Long-term efficacy and safety of Nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization

Journal of Urology

Volumn 158, Issue 1, 1997, Pages 160-163

  Dijkman, Gerhard A ^a   Janknegt, Rudi A ^a   De Reijke, Theo M ^a   Debruyne, Frans M J ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Hormones; Orchiectomy; Prostate specific antigen; Prostatic neoplasms

Indexed keywords

NILUTAMIDE; PLACEBO; PROSTATE SPECIFIC ANTIGEN;

ADULT; AGED; ARTICLE; CASTRATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG TOLERANCE; FOLLOW UP; HORMONAL REGULATION; HUMAN; MAJOR CLINICAL STUDY; MALE; ORCHIECTOMY; PRIORITY JOURNAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; TREATMENT PLANNING;

EID: 0030915668     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1097/00005392-199707000-00051     Document Type: Article

References (23)

1. Knönagel, H., Bolle, J. F., Hering, F., Senn, E., Hodel, T., Neuenschwander, H. and Biedermann, C.: Therapy of metastatic prostate carcinoma by orchiectomy plus anandron versus orchiectomy plus placebo. Initial results of a randomized multicenter study. Helv. Chir. Acta., 56: 343, 1989.
2. Brisset, J. M., Bertagna, C., Fiet, J., de Géry, A., Hucher, M., Husson, J. M., Tremblay, D. and Raynaud, J. P.: Total androgen blockade vs orchiectomy in stage D prostate cancer. In: Hormonal Manipulation of Cancer: Peptides, Growth Factors and New (Anti) Steroidal Agents. Edited by J. G. M. Klijn, R. Paridaens and J. A. Foekens. New York: Raven Press, pp. 17-30, 1987.
3. Geller, J. and Albert, J. D.: DHT in prostate cancer tissue - a guide to management and therapy. Prostate, 6: 19, 1985.
4. Labrie, F.: Endocrine therapy for prostate cancer. Endocr. Metab. Clin. N. Amer., 20: 845, 1991.
5. Beland, G., Elhilali, M., Fradet, Y., Laroche, B., Ramsey, E. W., Trachtenberg, J., Venner, P. M. and Tewari, H. D.: A controlled trial of castration with and without nilutamide in metastatic prostatic carcinoma. Cancer, 66: 1074, 1990.
6. Janknegt, R. A., Abbou, C. C., Bartoletti, R., Bernstein-Hahn, L., Bracken, B., Brisset, J. M., Calais Da Silva, F., Chisholm, G., Crawford, E. D., Debruyne, F. M. J., Dijkman, G. D., Frick, J., Goedhals, L., Knönagel, H. and Venner, P. M.: Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J. Urol., 149: 77, 1993.
7. Bertagna, C., De Gery, A., Hucher, M., François, J. P. and Zanirato, J.: Efficacy of the combination of nilutamide plus orchidectomy in patients with metastatic prostatic cancer. A meta-analysis of seven randomised double-blind trials (1056 patients). Brit. J. Urol., 73: 396, 1994.
8. Abbou, C. C., Brisset, J. M., Bracken, B., Bartoletti, R., Bernstein-Hahn, L., Calais Da Silva, F., Chisholm, G., Crawford, E., Debruyne, F. M. J., Frick, J., Goedhals, L., Janknegt, R., Knönagel, H. and Venner, P. for the International Anandron Study Group: Prostate specific antigen: prognostic value for response to treatment in stage D2 prostate cancer patients: evaluation in a large study (457 patients) with central PSA assay. Read at European Association of Urology Xth Congress, p. 351, abstract P267, Genoa, Italy, July 22-25, 1992.
9. Matzkin, H., Eber, P., v.d. Zwaag, R. and Soloway, M. S.: Prognostic value of prostatic specific markers in hormonally treated stage D2 prostatic cancer patients. Read at European Association of Urology Xth Congress, p. 351, abstract P268, Genoa, Italy, July 22-25, 1992.
10. Namer, M., Toubol, J., Caty, A., Couette, J. E., Douchez, J., Kerbrat, P. and Droz, J. P.: A randomized double-blind study evaluating Anandron associated with orchiectomy in stage D prostate cancer. J. Steroid Biochem. Mol. Biol., 37: 909, 1990.
11. Pfitzenmeyer, P., Foucher, P., Piard, F., Coudert, B., Braud, M. L., Gabez, P., Lacroix, S., Mabille, J. P. and Camus, P.: Nilutamide pneumonitis: a report on eight patients. Thorax, 47: 622, 1992.
12. Denis, L. J., Carneiro De Moura, J. L., Bono, A., Sylvester, R., Whelan, P., Newling, D. and Depauw, M.: Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology, 42: 119, 1993.
13. Keuppens, F., Denis, L., Smith, P., Carvalho, A. P., Newling, D., Bond, A., Sylvester, R., De Pauw, M., Vermeylen, K. and Ongena, P.: Zoladex and flutamide versus bilateral orchiectomy. A randomized phase II EORTC 30853 study. The EORTC GU group. Cancer, suppl., 66: 1045, 1990.
14. Crawford, E. D., Eisenberger, M. A., McLeod, D. G., Spaulding, J. T., Benson, R., Dorr, F. A., Blumenstein, B. A., Davis, M. A. and Goodman, P. J.: A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. New Engl. J. Med., 321: 419, 1989.
15. Jurincic, C. D., Horlbeck, R. and Klippel, K. F.: Combined treatment (goserelin plus flutamide) versus monotherapy (goserelin alone) in advanced prostate cancer: a randomized study. Semin. Oncol., suppl. 6, 18: 21, 1991.
16. Tyrell, C. J., Altwein, J. E., Klippel, F., Varenhorst, E., Lunglmayr, G., Boccardo, F., Holdaway, I. M., Haefliger, J.-M., Jordaan, J. P. and Sotarauta, M. for the International Prostate Cancer Study Group. A multicenter randomized trial comparing the luteinizing hormone-releasing hormone analogue goserelin acetate alone and with flutamide in the treatment of advanced prostate cancer. J. Urol., 146: 1321, 1991.
17. Brewster, S. F., Gillatt, D. A., Chadwick, D. and Gingell, J. C. on behalf of British Prostate Cancer Study Group: A randomised controlled trial of the LH-RH analogue Zoladex versus cyproterone-acetate versus a combination of the two in metastatic carcinoma of the prostate. Read at European Association of Urology Xth Congress, p. 399, abstract P312, Genoa, Italy, July 22-25, 1992.
18. Robinson, M. R.: A further analysis of European Organization for Research and Treatment of Cancer protocol 30805: orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose diethylstilbestrol. Cancer, 72: 3855, 1993.
19. Debruyne, F. M. J., Denis, L., Lunglmayer, G., Mahler, C., Newling, D. W. N., Richards, B., Robinson, M. R. G., Smith, P. H., Weil, E. H. J. and Whelan, P.: Long-term therapy with a depot luteinizing hormone-releasing hormone analogue (Zoladex) in patients with advanced prostatic carcinoma. J. Urol., 140: 775, 1988.
20. Smith, J. A., Jr., Lange, P. H., Janknegt, R. A., Abbou, C. C. and deGery, A.: Serum markers as a predictor of response duration and patient survival after hormonal therapy for metastatic carcinoma of the prostate. J. Urol., 157: 1329, 1997.
21. Harris, M. G., Coleman, S. G., Faulds, D. and Chrisp, P.: Nilutamide. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in prostate cancer. Drugs Aging, 3: 9, 1993.
22. Greenberg, R. N.: Overview of patient compliance with medication dosing: a literature review. Clin. Ther., 6: 592, 1984.
23. Alivizatos, G. and Oosterhof, G. O.: Update of hormonal treatment in cancer of the prostate. Anti-Cancer Drugs, 4: 301, 1993.