Back to Search
Start Over
A nationwide real-world study for evaluation of effectiveness and safety of T-DM1 in patients with HER2-positive metastatic breast cancer in Korea (KCSG BR19-15).
- Source :
-
Therapeutic advances in medical oncology [Ther Adv Med Oncol] 2024 Jan 28; Vol. 16, pp. 17588359231225029. Date of Electronic Publication: 2024 Jan 28 (Print Publication: 2024). - Publication Year :
- 2024
-
Abstract
- Purpose: This study aimed to investigate clinical practices and factors related to the outcomes of T-DM1 use in patients with HER2-positive metastatic breast cancer (mBC).<br />Methods: We included patients with HER2-positive mBC who received T-DM1 as a palliative therapy between August 2017 and December 2018. The safety and outcomes of T-DM1, including overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), were evaluated. A Cox proportional hazards model was used to estimate the hazard ratio and 95% confidence interval (CI) for mortality or progression to HER2-positive mBC.<br />Results: In total, 824 patients were enrolled during the study period. The mean age of patients was 58 years, and 516 (62.6%) patients relapsed after curative treatment. Excluding a history of endocrine therapy, 341 (41.4%) patients previously received none or first-line chemotherapy, 179 (21.7%) received second-line therapy, and 303 (36.9%) received third-or later-line chemotherapy before T-DM1 therapy. During a median follow-up of 16.8 months, the ORR was 35%, the median PFS was 6.6 months, and the median OS was not reached. The clinical factors associated with the hazard of progression were age (<65 years), poor performance status (⩾2), advanced line of palliative chemotherapy (⩾2), prior pertuzumab use, and treatment duration of palliative trastuzumab (<10 months). Common grade 3-4 adverse events were thrombocytopenia ( n = 107, 13.2%), neutropenia ( n = 23, 2.8%), anemia ( n = 21, 2.6%), and elevated liver enzyme ( n = 20, 2.5%). Hypokalemia (⩽3.0 mmol/L) and any-grade bleeding events occurred in 25 (3.1%) and 94 (22.6%) patients, respectively.<br />Conclusion: This is the first nationwide real-world study of T-DM1 use in patients with HER2-positive mBC in Korea. The effectiveness and toxicity profiles of T-DM1 in real-world practice were comparable to those in randomized trials. Moreover, patient factors and previous anti-HER2 therapy could predict the outcomes of T-DM1 therapy.<br />Competing Interests: The authors declare that there is no conflict of interest.<br /> (© The Author(s), 2024.)
Details
- Language :
- English
- ISSN :
- 1758-8340
- Volume :
- 16
- Database :
- MEDLINE
- Journal :
- Therapeutic advances in medical oncology
- Publication Type :
- Academic Journal
- Accession number :
- 38288157
- Full Text :
- https://doi.org/10.1177/17588359231225029