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. 2023 Dec;23(8):5113-5120.
doi: 10.1007/s10238-023-01144-8. Epub 2023 Aug 27.

Non-pegylated liposomal doxorubicin in older adjuvant early breast cancer patients: cardiac safety analysis and final results of the COLTONE study

Luigi Coltelli  1   2 , Chiara Finale  3   4 , Gianna Musettini  3   4 , Andrea Fontana  5 , Maria Teresa Barletta  6   4 , Alessandra Renata Lucarini  7   8 , Iacopo Fabiani  9 , Marco Scalese  10 , Guido Bocci  11 , Luna Chiara Masini  3   4 , Giulia Soria  3   4 , Samanta Cupini  3   4 , Giada Arrighi  6   4 , Cecilia Barbara  3   4 , Ermelinda De Maio  3   4 , Barbara Salvadori  5 , Andrea Marini  3   4 , Antonio Pellino  3   4 , Irene Stasi  3   4 , Michele Emdin  9   12 , Stefano Giaconi  7   8 , Lorenzo Marcucci  6   4 , Giacomo Allegrini  3   6   4
Affiliations

Non-pegylated liposomal doxorubicin in older adjuvant early breast cancer patients: cardiac safety analysis and final results of the COLTONE study

Luigi Coltelli et al. Clin Exp Med. 2023 Dec.

Abstract

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.

Keywords: Adjuvant chemotherapy; Cardiac safety; Early breast cancer patients; High risk; Non-pegylated liposomal doxorubicin.

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Conflict of interest statement

The authors declare no competing interests.

The present work was supported by The Fondazione per le Attività di Ricerca in Oncologia (F.A.R.O.) of Pontedera, Pisa, (Italy). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. No writing assistance was utilized in the production of this manuscript.

Figures

Fig. 1
Fig. 1
Disease Free Survival curve in patients treated with NPL-DOX, CTX, paclitaxel calculated by the Kaplan–Meier method
Fig. 2
Fig. 2
Overall Survival curve in patients treated with NPL-DOX, CTX, paclitaxel calculated by the Kaplan–Meier method
See this image and copyright information in PMC

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