Safety and efficacy of the MDR inhibitor Incel (biricodar, VX-710) in combination with mitoxantrone and prednisone in hormone-refractory prostate cancer (original) (raw)

References

1. Ambudkar SV, Dey S, Hrycyna CA, Ramachandra M, Pastan I, Gottesman MM (1999) Biochemical, cellular, and pharmacological aspects of the multidrug transporter. Annu Rev Pharmacol Toxicol 39:361
   CAS PubMed Google Scholar
2. Batra S, Karlsson R, Witt L (1996) Potentiation by estramustine of the cytotoxic effect of vinblastine and doxorubicin in prostatic tumor cells. Int J Cancer 68:644
   Article CAS PubMed Google Scholar
3. Bhangal G, Halford S, Wang J, Roylance R, Shah R, Waxman J (2000) Expression of the multidrug resistance gene in human prostate cancer. Urol Oncol 5:118
   Article PubMed Google Scholar
4. Borst P, Evers R, Kool M, Wijnholds J (2000) A family of drug transporters: the multidrug resistance-associated proteins. J Natl Cancer Inst 92:1295
   CAS PubMed Google Scholar
5. Bradshaw DM, Arceci RJ (1998) Clinical relevance of transmembrane drug efflux as a mechanism of multidrug resistance. J Clin Oncol 16:3674
   CAS PubMed Google Scholar
6. Bramwell VH, Morris D, Ernst DS, Hings I, Blackstein M, Venner PM, Ette EI, Harding MW, Waxman A, Demetri GD (2002) Safety and efficacy of the multidrug-resistance inhibitor biricodar (VX-710) with concurrent doxorubicin in patients with anthracycline-resistant advanced soft tissue sarcoma. Clin Cancer Res 8:383–393
   CAS PubMed Google Scholar
7. Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, Figg WD, Freidlin B, Halabi S, Hudes G, Hussain M, Kaplan R, Myers C, Oh W, Petrylak DP, Reed E, Roth B, Sartor O, Scher H, Simons J, Sinibaldi V, Small EJ, Smith MR, Trump DL, Wilding G (1999) Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 17:3461
   CAS PubMed Google Scholar
8. Chaudhary PM, Roninson IB (1991) Expression and activity of P-glycoprotein, a multidrug efflux pump, in human hematopoietic stem cells. Cell 66:85
   CAS PubMed Google Scholar
9. Cole SP, Sparks KE, Fraser K, Loe DW, Grant CE, Wilson GM, Deeley RG (1994) Pharmacological characterization of multidrug resistant MRP-transfected human tumor cells. Cancer Res 54:5902
   CAS PubMed Google Scholar
10. Culine S, Droz JP (2000) Chemotherapy in advanced androgen-independent prostate cancer 1990–1999: a decade of progress? Ann Oncol 11:1523
    Article CAS PubMed Google Scholar
11. Drach D, Zhao S, Drach J, Mahadevia R, Gattringer C, Huber H, Andreeff M (1992) Subpopulations of normal peripheral blood and bone marrow cells express a functional multidrug resistant phenotype. Blood 80:2729
    CAS PubMed Google Scholar
12. Ehninger G, Schuler U, Proksch B, Zeller KP, Blanz J (1990) Pharmacokinetics and metabolism of mitoxantrone. A review. Clin Pharmacokinet 18:365
    CAS PubMed Google Scholar
13. Ferry DR, Traunecker H, Kerr DJ (1996) Clinical trials of P-glycoprotein reversal in solid tumours. Eur J Cancer 32A: 1070
    Article CAS PubMed Google Scholar
14. Flens MJ, Zaman GJ, van der Valk P, Izquierdo MA, Schroeijers AB, Scheffer GL, van der Groep P, de Haas M, Meijer CJ, Scheper RJ (1996) Tissue distribution of the multidrug resistance protein. Am J Pathol 148:1237
    CAS PubMed Google Scholar
15. Germann UA, Ford PJ, Shlyakhter D, Mason VS, Harding MW (1997) Chemosensitization and drug accumulation effects of VX-710, verapamil, cyclosporin A, MS-209 and GF120918 in multidrug resistant HL60/ADR cells expressing the multidrug resistance-associated protein MRP. Anticancer Drugs 8:141
    CAS PubMed Google Scholar
16. Germann UA, Shlyakhter D, Mason VS, Zelle RE, Duffy JP, Galullo V, Armistead DM, Saunders JO, Boger J, Harding MW (1997) Cellular and biochemical characterization of VX-710 as a chemosensitizer: reversal of P-glycoprotein-mediated multidrug resistance in vitro. Anticancer Drugs 8:125
    CAS PubMed Google Scholar
17. Hipfner DR, Deeley RG, Cole SP (1999) Structural, mechanistic and clinical aspects of MRP1. Biochim Biophys Acta 1461:359
    CAS PubMed Google Scholar
18. Hudes GR, Nathan F, Khater C, Haas N, Cornfield M, Giantonio B, Greenberg R, Gomella L, Litwin S, Ross E, Roethke S, McAleer C (1997) Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer. J Clin Oncol 15:3156
    CAS PubMed Google Scholar
19. Izbicka E, Dalton WS, Troyer D, Von Hoff DD (1998) Expression of two multidrug resistance genes in human prostatic carcinomas. J Natl Cancer Inst 90:166
    CAS PubMed Google Scholar
20. Kantoff PW, Halabi S, Conaway M, Picus J, Kirshner J, Hars V, Trump D, Winer EP, Vogelzang NJ (1999) Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B 9182 study. J Clin Oncol 17:2506
    CAS PubMed Google Scholar
21. Kawai K, Sakurai M, Sakai T, Misaki M, Kusano I, Shiraishi T, Yatani R (2000) Demonstration of MDR1 P-glycoprotein isoform expression in benign and malignant human prostate cells by isoform-specific monoclonal antibodies. Cancer Lett 150:147
    Article CAS PubMed Google Scholar
22. Kelly WK, Curley T, Slovin S, Heller G, McCaffrey J, Bajorin D, Ciolino A, Regan K, Schwartz M, Kantoff P, George D, Oh W, Smith M, Kaufman D, Small EJ, Schwartz L, Larson S, Tong W, Scher H (2001) Paclitaxel, estramustine phosphate, and carboplatin in patients with advanced prostate cancer. J Clin Oncol 19:44
    CAS PubMed Google Scholar
23. Lum BL, Gosland MP (1995) MDR expression in normal tissues. Pharmacologic implications for the clinical use of P-glycoprotein inhibitors. Hematol Oncol Clin North Am 9:319
    CAS PubMed Google Scholar
24. Oh WK (2000) Chemotherapy for patients with advanced prostate carcinoma: a new option for therapy. Cancer 88:3015
    Article CAS PubMed Google Scholar
25. Oh WK, Kantoff PW (1998) Management of hormone refractory prostate cancer: current standards and future prospects. J Urol 160:1220
    CAS PubMed Google Scholar
26. Oh WK, Kantoff PW (1999) Treatment of locally advanced prostate cancer: is chemotherapy the next step? J Clin Oncol 17:3664
    CAS PubMed Google Scholar
27. Peck RA, Hewett J, Harding MW, Wang YM, Chaturvedi PR, Bhatnagar A, Ziessman H, Atkins F, Hawkins MJ (2001) Phase I and pharmacokinetic study of the novel MDR1 and MRP1 inhibitor biricodar administered alone and in combination with doxorubicin. J Clin Oncol 19:3130
    CAS PubMed Google Scholar
28. Petrylak DP, Macarthur RB, O'Connor J, Shelton G, Judge T, Balog J, Pfaff C, Bagiella E, Heitjan D, Fine R, Zuech N, Sawczuk I, Benson M, Olsson CA (1999) Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. J Clin Oncol 17:958
    CAS PubMed Google Scholar
29. Rowinsky EK, Smith L, Wang YM, Chaturvedi P, Villalona M, Campbell E, Aylesworth C, Eckhardt SG, Hammond L, Kraynak M, Drengler R, Stephenson J Jr, Harding MW, Von Hoff DD (1998) Phase I and pharmacokinetic study of paclitaxel in combination with biricodar, a novel agent that reverses multidrug resistance conferred by overexpression of both MDR1 and MRP. J Clin Oncol 16:2964
    CAS PubMed Google Scholar
30. Schummer B, Siegsmund M, Steidler A, Toktomambetova L, Kohrmann KU, Alken P (1999) Expression of the gene for the multidrug resistance-associated protein in human prostate tissue. Urol Res 27:164
    Article CAS PubMed Google Scholar
31. Siegsmund MJ, Cardarelli C, Aksentijevich I, Sugimoto Y, Pastan I, Gottesman MM (1994) Ketoconazole effectively reverses multidrug resistance in highly resistant KB cells. J Urol 151:485
    CAS PubMed Google Scholar
32. Siegsmund MJ, Kreukler C, Steidler A, Nebe T, Kohrmann KU, Alken P (1997) Multidrug resistance in androgen-independent growing rat prostate carcinoma cells is mediated by P-glycoprotein. Urol Res 25:35
    CAS PubMed Google Scholar
33. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1
    CAS PubMed Google Scholar
34. Smith DC, Esper P, Strawderman M, Redman B, Pienta KJ (1999) Phase II trial of oral estramustine, oral etoposide, and intravenous paclitaxel in hormone-refractory prostate cancer. J Clin Oncol 17:1664
    CAS PubMed Google Scholar
35. Sonneveld P (2000) Multidrug resistance in haematological malignancies. J Intern Med 247:521
    Article CAS PubMed Google Scholar
36. Speicher LA, Barone LR, Chapman AE, Hudes GR, Laing N, Smith CD, Tew KD (1994) P-glycoprotein binding and modulation of the multidrug-resistant phenotype by estramustine. J Natl Cancer Inst 86:688
    CAS PubMed Google Scholar
37. Sullivan GF, Amenta PS, Villanueva JD, Alvarez CJ, Yang JM, Hait WN (1998) The expression of drug resistance gene products during the progression of human prostate cancer. Clin Cancer Res 4:1393
    CAS PubMed Google Scholar
38. Tannock IF, Osoba D, Stockler MR, Ernst DS, Neville AJ, Moore MJ, Armitage GR, Wilson JJ, Venner PM, Coppin CM, Murphy KC (1996) Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 14:1756
    Google Scholar
39. Toppmeyer D, Seidman AD, Pollak M, Russell C, Tkaczuk K, Verma S, Overmoyer B, Garg V, Ette E, Harding MW, Demetri GD (2002) Safety and efficacy of the multidrug resistance inhibitor Incel (biricodar; VX-710) in combination with paclitaxel for advanced breast cancer refractory to paclitaxel. Clin Cancer Res 8:670–678
    CAS PubMed Google Scholar
40. Van Brussel JP, Van Steenbrugge GJ, Van Krimpen C, Bogdanowicz JF, Van Der Kwast TH, Schroder FH, Mickisch GH (2001) Expression of multidrug resistance related proteins and proliferative activity is increased in advanced clinical prostate cancer. J Urol 165:130
    PubMed Google Scholar
41. Wiseman LR, Spencer CM (1997) Mitoxantrone. A review of its pharmacology and clinical efficacy in the management of hormone-resistant advanced prostate cancer. Drugs Aging 10:473
    CAS PubMed Google Scholar
42. Yanagisawa T, Newman A, Coley H, Renshaw J, Pinkerton CR, Pritchard-Jones K (1999) BIRICODAR (VX-710; Incel): an effective chemosensitizer in neuroblastoma. Br J Cancer 80:1190
    Article CAS PubMed Google Scholar
43. Yang CP, Shen HJ, Horwitz SB (1994) Modulation of the function of P-glycoprotein by estramustine. J Natl Cancer Inst 86:723
    CAS PubMed Google Scholar

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