Abstract
Introduction: Breast cancer is the most common female cancer in India and accounting for almost 1 in 4 cancer cases in women worldwide. According to GLOBOCAN 2018: breast cancer incidence is increased to 162,468 in 2018 compared to 144,937 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. Materials & Methods: 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. Results: 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 ± 17.06 months in locally advanced patients. Conclusion: 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 as same as either generic or original Trastuzumab.
Highlights
Breast cancer is the most common female cancer in India and accounting for almost 1 in 4 cancer cases in women worldwide
Materials & Methods: This prospective study was conducted in Healthcare Global Enterprises Ltd., Bengaluru, India, and all female patients diagnosed with Her2 positive, metastatic and Locally advanced breast cancer (LABC), between March 2013 and November 2014, with at least 4 years of post-treatment follow up
A total of 65 patients diagnosed with Her2 positive breast cancer and satisfied the selection criteria were included for the study
Summary
Breast cancer is the most common female cancer in India and accounting for almost 1 in 4 cancer cases in women worldwide. Materials & Methods: This prospective study was conducted in Healthcare Global Enterprises Ltd., Bengaluru, India, and all female patients diagnosed with Her 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. 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 ± 17.06 months in locally advanced patients. Conclusion: This prospective study shows the effectiveness of Trastuzumab for HER2-positive in locally advanced and metastatic breast cancer. Addition of anti-HER2 therapy to chemotherapy, as compared with chemotherapy alone, significantly improves progression-free and overall survival among patients with HER2+ metastatic breast cancer [4]. Our study evaluates the efficacy and safety of Trastuzumab biosimilars and assesses overall survival in the study population
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