Clinical Trials Evaluation And Treatment Of Her2...

Tanzir Mortuza PHAR 7100 Project 2 Clinical Trial Evaluation Primary Article: Vogel, Charles L., et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. Journal of Clinical Oncology 20.3 (2002): 719-726. 1.0 Introduction: Breast cancer is the most diagnosed cancer in the US for women (http://www.breastcancer.org/symptoms/understand_bc/statistics). Even though the diagnosis and treatment of this condition has improved dynamically over the past few decades, it is still one of the leading causes of mortality among the women in USA and all over the world. There are usually four stages of breast cancer (http://www.breastcancer.org/symptoms/understand_bc/statistics).†¦show more content†¦Around 25-30% of the total breast cancer patients are diagnosed with HER2 gene amplification (Vogel, Charles L., et al, 2002). Patients with HER2 gene overexpression also produces a higher level of protein therefore, the patients with this condition are susceptible to decreased disease free and shorter overall survival rate(Vogel, Charles L., et al, 2002). The non-targeted cytotoxic chemotherapy has been used as a standard treatment of this condition. However, there are several side effects for these non-targeted t herapies; such as vomiting, nausea, headache, fatigue, diarrhea, dizziness, anemia, thrombocytopenia, leukemia, anxiety, depression, anorexia and so on(O Shaughnessy, Joyce, et al, 2011). Therefore, a lot of patients are unable to use cytotoxic chemotherapy as a standard treatment. It is necessary to have a safe treatment that can serve the unmet purpose of these patients. Trastuzumab is a monoclonal antibody that recognizes the p185 site of HER2 (Vogel, Charles L., et al, 2002). As this is a humanized antibody, it reduces the chances of immunological response in the human body that may occur if a murine antibody was used. At the same time, this humanized monoclonal antibody initiates the maximum recruitment of patients’ endogenous immune system to attack and destroy the overexpressed cells (Vogel, Charles L., et al, 2002). The efficacy of this therapeutic has been already evaluated with presence of chemotherapy in several clinical