Daniela Cardinale1, Fabio Ciceri2, Roberto Latini3, Maria Grazia Franzosi4, Maria Teresa Sandri5, Maurizio Civelli6, GianFranco Cucchi7, Elisabetta Menatti8, Maurizio Mangiavacchi9, Raffaele Cavina10, Enrico Barbieri11, Stefania Gori12, Alessandro Colombo1, Giuseppe Curigliano13, Michela Salvatici5, Antonio Rizzo14, Francesco Ghisoni15, Alessandra Bianchi16, Cristina Falci17, Michele Aquilina18, Andrea Rocca19, Anna Monopoli20, Carlo Milandri21, Giuseppe Rossetti22, Marco Bregni23, Marco Sicuro24, Alessandra Malossi25, Daniele Nassiacos26, Claudio Verusio27, Monica Giordano28, Lidia Staszewsky4, Simona Barlera4, Enrico B Nicolis4, Michela Magnoli4, Serge Masson4, Carlo M Cipolla6. 1. Cardioncology Unit, European Institute of Oncology, Milano, Italy. 2. Haematology/Transplant Unit, Istituto Scientifico H. San Raffaele, Milano, Italy. 3. Department of Cardiovascular Research, IRCCS - Mario Negri Institute for Pharmacological Research, Milano, Italy. Electronic address: roberto.latini@marionegri.it. 4. Department of Cardiovascular Research, IRCCS - Mario Negri Institute for Pharmacological Research, Milano, Italy. 5. Laboratory Medicine Division, European Institute of Oncology, Milano, Italy. 6. Cardioncology Division, European Institute of Oncology, Milano, Italy. 7. Cardiology, Ospedale di Sondrio, Italy. 8. Oncology, Ospedale di Sondrio, Italy. 9. Cardiology, Istituto Clinico Humanitas, Rozzano, Italy. 10. Oncology, Istituto Clinico Humanitas, Rozzano, Italy. 11. Cardiology, Ospedale Sacro Cuore, Negrar, Italy. 12. Oncology, Ospedale Sacro Cuore, Negrar, Italy. 13. Division of Early Drug Development for Innovative Therapy, Department of Oncology and Hemato-Oncology, University of Milano, European Institute of Oncology, Milano, Italy. 14. Cardiology, Ospedale di Vaio, Fidenza, Italy. 15. Unità Operativa Complessa Cure Palliative, Ospedale di Vaio, Fidenza, Italy. 16. Cardiology, Istituto Oncologico Veneto, Padova, Italy. 17. Oncology, Istituto Oncologico Veneto, Padova, Italy. 18. Cardiology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRCCS, Meldola, Italy. 19. Oncology, IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy. 20. Cardiology, Nuovo Ospedale San Giuseppe, Empoli, Italy. 21. Oncology, Nuovo Ospedale San Giuseppe, Empoli, Italy. 22. Cardiology, Presidio Ospedaliero di Busto Arsizio, Italy. 23. Oncology, Presidio Ospedaliero di Busto Arsizio, Italy. 24. Cardiology, Ospedale Regionale Umberto Parini, Aosta, Italy. 25. Oncology, Ospedale Regionale Umberto Parini, Aosta, Italy. 26. Cardiology, Presidio Ospedaliero di Saronno, Saronno, Italy. 27. Oncology, Presidio Ospedaliero di Saronno, Saronno, Italy. 28. Oncology, Azienda Socio Sanitaria Territoriale Lariana, Como, Italy.
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.
RCT Entities:
BACKGROUND: Troponin changes over time have been suggested to allow for an early diagnosis of cardiac injury ensuing cancer chemotherapy; cancerpatients 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.
Authors: Neha Bansal; Javier G Blanco; Umesh C Sharma; Saraswati Pokharel; Shannon Shisler; Steven E Lipshultz Journal: Cancer Metastasis Rev Date: 2020-03 Impact factor: 9.264
Authors: José Luis Zamorano; Christer Gottfridsson; Riccardo Asteggiano; Dan Atar; Lina Badimon; Jeroen J Bax; Daniela Cardinale; Antonella Cardone; Elizabeth A M Feijen; Péter Ferdinandy; Teresa López-Fernández; Chris P Gale; John H Maduro; Javid Moslehi; Torbjørn Omland; Juan Carlos Plana Gomez; Jessica Scott; Thomas M Suter; Giorgio Minotti Journal: Eur J Heart Fail Date: 2020-10-02 Impact factor: 15.534
Authors: G Curigliano; D Lenihan; M Fradley; S Ganatra; A Barac; A Blaes; J Herrmann; C Porter; A R Lyon; P Lancellotti; A Patel; J DeCara; J Mitchell; E Harrison; J Moslehi; R Witteles; M G Calabro; R Orecchia; E de Azambuja; J L Zamorano; R Krone; Z Iakobishvili; J Carver; S Armenian; B Ky; D Cardinale; C M Cipolla; S Dent; K Jordan Journal: Ann Oncol Date: 2020-02 Impact factor: 32.976
Authors: Nina Rosa Neuendorff; Kah Poh Loh; Alice S Mims; Konstantinos Christofyllakis; Wee-Kheng Soo; Bediha Bölükbasi; Carlos Oñoro-Algar; William G Hundley; Heidi D Klepin Journal: Blood Adv Date: 2020-02-25