الفهرس 
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Abstract
Breast cancer is a major public health problem for women throughout the world. In the United States, breast cancer remains the most frequent cancer in women and the second most frequent cause of cancer death. Worldwide, breast cancer accounts for 23% of the total cancer cases and 14% of the cancer deaths, although there is a fivefold variation in incidence between high-incidence areas such as the United States and Western Europe, and low incidence areas such as Africa and Asia. In Egypt, breast cancer is estimated to be the most common cancer among females accounting for 37.7% in 2008. It is also the leading cause of cancer related mortality accounting for 29.1% of their total. The incidence to mortality ratio is poor (1.9:1). In Alexandria, it accounts for about 50.3 % of all malignancies in females.
Breast cancer is a heterogeneous, phenotypically diverse disease composed of several biologic subtypes that have distinct behavior. Amplification or overexpression of the human epidermal growth factor receptor 2 (HER2) oncogene is present in approximately 18 to 20 percent of primary invasive breast cancers. Women with early stage breast cancer that meet criteria for HER2 positivity are treated with chemotherapy and trastuzumab as adjuvant treatment. HER2 overexpression is detected by uniform intense membrane staining of >10 percent of invasive tumor cells (IHC 3+) or the presence of HER2 gene amplification by fluorescence in-situ hybridization (FISH) defined as a ratio of HER2/CEP17 (centromeric probe to chromosome 17) ratio ≥2.0.
Trastuzumab is the only HER2-directed agent to result in a survival benefit when administered (with chemotherapy) in the adjuvant treatment. All of the trials establishing the benefit of adjuvant trastuzumab limited eligibility to women with either node-positive or high risk node-negative breast cancer. THE optimum treatment duration with Herceptin is debatable.
This study aimed to compare the results of treatment with adjuvant Trastuzumab for nine months versus twelve months in Her2- positive breast cancer patients. The primary end point was disease–free survival. While the secondary endpoints were cardiac safety, tolerability, non- inferiority, cost effectiveness & overall survival.
This study included 60 patients non metastatic breast cancer patients presented to Clinical Oncology Department Alexandria University Hospitals, Clinical Oncology Department Medical Research Institute (MRI) & Ministry of Health Hospitals. Study patients were randomized into 2 groups:
group I: included 30 patients who haddone sugery & received adjuvant chemotherapy, radiotherapy & hormonal therapy if indicated .This group received adjuvant Trastuzumab for 12 months.
group II: included 30 patients who had done sugery & received adjuvant chemotherapy, radiotherapy & hormonal therapy if indicated. This group received adjuvant Trastuzumab for 9 months.
The study showed:
When the DFS of both groups in this study were compared at one year, no statistically significant difference was found between the two groups (p=0.402). The DFS for group I was 90.0 % & for group II was 83.3%.Proving non inferiority of nine month of adjuvant trastuzumab treatment in comparison to twelve month of adjuvant trastuzumab treatment regarding DFS. Also the overall survival of both groups was the same (100%).
Regarding the tolerability of patients to treatment in both groups, findings detected on clinical examination during adjuvant trastuzumab treatment were indifferent between the 2 groups, were resolved after completion of adjuvant trastuzumab treatment & were tolerable.
As there is absence of statistically significant difference in DFS & OS between the 12months & 9 months group together with having Egypt a developing low-to- middle income country . I suggest we can now council our patients that 9 months of treatment with trastuzumab is comparable 12 months regarding survival , shorter duration of treatment side effects & more affordable i.e better for the country economy putting less load upon. Giving the chance for more patients to receive trastuzumab & have the opportunity to improve their suvival.
Large randomized clinical trial with larger number of patients needs to be conducted for further confirmation of this study results