The Temporal Risk of Heart Failure Associated with Adjuvant Trastuzumab in Breast Cancer Patients: A Population Study

Journal of the National Cancer Institute

Volumn 108, Issue 1, 2016, Pages

  Goldhar, Hart A ^a   Yan, Andrew T ^a,b   Ko, Dennis T ^a,c   Earle, Craig C ^a,c,d   Tomlinson, George A ^a,e   Trudeau, Maureen E ^a   Krahn, Murray D ^a,f   Krzyzanowska, Monika K ^a,c,e   Pal, Raveen S ^a,g   Brezden Masley, Christine ^a,b   Gavura, Scott ^a,h   Lien, Kelly ^a   Chan, Kelvin K W ^a  

^a SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c INSTITUTE FOR CLINICAL EVALUATIVE SCIENCES   (Canada)

^d ONTARIO INSTITUTE FOR CANCER RESEARCH   (Canada)

^e UNIVERSITY HEALTH NETWORK   (Canada)

^f Toronto Health Economics and Technology Assessment   (Canada)

^g QUEEN S UNIVERSITY   (Canada)

^h CANCER CARE ONTARIO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; TRASTUZUMAB; ANTINEOPLASTIC AGENT;

ADULT; AGE; AGED; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER PATIENT; CANCER STAGING; CANCER SURVIVOR; CARDIOVASCULAR RISK; COHORT ANALYSIS; COMORBIDITY; DIABETES MELLITUS; FEMALE; FOLLOW UP; HEART FAILURE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; POPULATION BASED CASE CONTROL STUDY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK ASSESSMENT; ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; CANADA; CHEMICALLY INDUCED; EPIDEMIOLOGY; KAPLAN MEIER METHOD; MIDDLE AGED; PATHOLOGY; RISK FACTOR; STATISTICS AND NUMERICAL DATA; SURVIVOR; TIME;

ADULT; AGE FACTORS; AGED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COMORBIDITY; CONFOUNDING FACTORS (EPIDEMIOLOGY); FEMALE; HEART FAILURE; HUMANS; INCIDENCE; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; NEOPLASM STAGING; ONTARIO; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; SURVIVORS; TIME FACTORS; TRASTUZUMAB;

EID: 84956593610     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djv301     Document Type: Article

References (42)

1. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792.
2. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684.
3. Mackey J, McLeod D, Ragaz J, et al. Adjuvant targeted therapy in early breast cancer. Cancer. 2009;115(6):1154-1168.
4. Yin W, Jiang Y, Shen Z, et al. Trastuzumab in the adjuvant treatment of HER2-positive early breast cancer patients: a meta-analysis of published randomized controlled trials. PloS One. 2011;6(6):e21030.
5. Dahabreh IJ, Linardou H, Siannis F, et al. Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. Oncologist. 2008;13(6):620-630.
6. Viani GA, Afonso SL, Stefano EJ, et al. Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: a meta-analysis of published randomized trials. BMC Cancer. 2007;7:153.
7. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244(4905):707-712.
8. Owens MA, Horten BC, Da Silva MM. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer. 2004;5(63):63-69.
9. Procter M, Suter TM, de Azambuja E, et al. Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial. J Clin Oncol. 2010;28(21):3422-3428.
10. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672.
11. Suter TM, Procter M, van Veldhuisen DJ, et al. Trastuzumab-Associated Cardiac Adverse Effects in the Herceptin Adjuvant Trial. J Clin Oncol. 2007;25(25):3859-3865.
12. Perez EA, Suman VJ, Davidson NE, et al. Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial. J Clin Oncol. 2008;26(8):1231-1238.
13. Tan-Chiu E, Yothers G, Romond E, et al. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in nodepositive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol. 2005;23(31):7811-7819.
14. McArthur HL, Chia S. Cardiotoxicity of trastuzumab in clinical practice. N Engl J Med. 2007;357(1):94-95.
15. Guarneri V, Lenihan DJ, Valero V, et al. Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: The MD Anderson Cancer Center experience. J Clin Oncol. 2006;24(25):4107-4115.
16. Chen J, Long JB, Hurria A, et al. Incidence of heart failure or cardiomyopathy after adjuvant trastuzumab therapy for breast cancer. J Am Coll Cardiol. 2012;60(24):2504-2512.
17. Chavez-MacGregor M, Zhang N, Buchholz TA, et al. Trastuzumab-Related Cardiotoxicity Among Older Patients With Breast Cancer. J Clin Oncol. 2013;31(33):4222-4228.
18. Smith KL, Dang C, Seidman AD. Cardiac dysfunction associated with trastuzumab. Expt Opin Drug Saf. 2006;5(5):619-629.
19. Chien JA, Rugo HS. The cardiac safety of trastuzumab in the treatment of breast cancer. Expert Opin Drug Saf. 2010;9(2):335-346.
20. Bowles EJ, Wellman R, Feigelson HS, et al. Risk of heart failure in breast cancer patients after anthracycline and trastuzumab treatment: a retrospective cohort study. J Natl Cancer Inst. 2012;104(17):1293-1305.
21. Du XL, Xia R, Burau K, et al. Cardiac risk associated with the receipt of anthracycline and trastuzumab in a large nationwide cohort of older women with breast cancer, 1998-2005. Med Oncol. 2010;28:S80-S90.
22. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007;369(9555):29-36.
23. Slamon D, Eiermann W, Robert N, et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med. 2011;265:1273-1283.
24. Romond EH, Jeong JH, Rastogi P. Seven-year follow-up assessment of cardiac function in NSABP B-31, a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with node-positive, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2012;30(31):3792-3729.
25. de Azambuja E, Procter MJ, van Veldhuisen DJ, et al. Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant Trial (BIG 1-01). J Clin Oncol. 2014;32(20):2159-2165.
26. Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998;339(13):900-905.
27. Du XL, Xia R, Liu CC, et al. Cardiac toxicity associated with anthracyclinecontaining chemotherapy in older women with breast cancer. Cancer. 2009;115(22):5296-5308.
28. Pinder MC, Duan Z, Goodwin JS, et al. Congestive heart failure in older women treated with adjuvant anthracycline chemotherapy for breast cancer. J Clin Oncol. 2007;25(25):3808-3815.
29. Timolati F, Ott D, Pentassuglia L, et al. Neuregulin-1 beta attenuates doxorubicin-induced alterations of excitation-contraction coupling and reduces oxidative stress in adult rate cardiomyocytes. J Mol Cell Cardiol. 2006;41(5):845-854.
30. Gianni L, Salvatorelli E, Minotti G. Anthracycline cardiotoxicity in breast cancer patients: synergism with trastuzumab and taxanes. Cardiovasc Toxicol. 2007;7(2):67-71.
31. Schultz SE, Rothwell DM, Chen Z, et al. Identifying cases of congestive heart failure from administrative data: a validation study using primary care patient records. Chronic Dis Inj Can. 2013;33(3):160-166.
32. Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-383.
33. Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992;45(6):613-619.
34. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94:496-509.
35. Parsons, LS. Reducing bias in a propensity score matched-pair sample using greedy matching techniques. In SAS SUGI 26, Paper 214-226. 2001.
36. Kumachev A, Chin-Yee NJ, Yan A, et al. Impact of physician and center case volume on the adequacy of cardiac monitoring during adjuvant trastuzumab in breast cancer. J Clin Oncol (Meeting abstracts). 2013;31:No 26-suppl 128.
37. Seidman A, Hudis C, Pierri MK, et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol. 2002;20(5):1215-1221.
38. Mackey JR, Clemons M, Cote MA, et al. Cardiac management during adjuvant trastuzumab therapy: recommendations of the Canadian Trastuzumab Working Group. Curr Oncol. 2008;15(1):24-35.
39. Ewer SM, Ewer MS. Cardiotoxicity profile of trastuzumab. Drug Saf. 2008;31(6):459-467.
40. Fox KF. The evaluation of left ventricular function for patients being considered for, or receiving Trastuzumab (Herceptin) therapy. Br J Cancer. 2006;95(10):1454.
41. Curigliano G, Cardinale D, Suter T, et al. Cardiovascular toxicity induced by chemotherapy, targeted agents and radiotherapy: ESMO Clinical Practice Guidelines. Ann Oncol. 2012;23 (Suppl 7):vii55-vii166.
42. Jones AL, Barlow M, Barrett-Lee PJ, et al. Management of cardiac health in trastuzumab-treated patients with breast cancer: updated United Kingdom National Cancer Research Institute recommendations for monitoring. Br J Cancer. 2009;100(5):684-692.