Key result
Non-pegylated liposomal doxorubicin yields zero early CHF and ~7% asymptomatic LVEF reduction in older women.
Why the study?
The cardiac safety of adjuvant non-pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel in elderly women with high-risk breast cancer was not well established.
May indicate acceptable cardiac safety for non-pegylated liposomal doxorubicin in older women; hypothesis-generating and requires randomized confirmation.
AIMS: To explore the cardiac safety of adjuvant Non-Pegylated Liposomal Doxorubicin (NPL-DOX) plus Cyclophosphamide (CTX) followed by weekly Paclitaxel, in elderly women (≥ 65 years) with high-risk breast cancer. Previously, we described no symptomatic cardiac events within the first 12 months from starting treatment. We now reported the updated results after a median follow-up 76 months. METHODS: The cardiac activity was evaluated with left ventricular ejection fraction (LVEF) echocardiograms assessments, before starting chemotherapy and every 6 months, until 30 months from baseline, then yearly for at least 5 years. RESULTS: Forty-seven women were recruited by two Units of Medical Oncology (Ethics Committee authorization CESM-AOUP, 3203/2011; EudraCT identification number: 2010-024067-41, for Pisa and Pontedera Hospitals). An episode of grade 3 CHF (NCI-CTCAE, version 3.0) occurred after 18 months the beginning of chemotherapy. The echocardiograms assessments were performed comparing the LVEF values of each patient evaluated at fixed period of time, compared to baseline. We observed a slight changed in terms of mean values at 48, 60, 72 and 84 months. At these time points, a statistically significant reduction of - 3.2%, - 4.6%, - 6.4% and - 7.1%, respectively, was observed. However, LVEF remained above 50% without translation in any relevant clinical signs. No other cardiac significant episodes were reported. To this analysis, in 13 patients (28%) occurred disease relapse and, of them, 11 (23%) died due to metastatic disease. Eight patients died of cancer-unrelated causes. CONCLUSIONS: The combination including NPL-DOX in elderly patients revealed low rate of cardiac toxic effects. Comparative trials are encouraged.
No takes yet. Share an insight, caveat, or question.
Coltelli et al. (2023) studied High-risk early breast cancer (n=47). Non-pegylated liposomal doxorubicin plus cyclophosphamide followed by weekly paclitaxel was evaluated on Episodes of congestive heart failure (CHF) within the first 12 months. In older women with early breast cancer, non-pegylated liposomal doxorubicin adjuvant therapy resulted in no early congestive heart failure and only a 7.1% asymptomatic LVEF reduction at 7 years.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: