Randomized Prospective Phase III Trial of Difluoromethylornithine vs Placebo in Preventing Recurrence of Completely Resected Low Risk Superficial Bladder Cancer

Journal of Urology

Volumn 176, Issue 2, 2006, Pages 500-504

  Messing, Edward ^a   Kim, Kyung Mann ^b   Sharkey, Francis ^c   Schultz, Melissa ^b   Parnes, Howard ^e   Kim, Daniel ^f   Saltzstein, Daniel ^d   Wilding, George ^b  

^a UNIVERSITY OF ROCHESTER   (United States)

^b UNIVERSITY OF WISCONSIN MADISON   (United States)

^c UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^d Urology San Antonio Research   (United States)

^e NATIONAL CANCER INSTITUTE   (United States)

^f Medical and Clinical Research Associates   (United States)

Author keywords

bladder neoplasms; eflornithine; polyamines; primary prevention

Indexed keywords

EFLORNITHINE; PLACEBO;

ADULT; AGED; ARTICLE; BLADDER CANCER; CANCER GRADING; CANCER GROWTH; CANCER RECURRENCE; CANCER SURGERY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTOSCOPY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FATIGUE; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STRATIFICATION; SUPERFICIAL CANCER; TINNITUS; TREATMENT OUTCOME;

AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, TRANSITIONAL CELL; DOUBLE-BLIND METHOD; EFLORNITHINE; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; RISK FACTORS; URINARY BLADDER NEOPLASMS;

EID: 33745463143     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.juro.2006.03.061     Document Type: Article

References (20)

1. Oosterlinck W., Kurth K.H., Schroder F., Bultinck J., Hammond B., and Sylvester R. A prospective European Organization for Research and Treatment of Cancer Genitourinary Group randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta, T1 papillary carcinoma of the bladder. J Urol 149 (1993) 749
2. Prout G.R., Barton B.A., and Guffen P.P. Treated history of non invasive grade 1 transitional cell carcinoma. J Urol 148 (1992) 1413
3. Lamm D.L., Blumenstein B.A., Crawford E.D., Crissman J.D., Love B.A., Smith Jr. J.A., et al. Randomized intergroup comparison of bacillus Calmette-Guerin immunotherapy and Mitomycin C chemotherapy prophylaxis in superficial transitional cell carcinoma of the bladder. A Southwest Oncology Group Study. Urol Oncol 1 (1995) 119
4. Filbeck R., Pilchlmeier U., Kneuchel R., Wieland W.F., and Roessler W. Clinically relevant improvement of recurrence-free survival with 5-aminolevulinic acid induced fluorescence diagnosis in patient with superficial bladder tumors. J Urol 168: (2002) 67
5. Borhan A., Reeder J.E., O'Connell M.J., Wright K.O., Wheeless L.L., diSant'Agnese P.A., et al. Grade progression and regression in recurrent urothelial cancer. J Urol 169 (2003) 2106
6. Messing E.M., Young T.B., Hunt V.B., Gilchrist K.W., Newton M.A., Bram L.L., et al. Comparison of bladder cancer outcome in men undergoing hematuria homescreening versus those with standard clinical presentations. Urology 45 (1995) 387
7. Messing E.M., and Reznikoff C.A. Normal and malignant human urothelium. in vitro response to blockade of polyamine synthesis and interconversion. Cancer Res 48 (1988) 357
8. Homma Y., Ozono S., Numata L., Seidenfeld J., and Oyasu R. Inhibition of carcinogenesis by difluoromethylornithine in herotopically transplanted rat urinary bladders. Cancer Res 45 (1985) 648
9. Loprinzi C.L., Messing E.M., O'Fallon J.R., Poon M.A., Love R.R., Quella S.K., et al. Toxicity evaluation of difluoromethylornithine. doses for chemoprevention trials. Cancer Epidemiol Biomarkers Prev 5 (1996) 371
10. Messing E.M., Verma A., Storer B., Sansiman R., and Bram L. Ornithine decarboxylase (ODC) activity in normal and malignant urothelium - implications for prevention and treatment of bladder cancer (BC). J Urol 153: suppl (1995) 523A abstract 1177
11. Kim K., and Tsiatis A.A. Study duration for clinical trials with survival response and early stopping rule. Biometrics 46 (1990) 81
12. Kaplan F.L., and Meier P. Non-parametric estimation from incomplete estimation. J Am Stat Assoc 53 (1958) 457
13. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50 (1966) 163
14. Kruskal W.H., and Wallis W.A. Use of ranks in one criterion variance analysis. J Am Stat Assoc 47 (1952) 583
15. Gerner E.W., and Meyskens Jr. F.L. Polyamines and cancer. old molecules, new understanding. Nat Rev Cancer 4 (2004) 781
16. Messing E.M. Urothelial tumors of the urinary tract. In: Walsh P.C., Vaughan Jr. E.D., Retik A.B., and Wein A.J. (Eds). Campbell's Urology. 8th ed. (2002), W. B. Saunders, Co, Philadelphia 2732-2784
17. Hayes R.B., Friedell G.H., Zahm S.H., and Cole P. Are the known bladder cancer risk-factors associated with more advanced bladder cancer?. Cancer Causes Control 4: (1993) 157
18. Messing E.M. Clinical implications of the expression of epidermal growth factor receptors in human transitional cell carcinoma. Cancer Res 50 (1990) 2530
19. Linn J.F., Sesterhenn I., Mostofi F.K., and Schoenberg M. The molecular characteristics of bladder cancer in young patients. J Urol 159 (1998) 1493
20. Studer U.E., Jenzer S., Biedermann C., Chollet D., Kraft R., von Toggenburg H., et al. Adjuvant treatment with a vitamin A analogue (etretinate) after transurethral resection of superficial bladder tumors. Final analysis of a prospective, randomized multicenter trial in Switzerland. Eur Urol 28: (1995) 284