Sequential use of the androgen synthesis inhibitors ketoconazole and abiraterone acetate in castration-resistant prostate cancer and the predictive value of circulating androgens

Clinical Cancer Research

Volumn 20, Issue 24, 2014, Pages 6269-6276

  Kim, Won ^a   Zhang, Li ^a   Wilton, John H ^a   Fetterly, Gerald ^a   Mohler, James L ^b   Weinberg, Vivian ^a   Morse, Allison ^a   Szmulewitz, Russell Z ^b   Friedler, Terence W ^a   Fong, Lawrence ^a   Lin, Amy M ^a   Harzstark, Andrea L ^a   Molina, Arturo ^c   Small, Eric J ^a   Ryan, Charles J ^d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ABIRATERONE ACETATE; ANDROSTENEDIONE; ANDROSTERONE; IMIDAZOLE; KETOCONAZOLE; PREDNISONE; PROSTATE SPECIFIC ANTIGEN; TESTOSTERONE; ANDROGEN; ANDROSTANE DERIVATIVE; STEROID SYNTHESIS INHIBITOR;

ADULT; ADVANCED CANCER; AGED; ANDROGEN BLOOD LEVEL; ANDROGEN SYNTHESIS; ARTICLE; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; CONTROLLED STUDY; DISEASE COURSE; DRUG DOSE SEQUENCE; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; EDEMA; FATIGUE; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOKALEMIA; HYPOPHOSPHATEMIA; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MALE; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; NULL HYPOTHESIS; PHASE 2 CLINICAL TRIAL; PREDICTIVE VALUE; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; TANDEM MASS SPECTROMETRY; TREATMENT DURATION; TREATMENT RESPONSE; VERY ELDERLY; BLOOD; CLINICAL TRIAL; METASTASIS; MORTALITY; PATHOLOGY; PROGNOSIS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RETREATMENT; TREATMENT OUTCOME;

ABIRATERONE ACETATE; AGED; AGED, 80 AND OVER; ANDROGENS; ANDROSTENES; HUMANS; KETOCONAZOLE; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROGNOSIS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RETREATMENT; STEROID SYNTHESIS INHIBITORS; TREATMENT OUTCOME;

EID: 84919652846     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-1595     Document Type: Article

References (18)

1. Small EJ, Baron AD, Fippin L, Apodaca D. Ketoconazole retains activity in advanced prostate cancer patients with progression despite flutamide withdrawal. J Urol 1997;157:1204-7.
2. Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, et al. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol 2004;22:1025-33.
3. Allen JM, Kerle DJ, Ware H, Doble A, Williams G, Bloom SR. Combined treatment with ketoconazole and luteinising hormone releasing hormone analogue: a novel approach to resistant progressive prostatic cancer. Br Med J 1983;287:1766.
4. Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol 1994;50:267-73.
5. Potter GA, Barrie SE, Jarman M, Rowlands MG. Novel steroidal inhibitors of human cytochrome P45017 alpha (17 alpha-hydroxy-lase-C17,20-lyase): potential agents for the treatment of prostatic cancer. J Med Chem 1995;38:2463-71.
6. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005.
7. Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368:138-48.
8. Ryan CJ, Smith MR, Fong L, Rosenberg JE, Kantoff P, Raynaud F, et al. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol 2010;28:1481-8.
9. Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008;26:1148-59.
10. Wilton JH, Titus MA, Efstathiou E, Fetterly GJ, Mohler JL. Androgenic biomarker profiling in human matrices and cell culture samples using high throughput, electrospray tandem mass spectrometry. Prostate 2014;74:722-31.
11. Beer TM, Armstrong AJ, Sternberg CN, Higano C, Iverson P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): results of phase III PREVAIL study. J Clin Oncol 2014;32:suppl 4; abstr LBA1.
12. Petrylak DP, Ankerst DP, Jiang CS, Tangen CM, Hussain MH, Lara PN Jr, et al. Evaluation of prostate-specific antigen declines for surrogacy in patients treated on SWOG 99-16. J Natl Cancer Inst 2006;98: 516-21.
13. Armstrong AJ, Garrett-Mayer E, Ou Yang YC, Carducci MA, Tannock I, de Wit R, et al. Prostate-specific antigen and pain surrogacy analysis in metastatic hormone-refractory prostate cancer. J Clin Oncol 2007;25:3965-70.
14. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-40.
15. Lin DY, Fleming TR, De Gruttola V. Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med 1997;16: 1515-27.
16. Cai C, Chen S, Ng P, Bubley GJ, Nelson PS, Mostaghel EA, et al. Intratumoral de novo steroid synthesis activates androgen receptor in castration-resistant prostate cancer and is upregulated by treatment with CYP17A1 inhibitors. Cancer Res 2011;71:6503-13.
17. Ryan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, et al. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol 2013;31:2791-8.
18. Mailankody S, Prasad V. Comparative effectiveness questions in oncology. N Engl J Med 2014;370:1478-81.