A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer

Breast

Volumn 19, Issue 5, 2010, Pages 333-338

  Venturini, M ^a   Bighin, C ^b   Puglisi, F ^c   Olmeo, N ^d   Aitini, E ^e   Colucci, G ^f   Garrone, O ^g   Paccagnella, A ^h   Marini, G ⁱ   Crino L ^j   Mansutti, M ^c   Baconnet, B ^l   Barbato, A ^k   Del Mastro, L ^b  

^a Sacro Cuore Don Calabria Hospital   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

^c Azienda Ospedaliera Universitaria   (Italy)

^d SS Annunziata Hospital   (Italy)

^e CARLO POMA HOSPITAL   (Italy)

^f Oncologia Medica   (Italy)

^g S CROCE E CARLE HOSPITAL   (Italy)

^h Ospedale Civile   (Italy)

ⁱ SPEDALI CIVILI   (Italy)

^j SANTA MARIA DELLA MISERICORDIA HOSPITAL   (Italy)

^k Cephalon France   (France)

^l Cephalon Italy   (Italy)

more..

Author keywords

Cardiotoxicity; Docetaxel; Metastatic breast cancer; Non pegylated liposomal doxorubicin; Phase II trial; Trastuzumab

Indexed keywords

DOCETAXEL; DOXORUBICIN; TRASTUZUMAB;

ADULT; AGED; ALLERGIC REACTION; ALOPECIA; ARTICLE; ASTHENIA; BACKACHE; BLOOD TOXICITY; BONE PAIN; BREAST CANCER; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPNEA; EDEMA; ELECTROCARDIOGRAM; FEBRILE NEUTROPENIA; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; GRANULOCYTOPENIA; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE FIBROSIS; HEART PALPITATION; HUMAN; HYPOTENSION; LOADING DRUG DOSE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; OUTCOME ASSESSMENT; PAIN; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SINUS ARRHYTHMIA; VOMITING;

EID: 77957155047     PISSN: 09609776     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.breast.2010.01.018     Document Type: Article

References (29)

1. Honing S.F. Treatment of metastatic disease, hormonal therapy and chemotherapy. Breast diseases 1996, 669-734. Lippincott, Philadelphia, PA. J.R. Harris, M.E. Lippman, M. Morrow, S. Hellman (Eds.).
2. Bergh J., Jonsson P.E., Glimelius B., Nygren P. A systematic overview of chemotherapy effects in breast cancer. Acta Oncol 2001, 40:253-281.
3. Hamilton A., Hortobagyi G. Chemotherapy: what progress in the last 5 years?. J Clin Oncol 2005, 23:1760-1775.
4. Lord S., Ghersi D., Gattellari M., Wortley S., Wilcken N., Simes J. Antitumour antibiotic-containing regimens for metastatic breast cancer. Cochrane Database Syst Rev 2004, 4. CD003367.
5. Sledge G.W., Neuberg D., Bernardo P., Ingle J.N., Martino S., Rowinsky E.K., et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003, 21:588-592.
6. Slamon D.J., Leyland-Jones B., Shak S., Fuchs H., Paton V., Bajamonde A., 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.
7. Gennari A., Salvadori B., Donati S., Bengala C., Orlandini C., Danesi R., et al. Cardiotoxicity of epirubicin/paclitaxel-containing regimens: role of cardiac risk factors. J Clin Oncol 1999, 17:3596-3602.
8. Swain S.M., Whaley F.S., Ewer M.S. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer 2003, 97:2869-2879.
9. Von Hoff D.D., Layard M.W., Basa P., Davis H.L., Von Hoff A.L., Rozencweig M., et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 1979, 91:710-717.
10. Von Hoff D.D., Rozencweig M., Layard M., Slavik M., Muggia F.M. Daunomycin-induced cardiotoxicity in children and adults. A review of 110 cases. Am J Med 1977, 62:200-208.
11. Seidman A., Hudis C., Pierri M.K., Shak S., Paton V., Ashby M., et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002, 20:1215-1221.
12. Tan-Chiu E., Yothers G., Romond E., Geyer C.E., Ewer M., Keefe D., 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. Ewer M.S., Lippman M.S. Type II chemotherapy related cardiac dysfunction: time to recognize a new entity. J Clin Oncol 2005, 13:2900-2902.
14. Dando T.M., Keating G.M. Liposomal doxorubicin: a review of its use in metastatic breast cancer and potential in non-Hodgkin lymphoma. Am J Cancer 2005, 4:193-206.
15. Batist G., Ramakrishnan G., Rao C.S., Chandrasekharan A., Gutheil J., Guthrie T., et al. Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. J Clin Oncol 2001, 19:1444-1454.
16. Harris L., Batist G., Belt R., Rovira D., Navari R., Azarnia N., et al. Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast cancer. Cancer 2002, 94:25-36.
17. Batist G., Harris L., Azarnia N., Lee L.W., Daza-Ramirez P. Improved anti-tumor response rate with decreased cardiotoxicity of non-pegylated liposomal doxorubicin compared with conventional doxorubicin in first-line treatment of metastatic breast cancer in patients who had received prior adjuvant doxorubicin: results of a retrospective analysis. Anti-Cancer Drugs 2006, 17:587-595.
18. Leonard R.C., Williams S., Tulpule A., Levine A.M., Oliveros S. Improving the therapeutic index of anthracycline chemotherapy: focus on liposomal doxorubicin (Myocet). Breast 2009, 18(4):218-224.
19. Venturini M., Bighin C., Monfardini S., Cappuzzo F., Olmeo N., Durando A., et al. Multicenter phase II study of trastuzumab in combination with epirubicin and docetaxel as first-line treatment for HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat 2006, 95:45-53.
20. Marty M., Laurence V., Cottu P., Pierga J.-Y., Barton J., Huckle H., et al. A phase I dose escalation study of non-pegylated liposomal doxorubicin (M) and docetaxel (D) in patients (pts) with previously untreated advanced breast cancer. Ann Oncol 2002, 13(Suppl. 5):55. [Abstract 196P].
21. ® and paclitaxel is active and well tolerated in patients with HER2-positive locally advanced or metastatic breast cancer: a phase II study. Breast Cancer Res Treat 2003, 82(Suppl. 1):S83. [Abstract 351].
22. Cortes J., Di Cosimo S., Climent M.A., Cortés-Funes H., Lluch A., Gascón P., et al. Nonpegylated liposomal doxorubicin (TLC-D99), paclitaxel and trastuzumab in HER-2-overexpressing breast cancer: a multicenter phase I/I study. Clin Cancer Res 2009, 15(1):307-314.
23. World Health Organization Handbook for reporting results of cancer treatment 1979, WHO, Geneva.
24. Simon R. Optimal two-stage design for phase II clinical trials. Contr Clin Trials 1989, 10:1-10.
25. Paridaens R., Biganzoli L., Bruning P., Klijn J.G., Gamucci T., Houston S., et al. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer randomized study with cross-over. J Clin Oncol 2000, 18:724-733.
26. Chan S., Friedrichs K., Noel D., Pintér T., Van Belle S., Vorobiof D., et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999, 17:2341-2354.
27. Paik S., Bryant J., Park C., Fisher b., Tan-Chiu E., Hyams D., 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.
28. Pritchard K.I., O'Malley F.A., Audrulis I., Shepherd L.E., Tu D., Levine M.N., et al. Prognostic and predictive value of HER-2/neu in a randomized trial comparing CMF to CEF in premenopausal women with auxiliary lymph node positive breast cancer (NCIC CTG MA 5). Proc Am Soc Clin Oncol 2002, 21:42a. [Abstract 165].
29. Untch M., Eidtmann H., du Bois A., Meerpohl H.G., Thomssen Ch., Ebert 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.