A phase I pharmacokinetic and safety analysis of epothilone folate (BMS-753493), a folate receptor targeted chemotherapeutic agent in humans with advanced solid tumors

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• 作者：P. P. Peethambaram (1)
  L. C. Hartmann (1)
  D. J. Jonker (3)
  M. de Jonge (6)
  E. R. Plummer (4)
  L. Martin (2)
  J. Konner (5)
  J. Marshall (7)
  G. D. Goss (3)
  V. Teslenko (8)
  P. L. Clemens (8)
  L. J. Cohen (8)
  C. M. Ahlers (8)
  L. Alland (8) (9)
  
  1. Mayo Clinic Cancer Center ; Rochester ; MN ; USA
  3. The Ottawa Hospital Cancer Centre ; Ottawa ; ON ; Canada
  6. Erasmus MC-Daniel den Hoek Kliniek ; Rotterdam ; The Netherlands
  4. The Northern Centre for Cancer Care ; Newcastle upon Tyne ; United Kingdom
  2. Fox Chase Cancer Center ; Philadelphia ; PA ; USA
  5. Memorial Sloan-Kettering Cancer Center ; New York ; NY ; USA
  7. Georgetown University ; Georgetown ; Washington D.C. ; USA
  8. Bristol-Myers Squibb Research and Development ; Princeton ; NJ ; USA
  9. AstraZeneca Pharmaceuticals ; 35 Gatehouse Drive ; Waltham ; MA ; 02451 ; USA
  
• 关键词：Folate conjugate ; Epothilone ; Phase I trial ; Advanced cancer
• 刊名：Investigational New Drugs
• 出版年：2015
• 出版时间：April 2015
• 年：2015
• 卷：33
• 期：2
• 页码：321-331
• 全文大小：527 KB
• 参考文献：1. Jones, MB, Neuper, C, Clayton, A, Mariani, A, Konecny, G, Thomas, MB, Keeney, G, Hartmann, L, Podratz, KC (2008) Rationale for folate receptor alpha targeted therapy in 鈥渉igh risk鈥?endometrial carcinomas. Int J Cancer 123: pp. 1699-1703 CrossRef
  2. Garin-Chesa, P, Campbell, I, Saigo, PE, Lewis, JL, Old, LJ, Rettig, WJ (1993) Trophoblast and ovarian cancer antigen LK26. Sensitivity and specificity in immunopathology and molecular identification as a folate-binding protein. Am J Pathol 142: pp. 557-567
  3. Parker, N, Turk, MJ, Westrick, E, Lewis, JD, Low, PS, Leamon, CP (2005) Folate receptor expression in carcinomas and normal tissues determined by a quantitative radioligand binding assay. Anal Biochem 338: pp. 284-293 CrossRef
  4. Ross, JF, Chaudhuri, PK, Ratnam, M (1994) Differential regulation of folate receptor isoforms in normal and malignant tissues in vivo and in established cell lines. Physiologic and clinical implications. Cancer 73: pp. 2432-2443 CrossRef
  5. Kalli, KR, Oberg, AL, Keeney, GL, Christianson, TJ, Low, PS, Knutson, KL, Hartmann, LC (2008) Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecol Oncol 108: pp. 619-626 CrossRef
  6. Weitman, SD, Lark, RH, Coney, LR, Fort, DW, Frasca, V, Zurawski, VR, Kamen, BA (1992) Distribution of the folate receptor GP38 in normal and malignant cell lines and tissues. Cancer Res 52: pp. 3396-3401
  7. Bollag, DM, McQueney, PA, Zhu, J, Hensens, O, Koupal, L, Liesch, J, Goetz, M, Lazarides, E, Woods, CM (1995) Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res 55: pp. 2325-2333
  8. Kowalski, RJ, Giannakakou, P, Hamel, E (1997) Activities of the microtubule-stabilizing agents epothilones A and B with purified tubulin and in cells resistant to paclitaxel (Taxol(R)). J Biol Chem 272: pp. 2534-2541 CrossRef
  9. Vlahov, IR, Vite, GD, Kleindl, PJ, Wang, Y, Santhapuram, HK, You, F, Howard, SJ, Kim, SH, Lee, FF, Leamon, CP (2010) Regioselective synthesis of folate receptor-targeted agents derived from epothilone analogs and folic acid. Bioorg Med Chem Lett 20: pp. 4578-4581 mcl.2010.06.016" target="_blank" title="It opens in new window">CrossRef
  10. Covello K, Flefleh C, McGlinchey C, Menard K, Wen M-L, Westhouse R, Wiebesiek A, Reddy A, Vlahov I, Hunt J, Rose W, Leamon C, Vite G, Lee FYF (2008) Preclinical pharmacology of epothilone-folate conjugate BMS-753493, a tumor-targeting agent selected for clinical development. in AACR Annual Meeting. Los Angeles
  11. BMS data on file
  12. Sawada, Y, Sugita, K, Kabashima, R, Nakamura, M, Tokura, Y (2009) Docetaxel-induced Stevens-Johnson syndrome with regenerating epidermis composed of atypical keratinocytes. J Eur Acad Dermatol Venereol 23: pp. 1333-1335 CrossRef
  13. Sparano, JA, Vrdoljak, E, Rixe, O, Xu, B, Manikhas, A, Medina, C, Costa, SC, Ro, J, Rubio, G, Rondinon, M, Perez Manga, G, Peck, R, Poulart, V, Conte, P (2010) 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 28: pp. 3256-3263 CrossRef
  14. Ixempra package insert, revised 10/2011. http://packageinserts.bms.com/pi/pi_ixempra.pdf. Accessed June 11, 2012
  15. Leamon, CP, Reddy, JA, Vlahov, IR, Kleindl, PJ, Vetzel, M, Westrick, E (2006) Synthesis and biological evaluation of EC140: a novel folate-targeted vinca alkaloid conjugate. Bioconjug Chem 17: pp. 1226-1232 CrossRef
  16. Reddy, JA, Dorton, R, Westrick, E, Dawson, A, Smith, T, Xu, LC, Vetzel, M, Kleindl, P, Vlahov, IR, Leamon, CP (2007) Preclinical evaluation of EC145, a folate-vinca alkaloid conjugate. Cancer Res 67: pp. 4434-4442 CrossRef
  17. Siegel, BA, Dehdashti, F, Mutch, DG, Podoloff, DA, Wendt, R, Sutton, GP, Burt, RW, Ellis, PR, Mathias, CJ, Green, MA, Gershenson, DM (2003) Evaluation of 111In-DTPA-folate as a receptor-targeted diagnostic agent for ovarian cancer: initial clinical results. J Nucl Med 44: pp. 700-707
  18. Lu, Y, Low, PS (2002) Folate targeting of haptens to cancer cell surfaces mediates immunotherapy of syngeneic murine tumors. Cancer Immunol Immunother 51: pp. 153-162 CrossRef
  19. Lu, Y, Sega, E, Low, PS (2005) Folate receptor-targeted immunotherapy: induction of humoral and cellular immunity against hapten-decorated cancer cells. Int J Cancer 116: pp. 710-719 CrossRef
  20. Amato, RJ, Fagbeyiro, B, Messmann, R, Low, PS (2005) Phase I trial of EC90 (keyhole-limpet hemocyanin fluorescein isothiocyanate conjugate) with GPI-0100 adjuvant followed by EC17 (Folate-Fluorescein Isothiocyanate Conjugate) in Patients (pts) with metastatic renal cell carcinoma (MRCC). ASCO Meet Abstr 23: pp. 2590
  21. Messmann, R, Amato, R, Hernandez-McClain, J, Conley, B, Rogers, H, Lu, J, Low, P, Bever, S, Morgenstern, D (2007) A phase II study of FolateImmune (EC90 with GP1-0100 adjuvant followed by EC17) with low dose cytokines interleukin-2 (IL-2) and interferon-{alpha} (IFN-{alpha}) in patients with refractory or metastatic cancer. ASCO Meet Abstr 25: pp. 13516
  22. Sausville, E, LoRusso, P, Quinn, M, Forman, K, Leamon, C, Morganstern, D, Bever, S, Messmann, R (2007) A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors. ASCO Meet Abstr 25: pp. 2577
  23. Vlahov, IR, Santhapuram, HK, Kleindl, PJ, Howard, SJ, Stanford, KM, Leamon, CP (2006) Design and regioselective synthesis of a new generation of targeted chemotherapeutics. Part 1: EC145, a folic acid conjugate of desacetylvinblastine monohydrazide. Bioorg Med Chem Lett 16: pp. 5093-5096 mcl.2006.07.030" target="_blank" title="It opens in new window">CrossRef
  24. Li, J, Sausville, EA, Klein, PJ, Morgenstern, D, Leamon, CP, Messmann, RA, LoRusso, P (2009) Clinical pharmacokinetics and exposure-toxicity relationship of a folate-Vinca alkaloid conjugate EC145 in cancer patients. J Clin Pharmacol 49: pp. 1467-1476 CrossRef
  25. Naumann, R, Symanowski, J, Ghamande, S (2010) Precedent: a randomized phase II trial comparing EC145 and pegylated lisosomal doxyrubicin (PLD) versus PLD alone, in patients with platinum-resistant ovarian cancer. J Clin Oncol 31: pp. 4400-4406 CrossRef
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  Pharmacology and Toxicology
  
• 出版者：Springer Netherlands
• ISSN：1573-0646

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