Clinical Profile of Carcinoma Breast Patients Treated with Trastuzumab: A Single Centre Study

S. B. Jayappa, B. Lalkota, V. Mani, Reshma Elsa Jenny, K. P. Krishnamurthi, V. Sarathy, S. Thineshwaran, B. Nithin, Sumithra Martinovic, A. Ram, S. Patil, R. Naik
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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.
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曲妥珠单抗治疗乳腺癌患者的临床概况:单中心研究
简介:乳腺癌是印度最常见的女性癌症,占全球女性癌症病例的近四分之一。根据GLOBOCAN 2018:乳腺癌发病率从2012年的144937例增加到2018年的162468例。生物仿制药以节省成本的形式扩大了获得治疗的机会,并导致更好的整体健康结果。我们的研究评估了曲妥珠单抗生物类似药的有效性和安全性,并评估了研究人群的总生存期。材料与方法:本前瞻性研究于2013年3月至2014年11月在印度班加罗尔的Healthcare Global Enterprises Ltd.进行,所有诊断为Her2阳性,转移性(mBC)和局部晚期乳腺癌(LABC)的女性患者,治疗后随访至少4年。结果:共纳入65例Her2阳性乳腺癌患者,符合入选标准。42例(64.6%)患者出现部分缓解(PR), 11例(16.9%)患者出现病情稳定(SD), 12例(18.5%)患者出现病情进展(PD)。总体缓解率在转移人群中为46.1% PR, 30% SD, 23.8% PD,在局部晚期疾病中为76% PR, 7.2% SD, 15% PD。研究人群的平均总生存期转移患者为20.75±15.20个月,局部晚期患者为29.2±17.06个月。结论:这项前瞻性研究显示曲妥珠单抗治疗her2阳性局部晚期和转移性乳腺癌的有效性。反应率,存活率和毒性与其他全球研究相关。反应和生存期与仿制或原曲妥珠单抗相同。
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