|
|
Line 438: |
Line 438: |
| ===References=== | | ===References=== |
| # Tu SM, Millikan RE, Mengistu B, Delpassand ES, Amato RJ, Pagliaro LC, Daliani D, Papandreou CN, Smith TL, Kim J, Podoloff DA, Logothetis CJ. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet. 2001 Feb 3;357(9253):336-41. Erratum in: Lancet 2001 Apr 14;357(9263):1210. [https://www.thelancet.com/journals/lancet/article/PIIS0140673600036394/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11210994 PubMed] | | # Tu SM, Millikan RE, Mengistu B, Delpassand ES, Amato RJ, Pagliaro LC, Daliani D, Papandreou CN, Smith TL, Kim J, Podoloff DA, Logothetis CJ. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet. 2001 Feb 3;357(9253):336-41. Erratum in: Lancet 2001 Apr 14;357(9263):1210. [https://www.thelancet.com/journals/lancet/article/PIIS0140673600036394/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11210994 PubMed] |
− |
| |
− | ==Placebo==
| |
− | {| class="wikitable" style="float:right; margin-left: 5px;"
| |
− | |-
| |
− | |[[#top|back to top]]
| |
− | |}
| |
− | ===Regimen===
| |
− | {| class="wikitable" style="width: 100%; text-align:center;"
| |
− | !style="width: 20%"|Study
| |
− | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
| |
− | !style="width: 20%"|Comparator
| |
− | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
| |
− | !style="width: 20%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]]
| |
− | |-
| |
− | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(07)70147-X/abstract Nilsson et al. 2007]
| |
− | |style="background-color:#1a9851"|Randomized Phase II (C)
| |
− | |[[Prostate_cancer#Radium-223_monotherapy|Radium-223]]
| |
− | |style="background-color:#fee08b"|Might have inferior OS
| |
− | |
| |
− | |-
| |
− | |[https://www.nejm.org/doi/full/10.1056/NEJMoa1001294 Kantoff et al. 2010 (IMPACT<sub>prostate</sub>)]
| |
− | |style="background-color:#1a9851"|Phase III (C)
| |
− | |[[Prostate_cancer#Sipuleucel-T_monotherapy|Sipuleucel-T]]
| |
− | |style="background-color:#fc8d59"|Seems to have inferior OS
| |
− | |
| |
− | |-
| |
− | |[https://www.nejm.org/doi/full/10.1056/NEJMoa1207506 Scher et al. 2012 (AFFIRM)]
| |
− | |style="background-color:#1a9851"|Phase III (C)
| |
− | |[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]]
| |
− | |style="background-color:#d73027"|Inferior OS
| |
− | |
| |
− | |-
| |
− | |[https://www.nejm.org/doi/full/10.1056/NEJMoa1213755 Parker et al. 2013 (ALSYMPCA)]
| |
− | |style="background-color:#1a9851"|Phase III (C)
| |
− | |[[Prostate_cancer#Radium-223_monotherapy|Radium-223]]
| |
− | |style="background-color:#d73027"|Inferior OS
| |
− | |style="background-color:#d73027"|Inferior EQ-5D score
| |
− | |-
| |
− | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70189-5/abstract Kwon et al. 2014 (CA184-043)]
| |
− | |style="background-color:#1a9851"|Phase III (C)
| |
− | |Ipilimumab
| |
− | |style="background-color:#fee08b"|Might have inferior OS
| |
− | |
| |
− | |-
| |
− | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418931/ Beer et al. 2014 (PREVAIL)]
| |
− | |style="background-color:#1a9851"|Phase III (C)
| |
− | |[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]]
| |
− | |style="background-color:#d73027"|Inferior OS
| |
− | |style="background-color:#d73027"|Worse HRQoL
| |
− | |-
| |
− | |[https://doi.org/10.1200/JCO.2016.69.1584 Beer et al. 2016]
| |
− | |style="background-color:#1a9851"|Phase III (C)
| |
− | |Ipilimumab
| |
− | |style="background-color:#ffffbf"|Seems not superior
| |
− | |
| |
− | |-
| |
− | |}
| |
− | ''No active antineoplastic treatment; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.''
| |
− |
| |
− | ===References===
| |
− | # '''D9901:''' Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. 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 Jul 1;24(19):3089-94. [https://doi.org/10.1200/JCO.2005.04.5252 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16809734 PubMed]
| |
− | ## '''Pooled Update:''' Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. 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 Aug 15;115(16):3670-9. [https://onlinelibrary.wiley.com/doi/full/10.1002/cncr.24429 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/19536890 PubMed]
| |
− | # Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(07)70147-X/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17544845 PubMed]
| |
− | ## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. 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 Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.clinical-genitourinary-cancer.com/article/S1558-7673(12)00168-1/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed]
| |
− | # '''IMPACT:''' Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. [https://www.nejm.org/doi/full/10.1056/NEJMoa1001294 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20818862 PubMed]
| |
− | # '''AFFIRM:''' Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. [https://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22894553 PubMed]
| |
− | <!--
| |
− | # Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session]
| |
− | # A. Oliver Sartor, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Sten Nilsson, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, Chris Parker. Radium-223 chloride (Ra-223) impact on skeletal-related events (SREs) and ECOG performance status (PS) in patients with castration-resistant prostate cancer (CRPC) with bone metastases: Interim results of a phase III trial (ALSYMPCA). 2012 ASCO Annual Meeting Abstract 4551. [http://meetinglibrary.asco.org/content/94891-114 link to abstract]
| |
− | # Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract]
| |
− | # Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract]
| |
− | # '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. 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 Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.clinical-genitourinary-cancer.com/article/S1558-7673(12)00168-1/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed]
| |
− | -->
| |
− | # '''ALSYMPCA:''' Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. [https://www.nejm.org/doi/full/10.1056/NEJMoa1213755 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23863050 PubMed]
| |
− | ## '''Subgroup analysis:''' Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland ØS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. Epub 2014 May 13. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70183-4/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24836273 PubMed]
| |
− | ## '''Subgroup analysis:''' Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. Epub 2014 Oct 17. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25439694 PubMed]
| |
− | ## '''HRQoL analysis:''' Nilsson S, Cislo P, Sartor O, Vogelzang NJ, Coleman RE, O'Sullivan JM, Reuning-Scherer J, Shan M, Zhan L, Parker C. Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Ann Oncol. 2016 May;27(5):868-74. Epub 2016 Feb 23. [https://doi.org/10.1093/annonc/mdw065 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843190/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26912557 PubMed]
| |
− | # '''CA184-043:''' Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. Epub 2014 May 13. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70189-5/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418935/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24831977 PubMed]
| |
− | <!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] '''contains verified protocol''' -->
| |
− | # '''PREVAIL:''' Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. [https://www.nejm.org/doi/full/10.1056/NEJMoa1405095 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418931/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24881730 PubMed]
| |
− | ## '''Update:''' Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in men with chemotherapy-naïve metastatic castration-resistant prostate cancer: Extended analysis of the phase 3 PREVAIL study. Eur Urol. 2017 Feb;71(2):151-154. Epub 2016 Jul 28. [http://www.europeanurology.com/article/S0302-2838(16)30437-7/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5570461/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27477525 PubMed]
| |
− | ## '''HRQoL analysis:''' Devlin N, Herdman M, Pavesi M, Phung, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. [https://hqlo.biomedcentral.com/articles/10.1186/s12955-017-0704-y link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481866/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/28645287 PubMed]
| |
− | # Beer TM, Kwon ED, Drake CG, Fizazi K, Logothetis C, Gravis G, Ganju V, Polikoff J, Saad F, Humanski P, Piulats JM, Gonzalez Mella P, Ng SS, Jaeger D, Parnis FX, Franke FA, Puente J, Carvajal R, Sengeløv L, McHenry MB, Varma A, van den Eertwegh AJ, Gerritsen W. Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer. J Clin Oncol. 2017 Jan;35(1):40-47. Epub 2016 Oct 31. [https://doi.org/10.1200/JCO.2016.69.1584 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28034081 PubMed]
| |
| | | |
| ==Vinblastine monotherapy {{#subobject:1d9e22 |Regimen=1}}== | | ==Vinblastine monotherapy {{#subobject:1d9e22 |Regimen=1}}== |