Cabazitaxel for the second-line treatment of metastatic hormone-refractory prostate cancer: A NICE single technology appraisal

PharmacoEconomics

Volumn 31, Issue 6, 2013, Pages 479-488

  Kearns, Ben ^a   Lloyd Jones, Myfanwy ^a   Stevenson, Matt ^a   Littlewood, Chris ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CABAZITAXEL; DEXAMETHASONE; DEXCHLORPHENIRAMINE; DIPHENHYDRAMINE; DOCETAXEL; MITOXANTRONE; PLACEBO; PREDNISOLONE; PREDNISONE; PROSTATE SPECIFIC ANTIGEN; RANITIDINE;

BONE METASTASIS; BONE PAIN; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CASTRATION RESISTANT PROSTATE CANCER; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; HUMAN; INFUSION RELATED REACTION; KARNOFSKY PERFORMANCE STATUS; KIDNEY FAILURE; LEUKOPENIA; LYMPHEDEMA; METASTASIS; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; TUMOR GROWTH; WEIGHT REDUCTION;

ANTINEOPLASTIC AGENTS; COST-BENEFIT ANALYSIS; DISEASE-FREE SURVIVAL; GREAT BRITAIN; HUMANS; MALE; NEOPLASM METASTASIS; PROSTATIC NEOPLASMS; QUALITY-ADJUSTED LIFE YEARS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SURVIVAL RATE; TAXOIDS;

EID: 84877944939     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.1007/s40273-013-0050-9     Document Type: Review

References (45)

1. National Institute for Health and Clinical Excellence. Guide to the single technology appraisal (STA) process. London: NICE; Sep 2006. http://www.nice.org.uk/media/8DE/74/STA-Process-Guide.pdf. Accessed 20 March 2013.
2. Cancer Research UK. The stages of prostate cancer. London: Cancer Research UK. http://cancerhelp.cancerresearchuk.org/type/prostate-cancer/ treatment/the-stages-of-prostate-cancer. Accessed 20 March 2013.
3. National Collaborating Centre for Cancer. Prostate cancer: diagnosis and treatment - full guideline. Cardiff: National Collaborating Centre for Cancer; 2008.
4. Cancer Research UK. Prostate cancer symptoms. London: Cancer Research UK. http://www.cancerresearchuk.org/cancer-help/type/prostate-cancer/about/ prostate-cancer-symptoms. Accessed 20 March 2013.
5. The Prostate Cancer Charity. Living with prostate cancer. http://www.prostate-cancer.org.uk/information/living-with-prostate-cancer. Accessed 20 March 2013.
6. Cancer Research UK. Prostate cancer survival statistics. London: Cancer Research UK. http://info.cancerresearchuk.org/cancerstats/types/prostate/ survival/. Accessed 20 March 2013.
7. Cancer Research UK. Prostate cancer incidence statistics. London: Cancer Research UK. http://info.cancerresearchuk.org/cancerstats/types/prostate/ incidence/. Accessed 20 March 2013.
8. Cancer Research UK. Prostate cancer mortality statistics. London: Cancer Research UK. http://info.cancerresearchuk.org/cancerstats/types/prostate/ mortality/. Accessed 20 March 2013.
9. Stevenson M, Lloyd Jones M, Kearns B, Littlewood C, Wong R. Cabazitaxel for the second-line treatment of hormone refractory, metastatic prostate cancer. Sheffield: University of Sheffield, 30 Sept 2011. http://www.nice.org.uk/ nicemedia/live/13237/56544/56544.pdf. Accessed 20 March 2013.
10. Oudard S. TROPIC: phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. Future Oncol. 2011;7(4):497-506.
11. European Medicines Agency. Jevtana: summary of product characteristics. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/002018/WC500104764.pdf. Accessed 20 March 2013.
12. sanofi-aventis. Cabazitaxel for the second-line treatment of metastatic hormone refractory prostate cancer. Single technology appraisal submission to NICE. 8 June 2011. http://www.nice.org.uk/nicemedia/live/13237/56549/56549.pdf. Accessed 20 March 2013.
13. 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(9747):1147-54.
14. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chi KN, et al. Abiraterone and increased survival in metastatic prostate cancer. New Engl J Med. 2011;364(21):1995-2005.
15. de Bono JS, Fizazi K, Flechon A, Heidenreich A, Voog E, Davis NB, et al. Randomized phase II study of CNTO 328 (C), an anti-IL-6 monoclonal antibody, in combination with mitoxantrone (M) versus M alone in metastatic castration-resistant prostate cancer (CRPC) [abstract no. 86]. Genitourinary Cancers Symposium; 5-7 March 2010; San Francisco.
16. Fleming MT, Kolodziej MA, Awasthi S, Hutson TE, Martincic D, Sonpavde G, et al. Results of a randomized phase II study of mitoxantrone versus mitoxantrone with cetuximab in metastatic castrate-resistant prostate cancer (CRPC) previously treated with docetaxel-based chemotherapy [abstract no. 4555]. ASCO Annual Meeting; 4-8 June 2010; Chicago.
17. Rosenberg JE, Weinberg VK, Kelly WK, Michaelson D, Hussain MH, Wilding G, et al. Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients: randomized phase 2 study of ixabepilone or mitoxantrone and prednisone. Cancer. 2007;110:556-63.
18. Saad F, Hotte SJ, North S, Eigl BJ, Chi KN, Czaykowski P, et al. A phase II randomized study of custirsen (OGX-011) combination therapy in patients with poor-risk hormone refractory prostate cancer (HRPC) who relapsed on or within six months of 1st-line docetaxel therapy [abstract no. 5002]. ASCO Annual Meeting; 30 May-3 June 2008; Chicago, IL.
19. Sternberg CN, Petrylak DP, Sartor O, Witjes JA, Demkow T, Ferrero JM, et al. Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial. J Clin Oncol. 2009;27(32):5431-8.
20. FDA Center for Drug Evaluation and Research. Medical review(s): cabazitaxel [application no. 201023]. March 2009. http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2010/201023s000MedR.pdf. Accessed 20 March 2013.
21. Sullivan PW, Mulani PM, Fishman M, Sleep D, Sullivan PW, Mulani PM, et al. Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer. Qual Life Res. 2007;16(4):571-5.
22. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use. Statistical principles for clinical trials: ICH harmonised tripartite guidelines. Stat Med 1999;18:1905-42.
23. National Institute for Health and Clinical Excellence. Prostate cancer: cabazitaxel - appraisal consultation document. London: NICE; 24 Oct 2011. http://guidance.nice.org.uk/TA/Wave23/31/Consultation/DraftGuidance. Accessed 20 March 2013.
24. National Institute for Health and Clinical Excellence. Final appraisal determination: cabazitaxel for the second-line treatment of metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen. London: NICE; 12 Jan 2012. http://www.nice.org.uk/nicemedia/live/13237/ 57803/57803.pdf. Accessed 20 March 2013.
25. Sculpher M. Single technology appraisal at the UK National Institute for Health and Clinical Excellence: a source of evidence and analysis for decision making internationally. Pharmacoeconomics. 2010;28(5):347-9.
26. Rodgers M, Griffin S, Paulden M, et al. Alitretinoin for severe chronic hand eczema: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(5):351-62.
27. Bagust A, Greenhalgh J, Boland A, et al. Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(6):439-48.
28. Stevenson M, Pandor A. Febuxostat for the management of hyperuricaemia in patients with gout: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(2):133-40.
29. Scotland G, Waugh N, Royle P, et al. Denosumab for the prevention of osteoporotic fractures in post-menopausal women: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(11):951-61.
30. Dickson R, Bagust A, Boland A, et al. Erlotinib monotherapy for the maintenance treatment of non-small cell lung cancer after previous platinum-containing chemotherapy: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(12):1051-62.
31. McKenna C, Maund E, Sarowar M, et al. Dronedarone for the treatment of atrial fibrillation: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(1):35-46.
32. Holmes M, Carroll C, Papaioannou D. Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(2):137-46.
33. Yang H, Craig D, Epstein D, et al. Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(4):257-70.
34. Boyers D, Jia X, Jenkinson D, et al. Eltrombopag for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(6):483-95.
35. Burch J, Griffin S, McKenna C, Walker S, Paton J, Wright K, et al. Omalizumab for severe persistent asthma in children aged 6-11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(11):991-1004.
36. Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(12):1119-32.
37. Kilonzo M, Hislop J, Elders A, Fraser C, Bissett D, McClinton S, et al. Pazopanib for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(1):15-24.
38. Craig D, Rice S, Paton F, et al. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(2):101-10.
39. Spackman E, Rice S, Norman G, Suh D-C, Eastwood A, Palmer S. Trastuzumab for the treatment of HER2 positive metastatic gastric cancer: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(3):185-94.
40. Rafia R, Simpson E, Stevenson M, Papaioannou D. Trabectedin for the treatment of advanced metastatic soft tissue sarcoma: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi: 10.1007/s40273-013-0044-7.
41. Simpson EL, Fitzgerald P, Evans P, et al. Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi: 10.1007/s40273-013-0036-7.
42. Greenhalgh J, Bagust A, Boland A, Blundell M, Oyee J, Beale S, Dundar Y, Hockenhull J, Proudlove C, Chu P. Rituximab for the first-line maintenance treatment of follicular non-Hodgkin's lymphoma: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi: 10.1007/s40273-013-0043-8.
43. Armstrong N, Manuela J, van Asselt T, et al. Golimumab for the treatment of ankylosing spondylitis: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi: 10.1007/s40273-013-0049-2.
44. Tosh J, Archer R, Davis S, et al. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs: a NICE single technology appraisal. Pharmacoeconomics. In press.
45. Faria R, Spackman E, Burch J, Corbacho B, Todd D, Pepper C, et al. Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: a NICE single technology appraisal. PharmacoEconomics. In press.