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

被引：2

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

页码：684 / 696

页数：13

共 50 条

[21] Lessons From the ISCHEMIA Trial for Preventing Collateral Damage on Clinical Trial Outcomes
Thomas, Boban
Hassan, Imad
JACC-HEART FAILURE, 2021, 9 (06) : 468 - 469
[22] Evaluation of dexrazoxane effect on preventing acute cardiac arrhythmia in patients with breast cancer treated with neoadjuvant/adjuvant anthracycline-based chemotherapy
Kaplan, Ozgur
Kaplan, Nihal Bozdag
INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, 2021, 75 (11)
[23] Management of the axilla in operable breast cancer treated by breast conservation: a randomized clinical trial - Reply
Chetty, U
BRITISH JOURNAL OF SURGERY, 2000, 87 (07) : 969 - 970
[24] THE IMPACT OF CLINICAL TRIAL PARTICIPATION ON PATIENTS WITH METASTATIC BREAST CANCER
Wang, R.
Abbass, I. M.
Shah, A.
Cassoli, L.
Mitchell, E.
VALUE IN HEALTH, 2022, 25 (07) : S326 - S326
[25] GELATO — a clinical trial specific for patients with lobular breast cancer
Nature Cancer, 2023, 4 : 452 - 453
[26] GELATO - a clinical trial specific for patients with lobular breast cancer
不详
NATURE CANCER, 2023, 4 (04) : 452 - 453
[27] RANDOMIZED CLINICAL-TRIAL COMPARING MITOXANTRONE WITH DOXORUBICIN IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC BREAST-CANCER
HENDERSON, IC
ALLEGRA, JC
WOODCOCK, T
WOLFF, S
BRYAN, S
CARTWRIGHT, K
DUKART, G
HENRY, D
JOURNAL OF CLINICAL ONCOLOGY, 1989, 7 (05) : 560 - 571
[28] Safety and efficacy of eribulin in patients with advanced breast cancer treated outside of a clinical trial: A single institution experience
Kessler, Luisa
Bergh, Jonas
Foukakis, Theodoros
JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (15)
[29] Lithium and preventing chemotherapy-induced peripheral neuropathy in breast cancer patients: a placebo-controlled randomized clinical trial
Najafi, S.
Heidarali, Z.
Rajabi, M.
Omidi, Z.
Zayeri, F.
Salehi, M.
Haghighat, S.
TRIALS, 2021, 22 (01)
[30] Lithium and preventing chemotherapy-induced peripheral neuropathy in breast cancer patients: a placebo-controlled randomized clinical trial
S. Najafi
Z. Heidarali
M. Rajabi
Z. Omidi
F. Zayeri
M. Salehi
S. Haghighat
Trials, 22

← 1 2 3 4 5 →