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

Authors Subramanian S, Prasanna R, Biswas G, Das Majumdar SK, Joshi N, Bunger D, Khan MA, Ahmad I

Received 25 October 2019

Accepted for publication 15 January 2020

Published 22 May 2020 Volume 2020:12 Pages 77—85


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Pranela Rameshwar

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, USA

Correspondence: Imran Ahmad
Jina Pharmaceuticals Inc., Libertyville, IL, USA

Purpose: 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 ( NCT03671044).

Keywords: DoceAqualip, NDLS, nanosomal docetaxel lipid suspension, breast cancer

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