Anthracycline-trastuzumab regimens for HER2/neu-overexpressing breast cancer: Current experience and future strategies

Annals of Oncology

Volumn 19, Issue 9, 2008, Pages 1530-1539

  Rayson, Daniel ^a   Richel, D ^b   Chia, S ^c   Jackisch, C ^d   van der Vegt, S ^e   Suter, T ^f  

^a DALHOUSIE UNIVERSITY   (Canada)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c BRITISH COLUMBIA CANCER AGENCY   (Canada)

^d Klinikum Offenbach   (Germany)

^e Mesos Medical Centre   (Netherlands)

^f UNIVERSITY OF BERN   (Switzerland)

Author keywords

Adjuvant therapy; Anthracy clines; Breast cancer; Cardiotoxicity; HER2+; Pegylated liposomal doxorubicin; Trastuzumab

Indexed keywords

ANTHRACYCLINE; ANTINEOPLASTIC AGENT; CARBOPLATIN; CYCLOPHOSPHAMIDE; DAUNORUBICIN; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; FLUOROURACIL; LIPOSOME; MELPHALAN; METHOTREXATE; PACLITAXEL; TAXANE DERIVATIVE; TRASTUZUMAB;

ADJUVANT THERAPY; ALOPECIA; ANTINEOPLASTIC ACTIVITY; BREAST CANCER; BREAST METASTASIS; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG FORMULATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG POTENTIATION; DRUG TOLERABILITY; DRUG WITHDRAWAL; ESOPHAGITIS; FEBRILE NEUTROPENIA; GENE OVEREXPRESSION; HAND FOOT SYNDROME; HEART DISEASE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; LUNG SMALL CELL CANCER; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NONHUMAN; OVERALL SURVIVAL; OXIDATIVE STRESS; PATHOPHYSIOLOGY; PRIORITY JOURNAL; PROTEIN EXPRESSION; REVIEW; RISK FACTOR; SIDE EFFECT; STOMATITIS; TREATMENT RESPONSE; VOMITING;

ANTHRACYCLINES; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARDIOMYOPATHIES; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE III AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DOXORUBICIN; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; HEART FUNCTION TESTS; HUMANS; MASTECTOMY; MAXIMUM TOLERATED DOSE; NEOPLASM STAGING; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, ERBB-2; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 50849096058     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdn292     Document Type: Review

References (65)

1. Slamon DJ, Clark GM, Wong SG et al. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987; 235: 177-182.
2. 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: 707-712.
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. 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.
5. Slamon D, Eiermann W, Robert N et al. BCIRG 006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AT → T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC → TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2neu positive early breast cancer patients. Breast Cancer Treat Res 2006; 100(Suppl 1): SXX (Abstr 52).
6. Joensuu H, Kellokumpu-Lehtinen P-L, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006; 354: 809-820.
7. Paik S, Bryant J, Park C et al. erbB-2 and response to doxorubicin in patients with axillary lymph node-positive, hormone receptor-negative breast cancer. J Natl Cancer Inst 1998; 90: 1361-1370.
8. Paik S, Bryant J, Tan-Chiu E et al. HER2 and choice of adjuvant chemotherapy for invasive breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15. J Natl Cancer Inst 2000; 92: 1991-1998.
9. Pritchard KI, Shepherd LE, O'Malley FP et al. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med 2006; 354: 2103-2111.
10. 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: 783-792.
11. Bria E, Cuppone F, Fornier M et al. Cardiotoxicity and incidence of brain metastases after adjuvant trastuzumab for early breast cancer: The dark side of the moon? A meta-analysis of the randomized trials. Breast Cancer Res Treat 2007. http://www.springerlink.com/content/ y2746x471737468r471737468/ (15 January 2008, date last accessed).
12. Pegram M, Hsu S, Lewis G et al. Inhibitor effects of combinations of HER-2/neu antibody and chemotherapeutic agents use for treatment of human breast cancer. Oncogene 1999; 18(13): 2241-2251.
13. Pegram MD, Konecny GE, O'Callaghan C et al. Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer. J Natl Cancer Inst 2004; 96: 739-749.
14. Baselga J, Norton L, Albanell J et al. Recombinant humanized anti-HER2 antibody (Herceptin) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overexpressing human breast cancer xenografts. Cancer Res 1998; 58: 2825-2831.
15. Seidman A, Hudis C, Pierri MK et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002; 20: 1215-1221.
16. Levine MN, Bramwell VH, Pritchard KI et al. Randomized that of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with-cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. J Clin Oncol 1998; 16: 2651-2658.
17. Levine MN, Pritchard KI, Bramwell VHC et al. Randomized trial comparing cyclophosphamide, epirubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluourouracil in premenopausal women with node-positive breast cancer: Update of National Cancer Institute of Canada Clinical Trials Group Trial MA5. J Clin Oncol 2005; 23: 5166-5170.
18. O'Malley FP, Chia S, Tu D et al. Topoisomerase II alpha protein overexpression has predictive utility in a randomized trial comparing CMF to CEF in premenopausal women with node positive breast cancer (NCIC CTG MA.5). Breast Cancer Res Treat 2006; 100 (Spppl 1): (Abstr 38).
19. Gennari A, Sormani MP, Pronzato P et al. HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: A pooled analysis of randomized trials. J Natl Cancer Inst 2008; 100: 14-20.
20. Smith I, Procter M, Gelber RD et al. 2-Year follow-up of trastuzumab after adjuvant chemotherapy for HER2-positive breast cancer: A randomized controlled trial. Lancet 2007; 369: 29-36.
21. Suter TM, Procter M, van Veldhuisen DJ et al. Trastuzumab-associated cardiac adverse effects in the Herceptin Adjuvant Trial. J Clin Oncol 2007; 25: 3859-3865.
22. 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.
23. Jones SE, Savin MA, Holmes FA et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 2006; 24: 5381-5387.
24. Jones S, Holmes F, O'Shaughnessy J et al. Extended follow-up and analysis by age of the US Oncology Adjuvant trial 9735: Docetaxel/ cyclophosphamide is associated with an overall survival benefit compared doxorubicin/cyclophosphamide and is well-tolerated in women 65 or older. Breast Cancer Res Treat 2007; 106 (Suppl 1): S5 (Abstr 12).
25. Gunnarsdottir K, Jensen M-B, Zahrieh D et al. CEF is superior to CMF for tumors with topoisomerase IIα gene alterations: A STEPP (subpopulation treatment effect pattern plot) analysis on Danish breast cancer cooperative group study 89D. Breast Cancer Res Treat 2006; 100(Suppl 1): S46 (Abstr 1023).
26. Tanner M, Isola J, Wildund T et al. Topoisomerase IIα gene amplification predicts favorable treatment response to tailored and dose-escalated anthracycline-based adjuvant chemotherapy in HER-2/ neu-amplified breast cancer: Scandinavian Breast Group Trial 9401. J Clin Oncol 2006; 24: 2428-2436.
27. Knoop AS, Knudsen H, Balslev E et al. Retrospective analysis of topoisomerase IIa amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil: Danish Breast Cancer Cooperative Group. J Clin Oncol 2005; 23: 7483-7490.
28. Coon JS, Marcus E, Gupta-Burt S et al. Amplification and overexpression of topoisomerase IIα predict response to anthracycline-based therapy in locally advanced breast cancer. Clin Cancer Res 2002; 8: 1061-1067.
29. Slamon DJ, Mackey J, Robert N et al. Role of anthracycline-based therapy in the adjuvant treatment of breast cancer: Efficacy analysis determined by molecular subtypes of the disease. Breast Cancer Res Treat 2007; 106 (Suppl 1): S5 (Abstr 13).
30. Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: A retrospective analysis of three trials. Cancer 2003; 97: 2869-2879.
31. Perez EA, Suman VJ, Davidson NE et al. Effect of doxorubicin plus cyclophosphamide on left ventricular ejection fraction in patients with breast cancer in the North Central Treatment Group N9831 Intergroup Adjuvant Trial. J Clin Oncol 2004; 22: 3700-3704.
32. Vogel CL, Cobleigh MA, Tripathy D et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002: 20: 719-726.
33. Tripathy D, Slamon DJ, Cobleigh M et al. Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 2004; 22: 1063-1070.
34. Suter TM, Cook-Burns N, Barton C. Cardiotoxicity associated with trastuzumab (Herceptin) therapy in the treatment of metastatic breast cancer. Breast 2004; 13: 173-183.
35. Telli ML, Hunt SA, Carlson RW, Guardino AE. Trastuzumab-related cardiotoxicity: Calling into question the concept of reversibility. J Clin Oncol 2007; 25: 3525-3533.
36. Perez E, Suman V, Davidson N 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: 1231-1238.
37. Buzdar AU, Valero V, Ibrahim N et al. Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: An update of the initial randomized study population and data of additional patients treated with the same regimen. Clin Cancer Res. 2007; 13: 288-1233.
38. Gianni L, Semiglazov V, Manikhas GM et al. Neoadjuvant trastuzumab plus doxorubicin, paclitaxel and CMF in locally advanced breast cancer (NOAH trial): Feasibility, safety and antitumor effects. ASCO Breast Meeting 2007 (Abstr 144).
39. Zuppinger C, Timolati F, Suter TM. Pathophysiology and diagnosis of cancer drug induced cardiomyopathy. Cardiovasc Toxicol 2007; 7: 61-66.
40. Mann DL. Mechanisms and models in heart failure: A combinatorial approach. Circulation 1999; 100: 999-1008.
41. Mann DL, Bristow MR. Mechanisms and models in heart failure: The biomechanical model and beyond. Circulation 2005; 111: 2837-4539.
42. Chien KR. Herceptin and the heart - a molecular modifier of cardiac failure. N Engl J Med 2006; 354: 789-790.
43. Tokarska-Schlattner M, Zaugg M, Zuppinger C et al. New insights into doxorubicin-induced cardiotoxicity: The critical role of cellular energetics. J Mol Cell Cardiol 2006; 41: 389-405.
44. Minotti G, Menna P, Salvatorelli E et al. Anthracyclines: Molecular advances and pharmacologic developments in antitumor activity and cardiotoxicity. Pharmacol Rev 2004; 56: 185-229.
45. Giraud M-N, Fluck M, Zuppinger C, Suter TM. Expressional reprogramming of survival pathways in rat cardiocytes by neuregulin 1β. J Appl Physiol 2005; 99: 313-322.
46. Sawyer DB, Zuppinger C, Miller TA et al. Modulation of anthracycline-induced myofibrillar disarray in rat ventricular myocytes by neuregulin-1β and anti-erbB2. Potential mechanism for trastuzumab-induced cardiotoxicity. Circulation 2002; 105: 1551-1554.
47. Slamon D, Eiermann W, Robert N et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC → T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC ← TH) with docetaxel, carboplatin, and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study. Breast Cancer Res Treat 2005; 94(Suppl 1): S4 (Abstract 1 and Presentation).
48. Gennari A, Biadi O, Danesi R, Del Tacc M. Cardiotoxicity of other anthracyclines and anthracycline analogues. In Ewer MS, Yeh E (eds): Cancer and the Heart. Hamilton, Ontario: BC Decker Inc 2006; 33-41.
49. Untch M, Eidtmann H, du Bois A et al. Cardiac safety of trastuzumab in combination with epirubicin and cyclophosphamide in women with metastatic breast cancer: Results of a phase I trial. Eur J Cancer 2004; 40: 988-997.
50. Ryberg M, Nielsen DL, Cortese G et al. Epirubicin (E) cardiac toxicity: a retrospective analysis of 1097 patients (pts) treated for metastatic breast cancer (MBC). J Clin Oncol 2007; ASCO Meeting Proceedings Part I 2007; 25(18S): 1029.
51. Theodoulou M, Hudis C. Cardiac profiles of liposomal anthracyclines: greater cardiac safety versus conventional doxorubicin. Cancer 2004; 100: 2052-2063.
52. Martin FJ. Pegylated liposomal doxorubicin: Scientific rationale and preclinical pharmacology. Oncology 1997; 11(Suppl 1): 11-20.
53. Gabizon A, Dagan A, Goran D et al. Liposomes as in vivo carriers of adriamycin: Reduced cardiac uptake and preserved antitumor activity in mice. Cancer Res 1982; 42: 4734-4739.
54. Shapira J, Gotfried M, Lishner M, Ravid M. Reduced cardiotoxicity of doxorubicin by a 6-hour infusion regimen. A prospective randomized evaluation. Cancer 1990; 65: 870-873.
55. Lipshultz SE, Giantris AL, Lipstiz SR et al. Doxorubicin administration by continuous infusion is not cardioprotective: The Dana-Farber 91-01 acute lymphoblastic leukemia protocol. J Clin Oncol 2002; 20: 1677-1682.
56. Northfelt DW, Martin FJ, Kaplan LD et al. Pharmacokinetics (PK), tumour localization (TL) and safety of DOXIL (liposomal doxorubicin) in AIDS patients with Kaposi's Sarcoma (AIDS-KS) (abstract A8). Proc Am Soc Clin Oncol 1993; 12: 51.
57. O'Brien MER, Wigler N, Inbar M et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCL (Caelyx/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004; 15: 440-449.
58. Harris L, Batist G, Belt R et al. Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast carcinoma. Cancer 2002; 94: 25-36.
59. Theodoulou M, Campos SM, Batist G et al. TLC D99 (D, Myocet) and herceptin (H) is safe in advanced breast cancer (ABC): Final cardiac safety and efficacy analysis. Proc Am Soc Clin Oncol 2002; 21: 55a (Abstr 216).
60. Chia S, Clemons M, Martin L-A et al. Pegylated liposomal doxorubicin and trastuzumab in HER-2 overexpressing metastatic breast cancer: A multicenter phase II trial. J Clin Oncol 2006; 24: 2773-2778.
61. Wolff AC, Wang M, Sparano JA et al. Cardiac safety and clinical activity of pegylated liposomal doxorubicin (D) and docetaxel (T) with and without trastuzumab (H) as 1st line chemotherapy in HER2-positive and HER2-negative metastatic breast cancer (MBC): Eastern Cooperative Oncology Group (ECOG) trial E3198 (abstract 3040). Breast Cancer Res Treat 2004; 88(Suppl 1): S125.
62. Stickeler E, Watermann DO, Woll J et al. Cardiac safety of pegylated liposomal doxorubicin (PLD) in combination with trastuzumab (T) in patients with metastatic breast cancer (MBC): Results from a multicenter phase II study. J Clin Oncol 2007; ASCO Meeting Proceedings Part I 2007; 25(18S): 1106.
63. Andreopoulou E, Gaiotti D, Kim E et al. Feasibility and cardiac safety of pegylated liposomal doxorubicin plus trastuzumab in heavily pretreated patients with recurrent HER2-overexpressing metastatic breast cancer. Clin Breast Cancer 2007; 7: 690-696.
64. Trudeau M, Provencher L, Panasci L et al. Pegylated liposomal doxorubicin (PLD) plus cyclophosphamide as 1st-line therapy for metastatic breast cancer in patients previously treated with anthracyclines. J Clin Oncol 2005; ASCO Meeting Proceedings Part I 2005; 23(416S): 745.
65. Bilancia D, Rosati G, Dinota A et al. Lapatinib in breast cancer. Ann Oncol 2007; 18 (Suppl 6): Vi26-vi30.