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

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          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/m 2; 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).

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          Most cited references37

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          Incidence and Mortality and Epidemiology of Breast Cancer in the World.

          Hamid Salehiniya, Zahra pournamdar, Mahshid Ghoncheh (2016)
          Breast cancer is the most common malignancy in women around the world. Information on the incidence and mortality of breast cancer is essential for planning health measures. This study aimed to investigate the incidence and mortality of breast cancer in the world using age-specific incidence and mortality rates for the year 2012 acquired from the global cancer project (GLOBOCAN 2012) as well as data about incidence and mortality of the cancer based on national reports. It was estimated that 1,671,149 new cases of breast cancer were identified and 521,907 cases of deaths due to breast cancer occurred in the world in 2012. According to GLOBOCAN, it is the most common cancer in women, accounting for 25.1% of all cancers. Breast cancer incidence in developed countries is higher, while relative mortality is greatest in less developed countries. Education of women is suggested in all countries for early detection and treatment. Plans for the control and prevention of this cancer must be a high priority for health policy makers; also, it is necessary to increase awareness of risk factors and early detection in less developed countries.
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            Hypersensitivity reactions from taxol.

            Jeffrey B. Jones, Glynn Baker, D Trump … (1990)
            Taxol is an antitumor agent in clinical trial that has been shown to have activity against advanced ovarian carcinoma and melanoma. Hypersensitivity reactions (HSRs) have been one of the toxicities observed with administration of this drug. Of 301 patients treated, 32 patients have had definite (27 patients) or possible (five patients) hypersensitivity reactions to taxol. All but one patient had the reaction from the first or second exposure to this agent. Reactions occurred at a variety of doses and were characterized most frequently by dyspnea, hypotension, bronchospasm, urticaria, and erythematous rashes. Thirteen (41%) patients had received premedication designed to prevent such toxicity; nevertheless, they sustained HSRs. Prolonging the drug infusion appears to have somewhat reduced, but not obviated, the risk of HSRs. The cause (taxol itself or its excipient Cremophor EL; Badische Anilin und Soda-Fabrik AG [BASF], Ludwigshafen, Federal Republic of Germany) and the mechanism of these reactions to taxol are unknown. We provide guidelines to prevent or minimize such toxicity and treat reactions if they still occur.
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              Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735.

              Stephen Jones, Frankie Ann Holmes, Joyce O'Shaughnessy … (2009)
              We previously reported that four cycles of docetaxel/cyclophosphamide (TC) produced superior disease-free survival (DFS) compared with four cycles of doxorubicin/cyclophosphamide (AC) in early breast cancer. Older women are under-represented in adjuvant chemotherapy trials. In our trial 16% of patients were > or = 65 years. We now report 7-year results for DFS and overall survival (OS) as well as the impact of age, hormone receptor status, and HER2 status on outcome and toxicity. Patients were randomly assigned to receive either four cycles of standard-dose AC (60/600 mg/m(2); n = 510), or TC (75/600 mg/m(2); n = 506), administered by intravenous infusion every 3 weeks. The median age in women younger than 65, was 50 years (range, 27 to 64) and for women > or = 65 was 69 years (range, 65 to 77). Baseline characteristics in the two age subgroups were generally well matched, except that older women tended to have more lymph node involvement. At a median of 7 years follow-up, the difference in DFS between TC and AC was significant (81% TC v 75% AC; P = .033; hazard ratio [HR], 0.74; 95% CI 0.56 to 0.98) as was OS (87% TC v 82% AC; P = .032; HR, 0.69; 95% CI, 0.50 to 0.97). TC was superior in older patients as well as younger patients. There was no interaction of hormone-receptor status or HER-2 status and treatment. Older women experienced more febrile neutropenia with TC and more anemia with AC. With longer follow-up, four cycles of TC was superior to standard AC (DFS and OS) and was a tolerable regimen in both older and younger patients.
              Article 0 comments Cited 131 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Breast Cancer (Dove Med Press)
                Journal ID (iso-abbrev): Breast Cancer (Dove Med Press)
                Journal ID (publisher-id): BCTT
                Journal ID (pmc): bctt
                Title: Breast Cancer : Targets and Therapy
                Publisher: Dove
                ISSN (Electronic): 1179-1314
                Publication date (Electronic): 22 May 2020
                Publication date Collection: 2020
                Volume: 12
                Pages: 77-85
                Affiliations
                [1 ]VS Hospital, Madras Cancer Institute, Advanced Cancer Care , Chennai, Tamil Nadu 600031, India
                [2 ]Department of Medical Oncology, CBCC-GVN Cancer Center , Tiruchirappalli, Tamil Nadu 620005, India
                [3 ]Department of Medical Oncology, Sparsh Hospital, Bhubaneswar , Odisha 751007, India
                [4 ]Department of Radiotherapy, All India Institute of Medical Sciences , Bhubaneswar, Odisha 751019, India
                [5 ]Medical Affairs and Clinical Development, Intas Pharmaceuticals Ltd ., Ahmedabad, Gujarat 380054, India
                [6 ]Jina Pharmaceuticals Inc ., Libertyville, Illinois, USA
                Author notes
                Correspondence: Imran Ahmad Jina Pharmaceuticals Inc ., Libertyville, IL, USA Email imran@jinapharma.com
                Author information
                http://orcid.org/0000-0002-3557-4501
                http://orcid.org/0000-0003-0008-4315
                http://orcid.org/0000-0001-6383-0093
                Article
                Publisher ID: 236108
                DOI: 10.2147/BCTT.S236108
                PMC ID: 7250303
                PubMed ID: 32547188
                SO-VID: 2cb73682-87d3-4561-9244-e739f124dcaa
                Copyright © © 2020 Subramanian et al.
                License:

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                Date received : 25 October 2019
                Date accepted : 15 January 2020
                Page count
                Figures: 2, Tables: 2, References: 50, Pages: 9
                Funding
                This study was funded by an unrestricted research grant by Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.
                Categories
                Subject: Original Research

                Keywords: doceaqualip,ndls,nanosomal docetaxel lipid suspension,breast cancer
                Data availability:
                Keywords: doceaqualip, ndls, nanosomal docetaxel lipid suspension, breast cancer

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