摘要
<strong>Introduction:</strong> <span style="font-family:Verdana;">Breast cancer is the most common female cancer in India and account</span><span style="font-family:Verdana;">ing</span><span style="font-family:Verdana;"> for almost 1 in 4 cancer cases in women worldwide. According to GLOBOCAN 2018: breast cancer incidence is increased to 162</span><span style="font-family:Verdana;">,</span><span style="font-family:Verdana;">468 in 2018 compared to 144</span><span style="font-family:Verdana;">,</span><span style="font-family:;" "=""><span style="font-family:Verdana;">937 in 2012. Biosimilar drugs allow expanding access to the therapies in the form of cost savings and leading to better overall health outcomes. Our study evaluates the efficacy and safety of Trastuzumab biosimilars and assesses overall survival in the study population. </span><b><span style="font-family:Verdana;">Materials</span></b></span><b><span style="font-family:;" "=""> </span></b><b><span style="font-family:Verdana;">& Methods:</span></b><span style="font-family:;" "=""><span style="font-family:Verdana;"> This prospective study was conducted in Healthcare Global Enterprises Ltd., Bengaluru, India, and all female patients diagnosed with Her2 positive, metastatic (mBC) and Locally advanced breast cancer (LABC), between March 2013 and November 2014, with at least 4 years of post-treatment follow up. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> A total of 65 patients diagnosed with Her2 positive breast cancer and satisfied the selection criteria were included for the study. Partial Response (PR) was observed in 42 (64.6%) patients, Stable Disease (SD) in 11 (16.9%) patients and Progressive Disease (PD) in 12 (18.5%) patients. The overall response rates were 46.1% PR, 30% SD, 23.8% PD in metastatic population and 76% PR, 7.2% SD, 15% PD observed in locally advanced disease. The mean overall survival of the study population was 20.75 ± 15.20 months in metastatic and 29.2 ±</span></span><span style="font-family:;" "=""> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">17.06 months in locally advanced patients. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> This prospective study shows the effectiveness of Trastuzumab for HER2-positive in locally advanced and metastatic breast cancer. The response rates, survival and toxicity correlate with other global studies. The response and survival are </span></span><span style="font-family:Verdana;">as</span><span style="font-family:Verdana;"> same as either generic or original Trastuzumab.</span>
<strong>Introduction:</strong> <span style="font-family:Verdana;">Breast cancer is the most common female cancer in India and account</span><span style="font-family:Verdana;">ing</span><span style="font-family:Verdana;"> for almost 1 in 4 cancer cases in women worldwide. According to GLOBOCAN 2018: breast cancer incidence is increased to 162</span><span style="font-family:Verdana;">,</span><span style="font-family:Verdana;">468 in 2018 compared to 144</span><span style="font-family:Verdana;">,</span><span style="font-family:;" "=""><span style="font-family:Verdana;">937 in 2012. Biosimilar drugs allow expanding access to the therapies in the form of cost savings and leading to better overall health outcomes. Our study evaluates the efficacy and safety of Trastuzumab biosimilars and assesses overall survival in the study population. </span><b><span style="font-family:Verdana;">Materials</span></b></span><b><span style="font-family:;" "=""> </span></b><b><span style="font-family:Verdana;">& Methods:</span></b><span style="font-family:;" "=""><span style="font-family:Verdana;"> This prospective study was conducted in Healthcare Global Enterprises Ltd., Bengaluru, India, and all female patients diagnosed with Her2 positive, metastatic (mBC) and Locally advanced breast cancer (LABC), between March 2013 and November 2014, with at least 4 years of post-treatment follow up. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> A total of 65 patients diagnosed with Her2 positive breast cancer and satisfied the selection criteria were included for the study. Partial Response (PR) was observed in 42 (64.6%) patients, Stable Disease (SD) in 11 (16.9%) patients and Progressive Disease (PD) in 12 (18.5%) patients. The overall response rates were 46.1% PR, 30% SD, 23.8% PD in metastatic population and 76% PR, 7.2% SD, 15% PD observed in locally advanced disease. The mean overall survival of the study population was 20.75 ± 15.20 months in metastatic and 29.2 ±</span></span><span style="font-family:;" "=""> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">17.06 months in locally advanced patients. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> This prospective study shows the effectiveness of Trastuzumab for HER2-positive in locally advanced and metastatic breast cancer. The response rates, survival and toxicity correlate with other global studies. The response and survival are </span></span><span style="font-family:Verdana;">as</span><span style="font-family:Verdana;"> same as either generic or original Trastuzumab.</span>
作者
Srinivasa Belagutty Jayappa
Bhanu Prakash Lalkota
Veluswamy Mani
Reshma Elsa Jenny
Kiran P. Krishnamurthi
Vinu Sarathy
S. Thineshwaran
Bayas Nithin
Sumithra Martinovic
Amritanshu Ram
Shekar Patil
Radheshyam Naik
Srinivasa Belagutty Jayappa;Bhanu Prakash Lalkota;Veluswamy Mani;Reshma Elsa Jenny;Kiran P. Krishnamurthi;Vinu Sarathy;S. Thineshwaran;Bayas Nithin;Sumithra Martinovic;Amritanshu Ram;Shekar Patil;Radheshyam Naik(Department of Medical Oncology, Healthcare Global Enterprises Ltd., Bangalore, Karnataka, India;Center for Academics and Research, HCG Foundation, Bangalore, India;Department of Cytogenetics, Healthcare Global Enterprises Ltd., Bangalore, Karnataka, India)