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

Volumn 119, Issue 22, 2013, Pages 3943-3951

  Morris, Patrick G ^a   Iyengar, Neil M ^a   Patil, Sujata ^a   Chen, Carol ^a   Abbruzzi, Alyson ^a   Lehman, Robert ^a   Steingart, Richard ^a   Oeffinger, Kevin C ^a   Lin, Nancy ^b   Moy, Beverley ^c   Come, Steven E ^d   Winer, Eric P ^b   Norton, Larry ^a   Hudis, Clifford A ^a   Dang, Chau T ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

cardiac safety; dose dense chemotherapy; early breast cancer; efficacy; lapatinib; trastuzumab

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; LAPATINIB; PACLITAXEL; TRASTUZUMAB;

ADULT; AGED; BREAST CANCER; CONFERENCE PAPER; CONGESTIVE HEART FAILURE; DIARRHEA; DISEASE FREE SURVIVAL; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; EARLY CANCER; FOLLOW UP; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NEW YORK HEART ASSOCIATION CLASS; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SIDE EFFECT;

CARDIAC SAFETY; DOSE-DENSE CHEMOTHERAPY; EARLY BREAST CANCER; EFFICACY; LAPATINIB; TRASTUZUMAB;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; HEART FAILURE; HUMANS; MIDDLE AGED; PACLITAXEL; QUINAZOLINES; RECEPTOR, ERBB-2; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84887095282     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28284     Document Type: Conference Paper

References (39)

1. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005; 353: 1673-1684.
2. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006; 354: 809-820.
3. 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: 1659-1672.
4. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011; 365: 1273-1283.
5. Citron ML, Berry DA, Cirrincione C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003; 21: 1431-1439.
6. Hudis C, Citron ML, Berry D,. Five year follow-up of INT C9741: dose dense chemotherapy is safe and effective. Breast Cancer Res. 2005: 94 (suppl 1): S20.
7. Burnell M, Levine MN, Chapman JA, et al. Cyclophosphamide, epirubicin, and fluorouracil versus dose-dense epirubicin and cyclophosphamide followed by paclitaxel versus doxorubicin and cyclophosphamide followed by paclitaxel in node-positive or high-risk node-negative breast cancer. J Clin Oncol. 2009; 28: 77-82.
8. Moebus V, Jackisch C, Lueck HJ, et al. Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature Results of an AGO phase III study. J Clin Oncol. 2010; 28: 2874-2880.
9. Morris PG, Dickler M, McArthur HL, et al. Dose-dense adjuvant doxorubicin and cyclophosphamide is not associated with frequent short-term changes in left ventricular ejection fraction. J Clin Oncol. 2009; 27: 6117-6123.
10. 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: 1216-1222.
11. Dang C, Lin N, Moy B, et al. Dose-dense doxorubicin and cyclophosphamide followed by weekly paclitaxel with trastuzumab and lapatinib in HER2/neu-overexpressed/amplified breast cancer is not feasible because of excessive diarrhea. J Clin Oncol. 2010; 28: 2982-2988.
12. 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: 7811-7819.
13. 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: 3416-3421.
14. 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: 3422-3428.
15. Morris PG, Hudis CA,. Trastuzumab-related cardiotoxicity following anthracycline-based adjuvant chemotherapy: how worried should we be? J Clin Oncol. 2010; 28: 3407-3410.
16. Hudis CA, Barlow WE, Costantino JP, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007; 25: 2127-2132.
17. 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: 3792-3799.
18. Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet 2013; 13: 61094-61096.
19. Geyer C, Bryant J, Romond E, et al. Cardiac Safety Analysis of the First Stage of NSABP B-31, A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide (AC) Followed by Paclitaxel (Taxol) to That of AC Followed by Paclitaxel (Taxol) Plus Herceptin in Patients (Pts) With Operable, Node-Positive (N+), HER-2 Overexpressing Breast Cancer (HER2 + BC). Presented at San Antonio Breast Cancer Symposium; December 3-6, 2003; San Antonio, TX: Abstract 23.
20. Pinder MC, Duan Z, Goodwin JS, Hortobagyi GN, Giordano SH,. Congestive heart failure in older women treated with adjuvant anthracycline chemotherapy for breast cancer. J Clin Oncol. 2007; 25: 3808-3815.
21. Du XL, Xia R, Burau K, Liu CC,. 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. 2011; 28 (suppl 1): S80-S90.
22. 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: 1293-1305.
23. 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 Am Coll Cardiol. 2012; 60: 2504-2512.
24. Cardinale D, Colombo A, Torrisi R, et al. Trastuzumab-induced cardiotoxicity: clinical and prognostic implications of troponin I evaluation. J Clin Oncol. 2010; 28: 3910-3916.
25. Morris PG, Chen C, Steingart R, et al. Troponin I and C-reactive protein are commonly detected in patients with breast cancer treated with dose-dense chemotherapy incorporating trastuzumab and lapatinib. Clin Cancer Res. 2011; 17: 3490-3499.
26. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011; 29: 3366-3373.
27. Gianni L, Dafni U, Gelber RD, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011; 12: 236-244.
28. Romond E, Suman VJ, Jeong J-H, 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. Presented at CTRC-AACR San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX: Abstract S5-5.
29. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012; 13: 25-32.
30. Baselga J, Bradbury I, Eidtmann H, et al; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012; 379: 633-640.
31. Guarneri V, Frassoldati A, Bottini A, et al. Preoperative chemotherapy plus trastuzumab, lapatinib, or both in human epidermal growth factor receptor 2-positive operable breast cancer: Results of the randomized phase II CHER-LOB study. J Clin Oncol. 2012; 30: 1989-1995.
32. ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D. ClinicalTrials.gov NCT00490139. clinicaltrials.gov/ct2/ show/NCT00490139. Accessed July 15, 2013.
33. Robidoux A, Tang G, Rastogi P, et al. Evaluation of Lapatinib as a Component of Neoadjuvant Therapy for HER2+ Operable Breast Cancer: NSABP Protocol B-41. Presented at American Society of Clinical Oncology 48th Annual Meeting; June 1-5 2012; Chicago, IL.
34. 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: 5697-5704.
35. 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: 5461-5468.
36. 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: 1982-1988.
37. Jones S, Collea R, Paul D, et al. Phase II Trial of Adjuvant TC (Docetaxel/Cyclophosphamide) Plus Trastuzumab (HER TC) in HER2-Positive Early Stage Breast Cancer Patients. Presented at CTRC-AACR San Antonio Breast Cancer Symposium; December 6-10, 2011; San Antonio, TX: PD07-03.
38. Dang CT, Tolaney S, Najita J, et al. Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel and Trastuzumab for Node Negative, HER2 Positive Breast Cancer. Presented at CTRC-AACR San Antonio Breast Cancer Symposium; December 6-10, 2011; San Antonio, TX.
39. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Breast Cancer, Version 1.2012. nccn.org/professionals/ physician-gls/pdf/breast.pdf. Accessed June 20, 2012.