Cardiac safety of adjuvant pegylated liposomal doxorubicin with concurrent trastuzumab: A randomized phase II trial

Annals of Oncology

Volumn 23, Issue 7, 2012, Pages 1780-1788

  Rayson, D ^a   Suter, T M ^b   Jackisch, C ^c   Van der Vegt, S ^d   Bermejo, B ^e   Van den Bosch, J ^f   Vivanco, G L ^g   Van Gent, A M ^h   Wildiers, H ⁱ   Torres, A ^j   Provencher, L ^k   Temizkan, M ^l   Chirgwin, J ^m,n   Canon, J L ^o   Ferrandina, G ^p   Srinivasan, S ^q   Zhang, L ^q   Richel, D J ^r  

^a DALHOUSIE UNIVERSITY   (Canada)

^b UNIVERSITY OF BERN   (Switzerland)

^c Klinikum Offenbach GmbH   (Germany)

^d Mesos Medical Centre   (Netherlands)

^e HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^f ALBERT SCHWEITZER HOSPITAL   (Netherlands)

^g HOSPITAL DE CRUCES   (Spain)

^h AMPHIA HOSPITAL   (Netherlands)

ⁱ UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^j HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^k LAVAL UNIVERSITY   (Canada)

^l Department of Medical Oncology   (Netherlands)

^m MAROONDAH HOSPITAL   (Australia)

ⁿ BOX HILL HOSPITAL   (Australia)

^o Grand Hopital de Charleroi   (Belgium)

^p CATHOLIC UNIVERSITY   (Italy)

^q MERCK RESEARCH LABORATORIES   (United States)

^r ACADEMIC MEDICAL CENTER   (Netherlands)

more..

Author keywords

Adjuvant therapy; Anthracyclines; Breast cancer; Cardiotoxicity; Pegylated liposomal doxorubicin; Trastuzumab

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; TRASTUZUMAB;

ADJUVANT CHEMOTHERAPY; ADULT; AGED; ALOPECIA; ARTICLE; ASTHENIA; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CARDIOVASCULAR DISEASE; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; COUGHING; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG SCREENING; DRUG WITHDRAWAL; DYSPEPSIA; ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HEART DEATH; HEART FAILURE; HEART FUNCTION; HEART INFARCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT DURATION;

EID: 84864302673     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr519     Document Type: Article

References (29)

1. 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: 5685-5692.
2. 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.
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: 1673-1684.
4. 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 Her2neu positive early breast cancer patients: BCIRG 006 study. Presented at the 32nd Annual San Antonio Breast Cancer Symposium. 2009 (Abstr 62).
5. 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.
6. 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.
7. 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.
8. 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.
9. Bartlett JM, Munro AF, Dunn JA et al. Predictive markers of anthracycline benefit: a prospectively planned analysis of the UK National Epirubicin Adjuvant Trial (NEAT/BR9601). Lancet Oncol 2010; 11: 266-274.
10. Perez EA, Suman VJ, Davidson NE et al. Results of chemotherapy alone, with sequential or concurrent addition of 52 weeks of trastuzumab in the NCCTG N9831 HER2-positive adjuvant breast cancer trial. Presented at the 32nd Annual San Antonio Breast Cancer Symposium. 2009 (Abstr 80).
11. Buzdar AU, Ibrahim NK, Francis D et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol 2005; 23: 3676-3685.
12. Buzdar AU, Valero V, Ibrahim NK 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: 228-233.
13. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that over expresses HER2. N Engl J Med 2001; 344: 783-792.
14. 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.
15. Berry G, Billingham M, Alderman E et al. The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin. Ann Oncol 1998; 9: 711-716.
16. Safra T, Muggia F, Jeffers S et al. Pegylated liposomal doxorubicin (Doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses 500 mg/m2. Ann Oncol 2000; 8: 1029-1033.
17. Trudeau ME, Clemons MJ, Provencher L et al. Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines. J Clin Oncol 2009; 27: 5906-5910.
18. Wolff AC, Wang M, Li H et al. Phase II trial of pegylated liposomal doxorubicin plus docetaxel with and without trastuzumab in metastatic breast cancer: Eastern Cooperative Oncology Group trial E3198. Breast Cancer Res Treat 2010; 121: 111-120.
19. 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.
20. Christodoulou C, Kostopoulos I, Kalofonos HP et al. Trastuzumab combined with pegylated liposomal doxorubicin in patients with metastatic breast cancer: phase II study of the Hellenic Cooperative Oncology Group (HeCOG) with biomarker evaluation. Oncology 2009; 76: 275-285.
21. Stickeler E, Klar M, Watermann D et al. Pegylated liposomal doxorubicin and trastuzumab as 1st and 2nd line therapy in her2/neu positive metastatic breast cancer: a multicenter phase II trial. Breast Cancer Res Treat 2009; 117: 591-598.
22. 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.
23. Goldhirsch A, Glick JH, Gelber RD et al. Meeting highlights: international expert consensus on the primary treatment of early breast cancer 2005. Ann Oncol 2005; 16: 1569-1583.
24. Roche Registration Limited. Herceptin Package Insert Welwyn Garden City, UK 2005.
25. Ewer MS, Lippman SM. Type II chemotherapy-related cardiac dysfunction: time to recognize a new entity. J Clin Oncol 2005; 23: 2900-2902.
26. Theodoulou M, Hudis C. Cardiac profiles of liposomal anthracyclines: greater cardiac safety versus conventional doxorubicin. Cancer 2004; 100: 2052-2063.
27. Rayson D, Richel D, Chia S et al. Anthracycline-trastuzumab regimens for HER2/ neu-overexpressing breast cancer: current experience and future strategies. Ann Oncol 2008; 19: 1530-1539.
28. 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.
29. 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.