A phase i study of ixabepilone in combination with epirubicin in patients with metastatic breast cancer

Clinical Breast Cancer

Volumn 12, Issue 3, 2012, Pages 167-174

  Roché, Henri ^a   De Benedictis, Elena ^b   Cottura, Ewa ^a   Govi, Silvia ^c   Dalenc, Florence ^a   Locatelli, Alberta ^c   Deslandres, Marion ^d   Zambetti, Milvia ^c   Gladieff, Laurence ^a   Messina, Marianne ^e   Gianni, Luca ^c  

^a INSTITUT CLAUDIUS REGAUD   (France)

^b NATIONAL CANCER INSTITUTE   (Italy)

^c SAN RAFFAELE HOSPITAL   (Italy)

^d TOULOUSE UNIVERSITY HOSPITAL   (France)

^e BRISTOL MYERS SQUIBB   (United States)

Author keywords

Anthracycline; Epirubicin; Ixabepilone; Metastatic breast cancer; Taxane

Indexed keywords

EPIRUBICIN; IXABEPILONE;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; AREFLEXIA; ARTHRALGIA; ARTICLE; ASTHENIA; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER CYTODIAGNOSIS; CANCER DIAGNOSIS; CANCER INVASION; CANCER PATIENT; CLINICAL ARTICLE; CONSTIPATION; CYTOLOGY; DIARRHEA; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG TOLERABILITY; DRUG TOLERANCE; DRUG WITHDRAWAL; DYSESTHESIA; FATIGUE; FEMALE; FEVER; GASTRITIS; HEADACHE; HISTOLOGY; HISTOPATHOLOGY; HUMAN; HYPOREFLEXIA; LEUKOPENIA; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL DISEASE; NAUSEA; NEUTROPENIA; PARESTHESIA; PHASE 1 CLINICAL TRIAL; RECOMMENDED DRUG DOSE; RECURRENT CANCER; SIDE EFFECT; STOMATITIS; VOMITING; WEIGHT REDUCTION;

EID: 84861150414     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2012.03.009     Document Type: Article

References (24)

1. B. Sherrill, M. Amonkar, Y. Wu Relationship between effects on time-to-disease progression and overall survival in studies of metastatic breast cancer Br J Cancer 99 2008 1572 1578
2. C.J. Bode, M.L. Gupta Jr, E.A. Reiff Epothilone and paclitaxel: unexpected differences in promoting the assembly and stabilization of yeast microtubules Biochemistry 41 2002 3870 3874
3. E. Rivera, J. Lee, A. Davies Clinical development of ixabepilone and other epothilones in patients with advanced solid tumors Oncologist 13 2008 1207 1223
4. F.Y.F. Lee, R. Borzilleri, C.R. Fairchild Preclinical discovery of ixabepilone, a highly active antineoplastic agent Cancer Chemother Pharmacol 63 2008 157 166
5. J.A. Low, S.B. Wedam, J.J. Lee Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer J Clin Oncol 23 2005 2726 2734
6. N. Denduluri, J.A. Low, J.J. Lee Phase II trial of ixabepilone, an epothilone B analog, in patients with metastatic breast cancer previously untreated with taxanes J Clin Oncol 25 2007 3421 3427
7. H. Roché, L. Yelle, F. Cognetti Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy J Clin Oncol 25 2007 3415 3420
8. E.A. Perez, G. Lerzo, X. Pivot Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine J Clin Oncol 25 2007 3407 3414
9. E. Thomas, J. Tabernero, M. Fornier Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer J Clin Oncol 25 2007 3399 3406
10. E.S. Thomas, H.L. Gomez, R.K. Li Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment J Clin Oncol 25 2007 5210 5217
11. G.N. Hortobagyi, E. Perez, E. Vrdoljak Analysis of overall survival (OS) among patients (pts) with metastatic breast cancer (MBC) receiving either ixabepilone (I) plus capecitabine (C) or C alone: results from two randomized phase III trials Breast Cancer Symposium Proc 178 abstract 186 2008
12. R.J. Lechleider, E. Kaminskas, X. Jiang Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapies Clin Cancer Res 14 2008 4378 4384
13. K.K. Jain, E.S. Casper, N.L. Geller A prospective randomized comparison of epirubicin and doxorubicin in patients with advanced breast cancer J Clin Oncol 3 1985 818 826
14. D.J. Perez, V.J. Harvey, B.A. Robinson A randomized comparison of single-agent doxorubicin and epirubicin as first-line cytotoxic therapy in advanced breast cancer J Clin Oncol 9 1991 2148 2152
15. P.A. Lawton, M.F. Spittle, M.J. Ostrowski A comparison of doxorubicin, epirubicin, and mitoxantrone as single agents in advanced breast carcinoma Clin Oncol (R Coll Radiol) 5 1993 80 84
16. E.D. Razis, G. Fountzilas Paclitaxel: epirubicin in metastatic breast cancer-a review Ann Oncol 12 2001 593 598
17. M. Trudeau, O. Pagani Epirubicin in combination with the taxanes Semin Oncol 28 Suppl 12 2001 41 50
18. C. Sessa, O. Pagani Docetaxel and epirubicin in advanced breast cancer Oncologist 6 Suppl 3 2001 13 16
19. A.A. Argyriou, M. Koltzenburga, P. Polychronopoulos Peripheral nerve damage associated with administration of taxanes in patients with cancer Crit Rev Oncol Hematol 66 2008 218 228
20. M. Esposito, M. Venturini, M.O. Vannozzi Comparative effects of paclitaxel and docetaxel on the metabolism and pharmacokinetics of epirubicin in breast cancer patients J Clin Oncol 17 1999 1132
21. M. Venturini, G. Lunardi, L. Del Mastro Sequence effect of epirubicin and paclitaxel treatment on pharmacokinetics and toxicity J Clin Oncol 18 2000 2116 2125
22. G. Grasselli, L. Viganò, G. Capri Clinical and pharmacologic study of the epirubicin and paclitaxel combination in women with metastatic breast cancer J Clin Oncol 19 2001 2222 2231
23. G. Lunardi, M. Venturini, M.O. Vannozzi Influence of alternate sequences of epirubicin and docetaxel on the pharmacokinetic behaviour of both drugs in advanced breast cancer Ann Oncol 13 2002 280 285
24. R. Danesi, F. Innocenti, S. Fogli Pharmacokinetics and pharmacodynamics of combination chemotherapy with paclitaxel and epirubicin in breast cancer patients Br J Clin Pharmacol 53 2002 508 518