Bilateral orchiectomy with or without flutamide for metastatic prostate cancer

New England Journal of Medicine

Volumn 339, Issue 15, 1998, Pages 1036-1042

  Eisenberger, Mario A ^a,k   Blumenstein, Brent A ^b   Crawford, E David ^c   Miller, Gary ^c   McLeod, David G ^d   Loehrer, Patrick J ^e   Wilding, George ^f   Sears, Kathy ^b   Culkin, Daniel J ^g   Thompson Jr , Ian M ^h   Bueschen, Anton J ⁱ   Lowe, Bruce A ^j  

^a JOHNS HOPKINS HOSPITAL   (United States)

^b SW Oncology Group Statistical Center ^*  (United States)

^c UNIVERSITY OF COLORADO   (United States)

^d WALTER REED ARMY MEDICAL CENTER   (United States)

^e INDIANA UNIVERSITY MEDICAL CENTER   (United States)

^f UNIVERSITY OF WISCONSIN   (United States)

^g UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^h WILFORD HALL MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^j OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^k Southwest Oncology Group   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FLUTAMIDE;

ADENOCARCINOMA; ADULT; AGED; ANEMIA; ARTICLE; CANCER SURGERY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC APPROACH ROUTE; DIARRHEA; DISEASE CLASSIFICATION; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; METASTASIS; ORCHIECTOMY; PATIENT SELECTION; PRIORITY JOURNAL; PROSTATE CANCER; SURGICAL APPROACH; SURGICAL TECHNIQUE;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANDROGEN ANTAGONISTS; BONE NEOPLASMS; COMBINED MODALITY THERAPY; DOUBLE-BLIND METHOD; FLUTAMIDE; HUMANS; MALE; MIDDLE AGED; ORCHIECTOMY; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SOFT TISSUE NEOPLASMS; SURVIVAL ANALYSIS;

EID: 0032497522     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199810083391504     Document Type: Article

References (24)

1. Parker SL, Tong T, Bolden S, Wingo PA. Cancer statistics, 1997. CA Cancer J Clin 1997;47:5-47. [Erratum, CA Cancer J Clin 1997;47:68.]
2. Prostate Cancer Trialists' Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of 22 randomised trials with 3283 deaths in 5710 patients. Lancet 1995;346:265-9.
3. Huggins C, Hodges CV. Studies on prostatic cancer: effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res 1941;1:293-7.
4. Peeling WB. Phase III studies to compare goserelin (Zoladex) with orchiectomy and with diethylstilbestrol in treatment of prostatic carcinoma. Urology 1989;33:Suppl 5:45-52.
5. The Leuprolide Study Group. Leuprolide versus diethylstilbestrol for metastatic prostatic cancer. N Engl J Med 1984;311:1281-6.
6. Byar DP. The Veterans Administration Cooperative Urological Research Group's studies of cancer of the prostate. Cancer 1973;32:1126-30.
7. Eisenberger MA, Simon R, O'Dwyer PJ, Wittes RE, Friedman MA. A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol 1985;3:827-41.
8. Labrie F, Dupont A, Belanger A, et al. Combination therapy with flutamide and castration (LHRH agonist or orchiectomy) in advance prostate cancer: a marked improvement in response and survival. J Steroid Biochem 1985;23:833-41.
9. Labrie F, Veilleux R, Fournier A. Low androgen levels induce the development of androgen-hypersensitive cell clones in Shionogi mouse mammary carcinoma cells in culture. J Natl Cancer Inst 1988;80:1138-47.
10. Geller J, Albert J, Yen SS, Geller S, Loza D. Medical castration of males with megestrol acetate and small doses of diethylstilbestrol. J Clin Endocrinol Metab 1981;52:576-80.
11. Denis L, Murphy GP. Overview of phase III trials on combined androgen treatment in patients with metastatic prostate cancer. Cancer 1993; 72:Suppl:3888-95.
12. Crawford ED, Eisenberger MA, McLeod DG, et al. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med 1989;321:419-24. [Erratum, N Engl J Med 1989;321:1420.]
13. Denis LJ, Carnelro de Moura JL, Bono A, et al. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). Urology 1993;42:119-29.
14. Janknegt RA, Abbou CC, Bartoletti R, et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol 1993;149:77-82.
15. Caubet JF, Tosteson TD, Dong EW, et al. Maximum androgen blockade in advanced prostate cancer: a meta-analysis of published randomized controlled trials using nonsteroidal antiandrogens. Urology 1997;49:71-8.
16. Blumenstein BA. Some statistical considerations for the interpretation of trials of combined androgen therapy. Cancer 1993;72:Suppl:3834-40.
17. Idem. Overview analysis issues using combined androgen deprivation overview analysis as an example. Urol Oncol 1995;1:95-100.
18. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975;31: 103-15.
19. Rubinstein LV, Gail MH, Santner TJ. Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. J Chronic Dis 1981;34:469-79.
20. Fleming TR, Harrington DP, O'Brien PC. Designs for group sequential tests. Control Clin Trials 1984;5:348-61.
21. Eisenberger MA, O'Dwyer PJ, Friedman MA. Gonadotropin hormone-releasing hormone analogues: a new therapeutic approach for prostate carcinoma. J Clin Oncol 1986;4:414-24.
22. Kuhn J-M, Billebaud T, Navratil H, et al. Prevention of the transient adverse effects of a gonadotropin-releasing hormone analogue (buserelin) in metastatic prostatic carcinoma by administration of an antiandrogen (nilutamide). N Engl J Med 1989;321:413-8.
23. Eisenberger MA, Crawford ED, Wolf M, et al. Prognostic factors in stage D2 prostate cancer: important implications for future trials: results of a cooperative intergroup study (INT.0036): the National Cancer Institute Intergroup Study #0036. Semin Oncol 1994;21:613-9.
24. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-40.