Novel strategies to test biological hypotheses in early drug development for advanced prostate cancer

Clinical Chemistry

Volumn 59, Issue 1, 2013, Pages 75-84

  Ferraldeschi, Roberta ^a   Attard, Gerhardt ^a   De Bono, Johann S ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ABIRATERONE; ABIRATERONE ACETATE; ANTINEOPLASTIC AGENT; BRENTUXIMAB VEDOTIN; CABAZITAXEL; CRIZOTINIB; DOCETAXEL; ENZALUTAMIDE; ESTRAMUSTINE; MITOXANTRONE; PACLITAXEL; PREDNISONE; RADIUM CHLORIDE RA 223; SIPULEUCEL T; TUMOR MARKER; UNCLASSIFIED DRUG; VEMURAFENIB; ZALBORAF;

ADVANCED CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER PROGNOSIS; CANCER TISSUE; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL PROTOCOL; CROSS RESISTANCE; GENE EXPRESSION PROFILING; HISTOPATHOLOGY; HODGKIN DISEASE; HUMAN; HYPOTHESIS; IMMUNOFLUORESCENCE; LUNG NON SMALL CELL CANCER; METABOLOMICS; METASTATIC MELANOMA; PHARMACODYNAMICS; PROTEOMICS; SHORT SURVEY; VALIDATION PROCESS;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG DESIGN; HUMANS; MALE; PROSTATIC NEOPLASMS; TUMOR MARKERS, BIOLOGICAL;

EID: 84872044846     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2012.185157     Document Type: Short Survey

References (40)

1. Siegel R, Naishadham D, Jemal. Cancer statistics, 2012. CA Cancer J Clin 2012;62:10-29.
2. Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-12. (Pubitemid 39315317)
3. Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513-20. (Pubitemid 39315318)
4. Attard G, de Bono JS. Translating scientific advancement into clinical benefit for castration-resistant prostate cancer patients. Clin Cancer Res 2011;17:3867-75.
5. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363:411-22.
6. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010;376:1147-54.
7. Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA- 301 randomised, double-blind, placebocontrolled phase 3 study. Lancet Oncol 2012;13:983-92.
8. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller MD, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367:1187-97.
9. Parker C, Heinrich D, O'Sullivan JM, Fosså S, Chodacki A, Demkow T, et al. Overall survival benefit of radium-223 chloride (Alpharadin) in the treatment of patients with symptomatic bone metastases in castration-resistant prostate cancer (CRPC): a phase III randomized trial (ALSYMPCA) [Abstract]. Eur J Cancer 2011;47: abstract 1LBA.
10. Goozner M. Drug approvals 2011: focus on companion diagnostics. J Natl Cancer Inst 2012;104:84-6.
11. Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002;20:719-26. (Pubitemid 34111379)
12. Rubin BP, Singer S, Tsao C, Duensing A, Lux ML, Ruiz R, et al. KIT activation is a ubiquitous feature of gastrointestinal stromal tumors. Cancer Res 2001;61:8118-21. (Pubitemid 33091601)
13. Bio/BioMedTracker. Clinical Trial Success Rates Study http://insidebioia.files.wordpress.com/2011/02/bio-ceo-biomedtracker-bio-study- handout-final- 2-15-2011.pdf (Accessed August 2012).
14. Sartor O. State-of-the-art management for the patient with castration-resistant prostate cancer in 2012. 2012 educational book. Alexandria, VA: American Society of Clinical Oncology; 2012. p 289-91. http://www.asco.org/ ASCOv2/Education+ %26+Training/Educational+Book?&vmview=edbk-detail- view&confID=114&abstractID=174 (Accessed November 2012).
15. Yap TA, Sandhu SK, Workman P, de Bono JS. Envisioning the future of early anticancer drug development. Nat Rev Cancer 2010;10:514-23.
16. Dancey JE, Dobbin KK, Groshen S, Jessup JM, Hruszkewycz AH, Koehler M, et al. Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin Cancer Res 2010;16:1745-55.
17. Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol 2012;9:199-207.
18. European Medicines Agency (EMA). Reflection paper on methodological issues in confirmatory clinical trials with flexible design and analysis plan. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/ WC500003617.pdf (Accessed August 2012).
19. US Food and Drug Administration (FDA). Guidance for industry: adaptive design clinical trials for drugs and biologics. Draft guidance. http://www.fda.gov/downloads/Drugs/guidancecompliance regulatoryinformation/ guidances/ucm201790.pdf (Accessed August 2012).
20. Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov 2011;1:44-53.
21. Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. I-SPY 2: an adaptive breast cancer trial design in the setting of neo-adjuvant chemotherapy. Clin Pharmacol Ther 2009;86:97-100.
22. Brenner JC, Ateeq B, Li Y, Yocum AK, Cao Q, Asangani IA, et al. Mechanistic rationale for inhibition of poly(ADP-ribose) polymerase in ETS gene fusion-positive prostate cancer. Cancer Cell 2011;19:664-78.
23. Grasso CS, Wu YM, Robinson DR, Cao X, Dhanasekaran SM, Khan AP, et al. The mutational landscape of lethal castration-resistant prostate cancer. Nature 2012;487:239-43.
24. Basu B, Yap TA, Molife LR, de Bono JS. Targeting the DNA damage response in oncology: past, present and future perspectives. Curr Opin Oncol 2012;24:316-24.
25. 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.
26. Attard G, Reid AH, Yap TA, Raynaud F, Dowsett M, Settatree S, et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol 2008;26:4563-71.
27. Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet 2010;375:1437-46.
28. Attard G, Reid AH, A'Hern R, Parker C, Oommen NB, Folkerd E, et al. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin Oncol 2009;27:3742-8.
29. Al-Lazikani B, Banerji U, Workman P. Combinatorial drug therapy for cancer in the post-genomic era. Nat Biotechnol 2012;30:679-92.
30. Carver BS, Chapinski C, Wongvipat J, Hieronymus H, Chen Y, Chandarlapaty S, et al. Reciprocal feedback regulation of PI3K and androgen receptor signaling in PTEN-deficient prostate cancer. Cancer Cell 2011;19:575-86.
31. Richards J, Lim AC, Hay CW, Taylor AE, Wingate A, Nowakowska K, et al. Interactions of abiraterone, eplerenone and prednisolone with wild-type and mutant androgen receptor: a rationale for increasing abiraterone exposure or combining with MDV3100. Cancer Res 2012;72:2176-82.
32. Solit DB, She Y, Lobo J, Kris MG, Scher HI, Rosen N, Sirotnak FM. Pulsatile administration of the epidermal growth factor receptor inhibitor gefitinib is significantly more effective than continuous dosing for sensitizing tumors to paclitaxel. Clin Cancer Res 2005;11:1983-9. (Pubitemid 40471864)
33. Reid AH, Attard G, Brewer D, Miranda S, Riisnaes R, Clark J, et al. Novel, gross chromosomal alterations involving PTEN cooperate with allelic loss in prostate cancer. Mod Pathol 2012;25:902-10.
34. Rubin MA, Maher CA, Chinnaiyan AM. Common gene rearrangements in prostate cancer. J Clin Oncol 2011;29:3659-68.
35. Gerlinger M, Rowan AJ, Horswell S, Larkin J, Endesfelder D, Gronroos E, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 2012;366:883-92.
36. Scher HG, Heller G, Molina A, Kheoh TS, Attard G, Moreira J, et al. Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC): planned final analysis (FA) of COU-AA-301, a randomized double-blind, placebo-controlled phase III study of abiraterone acetate (AA) plus low-dose prednisone (P) post docetaxel [Abstract]. J Clin Oncol 2011;29:(Suppl): abstract LBA4517.
37. Attard G, Swennenhuis JF, Olmos D, Reid AH, Vickers E, A'Hern R, et al. Characterization of ERG, AR and PTEN gene status in circulating tumor cells from patients with castration-resistant prostate cancer. Cancer Res 2009;69:2912-8.
38. Navin N, Kendall J, Troge J, Andrews P, Rodgers L, McIndoo J, et al. Tumour evolution inferred by single-cell sequencing. Nature 2011;472:90-4.
39. Andersen RJ, Mawji NR, Wang J, Wang G, Haile S, Myung JK, et al. Regression of castratere-current prostate cancer by a small-molecule inhibitor of the amino-terminus domain of the androgen receptor. Cancer Cell 2010;17:535-46.
40. Centenera MM, Gillis JL, Hanson AR, Jindal S, Taylor RA, Risbridger GP, et al. Evidence for efficacy of new Hsp90 inhibitors revealed by ex vivo culture of human prostate tumors. Clin Cancer Res 2012;18:3562-70.