EAU GUIDELINES ON PROSTATE CANCERPART 2: TREATMENT OF ADVANCED, RELAPSING, AND CASTRATION-RESISTANT PROSTATE CANCER
Authors:
N. Mottet; J. Bellmunt; M. Bolla; S. Joniau; M. Mason; V. Matveev; H. P. Schmid; T. Van Der Kwast; T. Wiegel; F. Zattoni; A. Heidenreich
Published in the journal:
Urol List 2011; 9(2): 95-106
Summary
Objectives:
Our aim is to present a summary of the 2010 version of the European Association of Urology (EAU) Guidelines on the treatment of advanced, relapsing, and castration-resistant prostate cancer (CRPC).
Methods:
The working panel performed a literature review of the new data emerging from 2007 to 2010. The guidelines were updated, and the levels of evidence (LEs) and/or grades of recommendation (GR) were added to the text based on a systematic review of the literature, which included a search of online databases and bibliographic reviews.
Results:
Luteinising hormone-releasing hormone (LHRH) agonists are the standard of care in metastatic prostate cancer (PCa). Although LHRH antagonists decrease testosterone without any testosterone surge, their clinical benefit remains to be determined. Complete androgen blockade has a small survival benefit of about 5%. Intermittent androgen deprivation (IAD) results in equivalent oncologic efficacy when compared with continuous androgen-deprivation therapy (ADT) in well-selected populations. In locally advanced and metastatic PCa, early ADT does not result in a significant survival advantage when compared with delayed ADT. Relapse after local therapy is defined by prostate-specific antigen (PSA) values > 0.2 ng/ml following radical prostatectomy (RP) and > 2 ng/ml above the nadir after radiation therapy (RT). Therapy for PSA relapse after RP includes salvage RT at PSA levels < 0.5 ng/ml and salvage RP or cryosurgical ablation of the prostate in radiation failures. Endorectal magnetic resonance imaging and 11C-choline positron emission tomography/computed tomography (CT) are of limited importance if the PSA is < 2.5 ng/ml; bone scans and CT can be omitted unless PSA is > 20 ng/ml. Follow-up after ADT should include screening for the metabolic syndrome and an analysis of PSA and testosterone levels. Treatment of castration-resistant prostate cancer (CRPC) includes second-line hormonal therapy, novel agents, and chemotherapy with docetaxel at 75 mg/m2 every 3 wk. Cabazitaxel as a second-line therapy for relapse after docetaxel might become a future option. Zoledronic acid and denusomab can be used in men with CRPC and osseous metastases to prevent skeletal-related complications.
Conclusion:
The knowledge in the field of advanced, metastatic, and CRPC is rapidly changing. These EAU Guidelines on PCa summarise the most recent findings and put them into clinical practice. A full version is available at the EAU office or online at www.uroweb.org.
Key words:
prostate cancer, EAU Guidelines, review, follow-up, salvage radiation therapy, salvage radical prostatectomy, androgen deprivation, chemotherapy, MDV3100, abiraterone, docetaxel, zoledronic acid, denusomab
Zdroje
1. Heidenreich A, Aus G, Bolla M et al. EAU guidelines on prostate cancer. Eur Urol 2008; 53(1): 68–80.
2. Modified from Oxford Centre for Evidence-Based Medicine Levels of Evidence (May 2001). Produced by Phillips B, Ball C, Sackett D et al since November 1998. CEBM Web site. http://www.pdptoolkit.co.uk/ /Files/ebm/cebm/Doing%20ebm/levels_of_evidence.htm. Accessed November 2010.
3. McLeod. Hormonal therapy: historical perspective to future directions. Urology 2003; 61 (2 Suppl 1): 3–74.
4. Seidenfeld J, Samson DJ, Hasselblad V et al. Single-therapy androgen suppression in men with advanced prostate cancer: a systematic review and meta-analysis. Ann Intern Med 2000; 132(7): 566–577.
5. Klotz L, Boccon-Gibod L, Shore ND et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int 2008; 102(11): 1531–1538.
6. Tombal B, Miller K, Boccon-Gibod L et al. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol 2010; 57(5): 836–842.
7. Kaisary AV, Iversen P, Tyrrell CJ et al. Is there a role for antiandrogen monotherapy in patients with metastatic prostate cancer? Prost Cancer Prost Dis 2001; 4(4): 196–203.
8. Tyrrell CJ, Denis L, Newling D et al. Casodex® 10–200 mg daily, used as monotherapy for patients with advanced prostate cancer: an overview of the efficacy, tolerability and pharmacokinetics from three phase II dose-ranging studies. Casodex Study Group. Eur Urol 1998; 33(1): 39–53.
9. Tyrrell CJ, Kaisary AV, Iversen P et al. A randomised comparison of ‘Casodex®’ (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol 1998; 33(5): 447–456.
10. Schmitt B, Wilt TJ, Schellhammer PF et al. Combined androgen blockade with non-steroidal antiandrogens for advanced prostate cancer: a systematic review. Urology 2001; 57(4): 727–732.
11. Moul JW. Twenty years of controversy surrounding combined androgen blockade for advanced prostate cancer. Cancer 2009; 115(15): 3376–3378.
12. Cruz Guerra NA. Outcomes from the use of maximal androgen blockade in prostate cancer at health area with reference hospital type 2 (1st part). Quality of life: application of EORTC QLQ-C30 instrument. Arch Esp Urol 2009; 62(6): 431–457.
13. Abrahamsson PA. Potential benefits of intermittent androgen suppression therapy in the treatment of prostate cancer: a systematic review of the literature. Eur Urol 2010; 57(1): 49–59.
14. Hussain M, Tangen CM, Higano C et al. Southwest Oncology Group Trial 9346 (INT-0162). Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162). J Clin Oncol 2006; 24(24): 3984–3990.
15. Yu EY, Gulati R, Telesca D et al. Duration of first off-treatment interval is prognostic for time to castration resistance and death in men with biochemical relapse of prostate cancer treated on a prospective trial of intermittent androgen deprivation. J Clin Oncol 2010; 28(16): 2668–2673.
16. de Leval J, Boca P, Yousef E et al. Intermittent versus continuous total androgen blockade in the treatment of patients with advanced hormone-naive prostate cancer: results of a prospective randomized multicenter trial. Clin Prostate Cancer 2002; 1(3): 163–171.
17. Calais da Silva FEC, Bono AV, Whelan P et al. Intermittent androgen deprivation for locally advanced and metastatic prostate cancer: results from a randomised phase 3 study of the South European Uroncological Group. Eur Urol 2009; 55(6): 1269–1277.
18. Boccon-Gibod L, Hammerer P, Madersbacher S et al. The role of intermittent androgen deprivation in prostate cancer. BJU Int 2007; 100(4): 738–743.
19. Studer UE, Whelan P, Albrecht W et al. Immediate or deferred androgen deprivation for patients with prostate cancer not suitable for local treatment with curative intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891. J Clin Oncol 2006; 24(12): 1868–1876.
20. Studer UE, Collette L, Whelan P et al. EORTC Genitourinary Group. Using PSA to guide timing of androgen deprivation in patients with T0-4 N0-2 M0 prostate cancer not suitable for local curative treatment (EORTC 30891). Eur Urol 2008; 53: 941–949.
21. Schröder FH, Kurth KH, Fossa SD et al. Early versus delayed endocrine treatment of T2-T3 pN1-3 M0 prostate cancer without local treatment of the primary tumour: final results of European Organisation for the Research and Treatment of Cancer protocol 30846 after 13 years of follow-up (a randomised controlled trial). Eur Urol 2009; 55(1): 14–22.
22. Moul JW, Wu H, Sun L et al. Early versus delayed hormonal therapy for prostate specific antigen only recurrence of prostate cancer after radical prostatectomy. J Urol 2004; 171(3): 1141–1147.
23. Byar DP. Proceedings: the Veterans Administration Co-operative Urological Research Group studies of cancer of the prostate. Cancer 1973; 32: 1126–1130.
24. Jordan WP Jr, Blackard CE, Byar DP. Reconsideration of orchiectomy in the treatment of advanced prostatic carcinoma. South Med J 1977; 70(12): 1411–1413.
25. Immediate versus deferred treatment for advanced prostatic cancer: initial results of the Medical Research Council Trial. Medical Research Council Prostate Cancer Working Party Investigators Group. Br J Urol 1997; 79(2): 235–246.
26. Messing EM, Manola J, Sarosdy M et al. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. N Engl J Med 1999; 341(24): 1781–1788.
27. Nair B, Wilt T, MacDonald R et al. Early versus deferred androgen suppression in the
treatment of advanced prostatic cancer. Cochrane Database Syst Rev 2002; (1): CD003506.
28. Messing EM, Manola J, Yao J et al. Eastern Cooperative Oncology Group study EST 3886. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol 2006; 7(6): 472–479.
29. Wong YN, Freedland S, Egleston B et al. Role of androgen deprivation therapy for node-positive prostate cancer. J Clin Oncol 2009; 27(1): 100–105.
30. Morgan SC, Dearnaley SP. Additional therapy for high-risk prostate cancer treated with surgery: what is the evidence? Expert Rev Anticancer Ther 2009; 9(7): 939–951.
31 Serpa Neto A, Tobias-Machado M, Esteves MA et al. A systematic review and meta-analysis of bone metabolism in prostate adenocarcinoma. BMC Urol 2010; 10: 9.
32. Isbarn H, Boccon-Gibod L, Carroll PR et al. Androgen deprivation therapy for the treatment of prostate cancer: consider both benefits and risks. Eur Urol 2009; 55(1): 62–75.
33. Schulman CC, Irani J, Morote J et al. Testosterone measurement in patients with prostate cancer. Eur Urol 2010; 58(1): 65–74.
34. Morote J, Esquena S, Abascal JM et al. Failure to maintain a suppressed level of serum testosterone during long-acting depot luteinising hormone releasing hormone agonist therapy in patients with advanced prostate cancer. Urol Int 2006; 77(2): 135–138.
35. Perachino M, Cavalli V, Bravi F. Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance? BJU Int 2010; 105(5): 648–651.
36. Faris JE, Smith MR. Metabolic sequelae associated with androgen deprivation therapy for prostate cancer. Curr Opin Endocrinol Diabetes Obes 2010; 17(3): 240–246.
37. Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol 2009; 181(5): 1998–2006.
38. Stephenson AJ, Kattan MW, Eastham JA et al. Defining biochemical recurrence of prostate cancer after radical prostatectomy: a proposal for a standardized definition. J Clin Oncol 2006; 24(24): 3973–3978.
39. Roach M 3rd, Hanks G, Thames H Jr et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Biol Phys 2006; 65(4): 965–974.
40. Slovin SF, Wilton AS, Heller G et al. Time to detectable metastatic disease in patients with rising prostate-specific antigen values following surgery or radiation therapy. Clin Cancer Res 2005; 11 (24 Pt 1): 8669–8673.
41. Cher ML, Bianco FJ Jr, Lam JS et al. Limited role of radionuclide bone scintigraphy in patients with prostate specific antigen elevations after radical prostatectomy. J Urol 1998; 160(4): 1387–1391.
42. Kane CJ, Amling CL, Johnstone PAS et al. Limited value of bone scintigraphy and computed tomography in assessing biochemical failure after radical prostatectomy. Urology 2003; 61(3): 607–611.
43. Gomez P, Manoharan M, Kim SS et al. Radionuclide bone scintigraphy in patients with biochemical recurrence after radical prostatectomy: when is it indicated? BJU Int 2004; 94(3): 299–302.
44. Cirillo S, Petracchini M, Scotti L et al. Endorectal magnetic resonance imaging at 1.5 Tesla to assess local recurrence following radical prostatectomy using T2-weighted and contrast-enhanced imaging. Eur Radiol 2009; 19(3): 761–769.
45. Westphalen AC, Coakley FV, Roach M 3rd et al. Locally recurrent prostate cancer after external beam radiation therapy: diagnostic performance of 1.5-T endorectal MR imaging and MR spectroscopic imaging for detection. Radiology 2010; 256(2): 485–492.
46. Pelosi E, Arena V, Skanjeti A et al. Role of whole-body 18F-choline PET/CT in disease detection in patients with biochemical relapse after radical treatment for prostate cancer. Radiol Med 2008; 113(6): 895–904.
47. Breeuwsma AJ, Pruim J, van den Bergh AC et al. Detection of local, regional, and distant recurrence in patients with PSA relapse after external-beam radiotherapy using (11)C-choline positron emission tomography. Int J Radiat Oncol Biol Phys 2010; 77(1): 160–164.
48. Giovacchini G, Picchio M, Coradeschi E et al. Predictive factors of [(11)C]choline PET/CT in patients with biochemical failure after radical prostatec-tomy. Eur J Nucl Med Mol Imaging 2010; 37(2): 301–309.
49. Schillaci O, Calabria F, Tavolozza M et al. 18F-choline PET/CT physiological distribution and pitfalls in image interpretation: experience in 80 patients with prostate cancer. Nucl Med Commun 2010; 31(1): 39–45.
50. Stephenson AJ, Scardino PT, Kattan MW et al. Predicting outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol 2007; 25(15): 2035–2041.
51. Swanson GP, Hussey MA, Tangen CM et al. Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol 2007; 25(16): 2225–2229.
52. Trock BJ, Han M, Freedland SJ et al. Prostate cancer-specific survival following salvage radiotherapy vs observation in men with biochemical recurrence after radical prostatectomy. JAMA 2008; 299(23): 2760–2769.
53. Goldner G, Dimopoulos J, Pötter R. Is the Roach formula predictive for biochemical outcome in prostate cancer patients with minimal residual disease undergoing local radiotherapy after radical prostatectomy? Radiother Oncol 2010; 94(3): 324–327.
54. Da Pozzo LF, Cozzarini C, Briganti A et al. Long-term follow-up of patients with prostate cancer and nodal metastases treated by pelvic lymphadenectomy and radical prostatectomy: the positive impact of adjuvant radiotherapy. Eur Urol 2009; 55: 1003–1011.
55. Grossfeld GD, Li YP, Lubeck DP et al. Predictors of secondary cancer treatment in patients receiving local therapy for prostate cancer: data from cancer of the prostate strategic urologic research endeavor. J Urol 2002; 168(2): 530–535.
56. Heidenreich A, Semrau R, Thüer D et al. Radical salvage prostatectomy: treatment of local recurrence of prostate cancer after radiotherapy. Urologe A 2008; 47(11): 1441–1446.
57. Stephenson AJ, Scardino PT, Bianco FJ et al. Morbidity and functional outcomes of salvage radical prostatectomy for locally recurrent prostate cancer after radiation therapy. J Urol 2004; 172 (6 Pt 1): 2239–2243.
58. Heidenreich A, Ohlmann C, Ozgür E et al. Functional and oncological outcome of salvage prostatectomy of locally recurrent prostate cancer following radiation therapy Urologe A 2006; 45(4): 474–481.
59. Heidenreich A, Richter S, Thüer D et al. Prognostic parameters, complications, and oncologic and functional outcome of salvage radical prostatectomy for locally recurrent prostate cancer after 21st-century radiotherapy. Eur Urol 2010; 57(3): 437–445.
60. Stephenson AJ, Eastham JA. Role of salvage radical prostatectomy for recurrent prostate cancer after radiation therapy. J Clin Oncol 2005; 23(32): 8198–8203.
61. Pisters LL, von Eschenbach AC, Scott SM et al. The efficacy and complications of salvage cryotherapy of the prostate. J Urol 1997; 157(3): 921–925.
62. Cespedes RD, Pisters LL, von Eschenbach AC et al. Long-term follow-up of incontinence and obstruction after salvage cryosurgical ablation of the prostate: results in 143 patients. J Urol 1997; 157(1): 237–240.
63. Eisenberg ML, Shinohara K. Partial salvage cryoablation of the prostate for recurrent prostate cancer after radiotherapy failure. Urology 2008; 72(6): 1315–1318.
64. Pisters LL, Rewcastle JC, Donnelly BJ et al. Salvage prostate cryoablation: initial results from the cryo on-line data registry. J Urol 2008; 180(2): 559–563.
65. Bubley GJ, Carducci M, Dahut W et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999; 17(11): 3461–3467.
66. Warmuth M, Johansson T, Mad P. Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. Eur Urol 2010; 58(6): 803–815.
67. Murat FJ, Poissonnier L, Rabilloud M et al. Mid-term results demonstrate salvage high-intensity focused ultrasound (HIFU) as an effective and acceptably morbid salvage treatment option for locally radiorecurrent prostate cancer. Eur Urol 2009; 55(3): 640–649.
68. Scher HI, Halabi S, Tannock I et al. Prostate Cancer Clinical Trials Working Group. 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(7): 1148–1159.
69. Scher HI, Beer TM, Higano CS et al. Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate can-cer: a phase 1-2 study. Lancet 2010; 375(9724): 1437–1446.
70. Danila DC, Morris MJ, de Bono JS et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol 2010; 28(9): 1496–1501.
71. Manni A, Bartholomew M, Caplan R et al. Androgen priming and chemotherapy in advanced prostate cancer: evaluation of determinants of clinical outcome. J Clin Oncol 1988; 6(9): 1456–1466.
72. D’Amico AV, Chen MH, Renshaw AA et al. Interval to testosterone recovery after hormonal therapy for prostate cancer and risk of death. Int J Radiat Oncol Biol Phys 2009; 75(1): 10–15.
73. Di Lorenzo G, Buonerba C, Autorino R et al. Castration-resistant prostate cancer: current and emerging treatment strategies. Drugs 2010; 70(8): 983–1000.
74. Ryan C, Efstathiou E, Smith M et al. Phase II multicenter study of chemotherapy (chemo)-naive castration-resistant prostate cancer (CRPC) not exposed to ketoconazole (keto), treated with abiraterone acetate (AA) plus prednisone. J Clin Oncol 2009; 27: 15.
75. 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): 1513–1520.
76. Tannock IF, de Wit R, Berry WR et al. TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351(15): 1502–1512
77. Fitzpatrick JM, Anderson J, Sternberg CN et al. Optimizing treatment for men with advanced prostate cancer: expert recommendations and the multidisciplinary approach. Crit Rev Oncol Hematol 2008; 68 (Suppl 1): S9–S22.
78. Armstrong AJ, Garrett-Mayer E, de Wit R et al. Prediction of survival following first-line chemotherapy in men with castration-resistant metastatic prostate cancer. Clin Cancer Res 2010; 16(1): 203–211.
79. Loriot Y, Massard C, Gross-Goupil M et al. The interval from the last cycle of docetaxel-based chemotherapy to progression is associated with the efficacy of subsequent docetaxel in patients with prostate cancer. Eur J Cancer 2010; 46(10): 1770–1772.
80. Buonerba C, Palmieri G, di Lorenzo G. Docetaxel rechallenge in castration-resistant prostate cancer: scientific legitimacy of common clinical practice. Eur Urol 2010; 58(4): 636–637.
81. Eymard JC, Oudard S, Gravis G et al. Docetaxel reintroduction in patients with metastatic castration-resistant docetaxel-sensitive prostate cancer: a retrospective multicentre study. BJU Int 2010; 106(7): 974–978.
82. Ohlmann CH, Markert E, Gerharz M et al. Improving the efficacy of targeted trials by multiple-marker analysis in castration-resistant prostate cancer. Urol Oncol 2009. In press. doi:10.1016//j.urolonc.2009.09.010.
83. Fizazi K, Sternberg CN, Fitzpatrick JM et al. Role of targeted therapy in the treatment of advanced prostate cancer. BJU Int 2010; 105(6): 748–767.
84. Sternberg CN, Petrylak DP, Sartor O 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): 5431–5438.
85. Sartor AO, Oudard S, Ozguroglu M et al. for the TROPIC Investigators. Cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: Final results of a multinational phase III trial (TROPIC). 2010 Genitourinary Cancers Symposium. Abstract 9.
86. Kantoff PW, Higano CS, Shore ND et al. IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363(5): 411–422.
87. Saad F, Gleason DM, Murray R et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone refractory metastatic prostate carcinoma. J Natl Cancer Inst 2002; 94(19): 1458–1468.
88. Fizazi K, Carducci MA, Smith MR et al. A randomized phase III trial of denusomab versus zoledronic acid in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol 2009; 27(15): 2429–2435.
89. Kuhn JM, Billebaud T, Navratil H et al. Prevention of the transient adverse effects of a gonadotropin-releasing hormone analogue (buserelin) in metastatic prostatic carcinoma by administration of an antiandrogen (nilutamide). N Engl J Med 1989; 321(7): 413–418.
90. 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): 419–424.
Štítky
Paediatric urologist UrologyČlánok vyšiel v časopise
Urological Journal
2011 Číslo 2
Najčítanejšie v tomto čísle
- A SUMMARY OF NEW TECHNOLOGIES FOR PROSTATE CANCER (ROBOT, LAP, BRACHY, CRYO, CYBERKNIFE)
- EAU GUIDELINES ON PROSTATE CANCER - PART 1: SCREENING, DIAGNOSIS, AND TREATMENT OF CLINICALLY LOCALISED DISEASE
- SCREENING OF PROSTATE CANCER
- EAU GUIDELINES ON PROSTATE CANCERPART 2: TREATMENT OF ADVANCED, RELAPSING, AND CASTRATION-RESISTANT PROSTATE CANCER