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

Abstract

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 (ClinicalTrials.gov: NCT03671044).

Keywords:

• DoceAqualip
• NDLS
• nanosomal docetaxel lipid suspension
• breast cancer

Acknowledgments

The authors thank Mr Shreekant Sharma, MPharm, ISMPP CMPP^TM (Lambda Therapeutic Research Ltd., Ahmedabad, Gujarat, India) for providing writing assistance and Dr Venugopal Madhusudhana, MBBS, EPBM, ISMPP CMPP^TM (Lambda Therapeutic Research Ltd., Ahmedabad, Gujarat, India) for additional editorial assistance for the development of this manuscript. The authors also thank the clinical data management and biostatistics department of Lambda Therapeutic Research Ltd. for their contribution in the preparation of the statistical analysis report in this retrospective data collation and analysis.

Author Contributions

SS, RP, GB, SKDM performed the research, were involved in the acquisition of data, critically revised the manuscript for important intellectual content, and approved the final manuscript. NJ, DB, MAK and IA designed the study, were involved in the data interpretation, critically revised the manuscript for important intellectual content, and approved the final manuscript. All authors made substantial contributions to this study and agree to be accountable for all aspects of the work.

Disclosure

Drs Mujtaba A Khan, Deepak Bunger and Nisarg Joshi are employees of Intas Pharmaceuticals Ltd., India, and the product being mentioned is manufactured and marketed by Intas Ltd. Dr Imran Ahmad is an employee of Jina Pharmaceuticals Inc., USA. The authors report no other conflicts of interest in this work.