Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: A phase III trial (CALGB 9583)

Journal of Clinical Oncology

Volumn 22, Issue 6, 2004, Pages 1025-1033

  Small, Eric J ^a   Halabi, Susan ^a   Dawson, Nancy A ^a   Stadler, Walter M ^a   Rini, Brian I ^a   Picus, Joel ^a   Gable, Preston ^a   Torti, Frank M ^a   Kaplan, Ellen ^a   Vogelzang, Nicholas J ^a  

^a WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANDROGEN; ANTIANDROGEN; HYDROCORTISONE; KETOCONAZOLE; PROSTATE SPECIFIC ANTIGEN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS;

ARTICLE; CANCER GROWTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG WITHDRAWAL; HUMAN; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; PROSTATE CANCER; ADENOCARCINOMA; AGED; BLOOD; DISEASE FREE SURVIVAL; MALE; METASTASIS; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROSPECTIVE STUDY; PROSTATE TUMOR; RANDOMIZED CONTROLLED TRIAL; SURVIVAL;

ADENOCARCINOMA; AGED; ANDROGEN ANTAGONISTS; ANTINEOPLASTIC AGENTS, HORMONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE-FREE SURVIVAL; HUMANS; HYDROCORTISONE; KETOCONAZOLE; MALE; PROSPECTIVE STUDIES; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SURVIVAL ANALYSIS;

EID: 1842457650     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2004.06.037     Document Type: Article

References (32)

1. Jemal A, Murray T, Samuels A, et al: Cancer statistics 2003. CA Cancer J Clin 53:5-26, 2003
2. Huggins C, Hodges C: Studies on prostate cancer, 1: The effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res 1:293-297, 1941
3. Messing EM, Manola J, Saorsdy M, et al: Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. N Engl J Med 341:1781-1788, 1999
4. Prostate Cancer Trialists Collabortive Group. Maximum androgen blockade in advanced prostate cancer: An overview of the randomised trials. Lancet 355:1491-1498, 2000
5. Fowler JE Jr, Pandley P, Seaver LE, et al: Prostate specific antigen after gonadal androgen withdrawal and deferred flutamide treatment. J Urol 154:448-453, 1995
6. Scher HI, Kelly WK: Flutamide withdrawal syndrome: Its impact on clinical trials in hormone refractory prostate cancer. J Clin Oncol 11:1566-1572, 1993
7. Small EJ, Srinivas S: The antiandrogen withdrawal syndrome: Experience in a large cohort of unselected patients with advanced prostate cancer. Cancer 76:1428-1434, 1995
8. Figg W, Sartor O, Cooper ME, et al: Prostate specific antigen decline following the discontinuation of flutamide in patients with stage D2 prostate cancer. Am J Med 98:412-414, 1995
9. Taplin ME, Bubley GJ, Shuster TD, et al: Mutation of androgen receptor gene in meta-static androgen-independent prostate cancer. N Engl J Med 332:1393-1398, 1995
10. Sartor O, Cooper M, Weinberger M, et al: Surprising activity of flutamide withdrawal, when combined with aminoglutethimide, in treatment of hormone refractory prostate cancer. J Natl Cancer Inst 86:222-227, 1994
11. Trachtenberg J, Halpern N, Pont A: Ketoconazole: A novel and rapid treatment for advanced prostatic cancer. J Urol 130:152-153, 1983
12. Williams G, Kerle DJ, Ware H, et al: Objective responses to ketoconazole therapy in patients with relapsed progressive prostatic cancer. Br J Urol 58:45-51, 1986
13. Gerber GS, Chodak GW: Prostate specific antigen for assessing response to ketoconazole and prednisone in patients with hormone refractory metastatic prostate cancer. J Urol 144:1177-1179, 1990
14. Trump DL, Havlin KH, Messing EM, et al: High-dose ketoconazole in advanced hormone refractory prostate cancer: Endocrinologic and clinical effects. J Clin Oncol 7:1093-1098, 1989
15. Small EJ, Baron A, Pippin L, et al: Ketoconazole retains activity in hormone refractory prostate cancer. J Urol 157:1204-1207, 1997
16. Pocock SJ: Allocation of patients in clinical trials. Biometrics 35:183-197, 1979
17. Bubley GJ, Carducci M, Dahut W, et al: Eligibility and response guidelines for phase II clinical trials in androgen independent prostate cancer: Recommendations from the PSA Working Group. J Clin Oncol 17:3461-3467, 1999
18. Lan KK, DeMets DL: Discrete sequential boundaries for clinical trials. Biometrika 70:659-663, 1983
19. Cox DR: Regression models and life tables. J R Stat Soc 74:187-220, 1974
20. Kaplan E, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
21. Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response. J Clin Oncol 1:710-719, 1983
22. Taplin ME, Rajeshkumar B, Halabi S, et al: Androgen receptor mutations in androgen-independent prostate cancer: CALGB 9663. J Clin Oncol 21:2673-2678, 2003
23. Small EJ, Marshall ME, Reyno LM, et al: Suramin therapy for patients with symptomatic hormone refractory prostate cancer: Results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone. J Clin Oncol 18:1440-1450, 2000
24. Small EJ, Baron A, Bok R: Simultaneous antiandrogen withdrawal and treatment with ketoconazole and hydrocortisone in patients with advanced prostate carcinoma. Cancer 80:1755-1759, 1997
25. Muscato JJ, Ahmann TA, Johnson KM: Optimal dosing of ketoconazole and hydrocortisone leads to long responses in hormone refractory prostate cancer. Proc Am Soc Clin Oncol 13:229, 1994 (abstr 701)
26. Small EJ, McMillan A, Meyer M, et al: Serum PSA decline as a marker of clinical outcome in hormone refractory prostate cancer patients: Association with progression-free survival, pain endpoints and survival. J Clin Oncol 19:1304-1310, 2001
27. Kelly WK, Scher HI, Mazumdar M: Prostate specific antigen as a measure of disease outcome in metastatic hormone refractory prostate cancer. J Clin Oncol 11:607-615, 1993
28. Smith DC, Dunn RL, Strawderman MS, et al: Change in serum prostate specific antigen as a marker of response to cytotoxic therapy for hormone refractory prostate cancer. J Clin Oncol 16:1835-1843, 1998
29. Scher HJ, Kelly WK, Zhang ZF, et al: Post-therapy serum prostate specific antigen level and survival in patients with androgen-independent prostate cancer. J Natl Cancer Inst 91:244-251, 1999
30. Dawson NA, Conaway MR, Halabi S, et al: A randomized study comparing standard versus moderately high-dose megestrol acetate in advanced prostate cancer: CALGB 9181. Cancer 88:825-834, 2000
31. Kantoff PW, Conaway M, Winer E, et al: Hydrocortisone with or without mitoxantrone in patients with hormone refractory prostate cancer: Results of the Cancer and Leukemia Group B 9182 study. J Clin Oncol 17:2506-2513, 1999
32. Halabi S, Small EJ, Kantoff PW, et al: A prognostic model for predicting overall survival in men with advanced prostate cancer. J Clin Oncol 21:1232-1237, 2003