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/m2, 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.

Cardinale, D., Ciceri, F., Latini, R., Franzosi, M., Sandri, M., Civelli, M., et al. (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, 126-137 [10.1016/j.ejca.2018.02.005].

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

Senni M.;
2018

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/m2, 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.
Articolo in rivista - Articolo scientifico
Scientifica
Anthracyclines; Cancer chemotherapy; Cardiotoxicity; Clinical trial; Enalapril; Troponin;
English
Cardinale, D., Ciceri, F., Latini, R., Franzosi, M., Sandri, M., Civelli, M., et al. (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, 126-137 [10.1016/j.ejca.2018.02.005].
Cardinale, D; Ciceri, F; Latini, R; Franzosi, M; Sandri, M; Civelli, M; Cucchi, G; Menatti, E; Mangiavacchi, M; Cavina, R; Barbieri, E; Gori, S; Colombo, A; Curigliano, G; Salvatici, M; Rizzo, A; Ghisoni, F; Bianchi, A; Falci, C; Aquilina, M; Rocca, A; Monopoli, A; Milandri, C; Rossetti, G; Bregni, M; Malossi, A; Nassiacos, D; Verusio, C; Giordano, M; Staszewsky, L; Barlera, S; Nicolis, E; Magnoli, M; Masson, S; Cipolla, C; Latini, R; Franzosi, M; Sandri, M; Civelli, M; Cucchi, G; Menatti, E; Mangiavacchi, M; Cavina, R; Barbieri, E; Gori, S; Colombo, A; Salvatici, M; Curigliano, ; Ghisoni, F; Bianchi, A; Falci, C; Aquilina, M; Rocca, A; Monopoli, A; Milandri, C; Bregni, M; Sicuro, M; Rossetti, ; Nassiacos, D; Verusio, C; Giordano, M; Staszewsky, L; Barlera, S; Magnoli, M; Masson, S; Cipolla, C; Maggioni, A; Labianca, R; Tettamanti, M; Senni, M; Finzi, A; Grosso, F; Vago, T; Gramenzi, S; Balconi, G; Bernasconi, R; Nicolis, E; Buratti, M; Ojeda-Fernandez, M; Vasami, A; Thiebat, B; Bare, C; Corzani, A; Coccolo, F; Colecchia, S; Pellegrini, C; Appio, L; Caico, I; Mesenzani, O; Campana, C; Gilardoni, M; Scognamiglio, G; Corrado, G; Battagin, D; De Rosa, F; Carpino, C; Palazzo, S; Giannessi, P; Zipoli, G; Pastori, P; Callegari, S; Sesenna, C; Fodor, C; Guiducci, D; Mazza, R; Turazza, F; Vallerio, P; Marbello, L; Sala, E; Fragasso, G; Trinca, S; Farolfi, A; Andreis, D; Lanzoni, L; Marchetti, F; Mioranza, E; Banzato, A; Re, F; Gaibazzi, N; Gullo, M; Turina, M; Gervasi, E; Giaroli, F; Barco, B; Bertolini, A; Sinagra, G; Aleksova, A; Guglielmi, A; Pinotti, G; Gueli, R; Mongiardi, C; Vallini, I
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10281/372678
Citazioni
  • Scopus 111
  • ???jsp.display-item.citation.isi??? 103
Social impact