Background TDM-1 was approved in November 2013 by the European Medicines Agency for the treatment of unresectable or metastatic breast cancer in patients who had previously received Trastuzumab and a taxane separately or in combination.
Purpose To evaluate the effectiveness and safety of TDM-1 in patients with advanced/metastatic HER2-positive breast cancer.
Material and methods Observational retrospective survey which included patients that received treatment with TDM-1 in the abovementioned conditions from January 2015 to June 2018. TDM-1 was administered intravenously (3.6 mg/kg) every 3 week cycle. Variables collected were: gender, age, expression hormonal receptor (HR), previous lines, progression and death date, adverse events (AD), treatment discontinuation and dose reductions. Progression-free survival (PFS) and overall survival (OS) were measured from time of the start of treatment with TDM-1 to date of first progression or death, respectively. PFS and OS were calculated by Kaplan–Meier analysis. Data analysis was performed using the statistical package SPSS 21.0 for Windows. Clinical data were obtained from digital clinical history and prescription software Farmis Oncofarm.
Results We included 40 patients, all of them women with a mean age of 55 years (SD=±13.7). Eighty per cent were HR+. 17.5% of patients received TDM-1 in the metastatic first line. The remaining 82.5% were previously treated with one or more therapies for metastatic disease; and the median number of previous chemotherapy lines was two (range 1–6). Previous HER2-targeted therapies included trastuzumab-based regimen (55%), pertuzumab/trastuzumab/taxane (47.5%), lapatinib/capecitabine (15%) and lapatinib/trastuzumab (7.5%). Mean follow-up was 15 months. Median PFS was 7 months (95% CI 4.3 to 9.7). No statistically significant differences were found in PFS according to HR status, age >65 years, number of previous lines or anti-HER2 therapy previously administered. Median OS was not reached, the 12 month OS was 73%.
AD occurred in 82.5% of patients, the most frequent being: anaemia (44%), hepatotoxicity (42.5%), asthaenia (27.5%), thrombocytopaenia (17.5%), peripheral neuropathy (15%) and arthralgia (12.5%). Dose reduction was necessary in 15% of patients. 17.5% discontinued treatment due to intolerable toxicities. Three patients presented grade 4 hepatotoxicity.
Conclusion Our results show lower median PFS and 12 month OS than those from randomised trials. Most of the patients presented with AD. Toxicity profile was similar to those previously described in clinical trials.
References and/or acknowledgements To my co-workers.
No conflict of interest.
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