A single centre, real world experience of T-DM1 in the treatment of HER2-positive metastatic breast cancer patients in India

Vindhya Vasini; Mohana Vamsy; Monal Dayal; Pawan  Shinkar

doi:10.18231/j.joapr.2024.12.2.35.41

Authors

Vindhya Vasini Department of Medical Oncology, Omega Hospitals, Hyderabad, Telangana 500034
Mohana Vamsy Department of Surgical Oncology, Omega Hospitals, Hyderabad, Telangana 500034
Monal Dayal Department of Pathology, Omega Hospitals, Hyderabad, Telangana 500034
Pawan Shinkar Department of Radiology, Omega Hospitals, Hyderabad, Telangana 500034

DOI:

https://doi.org/10.18231/j.joapr.2024.12.2.35.41

Keywords:

Real world evidence, HER2 positive, metastatic breast cancer, T-DM1, Biosimilar

Abstract

Background: HER2 (Human Epidermal Growth Receptor 2) positive breast cancer is an aggressive subtype. Treatment for patients with HER2-positive breast cancer has advanced significantly over time with the introduction of targeted therapies like trastuzumab, pertuzumab, lapatinib, trastuzumab emtansine, trastuzumab, deruxtecan, and tucatinib. In a lower-middle-income nation, accessibility is still problematic for any newer therapy. This study aimed to describe the safety and practical effectiveness of the first T-DM1 biosimilar in India for treating patients with HER2-positive mBC. Methodology: This is a retrospective, observational, single-center study of patients with HER2-positive metastatic breast cancer treated with T-DM1 biosimilar. The study involved 16 mBC patients. The primary goal was to assess T-DM1's effectiveness regarding PFS and ORR, with safety and OS as the secondary goals. Results: The ORR was observed to be 81.3%. One (6.29%) of the patients achieved CR, while 3 patients (18.8%) are on stable disease, and 12 patients (75 %) achieved PR. The major adverse events reported among study patients were thrombocytopenia (31.25%) and anemia (31.25%), followed by neutropenia, hyperglycemia, and fatigue in 12.5 % of cases. Grade 3 thrombocytopenia was seen in 2 patients, and grade 3-4 fatigue was observed in 1 patient. Median PFS was nearly six months, and OS data is available for only 25% of patients; the rest continue the therapy. Conclusion: This retrospective observational study offers significant information about the safety and efficacy of T-DM1 biosimilar in treating HER2 positive mBC.

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