Apaziquone as an intravesical therapeutic agent for urothelial non-muscle-invasive bladder cancer

Expert Opinion on Investigational Drugs

Volumn 21, Issue 2, 2012, Pages 251-260

  Yutkin, Vladimir ^a   Chin, Joseph ^a  

^a WESTERN UNIVERSITY   (Canada)

Author keywords

Apaziquone; Bladder cancer; EO9; Intravesical chemotherapy

Indexed keywords

APAZIQUONE; BCG VACCINE; EPIRUBICIN; GEMCITABINE; MITOMYCIN C; PLACEBO; REDUCED NICOTINAMIDE ADENINE DINUCLEOTIDE (PHOSPHATE) DEHYDROGENASE (QUINONE); VALRUBICIN;

ANTINEOPLASTIC ACTIVITY; ARTICLE; BLADDER CANCER; BLADDER CARCINOMA; BLADDER DISCOMFORT; BLADDER TUMOR; CANCER CHEMOTHERAPY; CANCER RECURRENCE; CANCER SURVIVAL; DISEASE FREE SURVIVAL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INSTILLATION; DRUG PENETRATION; DRUG SENSITIVITY; DRUG WITHDRAWAL; ENZYME ACTIVITY; GLOMERULOPATHY; HUMAN; KIDNEY FAILURE; MULTICENTER STUDY (TOPIC); NON MUSCLE INVASIVE BLADDER CANCER; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROTEINURIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT CANCER; SYSTEMIC THERAPY; TRANSURETHRAL RESECTION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; UROGENITAL TRACT TUMOR;

ADMINISTRATION, INTRAVESICAL; ANIMALS; ANTINEOPLASTIC AGENTS; AZIRIDINES; CARCINOMA; HUMANS; INDOLEQUINONES; URINARY BLADDER NEOPLASMS;

EID: 84855812510     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2012.646081     Document Type: Article

References (52)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300
2. Herr HW. Uncertainty, stage and outcome of invasive bladder cancer. J Urol 1994;152:401-2 (Pubitemid 24221229)
3. Wolff EM, Chihara Y, Pan F, et al. Unique DNA methylation patterns distinguish noninvasive and invasive urothelial cancers and establish an epigenetic field defect in premalignant tissue. Cancer Res 2010;70:8169-78
4. Soloway MS, Masters S. Urothelial susceptibility to tumor cell implantation: influence of cauterization. Cancer 1980;46:1158-63 (Pubitemid 10043484)
5. Bulbul MA, Chin JL, Huben RP, et al. The effect of nitrofurantoin on bladder tumor cell lines: in vitro growth and implantation in the cauterized mouse bladder. J Urol 1985;134:1231-5 (Pubitemid 16207043)
6. Lamm DL, Blumenstein BA, Crissman JD, et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. J Urol 2000;163:1124-9 (Pubitemid 30169376)
7. Shang PF, Kwong J, Wang ZP, et al. Intravesical Bacillus Calmette-Guerin versus epirubicin for Ta and T1 bladder cancer. Cochrane Database Syst Rev 2011;5-CD006885
8. Shelley MD, Wilt TJ, Court J, et al. Intravesical bacillus Calmette-Guerin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials. BJU Int 2004;93:485-90
9. Nepple KG, Lightfoot AJ, Rosevear HM, et al. Bacillus Calmette-Guerin with or without interferon alpha-2b and megadose versus recommended daily allowance vitamins during induction and maintenance intravesical treatment of nonmuscle invasive bladder cancer. J Urol 2010;184:1915-19
10. Riemensberger J, Bohle A, Brandau S. IFN-gamma and IL-12 but not IL-10 are required for local tumour surveillance in a syngeneic model of orthotopic bladder cancer. Clin Exp Immunol 2002;127:20-6 (Pubitemid 34155453)
11. Saint F, Patard JJ, Maille P, et al. Prognostic value of a T helper 1 urinary cytokine response after intravesical bacillus Calmette-Guerin treatment for superficial bladder cancer. J Urol 2002;167:364-7 (Pubitemid 34024586)
12. Au JL, Badalament RA, Wientjes MG, et al. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst 2001;93:597-604 (Pubitemid 32409627)
13. Cheng CW, Chan PS, Chan LW, et al. 17-year follow-up of a randomized prospective controlled trial of adjuvant intravesical doxorubicin in the treatment of superficial bladder cancer. Int Braz J Urol 2005;31:204-11
14. Porena M, Del Zingaro M, Lazzeri M, et al. Bacillus Calmette-Guerin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int 2010;84:23-7
15. Colombo R, Salonia A, Leib Z, et al. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). BJU Int 2011;107:912-18
16. Colombo R, Lev A, Da Pozzo LF, et al. A new approach using local combined microwave hyperthermia and chemotherapy in superficial transitional bladder carcinoma treatment. J Urol 1995;153:959-63
17. Di Stasi SM, Giannantoni A, Giurioli A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Lancet Oncol 2006;7:43-51 (Pubitemid 43025392)
18. Oosterlinck W, Kirkali Z, Sylvester R, et al. Sequential intravesical chemoimmunotherapy with mitomycin C and bacillus Calmette-Guerin and with bacillus Calmette-Guerin alone in patients with carcinoma in situ of the urinary bladder: results of an EORTC genito-urinary group randomized phase 2 trial (30993). Eur Urol 2011;59:438-46
19. GuhaSarkar S, Banerjee R. Intravesical drug delivery: challenges, current status, opportunities and novel strategies. J Control Release 2010;148:147-59
20. Leakakos T, Ji C, Lawson G, et al. Intravesical administration of doxorubicin to swine bladder using magnetically targeted carriers. Cancer Chemother Pharmacol 2003;51:445-50 (Pubitemid 36791668)
21. Chuang YC, Tyagi P, Huang CC, et al. Urodynamic and immunohistochemical evaluation of intravesical botulinum toxin A delivery using liposomes. J Urol 2009;182:786-92
22. Matsumoto K, Kikuchi E, Horinaga M, et al. Intravesical interleukin-15 gene therapy in an orthotopic bladder cancer model. Hum Gene Ther 2011;22:1423-32
23. Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a meta-analysis of published results of randomized clinical trials. J Urol 2004;171:2186-90; quiz 435 (Pubitemid 38625431)
24. Di Stasi SM, Valenti M, Verri C, et al. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial. Lancet Oncol 2011;12:871-9
25. Hall MC, Chang SS, Dalbagni G, et al. Guideline for the management of nonmuscle invasive bladder cancer (stages Ta, T1, and Tis): 2007 update. J Urol 2007;178:2314-30 (Pubitemid 350080987)
26. Babjuk M, Oosterlinck W, Sylvester R, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2011 update. Eur Urol 2011;59:997-1008
27. Newling DW, Hetherington J, Sundaram SK, et al. The use of valrubicin for the chemoresection of superficial bladder cancer-a marker lesion study. Eur Urol 2001;39:643-7 (Pubitemid 32679632)
28. Pries AR, Cornelissen AJ, Sloot AA, et al. Structural adaptation and heterogeneity of normal and tumor microvascular networks. PLoS Comput Biol 2009;5:e1000394
29. Roudier E, Perrin A. Considering the role of pyruvate in tumor cells during hypoxia. Biochim Biophys Acta 2009;1796:55-62
30. Rauth AM, Melo T, Misra V. Bioreductive therapies: an overview of drugs and their mechanisms of action. Int J Radiat Oncol Biol Phys 1998;42:755-62 (Pubitemid 28559412)
31. Roed H, Aabo K, Vindelov L, et al. In vitro and in vivo evaluation of the indoloquinone EO-9 (NSC 382 459) against human small cell carcinoma of the lung. Eur J Cancer Clin Oncol 1989;25:1197-201 (Pubitemid 19209615)
32. Hendriks HR, Pizao PE, Berger DP, et al. EO9: a novel bioreductive alkylating indoloquinone with preferential solid tumour activity and lack of bone marrow toxicity in preclinical models. Eur J Cancer 1993;29A:897-906 (Pubitemid 23083626)
33. Bailey SM, Lewis AD, Knox RJ, et al. Reduction of the indoloquinone anticancer drug EO9 by purified DT-diaphorase: a detailed kinetic study and analysis of metabolites. Biochem Pharmacol 1998;56:613-21 (Pubitemid 28458900)
34. Fitzsimmons SA, Workman P, Grever M, et al. Reductase enzyme expression across the National Cancer Institute Tumor cell line panel: correlation with sensitivity to mitomycin C and EO9. J Natl Cancer Inst 1996;88:259-69
35. Plumb JA, Gerritsen M, Workman P. DT-diaphorase protects cells from the hypoxic cytotoxicity of indoloquinone EO9. Br J Cancer 1994;70:1136-43 (Pubitemid 24358951)
36. Collard J, Matthew AM, Double JA, Bibby MC. EO9: relationship between DT-diaphorase levels and response in vitro and in vivo. Br J Cancer 1995;71:1199-203
37. Cummings J, Spanswick VJ, Gardiner J, et al. Pharmacological and biochemical determinants of the antitumour activity of the indoloquinone EO9. Biochem Pharmacol 1998;55:253-60 (Pubitemid 28021736)
38. Workman P, Binger M, Kooistra KL. Pharmacokinetics, distribution, and metabolism of the novel bioreductive alkylating indoloquinone EO9 in rodents. Int J Radiat Oncol Biol Phys 1992;22:713-16
39. Schellens JH, Planting AS, van Acker BA, et al. Phase I and pharmacologic study of the novel indoloquinone bioreductive alkylating cytotoxic drug E09. J Natl Cancer Inst 1994;86:906-12 (Pubitemid 24177304)
40. Pavlidis N, Hanauske AR, Gamucci T, et al. A randomized phase II study with two schedules of the novel indoloquinone EO9 in non-small-cell lung cancer: a study of the EORTC Early Clinical Studies Group (ECSG). Ann Oncol 1996;7:529-31 (Pubitemid 26232962)
41. Dirix LY, Tonnesen F, Cassidy J, et al. EO9 phase II study in advanced breast, gastric, pancreatic and colorectal carcinoma by the EORTC Early Clinical Studies Group. Eur J Cancer 1996;32A:2019-22 (Pubitemid 26361700)
42. Phillips RM, Loadman PM, Cronin BP. Evaluation of a novel in vitro assay for assessing drug penetration into avascular regions of tumours. Br J Cancer 1998;77:2112-19 (Pubitemid 28263930)
43. Choudry GA, Stewart PA, Double JA, et al. A novel strategy for NQO1 (NAD (P)H:quinone oxidoreductase, EC 1.6.99.2) mediated therapy of bladder cancer based on the pharmacological properties of EO9. Br J Cancer 2001;85:1137-46 (Pubitemid 33052312)
44. van der Heijden AG, Verhaegh G, Jansen CF, et al. Effect of hyperthermia on the cytotoxicity of 4 chemotherapeutic agents currently used for the treatment of transitional cell carcinoma of the bladder: an in vitro study. J Urol 2005;173:1375-80 (Pubitemid 40380578)
45. Vainchtein LD, Rosing H, Mirejovsky D, et al. Stability experiments in human urine with EO9 (apaziquone): a novel anticancer agent for the intravesical treatment of bladder cancer. J Pharm Biomed Anal 2007;43:285-92 (Pubitemid 44856213)
46. Puri R, Palit V, Loadman PM, et al. Phase I/II pilot study of intravesical apaziquone (EO9) for superficial bladder cancer. J Urol 2006;176:1344-8 (Pubitemid 44307228)
47. van der Heijden AG, Moonen PM, Cornel EB, et al. Phase II marker lesion study with intravesical instillation of apaziquone for superficial bladder cancer: toxicity and marker response. J Urol 2006;176:1349-53; discussion 53 (Pubitemid 44307194)
48. Jain A, Phillips RM, Scally AJ, et al. Response of multiple recurrent TaT1 bladder cancer to intravesical apaziquone (EO9): comparative analysis of tumor recurrence rates. Urology 2009;73:1083-6
49. Hendricksen K, van der Heijden AG, Cornel EB, et al. Two-year follow-up of the phase II marker lesion study of intravesical apaziquone for patients with non-muscle invasive bladder cancer. World J Urol 2009;27:337-42
50. Chin JL, Kadhim SA, Batislam E, et al. Mycobacterium cell wall: an alternative to intravesical bacillus Calmette Guerin (BCG) therapy in orthotopic murine bladder cancer. J Urol 1996;156:1189-93 (Pubitemid 26269854)
51. Morales A, Phadke K, Steinhoff G. Intravesical mycobacterial cell wall-DNA complex in the treatment of carcinoma in situ of the bladder after standard intravesical therapy has failed. J Urol 2009;181:1040-5
52. (Ed.) (Eds) (U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894)