Anthracycline-induced cardiotoxicity: A multicenter randomised trial comparing two strategies for guiding prevention with enalapril: The International CardioOncology Society-one trial

D Cardinale, F Ciceri, R Latini, MG Franzosi, MT Sandri, M Civelli, GF Cucchi, G Cucchi, E Menatti, M Mangiavacchi, R Cavina, E Barbieri, S Gori, A Colombo, G Curigliano, Curigliano [Unknown], M Salvatici, A Rizzo, F Ghisoni, A BianchiC Falci, M Aquilina, A Rocca, A Monopoli, C Milandri, G Rossetti, Rossetti [Unknown], M Bregni, M Sicuro, A Malossi, D Nassiacos, C Verusio, M Giordano, L Staszewsky, S Barlera, EB Nicolis, M Magnoli, S Masson, CM Cipolla, on behalf of the ICOS-ONE Study Investigators

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Abstract

Background: Troponin changes over time have been suggested to allow for an early diagnosis of cardiac injury ensuing cancer chemotherapy; cancer patients with troponin elevation may benefit of therapy with enalapril. It is unknown whether a preventive treatment with enalapril may further increase the benefit. Methods: The International CardioOncology Society-one trial (ICOS-ONE) was a controlled, open-label trial conducted in 21 Italian hospitals. Patients were randomly assigned to two strategies: enalapril in all patients started before chemotherapy (CT; ‘prevention’ arm), and enalapril started only in patients with an increase in troponin during or after CT (‘troponin-triggered’ arm). Troponin was assayed locally in 2596 blood samples, before and after each anthracycline-containing CT cycle and at each study visit; electrocardiogram and echocardiogram were done at baseline, and at 1, 3, 6 and 12-month follow-up. Primary outcome was the incidence of troponin elevation above the threshold. Findings: Of the 273 patients, 88% were women, mean age 51 ± 12 years. The majority (76%) had breast cancer, 3% had a history of hypertension and 4% were diabetic. Epirubicin and doxorubicin were most commonly prescribed, with median cumulative doses of 360 [270–360] and 240 [240–240] mg/m 2 , respectively. The incidence of troponin elevation was 23% in the prevention and 26% in the troponin-triggered group (p = 0.50). Three patients (1.1%) -two in the prevention, one in the troponin-triggered group-developed cardiotoxicity, defined as 10% point reduction of LV ejection fraction, with values lower than 50%. Interpretation: Low cumulative doses of anthracyclines in adult patients with low cardiovascular risk can raise troponins, without differences between the two strategies of giving enalapril. Considering a benefit of enalapril in the prevention of LV dysfunction, a troponin-triggered strategy may be more convenient. © 2018 Elsevier Ltd
Original languageEnglish
Pages (from-to)126-137
Number of pages12
JournalEuropean Journal of Cancer
Volume94
Issue number3
DOIs
Publication statusPublished - 2018

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    Cardinale, D., Ciceri, F., Latini, R., Franzosi, MG., Sandri, MT., Civelli, M., Cucchi, GF., Cucchi, G., Menatti, E., Mangiavacchi, M., Cavina, R., Barbieri, E., Gori, S., Colombo, A., Curigliano, G., [Unknown], C., Salvatici, M., Rizzo, A., Ghisoni, F., ... Investigators, O. B. O. T. ICOS-ONE. S. (2018). Anthracycline-induced cardiotoxicity: A multicenter randomised trial comparing two strategies for guiding prevention with enalapril: The International CardioOncology Society-one trial. European Journal of Cancer, 94(3), 126-137. https://doi.org/10.1016/j.ejca.2018.02.005