Current development in toxicity, clinical trials guidelines for regulatory aspects of breast cancer nanomedicines

Author(s):  
Arpita Pandey Tiwari ◽  
Sonali S. Rohiwal
2020 ◽  
Vol 26 (11) ◽  
pp. 1191-1205 ◽  
Author(s):  
Ranjit K. Harwansh ◽  
Shiv Bahadur ◽  
Rohitas Deshmukh ◽  
Md. A. Rahman

: Breast cancer (BC) is a multifactorial disease and becoming a major health issue in women throughout the globe. BC is a malignant type of cancer which results from transcriptional changes in proteins and genes. Besides the availability of modern medicines and detection tools, BC has become a topmost deadly disease and its cure still remains challenging. Nanotechnology based approaches are being employed for the diagnosis and treatment of BC at clinical stages. Nanosystems have a significant role in the study of the interaction of malignant cells with their microenvironment through receptor-based targeted approach. Nowadays, lipid-based nanocarriers are being popularized in the domain of pharmaceutical and medical biology for cancer therapy. Lipidic nanoparticlized systems (LNPs) have proven to have high loading efficiency, less toxicity, improved therapeutic efficacy, enhanced bioavailability and stability of the bioactive compounds compared to traditional drug delivery systems. In the present context, several LNPs based formulations have been undertaken in various phases of clinical trials in different countries. This review highlights the importance of chemotherapeutics based lipidic nanocarriers and their anticipated use for the treatment of BC. Furthermore, the clinical trials and future prospective of LNPs have been widely elaborated.


Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1128
Author(s):  
Amy Kwan ◽  
Natalie Winder ◽  
Munitta Muthana

Oncolytic virotherapy (OV) is an emerging class of immunotherapeutic drugs. Their mechanism of action is two-fold: direct cell lysis and unmasking of the cancer through immunogenic cell death, which allows the immune system to recognize and eradicate tumours. Breast cancer is the most common cancer in women and is challenging to treat with immunotherapy modalities because it is classically an immunogenically “cold” tumour type. This provides an attractive niche for OV, given viruses have been shown to turn “cold” tumours “hot,” thereby opening a plethora of treatment opportunities. There has been a number of pre-clinical attempts to explore the use of OV in breast cancer; however, these have not led to any meaningful clinical trials. This review considers both the potential and the barriers to OV in breast cancer, namely, the limitations of monotherapy and the scope for combination therapy, improving viral delivery and challenges specific to the breast cancer population (e.g., tumour subtype, menopausal status, age).


2007 ◽  
Vol 25 (14) ◽  
pp. 1882-1890 ◽  
Author(s):  
Diana Crivellari ◽  
Matti Aapro ◽  
Robert Leonard ◽  
Gunter von Minckwitz ◽  
Etienne Brain ◽  
...  

Screening and adjuvant postoperative therapies have increased survival among women with breast cancer. These tools are seldom applied in elderly patients, although the usually reported incidence of breast cancer is close to 50% in women 65 years or older, reaching 47% after 70 years in the updated Surveillance, Epidemiology, and End Results (SEER) database. Elderly breast cancer patients, even if in good medical health, were frequently excluded from adjuvant clinical trials. Women age 70 years who are fit actually have a median life expectancy of 15.5 years, ie, half of them will live much longer and will remain exposed for enough time to the potentially preventable risks of a relapse and specific death. In the last few years, a new concern about this issue has developed. Treatment now faces two major end points, as in younger women: to improve disease-free survival in the early stages, and to palliate symptoms in advanced disease. However, in both settings, the absolute benefit of treatment is critical because protecting quality of life and all its related aspects (especially functional status and independence), is crucial in older persons who have more limited life expectancy. Furthermore, the new hormonal compounds (aromatase inhibitors) and chemotherapeutic drugs (capecitabine, liposomal doxorubicin), are potentially less toxic than and equally as effective as older more established therapies. These new treatments bring new challenges including higher cost, and defining their benefit in elderly breast cancer must include an analysis of the cost/benefit ratio. These issues emphasize the urgent need to develop and support clinical trials for this older population of breast cancer patients both in the adjuvant and metastatic settings, a move that will take us from a prejudiced, age-based medicine to an evidence-based medicine.


2015 ◽  
Vol 26 (7) ◽  
pp. 1280-1291 ◽  
Author(s):  
V. Bossuyt ◽  
E. Provenzano ◽  
W.F. Symmans ◽  
J.C. Boughey ◽  
C. Coles ◽  
...  

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