting. At a median follow-up of 21.6 months (range: 2.1 to 49.9 months), median OS was not reached in neoadjuvant and adjuvant settings, and it was 30.4 months in metastatic settings. At least one adverse event (AE) was reported in 59.3% of patients. Anemia, thrombocytopenia, lymphopenia, and neutropenia were the most common hematological AEs reported while hyperglycemia and alteration in liver function tests were the most common non-hematological AEs. NDLS-based treatment was well tolerated without any new safety concerns.Conclusion: Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of breast cancer. Further, NDLS is being evaluated prospectively in patients with triple-negative breast cancer (ClinicalTrials.gov: NCT03671044).Keywords: DoceAqualip, NDLS, nanosomal docetaxel lipid suspension, breast cancerSubramanian SPrasanna RBiswas GDas Majumdar SKJoshi NBunger DKhan MAAhmad IDove Medical Pressarticledoceaqualipndlsnanosomal docetaxel lipid suspensionbreast cancerNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBreast Cancer: Targets and Therapy, Vol Volume 12, Pp 77-85 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	doceaqualip ndls nanosomal docetaxel lipid suspension breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	doceaqualip ndls nanosomal docetaxel lipid suspension breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Subramanian S Prasanna R Biswas G Das Majumdar SK Joshi N Bunger D Khan MA Ahmad I Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study
description	Sundaram Subramanian,1 Rammohan Prasanna,2 Ghanashyam Biswas,3 Saroj Kumar Das Majumdar,4 Nisarg Joshi,5 Deepak Bunger,5 Mujtaba A Khan,5 Imran Ahmad6 1VS Hospital, Madras Cancer Institute, Advanced Cancer Care, Chennai, Tamil Nadu 600031, India; 2Department of Medical Oncology, CBCC-GVN Cancer Center, Tiruchirappalli, Tamil Nadu 620005, India; 3Department of Medical Oncology, Sparsh Hospital, Bhubaneswar, Odisha 751007, India; 4Department of Radiotherapy, All India Institute of Medical Sciences, Bhubaneswar, Odisha 751019, India; 5Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat 380054, India; 6Jina Pharmaceuticals Inc., Libertyville, Illinois, USACorrespondence: Imran AhmadJina Pharmaceuticals Inc., Libertyville, IL, USAEmail imran@jinapharma.comPurpose: The purpose of this study was to evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip)-based chemotherapy in breast cancer.Methods: Medical charts of patients with breast cancer, who were treated and followed up with NDLS (75– 100 mg/m2; 3-week cycle)-based chemotherapy from August 2014 to September 2018, were analyzed in this multicenter, retrospective study. The study endpoints were overall response rate (ORR: complete response [CR]+partial response [PR]) and disease control rate (DCR: CR+PR+stable disease [SD]) in neoadjuvant and metastatic settings. Overall survival (OS) and safety were evaluated for all settings.Results: Of 91 patients (neoadjuvant: 12, adjuvant: 61, metastatic: 18), efficacy evaluation in 29 patients (neoadjuvant: 12/12, metastatic: 17/18) demonstrated an ORR and DCR of 100%, respectively, in the neoadjuvant setting, and an ORR of 64.7% and DCR of 70.6%, respectively, in the metastatic setting. At a median follow-up of 21.6 months (range: 2.1 to 49.9 months), median OS was not reached in neoadjuvant and adjuvant settings, and it was 30.4 months in metastatic settings. At least one adverse event (AE) was reported in 59.3% of patients. Anemia, thrombocytopenia, lymphopenia, and neutropenia were the most common hematological AEs reported while hyperglycemia and alteration in liver function tests were the most common non-hematological AEs. NDLS-based treatment was well tolerated without any new safety concerns.Conclusion: Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of breast cancer. Further, NDLS is being evaluated prospectively in patients with triple-negative breast cancer (ClinicalTrials.gov: NCT03671044).Keywords: DoceAqualip, NDLS, nanosomal docetaxel lipid suspension, breast cancer
format	article
author	Subramanian S Prasanna R Biswas G Das Majumdar SK Joshi N Bunger D Khan MA Ahmad I
author_facet	Subramanian S Prasanna R Biswas G Das Majumdar SK Joshi N Bunger D Khan MA Ahmad I
author_sort	Subramanian S
title	Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study
title_short	Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study
title_full	Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study
title_fullStr	Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study
title_full_unstemmed	Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study
title_sort	nanosomal docetaxel lipid suspension-based chemotherapy in breast cancer: results from a multicenter retrospective study
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/358d8fccbb8844ecbeece7205ae7f687
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Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study

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