Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma The PROACT Clinical Trial

被引:5
|
作者
Austin, David [1 ,2 ]
Maier, Rebecca H. [1 ,2 ]
Akhter, Nasima [3 ]
Sayari, Mohammad [4 ]
Ogundimu, Emmanuel [4 ]
Maddox, Jamie M. [5 ]
Vahabi, Sharareh [6 ]
Humphreys, Alison C. [7 ]
Graham, Janine [7 ,8 ]
Oxenham, Helen [9 ]
Haney, Sophie [7 ,10 ]
Cresti, Nicola [11 ]
Verrill, Mark [11 ]
Osborne, Wendy [11 ]
Wright, Kathryn L. [11 ,12 ]
Goranova, Rebecca [13 ]
Bailey, James R. [14 ]
Kalakonda, Nagesh [15 ]
Macheta, Mac [16 ]
Kilner, Mari F. [17 ]
Young, Moya E. [18 ]
Morley, Nick J. [19 ]
Neelakantan, Pratap [20 ]
Gilbert, Georgia [1 ]
Thomas, Byju K. [1 ]
Graham, Richard J. [1 ]
Fujisawa, Takeshi [21 ]
Mills, Nicholas L. [21 ]
Hildreth, Victoria [22 ]
Prichard, Jonathan [22 ]
Kasim, Adetayo S. [23 ]
Hancock, Helen C.
Plummer, Chris [24 ,25 ]
机构
[1] South Tees Hosp NHS Fdn Trust, James Cook Univ Hosp, Acad Cardiovasc Unit, Marton Rd, Middlesbrough TS4 3BW, England
[2] Newcastle Univ, Populat Hlth Sci Inst, Newcastle Upon Tyne, England
[3] Teesside Univ, Sch Hlth & Life Sci, Middlesbrough, England
[4] Univ Durham, Durham Coll, Durham, England
[5] Teesside Univ, Dept Psychol, Middlesbrough TS1 3BX, England
[6] Univ Hosp Bristol & Weston NHS Fdn Trust, Bristol Heart Inst, Bristol, England
[7] South Tees Hosp NHS Fdn Trust, Middlesbrough, England
[8] North Tees & Hartlepool NHS Fdn Trust, Stockton On Tees, England
[9] North Tees & Hartlepool NHS Fdn Trust, Stockton On Tees, England
[10] Cty Durham & Darlington NHS Fdn Trust, Darlington, England
[11] Newcastle Upon Tyne Hosp NHS Fdn Trust, Freeman Hosp, Newcastle Upon Tyne, England
[12] South Tyneside & Sunderland NHS Fdn Trust, Sunderland, England
[13] Univ Hosp Plymouth NHS Trust, Derriford Hosp, Dept Microbiol, Plymouth, England
[14] Hull Univ Teaching Hosp NHS Trust, Castle Hill Hosp, Queens Ctr Oncol & Haematol, Dept Haematol, Kingston Upon Hull, England
[15] Univ Liverpool, Dept Mol & Clin Canc Med, Liverpool, England
[16] Blackpool Teaching Hosp, Dept Haematol, Blackpool, England
[17] Northumbria Healthcare NHS Fdn Trust, Pathol Serv, North Shields, England
[18] East Kent Hosp Univ NHS Fdn Trust, Dept Haematol, Canterbury, England
[19] Sheffield Teaching Hosp NHS Fdn Trust, Dept Haematol, Sheffield, England
[20] Royal Berkshire NHS Fdn Trust, Radiol Dept, Reading, England
[21] Univ Edinburgh, Ctr Cardiovasc Sci, Edinburgh, Scotland
[22] Newcastle Univ, Newcastle Clin Trials Unit, Newcastle Upon Tyne, England
[23] Univ Durham, Dept Anthropol, Durham, England
[24] Newcastle Upon Tyne NHS Fdn Trust, Dept Cardiol, Newcastle Upon Tyne, England
[25] Newcastle Univ, Fac Med Sci, Newcastle Upon Tyne, England
来源
JACC: CARDIOONCOLOGY | 2024年 / 6卷 / 05期
关键词
anthracycline; biomarkers; breast cancer; echocardiography; lymphoma; prevention; INDUCED CARDIOTOXICITY; DYSFUNCTION; ENALAPRIL; DOXORUBICIN; INHIBITION; TOXICITY; THERAPY;
D O I
10.1016/j.jaccao.2024.07.010
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background Cardiotoxicity is a concern for cancer survivors undergoing anthracycline chemotherapy. Enalapril has been explored for its potential to mitigate cardiotoxicity in cancer patients. The dose-dependent cardiotoxicity effects of anthracyclines can be detected early through the biomarker cardiac troponin. Objectives The PROACT (Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma) clinical trial assessed the effectiveness of enalapril in preventing cardiotoxicity, manifesting as myocardial injury and cardiac function impairment, in patients undergoing high-dose anthracycline-based chemotherapy for breast cancer or non-Hodgkin lymphoma. Methods This prospective, multicenter, open-label, randomized controlled trial employed a superiority design with observer-blinded endpoints. A total of 111 participants, scheduled for 6 cycles of chemotherapy with a planned dose of >= 300 mg/m(2) doxorubicin equivalents, were randomized to receive either enalapril (titrated up to 20 mg daily) or standard care without enalapril. Results Myocardial injury, indicated by cardiac troponin T (>= 14 ng/L), during and 1 month after chemotherapy, was observed in 42 (77.8%) of 54 patients in the enalapril group vs 45 (83.3%) of 54 patients in the standard care group (OR: 0.65; 95% CI: 0.23-1.78). Injury detected by cardiac troponin I (>26.2 ng/L) occurred in 25 (47.2%) of 53 patients on enalapril compared with 24 (45.3%) of 53 in standard care (OR: 1.10; 95% CI: 0.50-2.38). A relative decline of more than 15% from baseline in left ventricular global longitudinal strain was observed in 10 (21.3%) of 47 patients on enalapril and 9 (21.9%) of 41 in standard care (OR: 0.95; 95% CI: 0.33-2.74). An absolute decline of >10% to <50% in left ventricular ejection fraction was seen in 2 (4.1%) of 49 patients on enalapril vs none in patients in standard care. Conclusions Adding enalapril to standard care during chemotherapy did not prevent cardiotoxicity in patients receiving high-dose anthracycline-based chemotherapy. (PROACT: Can we prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?; NCT03265574)
引用
收藏
页码:684 / 696
页数:13
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