Radium-223 for the treatment of prostate cancer

Expert Opinion on Investigational Drugs

Volumn 22, Issue 3, 2013, Pages 379-387

  Hafeez, Shaista ^a   Parker, Christopher ^a  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

Author keywords

Bone metastases; Castration resistant; Pain; Prostate cancer; Radium 223

Indexed keywords

ABIRATERONE; BICALUTAMIDE; CABAZITAXEL; DENOSUMAB; DOCETAXEL; ENZALUTAMIDE; LEXIDRONAM SAMARIUM SM 153; MITOXANTRONE; PLACEBO; PREDNISOLONE; PREDNISONE; RADIOISOTOPE; RADIUM 223; SIPULEUCEL T; STRONTIUM 89; UNCLASSIFIED DRUG; ZOLEDRONIC ACID;

ANEMIA; ARTICLE; BONE MARROW SUPPRESSION; BONE MARROW TOXICITY; BONE METASTASIS; BONE PAIN; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER PALLIATIVE THERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CONSTIPATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EXTERNAL BEAM RADIOTHERAPY; FATIGUE; GASTROINTESTINAL TOXICITY; HUMAN; MEDLINE; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; RADIUM THERAPY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SINGLE DRUG DOSE; THROMBOCYTOPENIA; VOMITING;

BONE NEOPLASMS; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; MALE; PROSTATIC NEOPLASMS; RADIUM;

EID: 84873691909     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2013.761974     Document Type: Article

References (72)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics. CA Cancer J Clin 2010;60(5):277-300
2. Shapiro D, Tareen B. Current and emerging treatments in the management of castration-resistant prostate cancer. Expert Rev Anticancer Ther 2012;12(7):951-64
3. Lipton A. Implications of bone metastases and the benefits of bone-targeted therapy. Semin Oncol 2010;37(Suppl 2):S15-29
4. Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer 2002;2(8):584-93
5. DePuy V, Anstrom KJ, Castel LD, et al. Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer. Support Care Cancer 2007;15(7):869-76
6. Akaza H, Hinotsu S, Usami M, et al. Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase 3, double-blind, randomized study for survival. Cancer 2009;115(15):3437-45
7. Crawford ED, Eisenberger MA, McLeod DG, et al. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med 1989;321(7):419-24
8. Eisenberger MA, Blumenstein BA, Crawford ED, et al. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med 1998;339(15):1036-42
9. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351(15):1502-12
10. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351(15):1513-20
11. Sartor AO, Tangen CM, Hussain MH, et al. Antiandrogen withdrawal in castrate-refractory prostate cancer: a Southwest Oncology Group trial (SWOG 9426). Cancer 2008;112(11):2393-400
12. Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14(6):1756-64
13. Prostate cancer. NCCN clinical practice guidelines in oncology. 2012. Available from: http://www.nccn.org
14. NICE clinical guidelines on prostate cancer. Available from: http://pathways. nice.org.uk/pathways/prostate-cancer [Accessed December 2012]
15. Urology EAo: Guidelines on prostate cancer. 2012. Available from: http://www.uroweb.org
16. de Bono JS, Oudard S, Ozguroglu M, 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
17. Cabazitaxel versus docetaxel both with prednisone in patients with metastatic castration resistant prostate cancer (FIRSTANA). NCT01308567 Available from: http://clinicaltrials.gov
18. Berthold DR, Sternberg CN, Tannock IF. Management of advanced prostate cancer after first-line chemotherapy. J Clin Oncol 2005;23(32):8247-52
19. Smith DC, Redman BG, Flaherty LE, et al. A phase II trial of oral diethylstilbestrol as a second-line hormonal agent in advanced prostate cancer. Urology 1998;52(2):257-60
20. Wilkins A, Shahidi M, Parker C, et al. Diethylstilbestrol in castration-resistant prostate cancer. BJU Int2012. [Epub ahead of print]
21. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364(21):1995-2005
22. Abiraterone acetate in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer. Available from: http://clinicaltrials.gov/ct2/show/NCT00887198. ClinicalTrials.gov
23. Ryan CJ, Smith MR, De Bono JS, et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 2012;30(Suppl):LBA4518
24. Available from: www.fda.gov/drugs [Accessed December 2012]
25. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367(13):1187-97
26. A safety and efficacy study of oral MDV3100 in chemotherapy-naive patients with progressive metastatic prostate cancer (PREVAIL). Available from: http://clinicaltrials.gov/ct2/show/NCT01212991. ClinicalTrials.gov
27. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol 2006;24(19):3089-94
28. Goldman B, DeFrancesco L. The cancer vaccine roller coaster. Nat Biotechnol 2009;27(2):129-39
29. Higano CS, Schellhammer PF, Small EJ, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009;115(16):3670-9
30. McQuay HJ, Carroll D, Moore RA. Radiotherapy for painful bone metastases: a systematic review. Clin Oncol (R Coll Radiol) 1997;9(3):150-4
31. Wu JS, Wong R, Johnston M, et al. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys 2003;55(3):594-605
32. Sze WM, Shelley MD, Held I, et al. Palliation of metastatic bone pain: single fraction versus multifraction radiotherapy: a systematic review of randomised trials. Clin Oncol (R Coll Radiol) 2003;15(6):345-52
33. Roos DE, Turner SL, O'Brien PC, et al. Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05). Radiother Oncol 2005;75(1):54-63
34. Chow E, Zeng L, Salvo N, et al. Update on the systematic review of palliative radiotherapy trials for bone metastases. Clin Oncol (R Coll Radiol) 2012;24(2):112-24
35. van der Linden YM, Lok JJ, Steenland E, et al. Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment. Int J Radiat Oncol Biol Phys 2004;59(2):528-37
36. Salazar OM, Sandhu T, da Motta NW, et al. Fractionated half-body irradiation (HBI) for the rapid palliation of widespread, symptomatic, metastatic bone disease: a randomized Phase III trial of the International Atomic Energy Agency (IAEA). Int J Radiat Oncol Biol Phys 2001;50(3):765-75
37. Dearnaley DP, Bayly RJ, A'Hern RP, et al. Palliation of bone metastases in prostate cancer. Hemibody irradiation or strontium-89? Clin Oncol (R Coll Radiol) 1992;4(2):101-7
38. Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst 2004;96(11):879-82
39. Small EJ, Smith MR, Seaman JJ, et al. Combined analysis of two multicenter, randomized, placebo-controlled studies of pamidronate disodium for the palliation of bone pain in men with metastatic prostate cancer. J Clin Oncol 2003;21(23):4277-84
40. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet 2011;377(9768):813-22
41. Serafini AN. Samarium Sm-153 lexidronam for the palliation of bone pain associated with metastases. Cancer 2000;88(Suppl 12):2934-9
42. Collins C, Eary JF, Donaldson G, et al. Samarium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: a phase I/II trial. J Nucl Med 1993;34(11):1839-44
43. Sartor O, Reid RH, Hoskin PJ, et al. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology 2004;63(5):940-5
44. Sartor O, Reid RH, Bushnell DL, et al. Safety and efficacy of repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain. Cancer 2007;109(3):637-43
45. Finlay IG, Mason MD, Shelley M. Radioisotopes for the palliation of metastatic bone cancer: a systematic review. Lancet Oncol 2005;6(6):392-400
46. Fizazi K, Beuzeboc P, Lumbroso J, et al. Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol 2009;27(15):2429-35
47. A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined (TRAPEZE). Available from: http://clinicaltrials.gov; ISRCTN12808747. NCT00554918
48. Bruland OS, Nilsson S, Fisher DR, Larsen RH. High-linear energy transfer irradiation targeted to skeletal metastases by the alpha-emitter 223Ra: adjuvant or alternative to conventional modalities? Clin Cancer Res 2006;12(20 Pt 2):6250s-7s
49. I.C.R.P. Publication 92: Relative Biological Effectiveness (REBE), Quality Factor (Q) and Radiation Weighting Factor (wR). Elsevier, New York; 2003
50. McDevitt MR, Sgouros G, Finn RD, et al. Radioimmunotherapy with alpha-emitting nuclides. Eur J Nucl Med 1998;25(9):1341-51
51. Henriksen G, Breistol K, Bruland OS, et al. Significant antitumor effect from bone-seeking, alpha-particle-emitting (223)Ra demonstrated in an experimental skeletal metastases model. Cancer Res 2002;62(11):3120-5
52. Nilsson S, Larsen RH, Fossa SD, et al. First clinical experience with alpha-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res 2005;11(12):4451-9
53. Soderquist CZ, McNamara BK, Fisher DR. Production of high-purity radium-223 from legacy actinium-beryllium neutron sources. Curr Radiopharm 2012;5(3):244-52
54. Henriksen G, Hoff P, Alstad J, Larsen RH. 223Ra for endoradiotherapeutic applications prepared from an immobilized 227Ac/227Th source. Radiochim Acta 2001;89(10):661
55. Morris M, Carrasquillo J, O'Donoghue J, et al. Phase I pharmacokinetic (PK) and biodistribution study with escalating doses of radium-223 in men with castration-resistant metastatic prostate cancer (CRMPC) [abstract 211]. ASCO Genitourinary Cancers Symposium; 2010. Available from: http://www.asco. org/ASCOv2/Meetings/Abstracts& vmview=abst-detail-view&confID=73& abstractID=30493
56. Lewington V, Parker C, Hindorf C, et al. Alpharadin: a novel, targeted approach for treatment of bone metastases from CRPC-calculated alphaparticle dosimetry compared to a favorable clinical safety profile. ASCO Genitourinary Cancers Symposium. J Clin Oncol (Meeting Abstracts) 2010;28(15 Suppl):e15009
57. Hindorf C, Chittenden S, Aksnes AK, et al. Quantitative imaging of 223Ra-chloride (Alpharadin) for targeted alpha-emitting radionuclide therapy of bone metastases. Nucl Med Commun 2012;33(7):726-32
58. Nilsson S, Franzen L, Parker C, et al. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol 2007;8(7):587-94
59. Nilsson S, Franzen L, Parker C, et al. Two-Year Survival Follow-Up of the Randomized, Double-Blind, Placebo-Controlled Phase II Study of Radium-223 Chloride in Patients With Castration-Resistant Prostate Cancer and Bone Metastases. Clin Genitourin Cancer2012. [Epub ahead of print]
60. Nilsson S, Strang P, Aksnes AK, et al. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer 2012;48(5):678-86
61. Parker CC, Pascoe S, Chodacki A, et al. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol 2013;6(2):189-97
62. Bayer: Alpharadin significantly improves overall survival in phase III trial in patients with castration resistant prostate cancer that has spread to bone. 2011. Available from: http://www.bayer.com/en/news-detailaspx?newsid=14775
63. Nilsson S, O'Bryan-Tear CG, Bolstad B, et al. Alkaline Phosphatase (ALP) normalisation and overall survival in patients with bone metastases from castration-resistant prostate cancer (CRPC) treated with radium-223 [abstract]. J Clin Oncol 2011;29(Suppl 7):abstract 49
64. Parker C, Heinrich D, O'Sullivan JM, et al. on behalf of the ALSYMPCA Investigators: 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 Randomised Trial (ALSYMPCA). ASCO Annual Meeting Proceedings (Post-Meeting Edition). J Clin Oncol 2012;30(18 Suppl): LBA4512; June 20 Supplement
65. Parker C, Coleman RE, Nilsson S, et al. Quality of life (QOL) and updated survival and safety data of radium-223 chloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases from the phase 3 ALSYMPCA study [abstract]. NCRI 2012. Available from: http://www.ncri.org.uk/ ncriconference/2012abstracts/abstracts/B218.html
66. Wick RR, Nekolla EA, Gaubitz M, Schulte TL. Increased risk of myeloid leukaemia in patients with ankylosing spondylitis following treatment with radium-224. Rheumatology (Oxford) 2008;47(6):855-9
67. Sciuto R, Festa A, Rea S, et al. Effects of low-dose cisplatin on 89Sr therapy for painful bone metastases from prostate cancer: a randomized clinical trial. J Nucl Med 2002;43(1):79-86
68. Tu SM, Millikan RE, Mengistu B, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet 2001;357(9253):336-41
69. Morris MJ, Pandit-Taskar N, Carrasquillo J, et al. Phase I study of samarium-153 lexidronam with docetaxel in castration-resistant metastatic prostate cancer. J Clin Oncol 2009;27(15):2436-42
70. A Study of Alpharadin-with Docetaxel in patients with bone metastasis from Castration-Resistant Prostate Cancer (CRPC). Available from: http://clinicaltrials.gov; NCT01106352
71. Olmos D, Brewer D, Clark J, et al. Prognostic value of blood mRNA expression signatures in castration-resistant prostate cancer: a prospective, two-stage study. Lancet Oncol 2012;13(11):1114-24
72. Yap TA, Swanton C, de Bono JS. Personalization of prostate cancer prevention and therapy: are clinically qualified biomarkers in the horizon? EPMA J 2012;3(1):3