Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study. Issue 13 (September 2015)

• Record Type: Journal Article
• Authors: Pivot, Xavier; Suter, Thomas; Nabholtz, Jean Marc; Pierga, Jean Yves; Espie, Marc; Lortholary, Alain; Khayat, David; Pauporte, Iris; Romieu, Gilles; Kramar, Andrew; Fumoleau, Pierre
• Is Part Of: European journal of cancer. Volume 51:Issue 13(2015:Sep.)
• Page Start: 1660
• Page End: 1666
• Publication Date: 2015-09
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.05.028
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st005">Abstract</title> <sec> <title id="st010">Background</title> <p id="sp0005">This article reports, the cardiac toxicity according to 6- versus 12-month durations of adjuvant trastuzumab in PHARE randomised trial (NCT00381901).</p> </sec> <sec> <title id="st015">Patients and methods</title> <p id="sp0010">Cardiac follow-up and Left Ventricular Ejection Fraction (LVEF) assessment by echocardiography or multigated acquisition scan were performed every 3 months while patients received trastuzumab and after completion of treatment over the first 2 years and every 6 months afterwards. The primary cardiac end-point was Cardiac Heart Failure (CHF) defined as New York Heart Association (NYHA) class III or IV. The secondary cardiac end-points were: cardiac events, cardiac dysfunctions defined by NYHA class I and II; LVEF decreases, cardiac recoveries. The cardiac subcommittee reviewed cardiac events and assessed if patients had favourable outcomes or not on the basis of trends from LVEF measurements.</p> </sec> <sec> <title id="st020">Results</title> <p id="sp0015">Among 3380 patients the cardiac dysfunction assessment included 14, 055 and 13, 218 LVEF measurements in the 12- and 6-month arms. The overall incidences of CHF were 0.65% (11/1690) and 0.53% (9/1690) in the 12 and 6 month arms, respectively (<italic>p</italic> > 0.05). Cardiac dysfunction occurred in 5.9% (100/1690) and 3.4% (58/1690) of patients in the 12 and 6 month arms, respectively (<italic>p</italic> = 0.001). Recoveries were observed for the majority patients and 0.79% (27/3380) of patients experienced an unfavourable cardiac outcome.</p> </sec> <sec> <title id="st025">Conclusion</title> <p id="sp0020">PHARE confirm that the incidence of cardiac end-points remains low and mostly reversible after trastuzumab. Identification at baseline of cardiac risk categories of patients should be of interest to provide an optimal adaptation of adjuvant modalities and a shorter duration might be an option.</p> </sec> </abstract>