Cardiac outcomes of patients receiving adjuvant weekly paclitaxel and trastuzumab for node-negative, ERBB2-positive breast cancer

JAMA Oncology

Volumn 2, Issue 1, 2016, Pages 29-36

  Dang, Chau ^a   Guo, Hao ^b   Najita, Julie ^b   Yardley, Denise ^c   Marcom, Kelly ^d   Albain, Kathy ^e   Rugo, Hope ^f   Miller, Kathy ^g   Ellis, Matthew ^h   Shapira, Iuliana ⁱ   Wolff, Antonio C ^j   Carey, Lisa A ^k   Moy, Beverly ^l   Groarke, John ^b   Moslehi, Javid ^m   Krop, Ian ^b   Burstein, Harold J ^b   Hudis, Clifford ^a   Winer, Eric P ^b   Tolaney, Sara M ^b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c SARAH CANNON RESEARCH INSTITUTE   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e LOYOLA UNIVERSITY CHICAGO   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g INDIANA UNIVERSITY   (United States)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

^j JOHNS HOPKINS UNIVERSITY   (United States)

^k UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^l MASSACHUSETTS GENERAL HOSPITAL   (United States)

^m VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERBB2 PROTEIN, HUMAN; PACLITAXEL; TRASTUZUMAB; TUMOR MARKER;

ADJUVANT CHEMOTHERAPY; ADULT; AGED; ANTAGONISTS AND INHIBITORS; BREAST NEOPLASMS; CANCER STAGING; CHEMICALLY INDUCED; CLINICAL TRIAL; DIAGNOSIS; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; DRUG EFFECTS; ENZYMOLOGY; FEMALE; HEART LEFT VENTRICLE FUNCTION; HEART STROKE VOLUME; HUMAN; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PATHOPHYSIOLOGY; RISK ASSESSMENT; RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOMARKERS, TUMOR; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; RECEPTOR, ERBB-2; RISK ASSESSMENT; RISK FACTORS; STROKE VOLUME; TIME FACTORS; TRASTUZUMAB; TREATMENT OUTCOME; UNITED STATES; VENTRICULAR DYSFUNCTION, LEFT; VENTRICULAR FUNCTION, LEFT; YOUNG ADULT;

EID: 84973499904     PISSN: 23742437     EISSN: 23742445     Source Type: Journal    
DOI: 10.1001/jamaoncol.2015.3709     Document Type: Conference Paper

References (39)

1. Cancer Facts and Figures. American Cancer Society. http://www.cancer.org/research/cancerfactsfigures /cancerfactsfigures/cancer-facts-figures-2013. Accessed September 22, 2015.
2. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785):177-182.
3. 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.
4. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for HER2-positive breast cancer: final planned joint analysis of overall survival (OS) from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33): 3744-3752.
5. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005; 353(16):1659-1672.
6. 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.
7. Slamon D, Eiermann W, Robert N, et al; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283.
8. Joensuu H, Bono P, Kataja V, et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial. J Clin Oncol. 2009;27(34):5685-5692.
9. Curigliano G, Viale G, Bagnardi V, et al. Clinical relevance of HER2 overexpression/amplification in patients with small tumor size and node-negative breast cancer. J Clin Oncol. 2009;27(34): 5693-5699.
10. Gonzalez-Angulo AM, Litton JK, Broglio KR, et al. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cmor smaller. J Clin Oncol. 2009;27(34): 5700-5706.
11. Chia S, Norris B, Speers C, et al. Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of node-negative breast cancers. J Clin Oncol. 2008;26(35):5697-5704.
12. McArthur HL, Mahoney KM, Morris PG, et al. Adjuvant trastuzumab with chemotherapy is effective in women with small, node-negative, HER2-positive breast cancer. Cancer. 2011;117(24): 5461-5468.
13. Kiess AP, McArthur HL, Mahoney K, et al. Adjuvant trastuzumab reduces locoregional recurrence in women who receive breast-conservation therapy for lymph node-negative, human epidermal growth factor receptor 2-positive breast cancer. Cancer. 2012;118 (8):1982-1988.
14. Vaz-Luis I, Ottesen RA, Hughes ME, et al. Outcomes by tumor subtype and treatment pattern in women with small, node-negative breast cancer: a multi-institutional study. J Clin Oncol. 2014;32 (20):2142-2150.
15. Advani PP, Ballman KV, Dockter TJ, et al. Long-term cardiac safety analysis of NCCTG N9831 (Alliance) Adjuvant Trastuzumab trial [published online September 21, 2015]. J Clin Oncol. doi:10.1200/JCO.2015.61.8413.
16. Ewer MS, Lippman SM. Type II chemotherapy-related cardiac dysfunction: time to recognize a new entity. J Clin Oncol. 2005;23(13): 2900-2902.
17. Spielmann M, Roche H, Humblet Y, et al. 3 year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. Breast Cancer Res Treat. 2007;106(suppl 1):S72.
18. Dang C, Fornier M, Sugarman S, et al. The safety of dose-dense doxorubicin and cyclophosphamide followed by paclitaxel with trastuzumab in HER-2/neu overexpressed/amplified breast cancer. J Clin Oncol. 2008;26(8): 1216-1222.
19. Morris PG, Iyengar NM, Patil S, et al. Long-term cardiac safety and outcomes of dose-dense doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab with and without lapatinib in patients with early breast cancer. Cancer. 2013;119(22):3943-3951.
20. Ky B, Vejpongsa P, Yeh ET, Force T, Moslehi JJ. Emerging paradigms in cardiomyopathies associated with cancer therapies. Circ Res. 2013;113 (6):754-764.
21. Tolaney SM, Barry WT, Dang CT, et al. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015; 372(2):134-141.
22. Wilson EB. Probable inference, the law of succession, and statistical inference. J AmStat Assoc. 1927;22(158):209-212.
23. Greenland S. Model-based estimation of relative risks and other epidemiologic measures in studies of common outcomes and in case-control studies. Am J Epidemiol. 2004;160(4): 301-305.
24. Spiegelman D, Hertzmark E. Easy SAS calculations for risk or prevalence ratios and differences. Am J Epidemiol. 2005;162(3):199-200.
25. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 formetastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11): 783-792.
26. Jones SE, Collea R, Paul D, et al. Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open-label, phase 2 study. Lancet Oncol. 2013;14(11):1121-1128.
27. Francis SA, Cheng S, Arteaga CL, Moslehi J. Heart failure and breast cancer therapies:moving towards personalized risk assessment. J AmHeart Assoc. 2014;3(1):e000780.
28. Romond EH, Jeong JH, Rastogi P, et al. 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):3792-3799.
29. Bowles EJ, Wellman R, Feigelson HS, et al; Pharmacovigilance Study Team. 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.
30. Chen J, Long JB, Hurria A, Owusu C, Steingart RM, Gross CP. Incidence of heart failure or cardiomyopathy after adjuvant trastuzumab therapy for breast cancer. J AmColl Cardiol. 2012; 60(24):2504-2512.
31. 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.
32. Ezaz G, Long JB, Gross CP, et al. Risk prediction model for heart failure and cardiomyopathy after adjuvant trastuzumab therapy for breast cancer. Journal of the American Heart Association. http://jaha .ahajournals.org/content/3/1/e000472.short. Published February 28, 2014. Accessed September 22, 2015.
33. Russell SD, Blackwell KL, Lawrence J, et al. Independent adjudication of symptomatic heart failure with the use of doxorubicin and cyclophosphamide followed by trastuzumab adjuvant therapy: a combined review of cardiac data from the National Surgical Adjuvant breast and Bowel Project B-31 and the North Central Cancer Treatment Group N9831 clinical trials. J Clin Oncol. 2010;28(21):3416-3421.
34. Ewer SM, Ewer MS. Cardiotoxicity profile of trastuzumab. Drug Saf. 2008;31(6):459-467.
35. Suter TM, ProcterM, van Veldhuisen DJ, et al. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol. 2007;25 (25):3859-3865.
36. 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 node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol. 2005;23 (31):7811-7819.
37. 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.
38. Halyard MY, Pisansky TM, Dueck AC, et al. Radiotherapy and adjuvant trastuzumab in operable breast cancer: tolerability and adverse event data from the NCCTG Phase III Trial N9831. J Clin Oncol. 2009;27(16):2638-2644.
39. Sharma K, Kass DA. Heart failure with preserved ejection fraction: mechanisms, clinical features, and therapies. Circ Res. 2014;115(1):79-96.