Ixabepilone: In locally advanced or metastatic breast cancer

Drugs

Volumn 69, Issue 11, 2009, Pages 1471-1481

  Moen, Marit D ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TUBULIN; ANTHRACYCLINE DERIVATIVE; ATAZANAVIR; CAPECITABINE; CARBAMAZEPINE; CLARITHROMYCIN; CORTICOSTEROID; CYTOCHROME P450 INHIBITOR; DEXAMETHASONE; DOCETAXEL; FLUOROURACIL; HISTAMINE H1 RECEPTOR ANTAGONIST; HISTAMINE H2 RECEPTOR ANTAGONIST; ITRACONAZOLE; IXABEPILONE; KETOCONAZOLE; NEFAZODONE; PACLITAXEL; PHENOBARBITAL; PHENYTOIN; RIFABUTIN; RIFAMPICIN; TAXANE DERIVATIVE; TELITHROMYCIN; VORICONAZOLE;

ADVANCED CANCER; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; AREA UNDER THE CURVE; ARTHRALGIA; ASTHENIA; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER RESISTANCE; CANCER SURVIVAL; CELL CYCLE ARREST; CLINICAL TRIAL; COLON TUMOR; CONTROLLED CLINICAL TRIAL; COST UTILITY ANALYSIS; DIARRHEA; DOSE LIVER FUNCTION RELATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENTIATION; DRUG RESPONSE; DRUG SENSITIVITY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; HAND FOOT SYNDROME; HUMAN; IC 50; KIDNEY CANCER; LEUKOPENIA; LYMPHOMA; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; METASTASIS; MONOTHERAPY; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; MYALGIA; NEUROTOXICITY; NEUTROPENIA; NONHUMAN; OVARY CARCINOMA; PAIN; PERIPHERAL NEUROPATHY; PREMEDICATION; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; REVIEW; SENSORY NEUROPATHY; SOLID TUMOR; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA;

ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BREAST NEOPLASMS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DEOXYCYTIDINE; DRUG THERAPY, COMBINATION; EPOTHILONES; FEMALE; FLUOROURACIL; HUMANS; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

ANIMALIA;

EID: 67749102034     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/00003495-200969110-00006     Document Type: Review

References (35)

1. Beslija S, Bonneterre J, Burstein H, et al. Second consensus on medical treatment of metastatic breast cancer. Ann Oncol 2007 Feb; 18 (2): 215-25
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer V.I. 2009 [online]. Available from URL: http://www.nccn. org/professionals/physician-gls/PDF/breast.pdf [Accessed 2009 Mar 4]
3. European School of Oncology (ESO)-MBC Task Force. Metastatic breast cancer: recommendations proposal from the European School of Oncology (ESO)-MBC Task Force. Breast 2007 Feb; 16 (1): 9-10
4. Coley HM. Mechanisms and strategies to overcome chemotherapy resistance in metastatic breast cancer. Cancer Treat Rev 2008 Jun; 34 (4): 378-90
5. Vahdat L. Ixabepilone: a novel antineoplastic agent with low susceptibility to multiple tumor resistance mechanisms. Oncologist 2008 Mar; 13 (3): 214-21
6. Lee FY, Smykla R, Johnston K, et al. Preclinical efficacy spectrum and pharmacokinetics of ixabepilone. Cancer Chemother Pharmacol 2009 Jan; 63 (2): 201-12
7. Lee FY, Borzilleri R, Fairchild CR, et al. Preclinical discovery of ixabepilone, a highly active antineoplastic agent. Cancer Chemother Pharmacol 2008 Dec; 63 (1): 157-66
8. Ixempra® Kit (ixabepilone) for injection: US prescribing information. Princeton (NJ): Bristol-Myers Squibb Company, 2009 May
9. Denduluri N, Swain SM. Ixabepilone for the treatment of solid tumors: a review of clinical data. Expert Opin Investig Drugs 2008 Mar; 17 (3): 423-35
10. Pivot X, Dufresne A, Villanueva C. Efficacy and safety of ixabepilone, a novel epothilone analogue. Clin Breast Cancer 2007 Apr; 7 (7): 543-9
11. Fumoleau P, Coudert B, Isambert N, et al. Novel tubulin-targeting agents: anticancer activity and pharmacologic profile of epothilones and related analogues. Ann Oncol 2007 Jul; 18 Suppl. 5: v9-15
12. Pivot X, Villanueva C, Chaigneau L, et al. Ixabepilone, a novel epothilone analog in the treatment of breast cancer. Expert Opin Investig Drugs 2008 Apr; 17 (4): 593-9
13. Lee FY, Borzilleri R, Fairchild CR, et al. BMS-247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res 2001 May; 7 (5): 1429-37
14. McDaid HM, Mani S, Shen HJ, et al. Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a phase I clinical study. Clin Cancer Res 2002 Jul; 8 (7): 2035-43
15. Zhuang SH, Hung YE, Hung L, et al. Evidence for microtubule target engagement in tumors of patients receiving ixabepilone. Clin Cancer Res 2007 Dec 15; 13 (24): 7480-6
16. Lee FY, Camuso A, Castenada S, et al. Preclinical efficacy evaluation of ixabepilone (BMS-247550) in combination with cetuximab or capecitabine in human colon and lung carcinoma xenografts [abstract no. 12017]. J Clin Oncol 2006 Jun 20; 24 (18 Suppl. Pt 1): 597s
17. Baselga J, Zambetti M, Llombart-Cussac A, et al. Phase II genomics study of ixabepilone as neoadjuvant treatment for breast cancer. J Clin Oncol 2009 Feb 1; 27 (4): 526-34
18. Aghajanian 3rd C, Burris HA, Jones S, et al. Phase I study of the novel epothilone analog ixabepilone (BMS-247550) in patients with advanced solid tumors and lymphomas. J Clin Oncol 2007 Mar 20; 25 (9): 1082-8
19. Mani S, McDaid H, Hamilton A, et al. Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Clin Cancer Res 2004 Feb 15; 10 (4): 1289-98
20. Gadgeel SM, Wozniak A, Boinpally RR, et al. Phase I clinical trial of BMS-247550, a derivative of epothilone B, using accelerated titration 2B design. Clin Cancer Res 2005 Sep 1; 11 (17): 6233-9
21. Abraham J, Agrawal M, Bakke S, et al. Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days. J Clin Oncol 2003 May 1; 21 (9): 1866-73
22. Shimizu T, Yamamoto N, Yamada Y, et al. Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Cancer Chemother Pharmacol 2008 Apr; 61 (5): 751-8
23. Takimoto CH, Liu PY, Lenz H, et al. A phase I pharmacokinetic study of the epothilone B analogue, ixabepilone (BMS-247550) in patients with advanced malignancies and varying degrees of hepatic impairment: a SWOG Early Therapeutics Committee and NCI Organ Dysfunction Working Group Trial [abstract no. 2004]. J Clin Oncol 2006 Jun 20; 24 (18 Suppl. Pt 1): 80s
24. Goel S, Cohen M, Çömezoglu SN, et al. The effect of keto-conazole on the pharmacokinetics and pharmacodynamics of ixabepilone: a first in class epothilone B analogue in late-phase clinical development. Clin Cancer Res 2008 May 1; 14 (9): 2701-9
25. Thomas ES, Gomez HL, Li RK, et al. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 2007 Nov 20; 25 (33): 5210-7
26. Perez EA, Lerzo G, Pivot X, et al. 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 2007 Aug 10; 25 (23): 3407-14
27. Pivot XB, Lee RK, Thomas ES, et al. Phase III study of ix-abepilone plus capecitabine inpatients with metastatic breast cancer resistant to anthracyclines/taxanes: subgroup analysis by estrogen receptor status [abstract no. 221]. 2007 Breast Cancer Symposium; 2007 Sep 7-8; San Francisco (CA)
28. Rugo HS, Thomas ES, Lee RK, et al. Combination therapy with the novel epothilone B analog, ixabepilone, plus cape-citabine has efficacy in ER/PR/HER2-negative breast cancer resistant to anthracyclines and taxanes [abstract no. 6069]. Breast Cancer Res Treat 2007 Dec; 106 Suppl. 1: S270. Plus poster presented at the 30th Annual San Antonio Breast Cancer Symposium; 2007 Dec 13-16; San Antonio (TX)
29. Hortobagyi GN, Perez E, Vrdoljak E, et al. 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 [abstract no. 186]. 2008 Breast Cancer Symposium; 2008 Sep 5-8; Washington, DC
30. Roche H, Yelle L, Cognetti F, et al. 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 2007 Aug 10; 25 (23): 3415-20
31. Thomas E, Tabernero J, Fornier M, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol 2007 Aug 10; 25 (23): 3399-406
32. Denduluri N, Low JA, Lee JJ, et al. Phase II trial of ix-abepilone, an epothilone B analog, in patients with meta-static breast cancer previously untreated with taxanes. J Clin Oncol 2007 Aug 10; 25 (23): 3421-7
33. Low JA, Wedam SB, Lee JJ, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer. J Clin Oncol 2005 Apr 20; 23 (12): 2726-34
34. Denduluri N, Lee JJ, Walshe J, et al. Phase II trial of ix-abepilone, an epothilone B analog, given daily for three days every three weeks, in metastatic breast cancer. Invest New Drugs 2007 Feb; 25 (1): 63-7
35. Reed SD, Li Y, Anstrom KJ, et al. Cost effectiveness of ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 2009 May 1; 27 (13): 2185-91