Antitumour activity of MDV3100 in castration-resistant prostate cancer: A phase 1-2 study

The Lancet

Volumn 375, Issue 9724, 2010, Pages 1437-1446

  Scher, H I ^a   Anand, A ^a   Rathkopf, D ^a   Shelkey, J ^a   Morris, M J ^a   Danila, D C ^a   Larson, S ^b   Humm, J ^c   Fleisher, M ^d   Sawyers, C L ^e,g   Beer, T M ^f   Alumkal, J ^f   Higano, C S ^h   Yu, E Y ^h   Taplin, M E ⁱ   Efstathiou, E ^j   Hung, D ^k   Hirmand, M ^k   Seely, L ^k  

^a Genitourinary Oncology Service   (United States)

^b Nuclear Medicine Service   (United States)

^c Department of Clinical Laboratories ^*  (United States)

^d Human Oncology and Pathogenesis Program   (United States)

^e MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^g HOWARD HUGHES MEDICAL INSTITUTE   (United States)

^h UNIVERSITY OF WASHINGTON   (United States)

ⁱ DANA FARBER CANCER INSTITUTE   (United States)

^j UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^k Medivation Inc   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANDROGEN RECEPTOR; ANDROSTANOLONE; ANTIANDROGEN; ANTINEOPLASTIC AGENT; CALCIUM; FLUORODEOXYGLUCOSE F 18; MDV 3100; METHYLPHENIDATE; OLANZAPINE; PROCHLORPERAZINE; PROSTATE SPECIFIC ANTIGEN; UNCLASSIFIED DRUG; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; DRUG DERIVATIVE; PHENYLTHIOHYDANTOIN;

ADULT; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; BONE METASTASIS; CANCER GROWTH; CANCER HORMONE THERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CELL COUNT; CHEMOTHERAPY INDUCED EMESIS; CIRCULATING TUMOUR CELL; CLINICAL TRIAL; DRUG ABSORPTION; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG ERUPTION; DRUG HALF LIFE; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHROCYTE TRANSFUSION; FATIGUE; HEART INFARCTION; HUMAN; HYPOCALCEMIA; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; NAUSEA; OPTIMAL DRUG DOSE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROSTATE CANCER; RECEPTOR BLOCKING; SEIZURE; SIGNAL TRANSDUCTION; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE; TUMOR CELL; VISCERAL METASTASIS; DOSE RESPONSE; METASTASIS; MIDDLE AGED; ORCHIECTOMY; PATHOPHYSIOLOGY; PROSTATE TUMOR; TREATMENT OUTCOME; VALIDATION STUDY;

ADULT; AGED; AGED, 80 AND OVER; ANDROGEN ANTAGONISTS; ANTINEOPLASTIC AGENTS, HORMONAL; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; ORCHIECTOMY; PHENYLTHIOHYDANTOIN; PROSTATIC NEOPLASMS; TREATMENT OUTCOME;

EID: 77952105685     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(10)60172-9     Document Type: Article

References (30)

1. Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F, et al. Oncogenic activation of the RAS/RAF signaling pathway impairs the response of metastatic colorectal cancers to anti-epidermal growth factor receptor antibody therapies. Cancer Res 2007;67:2643-48.
2. Linardou H, Dahabreh IJ, Kanaloupiti D, et al. Assessment of somatic k-RAS mutations as a mechanism associated with resistance to EGFR-targeted agents: a systematic review and meta-analysis of studies in advanced non-small-cell lung cancer and metastatic colorectal cancer. Lancet Oncol 2008;9:962-72.
3. Cortes J, Jabbour E, Kantarjian H, et al. Dynamics of BCR-ABL kinase domain mutations in chronic myeloid leukemia after sequential treatment with multiple tyrosine kinase inhibitors. Blood 2007;110:4005-11.
4. Shah NP, Skaggs BJ, Branford S, et al. Sequential ABL kinase inhibitor therapy selects for compound drug-resistant BCR-ABL mutations with altered oncogenic potency. J Clin Invest 2007;117:2562-69.
5. Pao W, Miller VA, Politi KA, et al. Acquired resistance of lung adenocarcinomas to gefi tinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2005;2: e73.
6. Antonescu CR, Besmer P, Guo T, et al. Acquired resistance to imatinib in gastrointestinal stromal tumour occurs through secondary gene mutation. Clin Cancer Res 2005;11:4182-90.
7. Talpaz M, Shah NP, Kantarjian H, et al. Dasatinib in imatinibresistant Philadelphia chromosome-positive leukemias. N Engl J Med 2006;354:2531-41.
8. Gajiwala KS, Wu JC, Christensen J, et al. KIT kinase mutants show unique mechanisms of drug resistance to imatinib and sunitinib in gastrointestinal stromal tumour patients. Proc Natl Acad Sci USA 2009;106:1542-47.
9. Demetri GD, Heinrich MC, Fletcher JA, et al. Molecular target modulation, imaging, and clinical evaluation of gastrointestinal stromal tumour patients treated with sunitinib malate after imatinib failure. Clin Cancer Res 2009;15:5902-09.
10. Scher HI, Liebertz C, Kelly WK, et al. Bicalutamide for advanced prostate cancer: the natural versus treated history of disease. J Clin Oncol 1997;15:2928-38.
11. Pomerantz M, Kantoff P. Advances in the treatment of prostate cancer. Ann Rev Med 2007;58:205-20.
12. Small EJ, Vogelzang NJ. Second-line hormonal therapy for advanced prostate cancer: a shifting paradigm. J Clin Oncol 1997;15:382-88.
13. Scher HI, Sawyers C. Biology of progressive castration resistant prostate cancer: directed therapies targeting the androgen receptor signaling axis. J Clin Oncol 2005;23:8253-61.
14. Linja MJ, Savinainen KJ, Saramaki OR, Tammela TL, Vessella RL, Visakorpi T. Amplifi cation and overexpression of androgen receptor gene in hormone-refractory prostate cancer. Cancer Res 2001;61:3550-55.
15. Holzbeierlein J, Lal P, LaTulippe E, et al. Gene expression analysis of human prostate carcinoma during hormonal therapy identifies androgen-responsive genes and mechanisms of therapy resistance. Am J Pathol 2004;164:217-27.
16. Stanbrough M, Bubley GJ, Ross K, et al. Increased expression of genes converting adrenal androgens to testosterone in androgen-independent prostate cancer. Cancer Res 2006;66:2815-25.
17. Chen CD, Welsbie DS, Tran C, et al. Molecular determinants of resistance to antiandrogen therapy. Nat Med 2004;10:33-39.
18. Tran C, Ouk S, Clegg NJ, et al. Development of a secondgeneration antiandrogen for treatment of advanced prostate cancer. Science 2009;324:787-90.
19. Scher HI, Kolvenbag GJ. The antiandrogen withdrawal syndrome in relapsed prostate cancer. Eur Urol 1997;31(suppl 2):3-7.
20. Morris MJ, Basch EM, Wilding G, et al. Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research. Clin Genitourin Cancer 2009;7:51-57.
21. Morris MJ, Akhurst T, Larson SM, et al. Fluorodeoxyglucose positron emission tomography as an outcome measure for castrate metastatic prostate cancer treated with chemotherapy. Clin Cancer Res 2005;11:3210-16.
22. Scher HI, Halabi S, Tannock I, 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.
23. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumours. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
24. Veridex LLC. CellSearch circulating tumor cell kit premarket notifi cation-expanded indications for use-metastatic prostate cancer. February, 2008. http://www.accessdata.fda.gov/cdrh-docs/pdf7/K073338pdf. (accessed March 18, 2010).
25. Danila DC, Heller G, Gignac GA, et al. Circulating tumour cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res 2007;13:7053-58.
26. Scher HI, Warren M, Heller G. The Association Between Measures of Progression and Survival in Castrate-Metastatic Prostate Cancer. Clin Cancer Res 2007;13:1488-92.
27. Basch EM, Somerfield MR, Beer TM, et al. American Society of Clinical Oncology endorsement of the Cancer Care Ontario Practice Guideline on nonhormonal therapy for men with metastatic hormone-refractory (castration-resistant) prostate cancer. J Clin Oncol 2007;25:5313-18.
28. de Bono JS, Scher HI, Montgomery RB, et al. Circulating tumour cells predict survival benefi t from treatment in metastatic castrationresistant prostate cancer. Clin Cancer Res 2008;14:6302-09.
29. Cristofanilli M, Budd G T, Ellis MJ, et al. Circulating tumour cells, disease progression, and survival in metastatic breast cancer. N Engl J Med 2004;351:781-91.
30. Cohen SJ, Punt CJA, Iannotti N, et al. The relationship of circulating tumour cells to tumour response, progression-free survival, and overall survival in patients with metastatic colorectal carcinoma. J Clin Oncol 2008;26:3213-21.