Ixabepilone for the treatment of breast cancer

References

• American Cancer Society, 2007. Breast Cancer Facts & Figures 2007–2008. Atlanta, Georgia: American Cancer Society. www.cancer.org/downloads/STT/BCFF-Final.pdf (accessed in June 2009).
   Google Scholar
• Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007;57:43–66.
   PubMed Web of Science ®Google Scholar
• Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010;60:277–300.
   PubMed Web of Science ®Google Scholar
• Arriagada R, Spielmann M, Koscielny S, Le Chevalier T, Delozier T, Ducourtieux M, . Patterns of failure in a randomized trial of adjuvant chemotherapy in postmenopausal patients with early breast cancer treated with tamoxifen. Ann Oncol. 2002;13:1378–86.
   PubMed Web of Science ®Google Scholar
• Jemal A, Siegel R, Ward E, . Cancer statistics, 2008. CA Cancer J Clin. 2008;58:71–96.
   PubMed Web of Science ®Google Scholar
• Ravdin P, Cronin KA, Howlader N, Berg CD, Chlebowski R, Feuer EJ, . The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med. 2007; 356:1670–4.
   PubMed Web of Science ®Google Scholar
• Giordano SH, Buzdar AU, Smith TL, Kau SW, Yang Y, Hortobagyi GN. Is breast cancer survival improving? Cancer. 2004;100:44–52.
   PubMed Web of Science ®Google Scholar
• Fumoleau P, Delgado FM, Delozier T, Monnier A, Gil Delgado MA, Kerbrat P, . Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol. 1993;11:1245–52.
   PubMed Web of Science ®Google Scholar
• Livingston RB, Ellis GK, Gralow JR, Williams MA, White R, McGuirt C, . Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1997;15:1395–400.
   PubMed Web of Science ®Google Scholar
• Albain KS, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, . Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol. 2008;26:3950–7.
   PubMed Web of Science ®Google Scholar
• Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, . Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999;17:485–93.
   PubMed Web of Science ®Google Scholar
• Remis RS, O'Shaughnessy MV, Tsoukas C, Growe GH, Schechter MT, Palmer RW, . HIV transmission to patients with hemophilia by heat-treated, donor-screened factor concentrate. CMAJ. 1990;142:1247–54.
   PubMedGoogle Scholar
• Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, . Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23:7794–803.
   PubMed Web of Science ®Google Scholar
• Low JA, Wedam SB, Lee JJ, Berman AW, Brufsky A, Yang SX, . Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer. J Clin Oncol. 2005;23:2726–34.
   PubMed Web of Science ®Google Scholar
• Thomas E, Tabernero J, Fornier M, Conte P, Fumoleau P, Lluch A, . Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol. 2007;25: 3399–406.
   PubMed Web of Science ®Google Scholar
• Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, . 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;25:3407–14.
   PubMed Web of Science ®Google Scholar
• Roche H, Yelle L, Cognetti F, Mauriac L, Bunnell C, Sparano J, . 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;25: 3415–20.
   PubMed Web of Science ®Google Scholar
• Horwitz SB. Mechanism of action of taxol. Trends Pharmacol Sci. 1992;13:134–6.
   PubMed Web of Science ®Google Scholar
• Marcus AI, Moore RC, Cyr RJ. The role of microtubules in guard cell function. Plant Physiol. 2001;125:387–95.
   PubMed Web of Science ®Google Scholar
• Westermann S, Weber K. Post-translational modifications regulate microtubule function. Nat Rev Mol Cell Biol. 2003;4:938–47.
   PubMed Web of Science ®Google Scholar
• Lee G, Rook SL. Expression of tau protein in non-neuronal cells: microtubule binding and stabilization. J Cell Sci. 1992;102 (Pt 2):227–37.
   PubMedGoogle Scholar
• Bollag DM, McQueney PA, Zhu J, Hensens O, Koupal L, Liesch J, . Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res. 1995;55:2325–33.
   PubMed Web of Science ®Google Scholar
• Hofle G. The epothilones: an outstanding family of anti-tumor agents. General aspects. Fortschr Chem Org Naturst. 2009;90:5–28.
   PubMedGoogle Scholar
• Lee FY, Borzilleri R, Fairchild CR, Kim SH, Long BH, Reventos-Suarez C, . BMS-247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res. 2001;7:1429–37.
   PubMed Web of Science ®Google Scholar
• Goodin S, Kane MP, Rubin EH. Epothilones: mechanism of action and biologic activity. J Clin Oncol. 2004;22: 2015–25.
   PubMed Web of Science ®Google Scholar
• Cortes J, Baselga J. Targeting the microtubules in breast cancer beyond taxanes: the epothilones. Oncologist. 2007; 12:271–80.
   PubMed Web of Science ®Google Scholar
• Lee FY, Smykla R, Johnston K, Menard K, McGlinchey K, Peterson RW, . Preclinical efficacy spectrum and pharmacokinetics of ixabepilone. Cancer Chemother Pharmacol. 2009;63:201–12.
   PubMed Web of Science ®Google Scholar
• Coley HM. Mechanisms and strategies to overcome chemotherapy resistance in metastatic breast cancer. Cancer Treat Rev. 2008;34:378–90.
   PubMed Web of Science ®Google Scholar
• Nicolaou KC, Winssinger N, Pastor J, Ninkovic S, Sarabia F, He Y, . Synthesis of epothilones A and B in solid and solution phase. Nature. 1997;387:268–72.
   PubMed Web of Science ®Google Scholar
• Chou TC, O'Connor OA, Tong WP, Guan Y, Zhang ZG, Stachel SJ, . The synthesis, discovery, and development of a highly promising class of microtubule stabilization agents: curative effects of desoxyepothilones B and F against human tumor xenografts in nude mice. Proc Natl Acad Sci U S A. 2001;98:8113–8.
   PubMed Web of Science ®Google Scholar
• Kamath AV, Chang M, Lee FY, . Preclinical pharmacokinetics and oral bioavailability of bms-310705, a novel epothilone b analog. Cancer Chemother Pharmacol. 2005; 56:145–53.
   PubMed Web of Science ®Google Scholar
• Szakacs G, Paterson JK, Ludwig JA, Booth-Genthe C, Gottesman MM. Targeting multidrug resistance in cancer. Nat Rev Drug Discov. 2006;5:219–34.
   PubMed Web of Science ®Google Scholar
• Galmarini CM, Kamath K, Vanier-Viornery A, Hervieu V, Peiller E, Falette N, . Drug resistance associated with loss of p53 involves extensive alterations in microtubule composition and dynamics. Br J Cancer. 2003;88: 1793–9.
   PubMed Web of Science ®Google Scholar
• Bonnet C, Boucher D, Lazereg S, Pedrotti B, Islam K, Denoulet P, . Differential binding regulation of microtubule-associated proteins MAP1A, MAP1B, and MAP2 by tubulin polyglutamylation. J Biol Chem. 2001;276: 12839–48.
   PubMed Web of Science ®Google Scholar
• Dumontet C, Sikic BI. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol. 1999;17:1061–70.
   PubMed Web of Science ®Google Scholar
• Rouzier R, Rajan R, Wagner P, Hess KR, Gold DL, Stec J, . Microtubule-associated protein tau: a marker of paclitaxel sensitivity in breast cancer. Proc Natl Acad Sci U S A. 2005;102:8315–20.
   PubMed Web of Science ®Google Scholar
• Lee FY, Borzilleri R, Fairchild CR, Kamath A, Smykla R, Kramer R, . Preclinical discovery of ixabepilone, a highly active antineoplastic agent. Cancer Chemother Pharmacol. 2008;63:157–66.
   PubMed Web of Science ®Google Scholar
• Gerth K, Bedorf N, Hofle G, Irschik H, Reichenbach H. Epothilons A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria). Production, physico-chemical and biological properties. J Antibiot (Tokyo). 1996;49:560–3.
   PubMed Web of Science ®Google Scholar
• McDaid HM, Mani S, Shen HJ, Muggia F, Sonnichsen D, Horwitz SB. Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a phase I clinical study. Clin Cancer Res. 2002;8:2035–43.
   PubMed Web of Science ®Google Scholar
• Lee FY, Borzilleri R, Fairchild CR, . Bms-247550: A novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res. 2001;7:1429–37.
   PubMed Web of Science ®Google Scholar
• Aghajanian C, Burris HA 3rd, Jones S, Spriggs DR, Cohen MB, Peck R, . Phase I study of the novel epothilone analog ixabepilone (BMS-247550) in patients with advanced solid tumors and lymphomas. J Clin Oncol. 2007;25: 1082–8.
   PubMed Web of Science ®Google Scholar
• Ixempra Kit (ixabepilone) for injection: US prescribing information [database on the Internet]. Princeton (NJ): Bristoy-Myers Squibb Company; 2009.
   Google Scholar
• Valero V, Jones SE, Von Hoff DD, Booser DJ, Mennel RG, Ravdin PM, . A phase II study of docetaxel in patients with paclitaxel-resistant metastatic breast cancer. J Clin Oncol. 1998;16:3362–8.
   PubMed Web of Science ®Google Scholar
• Green MC, Buzdar AU, Smith T, Ibrahim NK, Valero V, Rosales MF, . Weekly paclitaxel improves pathologic complete remission in operable breast cancer when compared with paclitaxel once every 3 weeks. J Clin Oncol. 2005;23:5983–92.
   PubMed Web of Science ®Google Scholar
• Llombart Cussac A, Baselga J, Manikhas G, . Phase II genomics study in patients receiving ixabepilone as neoadjuvant treatment for breast cancer (BC): preliminary efficacy and safety data. J Clin Oncol 2005;23(Suppl):25s (Abstr 586).
   Google Scholar
• Baselga J, Zambetti M, Llombart-Cussac A, Manikhas G, Kubista E, Steger GG, . Phase II genomics study of ixabepilone as neoadjuvant treatment for breast cancer. J Clin Oncol. 2009;27:526–34.
   PubMed Web of Science ®Google Scholar
• Ayers M, Symmans WF, Stec J, Damokosh AI, Clark E, Hess K, . Gene expression profiles predict complete pathologic response to neoadjuvant paclitaxel and fluorouracil, doxorubicin, and cyclophosphamide chemotherapy in breast cancer. J Clin Oncol. 2004;22:2284–93.
   PubMed Web of Science ®Google Scholar
• Saura C, Tseng L-M, Chan S, Chacko RT, Campone M, Liu D, . Phase 2 study of ixabepilone versus paclitaxel as neoadjuvant therapy for early stage breast cancer with comparative biomarker analysis. San Antonio Breast Cancer Symposium; 11 December 2010; San Antonio, TX, USA.
   Google Scholar
• Rivera E, Lee J, Davies A. Clinical development of ixabepilone and other epothilones in patients with advanced solid tumors. Oncologist. 2008;13:1207–23.
   PubMed Web of Science ®Google Scholar
• Horak CE, Pusztai L, Mudenda B, Xing G, Trifan O, Saura C, . B-III tubulin expression by immunohistochemistry (IHC) and mRNA in a randomized phase 2 neoadjuvant breast cancer (BC) study of ixabepilone (Ixa) compared to paclitaxel (pac). San Antonio Breast Cancer Symposium; 11 December 2010; San Antonio, TX, USA.
   Google Scholar
• Hortobagyi GN, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, . Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes. Breast Cancer Res Treat. 2010;122:409–18.
   PubMed Web of Science ®Google Scholar
• Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, . Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011;125:755–65.
   PubMed Web of Science ®Google Scholar
• Fountzilas G, Dafni U, Dimopoulos MA, Koutras A, Skarlos D, Papakostas P, . A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer: a Hellenic Cooperative Oncology Group study. Breast Cancer Res Treat. 2009;115:87–99.
   PubMed Web of Science ®Google Scholar
• Abraham J, Agrawal M, Bakke S, Rutt A, Edgerly M, Balis FM, . 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;21: 1866–73.
   PubMed Web of Science ®Google Scholar
• Mani S, McDaid H, Hamilton A, Hochster H, Cohen MB, Khabelle D, . Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Clin Cancer Res. 2004;10:1289–98.
   PubMed Web of Science ®Google Scholar
• Gadgeel SM, Wozniak A, Boinpally RR, Wiegand R, Heilbrun LK, Jain V, . Phase I clinical trial of BMS-247550, a derivative of epothilone B, using accelerated titration 2B design. Clin Cancer Res. 2005;11:6233–9.
   PubMed Web of Science ®Google Scholar
• Zhuang SH, Agrawal M, Edgerly M, Bakke S, Kotz H, Thambi P, . A phase I clinical trial of ixabepilone (BMS-247550), an epothilone B analog, administered intravenously on a daily schedule for 3 days. Cancer. 2005;103:1932–8.
   PubMed Web of Science ®Google Scholar
• Shimizu T, Yamamoto N, Yamada Y, Fujisaka Y, Yamada K, Fujiwara Y, . 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; 61:751–8.
   PubMed Web of Science ®Google Scholar
• Denduluri N, Lee JJ, Walshe J, Berman AW, Vatas U, Chow CK, . Phase II trial of ixabepilone, an epothilone B analog, given daily for three days every three weeks, in metastatic breast cancer. Invest New Drugs. 2007;25:63–7.
   PubMed Web of Science ®Google Scholar
• Denduluri N, Low JA, Lee JJ, Berman AW, Walshe JM, Vatas U, . Phase II trial of ixabepilone, an epothilone B analog, in patients with metastatic breast cancer previously untreated with taxanes. J Clin Oncol. 2007;25:3421–7.
   PubMed Web of Science ®Google Scholar
• Rugo HS, Campone M, Amadori D, Wardley A, Villa E, Conte PF, . Randomized phase II study of weekly versus every-3-week ixabepilone plus bevacizumab (ixa/bev) versus paclitaxel plus bev (pac/bev) as first-line therapy for metastatic breast cancer (MBC). 2009 ASCO Annual Meeting; 2009: J Clin Onc.
   Google Scholar
• Moulder S, Hailun L, Wang M, Gradishar WJ, Perez EA, Sparano JA, . A phase II trial of trastuzumab plus weekly ixabepilone and carboplatin in patients with HER2-positive metastatic breast cancer: an Eastern Cooperative Oncology Group Trial. Breast Cancer Res Treat. 2010;119:663–71.
   PubMed Web of Science ®Google Scholar
• Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, . Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007;25:5210–7.
   PubMed Web of Science ®Google Scholar
• Sparano JA, Vrdoljak E, Rixe O, Xu B, Manikhas A, Medina C, . Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2010;28:3256–63.
   PubMed Web of Science ®Google Scholar