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 Research and Treatment

Volumn 117, Issue 3, 2009, Pages 591-598

  Stickeler, Elmar ^a   Klar, Maximilian ^a   Watermann, Dirk ^a   Geibel, Annette ^a   Földi, Martha ^a   Hasenburg, Annette ^a   Gitsch, Gerald ^a  

^a UNIVERSITY OF FREIBURG   (Germany)

Author keywords

Cardiotoxicity; Metastatic breast cancer; Pegylated doxorubicin; Trastuzumab

Indexed keywords

DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; TRASTUZUMAB;

ADULT; AGED; ALOPECIA; ARTICLE; ATRIOVENTRICULAR BLOCK; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIASTOLIC DYSFUNCTION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPHAGIA; DYSPNEA; FEMALE; FOLLOW UP; HAND FOOT SYNDROME; HEART FUNCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; LIVER FAILURE; LOADING DRUG DOSE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL; NAUSEA; NEUROPATHY; OPEN STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; ST SEGMENT; STOMATITIS; SURVIVAL TIME; THROMBOGENESIS; THROMBUS; TRANSTHORACIC ECHOCARDIOGRAPHY;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; DOXORUBICIN; ECHOCARDIOGRAPHY; FEMALE; HEART; HEART FAILURE; HISTORY, 16TH CENTURY; HUMANS; KAPLAN-MEIERS ESTIMATE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RECEPTOR, ERBB-2; STROKE VOLUME;

EID: 70349567015     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-008-0306-9     Document Type: Article

References (33)

1. DJ Slamon W Godolphin LA Jones JA Holt SG Wong DE Keith WJ Levin SG Stuart J Udove A Ullrich, et al. 1989 Studies of the Her-2/Neu proto-oncogene in human breast and ovarian cancer Science 244 4905 707 712 10.1126/science. 2470152 2470152 10.1126/science.2470152 1:STN:280:DyaL1M3kt1Wntg%3D%3D
2. PM Ravdin GC Chamness 1995 The C-Erbb-2 Proto-Oncogene as a prognostic and predictive marker in breast cancer: a paradigm for the development of other macromolecular markers-a review Gene 159 1 19 27 10.1016/0378-1119(94)00866-Q 7607568 10.1016/0378-1119(94)00866-Q 1:CAS:528:DyaK2MXmvFWru78%3D
3. C Lohrisch M Piccart 2001 An overview of Her2 Semin Oncol 28 6 (suppl 18) 3 11 10.1053/sonc.2001.29713 11774200 10.1016/S0093-7754(01)90103-4 1:CAS:528:DC%2BD38XhtFOitLo%3D
4. L Norton D Slamon B Leyland-Jones, et al. 1999 Overall survival (OS) advantage to simultaneous chemotherapy (CRx) plus the humanized anti-HER2 monoclonal antibody Herceptin (H) in HER2-overexpressing (HER2 +) metastatic breast cancer (MBC) Proc Am Soc Clin Oncol 18 127a
5. CL Vogel SX Franco 2003 Clinical experience with trastuzumab (Herceptin) Breast J 9 6 452 462 10.1046/j.1524-4741.2003.09602.x 14616939 10.1046/j.1524-4741.2003.09602.x 1:CAS:528:DC%2BD3sXpvFOks7g%3D (Pubitemid 37433210)
6. JA O'Shaughnessy 2003 Pegylated liposomal doxorubicin in the treatment of breast cancer Clin Breast Cancer 4 5 318 328 10.3816/CBC.2003.n.037 14715106 10.3816/CBC.2003.n.037
7. MD Pegram RS Finn K Arzoo M Beryt RJ Pietras DJ Slamon 1997 The effect of Her-2/Neu overexpression on chemotherapeutic drug sensitivity in human breast and ovarian cancer cells Oncogene 15 5 537 547 10.1038/sj.onc.1201222 9247307 10.1038/sj.onc.1201222 1:CAS:528:DyaK2sXls1OltLc%3D
8. M Pegram S Hsu G Lewis R Pietras M Beryt M Sliwkowski D Coombs D Baly F Kabbinavar D Slamon 1999 Inhibitory effects of combinations of Her-2/Neu antibody and chemotherapeutic agents used for treatment of human breast cancers Oncogene 18 13 2241 2251 10.1038/sj.onc.1202526 10327070 10.1038/sj.onc.1202526 1:CAS:528:DyaK1MXis12murk%3D
9. D Slamon M Pegram 2001 Rationale for trastuzumab (Herceptin) in adjuvant breast cancer trials Semin Oncol 28 Suppl 3 13 19 10.1053/sonc.2001.22812 11301370 10.1016/S0093-7754(01)90188-5 1:CAS:528:DC%2BD3MXjtFWqsr8%3D
10. L Gianni E Salvatorelli G Minotti 2007 Anthracycline cardiotoxicity in breast cancer patients: synergism with trastuzumab and taxanes Cardiovasc Toxicol 7 2 67 71 10.1007/s12012-007-0013-5 17652806 10.1007/s12012-007-0013-5 1:CAS:528:DC%2BD2sXot1Cmu78%3D (Pubitemid 47339869)
11. DJ Slamon B Leyland-Jones S Shak H Fuchs V Paton A Bajamonde T Fleming W Eiermann J Wolter M Pegram J Baselga L Norton 2001 Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2 N Engl J Med 344 783 792 10.1056/NEJM200103153441101 11248153 10.1056/NEJM200103153441101 1:CAS:528:DC%2BD3MXisVGktrc%3D (Pubitemid 32222155)
12. JR Carver CL Shapiro A Ng L Jacobs C Schwartz KS Virgo KL Hagerty MR Somerfield DJ Vaughn 2007 American Society of Clinical Oncology Clinical Evidence on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects J Clin Oncol 25 3991 4008 10.1200/JCO.2007.10.9777 17577017 10.1200/JCO.2007.10.9777 1:CAS:528:DC%2BD2sXhtFanu73F (Pubitemid 47477279)
13. S Chia M Clemons LA Martin A Rodgers K Gelmon GR Pond L Panasci 2006 Pegylated liposomal doxorubicin and trastuzumab in her-2 overexpressing metastatic breast cancer: a multicenter phase II trial J Clin Oncol 24 18 2773 2778 10.1200/JCO.2005.03.8331 16682726 10.1200/JCO.2005.03.8331 1:CAS:528:DC%2BD28XntV2hu7o%3D (Pubitemid 46630575)
14. E Andreopoulou D Gaiotti E Kim M Volm R Oratz R Freedberg A Downey CL Vogel S Chia F Muggia 2007 Feasibility and cardiac safety of pegylated liposomal doxorubicin plus trastuzumab in heavily pretreated patients with recurrent HER2-overexpressing metastatic breast cancer Clin Breast Cancer 7 9 690 696 10.3816/CBC.2007.n.028 17919349 10.3816/CBC.2007.n.028 1:CAS:528: DC%2BD2sXhtVOrsbbI
15. M Theodoulou SM Campos G Batist, et al. 2002 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 21 55a (Abstr 216)
16. Trigo J, Climent MA, Lluch A et al. (2003) Liposomal doxorubicin (Myocet) in combination with Herceptin and paclitaxel is active and well tolerated in patients with HER2-positive locally advanced or metastatic breast cancer (LA/MBC): a phase II study. Poster presented at the 26th annual san antonio breast cancer symposium, San Antonio, Texas, 3-6 December 2003
17. ML Telli SA Hunt RW Carlson AE Guardino 2007 Trastuzumab related cardiotoxicity: calling into question the concept of reversibility J Clin Oncol 25 3525 3533 10.1200/JCO.2007.11.0106 17687157 10.1200/JCO.2007.11.0106 1:CAS:528:DC%2BD2sXhtVajsb3M (Pubitemid 47310891)
18. GA Viani SL Afonso EJ Stefano LI De Fendi FV Soares 2007 Adjuvant trastuzumab in the treatment of her2 positive early breast cancer: a metaanalysis of published randomized trials BMC Cancer 7 153 164 10.1186/1471-2407-7-153 17686164 10.1186/1471-2407-7-153 (Pubitemid 47354734)
19. Gianni L, Semiglazov V, Manikhas GM et al. (2007) 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)
20. MF Press C Cordon-Cardo DJ Slamon 1990 Expression of the Her-2/Neu proto-oncogene in normal human adult and fetal tissues Oncogene 5 7 953 962 1973830 1:CAS:528:DyaK3cXkvFalsbc%3D
21. JJ Doyle AI Neugut JS Jacobson VR Grann DL Hershman 2006 Chemotherapy and cardiotoxicity in older breast cancer patients: a population based study J Clin Oncol 34 8597 8605
22. VB Pai MC Nahata 2000 Cardiotoxicity of chemotherapeutic agents: incidence, treatment and prevention Drug Saf 22 4 263 302 10.2165/00002018- 200022040-00002 10789823 10.2165/00002018-200022040-00002 1:CAS:528: DC%2BD3cXjtFaitb4%3D
23. MS Ewer SM Lippmann 2005 Typ II chemotherapy-related cardiac dysfunction: time to recognize a new entity J Clin Oncol 23 2900 2902 10.1200/JCO.2005.05. 827 15860848 10.1200/JCO.2005.05.827 1:CAS:528:DC%2BD2MXkslGhurg%3D (Pubitemid 46224107)
24. MS Ewer FJ Martin C Henderson CL Shapiro RS Benjamin AA Gabizon 2004 Cardiac safety of liposomal anthracyclines Semin Oncol 31 Suppl 13 161 181 10.1053/j.seminoncol.2004.08.006 15717742 10.1053/j.seminoncol.2004.08.006 1:CAS:528:DC%2BD2MXhtVynsL0%3D (Pubitemid 40023246)
25. L Harris G Batist R Belt D Rovira R Navari N Azarnia L Welles E Winer 2002 Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast carcinoma Cancer 94 1 25 36 10.1002/cncr.10201 11815957 10.1002/cncr.10201 1:CAS:528:DC%2BD38XlslKgsw%3D%3D (Pubitemid 34049039)
26. 2 Ann Oncol 11 8 1029 1033 11038041 10.1023/A:1008365716693 1:STN:280:DC%2BD3cvoslOrsQ%3D%3D (Pubitemid 30739918)
27. M Theodoulou C Hudis 2004 Cardiac profiles of liposomal anthracyclines: greater cardiac safety versus conventional doxorubicin? Cancer 100 10 2052 2063 15139046 10.1002/cncr.20207 1:CAS:528:DC%2BD2cXksF2ku7c%3D (Pubitemid 38580322)
28. ME O'Brien N Wigler M Inbar R Rosso E Grischke A Santoro R Catane DG Kieback P Tomczak SP Ackland F Orlandi L Mellars L Alland C Tendler CAELYX Breast Cancer Study Group 2004 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 15 3 440 449 10.1093/annonc/mdh097 14998846 10.1093/annonc/mdh097 (Pubitemid 38444547)
29. EA Perez R Rodeheffer 2004 Clinical cardiac tolerability of trastuzumab J Clin Oncol 22 2 322 329 10.1200/JCO.2004.01.120 14722042 10.1200/JCO.2004.01. 120 1:CAS:528:DC%2BD2cXpsVKitLY%3D (Pubitemid 41095098)
30. A Seidman C Hudis MK Pierri S Shak V Paton M Ashby M Murphy SJ Stewart D Keefe 2002 Cardiac dysfunction in the trastuzumab clinical trials experience J Clin Oncol 20 5 1215 1221 10.1200/JCO.20.5.1215 11870163 10.1200/JCO.20.5.1215 1:CAS:528:DC%2BD38XisVWmuro%3D (Pubitemid 34177427)
31. AC Wolff M Bonetti JA Sparano M Wang NE Davidson on behalf of ECOG 2003 Cardiac safety of trastuzumab (H) in combination with pegylated liposomal doxorubicin (D) and docetaxel (T) in HER2-positive metastatic breast cancer (MBC): preliminary results of the eastern cooperative oncology group trial E3198 Proc Am Soc Clin Oncol 22 18a (abstr 70)
32. Untch M, Tjulandin S, Jonat W, Meerpohl H, Lichinitser M, Manikhas GM, Jänicke F, Muscholl M, pauschinger M, Thomssen C, Lehle M (2007) "Evaluation of first line trastuzumab in combination with epirubicin/cyclophosphamidefor patients with Her2-positive metastatic breast cancer" SABCS 2007 (abstract 4058)
33. Von Minckwitz G, Rezai M, Loibl S, Fasching P, Huober J, Tesch H, Bauerfeind I, Hilfrich J, Mehta K, Untch M (2007) "GeparQuattro: first interim safety analysis of a phase III trial exploring the efficacy of capecitabine and trastuzumab given concomitantly or in sequence to EC-Doc as neoadjuvant treatment of primary breast cancer". ASCO 2007 (abstract 222)