Key result
In patients with metastatic breast cancer previously treated with anthracyclines, high cumulative doses (≥400 mg/m2) of pegylated liposomal doxorubicin did not significantly increase the incidence of grade 2 LVEF decline compared to lower doses (6.5% vs 2.0%, p=0.555).
Why the study?
Data were limited regarding the cardiac safety of high cumulative doses of pegylated liposomal doxorubicin in patients with metastatic breast cancer previously treated with conventional anthracyclines.
Does high cumulative dose of pegylated liposomal doxorubicin increase cardiotoxicity in patients with metastatic breast cancer previously treated with conventional anthracyclines?
Cohort (n=81)
No
Does high cumulative dose of pegylated liposomal doxorubicin increase cardiotoxicity in patients with metastatic breast cancer previously treated with conventional anthracyclines?
Absolute Event Rate: 6.5% vs 2%
p-value: p=0.555
High cumulative doses of pegylated liposomal doxorubicin (≥400 mg/m2) do not significantly increase clinical cardiotoxicity or LVEF decline in metastatic breast cancer patients previously treated with conventional anthracyclines.
Supports limited cardiotoxicity with HCD PLD in anthracycline-pretreated MBC; leaves open need for prospective validation before changing monitoring.
Introduction: The treatment of metastatic breast cancer (MBC) is still challenging. Many studies documented the efficacy of pegylated liposomal doxorubicin (PLD) in patients with MBC, but there is a limited data about the cardiac safety with high cumulative dose (HCD) of PLD. Aim of the work: We conducted this trial to outline the cardiac safety of HCD of PLD in patients with MBC who previously received conventional anthracyclines. Methods: During the period of nine years (January 2011 to December 2019). We extracted the data of the patients with MBC receiving PLD at Medical Oncology Department, South Egypt Cancer Institute, Assiut University. These included patients’ demographics and therapeutic data including the full data of PLD, prior conventional anthracyclines, prior trastuzumab, and prior radiotherapy. Also, data about comorbidities as well as cardiac and other toxicities of PLD were obtained. The data was analysed using SPSS v. 21. Results: For all 81 eligible patients, the mean age was 43.9 years (±standard deviation (SD) 13.2). The mean cumulative dose of PLD was 378.4 mg/m2 (± SD of 250.2) and a range of 100 - 1200 mg/m2. About thirty-one (38.3%) patients received high cumulative dose (400 mg/m2 or more), while the remaining 50 patients did not. The decline in left ventricular ejection fraction (LVEF) was relatively rare; and of low grade. Grade 2 decline in LVEF occurred in only two patients who received high cumulative dose of PLD, and only one patient who did not reach HCD (p = 0.555). Grade 3 or 4 decline in LVEF did not occur in patients either with or without HCD. Regarding other toxicities, there was a significant increase in incidence of all grades palmar plantar erythrodysesthesia (PPE) in patients who received HCD of PLD when compared to those who did not reach the HCD (38.7% versus 16% respectively; p = 0.021). Conclusion: Our study concluded that the use of PLD seems to be a justified agent in the treatment of MBC who previously treated by conventional anthracyclines in the adjuvant, metastatic or both settings, even in patients reaching the cumulative dose of conventional anthracycline.
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Refaat et al. (2020) conducted a cohort in Metastatic breast cancer (n=81). High cumulative dose of pegylated liposomal doxorubicin vs. Cumulative dose <400 mg/m2 was evaluated on Grade 2 decline in left ventricular ejection fraction (LVEF) (p=0.555). In patients with metastatic breast cancer previously treated with anthracyclines, high cumulative doses (≥400 mg/m2) of pegylated liposomal doxorubicin did not significantly increase the incidence of grade 2 LVEF decline compared to lower doses (6.5% vs 2.0%, p=0.555).
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