Difference between revisions of "Staging page"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
m
Line 3: Line 3:
 
[[#top|Back to Top]]
 
[[#top|Back to Top]]
 
</div>
 
</div>
−
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Prostate_cancer|main prostate cancer page]] for current regimens.
+
{| class="wikitable" style="text-align:center; width:50%;"
 +
!colspan="2" align="center" style="color:white; font-size:125%; background-color:#de2d26"|'''Section editor'''
 +
|-
 +
|style="background-color:#F0F0F0"|[[File:Sanjay_mohan.png|frameless|upright=0.3|center]]
 +
|<big>[[User:Sanjaymohan|Sanjay R. Mohan, MD, MSCI]]<br>Vanderbilt University<br>Nashville, TN</big>
 +
|-
 +
|}
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
|-
 
|-
−
|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
+
|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
−
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
+
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
−
|}  
+
|}
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
−
=Definitive radiotherapy=
+
=Guidelines=
−
==Radiation therapy==
+
==NCCN==
 +
*[https://www.nccn.org/professionals/physician_gls/pdf/mlne.pdf NCCN Guidelines - Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Fusion Genes]
 +
=All lines of therapy=
 +
==Alemtuzumab monotherapy {{#subobject:9207db|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen===
+
===Regimen {{#subobject:45d126|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable" style="width: 40%; text-align:center;"  
−
!style="width: 20%"|Study
+
!style="width: 25%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/s0360-3016(01)01579-6 Pilepich et al. 2001 (RTOG 86-10)]
 
−
|1987-1991
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide, Goserelin, RT]]
 
−
|style="background-color:#fc8d59"|Seems to have inferior cause-specific mortality
 
−
|-
 
−
|[https://doi.org/10.1200/jco.1997.15.3.1013 Pilepich et al. 1997 (RTOG 85-31)]
 
−
|1987-1992
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Goserelin_.26_RT|Goserelin & RT]]
 
−
|style="background-color:#d73027"|Inferior DFS
 
−
|-
 
−
|[https://doi.org/10.1056/NEJM199707313370502 Bolla et al. 1997 (EORTC 22863)]
 
−
|1987-1995
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Goserelin_.26_RT|Goserelin & RT]]
 
−
|style="background-color:#d73027"|Inferior OS
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1012348 Jones et al. 2011 (RTOG 94-08)]
 
−
|1994-2001
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|1. [[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide, Goserelin, RT]]<br>2. [[Prostate_cancer#Flutamide.2C_Leuprolide.2C_RT|Flutamide, Leuprolide, RT]]
 
−
|style="background-color:#fc8d59"|Seems to have inferior OS
 
−
|-
 
−
|[http://jama.ama-assn.org/content/299/3/289.long D'Amico et al. 2008 (DFCI 95-096)]
 
−
|1995-2001
 
−
|style="background-color:#1a9851"|Randomized (C)
 
−
|[[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide, Goserelin, RT]]
 
−
|style="background-color:#d73027"|Inferior OS
 
−
|-
 
−
|rowspan=2|[https://doi.org/10.1016/S1470-2045(05)70348-X Denham et al. 2005 (TROG 96.01)]
 
−
|rowspan=2|1996-2000
 
−
|rowspan=2 style="background-color:#1a9851"|Phase 3 (C)
 
−
|1. [[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide & Goserelin x 3 mo, RT]]
 
−
|style="background-color:#d73027"|Inferior EFS<sup>1</sup>
 
 
|-
 
|-
−
|2. [[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide & Goserelin x 6 mo, RT]]
+
|[http://www.jacionline.org/article/S0091-6749(09)00223-1 Wagner et al. 2009]
−
|style="background-color:#d73027"|Inferior OS<sup>1</sup>
+
|style="background-color:#ffffbe"|Case report
−
|-
 
−
|[https://doi.org/10.1002/cncr.30093 McPartlin et al. 2016 (PMH 9907)]
 
−
|1999-2006
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Bicalutamide_.26_RT_99|Bicalutamide & RT]]
 
−
|style="background-color:#ffffbf"|Did not meet primary endpoint of BFI
 
 
|-
 
|-
 
|}
 
|}
−
''<sup>1</sup>Reported efficacy for TROG 96.01 is based on the 2011 update.''<br>
+
''Note: treatment is to be given bi-weekly, exact days not specified; below is an example. Duration also not specified.''
−
''Demonstrated to be inferior in almost all studies; here for reference purposes only.''
+
<div class="toccolours" style="background-color:#b3e2cd">
−
====Radiotherapy====
+
====Targeted therapy====
−
*[[External beam radiotherapy]] of varying doses (see papers for details)
+
*[[Alemtuzumab (Campath)]] 30 mg IV once per day on days 1 & 4
 +
'''7-day cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# '''RTOG 85-31:''' Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. [https://doi.org/10.1200/jco.1997.15.3.1013 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/9060541 PubMed]
+
# '''Case report:''' Wagner LA, Speckart S, Cutter B, Gleich GJ. Treatment of FIP1L1/PDGFRA-negative hypereosinophilic syndrome with alemtuzumab, an anti-CD52 antibody. J Allergy Clin Immunol. 2009 Jun;123(6):1407-8. Epub 2009 Apr 1. [http://www.jacionline.org/article/S0091-6749(09)00223-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/19342084 PubMed]
−
## '''Update:''' Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. [https://doi.org/10.1016/s0360-3016(00)01516-9 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/11240234 PubMed]
+
# '''Retrospective:''' Strati P, Cortes J, Faderl S, Kantarjian H, Verstovsek S. Long-term follow-up of patients with hypereosinophilic syndrome treated with Alemtuzumab, an anti-CD52 antibody. Clin Lymphoma Myeloma Leuk. 2013 Jun;13(3):287-91. Epub 2012 Nov 1. [http://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(12)00202-9 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445419/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23123105 PubMed]
−
## '''Update:''' Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. [https://doi.org/10.1016/j.ijrobp.2004.08.047 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/15817329 PubMed]
+
==Benralizumab monotherapy {{#subobject:39b68c|Regimen=1}}==
−
# '''EORTC 22863:''' Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. [https://doi.org/10.1056/NEJM199707313370502 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9233866 PubMed] NCT00849082
 
−
## '''Update:''' Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. [https://doi.org/10.1016/S0140-6736(02)09408-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12126818 PubMed]
 
−
## '''Update:''' Bolla M, Van Tienhoven G, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Billiet I, Torecilla JL, Pfeffer R, Cutajar CL, Van der Kwast T, Collette L. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010 Nov;11(11):1066-73. Epub 2010 Oct 7. [https://doi.org/10.1016/S1470-2045(10)70223-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20933466 PubMed]
 
−
# '''RTOG 86-10:''' Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. [https://doi.org/10.1016/s0360-3016(01)01579-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11483335 PubMed]
 
−
## '''Update:''' Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. [https://doi.org/10.1200/jco.2007.13.9881 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18172188 PubMed]
 
−
# '''TROG 96.01:''' Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. [https://doi.org/10.1016/S1470-2045(05)70348-X link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/16257791 PubMed] ACTRN12607000237482
 
−
## '''Update:''' Denham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, Atkinson C, North J, Christie D, Spry NA, Tai KH, Wynne C, D'Este C. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol. 2011 May;12(5):451-9. [https://doi.org/10.1016/S1470-2045(11)70063-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21440505 PubMed]
 
−
# '''DFCI 95-096:''' D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. [http://jama.ama-assn.org/content/299/3/289.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/18212313 PubMed] content property of [http://hemonc.org HemOnc.org] NCT00116220
 
−
# '''RTOG 94-08:''' Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [https://doi.org/10.1056/NEJMoa1012348 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21751904 PubMed] NCT00002597
 
−
# '''PMH 9907:''' McPartlin AJ, Glicksman R, Pintilie M, Tsuji D, Mok G, Bayley A, Chung P, Bristow RG, Gospodarowicz MK, Catton CN, Milosevic M, Warde PR. PMH 9907: Long-term outcomes of a randomized phase 3 study of short-term bicalutamide hormone therapy and dose-escalated external-beam radiation therapy for localized prostate cancer. Cancer. 2016 Aug 15;122(16):2595-603. Epub 2016 May 24. [https://doi.org/10.1002/cncr.30093 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27219522 PubMed]
 
−
#'''EORTC 22991:''' Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, Sundar S, van der Steen-Banasik EM, Armstrong J, Bosset JF, Herrera FG, Pieters B, Slot A, Bahl A, Ben-Yosef R, Boehmer D, Scrase C, Renard L, Shash E, Coens C, van den Bergh AC, Collette L. Short androgen suppression and radiation dose escalation for intermediate- and high-risk localized prostate cancer: results of EORTC trial 22991. J Clin Oncol. 2016 May 20;34(15):1748-56. Epub 2016 Mar 14. [https://doi.org/10.1200/JCO.2015.64.8055 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26976418 PubMed] NCT00021450
 
−
##'''Subgroup analysis:''' Bolla M, Neven A, Maingon P, Carrie C, Boladeras A, Andreopoulos D, Engelen A, Sundar S, van der Steen-Banasik EM, Armstrong J, Peignaux-Casasnovas K, Boustani J, Herrera FG, Pieters BR, Slot A, Bahl A, Scrase CD, Azria D, Jansa J, O'Sullivan JM, Van Den Bergh ACM, Collette L; EORTC Radiation Oncology Group. Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease. J Clin Oncol. 2021 Sep 20;39(27):3022-3033. Epub 2021 Jul 26. [https://doi.org/10.1200/jco.21.00855 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34310202/ PubMed]
 
−
=Hormonal therapy for locally advanced or metastatic disease=
 
−
==Castration==
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen===
+
===Regimen {{#subobject:2gh77d|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
 
!style="width: 20%"|Years of enrollment
 
!style="width: 20%"|Years of enrollment
Line 99: Line 50:
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://doi.org/10.1016/S0140-6736(85)90739-1 Parmar et al. 1985]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557265/ Kuang et al. 2019 (NIAID 14-I-0081)]
−
|1984-1985
+
|2014-2017
−
|style="background-color:#1a9851"|Phase 3 (C)
+
| style="background-color:#91cf61" |Randomized Phase 2, <20 pts (E-esc)
−
|[[#D-Trp-6-LHRH_monotherapy_77|D-Trp-6-LHRH]]
+
|[[#Placebo_88|Placebo]]
−
|style="background-color:#ffffbf"|Seems not superior
+
| style="background-color:#91cf60" |Seems to have superior primary endpoint
−
|-
 
−
|[https://doi.org/10.1016/0090-4295(91)80077-K Soloway et al. 1991]
 
−
|NR
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]]
 
−
|style="background-color:#ffffbf"|Did not meet efficacy endpoints
 
−
|-
 
−
|[https://doi.org/10.1002/1097-0142(19931215)72:12+%3C3855::aid-cncr2820721718%3E3.0.co;2-i Robinson 1993 (EORTC 30805)]
 
−
|1981-1986
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|1. [[#Castration_.26_Cyproterone_acetate_99|Castration & Cyproterone acetate]]<br>2. [[#DES_monotherapy|DES]]
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://doi.org/10.1111/j.1464-410X.1991.tb15195.x Kaisary et al. 1991]
 
−
|1983-1986
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]]
 
−
|style="background-color:#ffffbf"|Did not meet efficacy endpoints
 
−
|-
 
−
|[https://doi.org/10.1002/cncr.1990.66.s5.1045 Keuppens et al. 1990 (EORTC 30853)]
 
−
|1986-1988
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Flutamide_.26_Goserelin|Flutamide & Goserelin]]
 
−
|style="background-color:#fc8d59"|Seems to have inferior OS<sup>1</sup>
 
−
|-
 
−
|[https://doi.org/10.1016/s0022-5347(17)36003-2 Janknegt et al. 1993 (International Anandron Study)]
 
−
|1986-NR
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Nilutamide_.26_Orchiectomy|Nilutamide & Orchiectomy]]
 
−
|style="background-color:#d73027"|Inferior PFS
 
−
|-
 
−
|[https://doi.org/10.3109/00365599609182309 Bruun et al. 1996]
 
−
|NR
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|1. [[#Buserelin_monotherapy_77|Buserelin]]<br>2. Estrogens
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.2004.11.514 Studer et al. 2004 (SAKK 08/88)]
 
−
|1988-1992
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Castration|Orchiectomy]]; deferred
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://www.karger.com/Article/Abstract/480795 Boccon-Gibod et al. 1997]
 
−
|1989-1991
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Flutamide_monotherapy|Flutamide]]
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://www.karger.com/Article/Abstract/19547 de Voogt et al. 1998 (EORTC 30843)]
 
−
|NR in abstract
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Buserelin_.26_Cyproterone_acetate_77|Buserelin & Cyproterone acetate]]
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://doi.org/10.1056/NEJM199810083391504 Eisenberger et al. 1998]
 
−
|1989-1994
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Flutamide_.26_Orchiectomy_99|Flutamide & Orchiectomy]]
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://www.karger.com/Article/Abstract/19634 Tyrrell et al. 1998]
 
−
|NR in abstract
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[Prostate_cancer#Bicalutamide_monotherapy|Bicalutamide]]
 
−
| style="background-color:#ffffbf" |Seems not superior<sup>2</sup>
 
−
|-
 
−
|[https://www.auajournals.org/doi/full/10.1016/S0022-5347%2805)68191-8 de Reijke et al. 1999]
 
−
|1990-1995
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Mitomycin_.26_Orchiectomy_99|Mitomycin & Orchiectomy]]
 
−
|style="background-color:#ffffbf"|Seems not superior
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3864402/ Millikan et al. 2008 (MDA DM95-231)]
 
−
|1996-2003
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#ADT_.26_KA.2FVE_99|ADT & KA/VE]]
 
−
|style="background-color:#ffffbf"|Seems not superior
 
 
|-
 
|-
 
|}
 
|}
−
''<sup>1</sup>Reported efficacy for EORTC 30853 is based on the 1998 final update.''<br>
+
<div class="toccolours" style="background-color:#b3e2cd">
−
''<sup>2</sup>Reported efficacy for Tyrrell et al. 1998 is based on the 2000 update.''<br>
+
====Immunosuppressive therapy====
−
''No longer widely used as monotherapy in the United States; included for reference purposes only.''
+
*[[Benralizumab (Fasenra)]] 30 mg SC once on day 1
−
====Endocrine therapy====
+
'''28-day cycle for 6 or more cycles'''
−
*[[Endocrine_ablation_surgery#Bilateral_orchiectomy|Bilateral orchiectomy]]
 
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Parmar H, Phillips RH, Lightman SL, Edwards L, Allen L, Schally AV. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet. 1985 Nov 30;2(8466):1201-5. [https://doi.org/10.1016/S0140-6736(85)90739-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2866289 PubMed]
+
# '''NIAID 14-I-0081:''' Kuang FL, Legrand F, Makiya M, Ware J, Wetzler L, Brown T, Magee T, Piligian B, Yoon P, Ellis JH, Sun X, Panch SR, Powers A, Alao H, Kumar S, Quezado M, Yan L, Lee N, Kolbeck R, Newbold P, Goldman M, Fay MP, Khoury P, Maric I, Klion AD. Benralizumab for PDGFRA-negative hypereosinophilic syndrome. N Engl J Med. 2019 Apr 4;380(14):1336-1346. [https://doi.org/10.1056/NEJMoa1812185 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557265/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30943337 PubMed] NCT00001406
−
#'''EORTC 30853:''' Keuppens F, Denis L, Smith P, Carvalho AP, Newling D, Bond A, Sylvester R, De Pauw M, Vermeylen K, Ongena P; EORTC GU Group. Zoladex and flutamide versus bilateral orchiectomy: a randomized phase III EORTC 30853 study. Cancer. 1990 Sep 1;66(5 Suppl):1045-57. [https://doi.org/10.1002/cncr.1990.66.s5.1045 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2144206/ PubMed]
+
==Cladribine & Cytarabine {{#subobject:b80308|Regimen=1}}==
−
##'''Update:''' Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, De Pauw M; [[Study_Groups#EORTC|EORTC]] GU Group. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). Urology. 1993 Aug;42(2):119-29. [https://doi.org/10.1016/0090-4295(93)90634-M link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/8367920 PubMed]
 
−
##'''Update:''' Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R; [[Study_Groups#EORTC|EORTC]] Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. Eur Urol. 1998;33(2):144-51. [https://doi.org/10.1159/000019546 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9519355 PubMed]
 
−
# Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC; Zoladex Prostate Study Group. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Urology. 1991 Jan;37(1):46-51. [https://doi.org/10.1016/0090-4295(91)80077-K link to original article] [https://pubmed.ncbi.nlm.nih.gov/1824732 PubMed]
 
−
## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT; Zoladex Prostate Study Group. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Urology. 1995 Aug;46(2):220-6. [https://doi.org/10.1016/s0090-4295(99)80197-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/7624991 PubMed]
 
−
# Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. [https://doi.org/10.1111/j.1464-410X.1991.tb15195.x link to original article] [https://pubmed.ncbi.nlm.nih.gov/1828183 PubMed]
 
−
# '''International Anandron Study:''' Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM, Dijkman GD, Frick J, Goedhals J, Knönagel H, Venner PM. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82. [https://doi.org/10.1016/s0022-5347(17)36003-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/7678043 PubMed]
 
−
## '''Update:''' Janknegt RA; Anandron International Study Group. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. [https://doi.org/10.1002/1097-0142(19931215)72:12+%3C3874::aid-cncr2820721722%3E3.0.co;2-# link to original article] [https://pubmed.ncbi.nlm.nih.gov/8252507 PubMed]
 
−
## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM; International Anandron Study Group. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. J Urol. 1997 Jul;158(1):160-3. [https://doi.org/10.1097/00005392-199707000-00051 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9186345 PubMed]
 
−
## '''Update:''' de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. [https://doi.org/10.1016/s0302-2838(02)00272-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/12160584 PubMed]
 
−
# '''EORTC 30805:''' Robinson MR. A further analysis of European Organization for Research and Treatment of Cancer protocol 30805: orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose diethylstilbestrol. Cancer. 1993 Dec 15;72(12 Suppl):3855-7. [https://doi.org/10.1002/1097-0142(19931215)72:12+%3C3855::aid-cncr2820721718%3E3.0.co;2-i link to original article] [https://pubmed.ncbi.nlm.nih.gov/8252503 PubMed]
 
−
## '''Update:''' Robinson MR, Smith PH, Richards B, Newling DW, de Pauw M, Sylvester R. The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate. Eur Urol. 1995;28(4):273-83. [https://www.karger.com/Article/Abstract/475067 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8575493 PubMed]
 
−
# Bruun E, Frimodt-Møller C; Danish Buserelin Study Group. The effect of Buserelin versus conventional antiandrogenic treatment in patients with T2-4NXM1 prostatic cancer; A prospective, randomized multicentre phase III trial. Scand J Urol Nephrol. 1996 Aug;30(4):291-7. [https://doi.org/10.3109/00365599609182309 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8908651 PubMed]
 
−
# Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5. [https://www.karger.com/Article/Abstract/480795 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/9412794 PubMed]
 
−
# '''EORTC 30843:''' de Voogt HJ, Studer U, Schröder FH, Klijn JG, de Pauw M, Sylvester R; [[Study_Groups#EORTC|EORTC]] Genito-Urinary Tract Cancer Cooperative Group. Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer: final analysis of EORTC GU Group Trial 30843. Eur Urol. 1998;33(2):152-8. [https://www.karger.com/Article/Abstract/19547 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9519356 PubMed]
 
−
# Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, Wilding G, Sears K, Culkin DJ, Thompson IM Jr, Bueschen AJ, Lowe BA. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998 Oct 8;339(15):1036-42. [https://doi.org/10.1056/NEJM199810083391504 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9761805 PubMed]
 
−
# Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. 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):447-56. [https://www.karger.com/Article/Abstract/19634 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/9643663 PubMed]
 
−
## '''Update:''' Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. [https://www.auajournals.org/article/S0022-5347(05)67032-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11025708 PubMed]
 
−
# de Reijke TM, Keuppens FI, Whelan P, Kliment J, Robinson MR, Rea LA, Sylvester RJ; European Organisation for Research in Cancer Therapy Genitourinary Group. Orchiectomy and orchiectomy plus mitomycin C for metastatic prostate cancer in patients with poor prognosis: the final results of a European Organisation for Research in Cancer Therapy Genitourinary Group trial. J Urol. 1999 Nov;162(5):1658-64. [https://www.auajournals.org/doi/full/10.1016/S0022-5347%2805)68191-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10524892 PubMed]
 
−
# '''SAKK 08/88:''' Studer UE, Hauri D, Hanselmann S, Chollet D, Leisinger HJ, Gasser T, Senn E, Trinkler FB, Tscholl RM, Thalmann GN, Dietrich D. Immediate versus deferred hormonal treatment for patients with prostate cancer who are not suitable for curative local treatment: results of the randomized trial SAKK 08/88. J Clin Oncol. 2004 Oct 15;22(20):4109-18. Erratum in: J Clin Oncol. 2005 Feb 1;23(4):936. [https://doi.org/10.1200/JCO.2004.11.514 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15483020 PubMed]
 
−
# '''MDA DM95-231:''' Millikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. Epub 2008 Nov 24. [https://doi.org/10.1200/JCO.2007.15.9830 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3864402/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19029421 PubMed] NCT00002855
 
−
# '''ECOG E8892:''' NCT00002881
 
−
==Cortisone monotherapy {{#subobject:7b59ef |Regimen=1}}==
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:4f90a2 |Variant=1}}===
+
===Regimen {{#subobject:d51fc2|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
!style="width: 25%"|Study
 
!style="width: 25%"|Study
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://doi.org/10.1016/s0022-5347(17)67614-6 Miller & Hinman 1954]
+
|[https://doi.org/10.1002/cncr.21186 Jabbour et al. 2005]
−
|style="background-color:#91cf61"|Non-randomized
+
|style="background-color:#ffffbe"|Phase 2, <20 pts
 
|-
 
|-
 
|}
 
|}
 +
''Note: the timing of drug administration is in hours in the manuscript, starting at t = 0 hours.''
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Endocrine therapy====
+
====Chemotherapy====
−
*[[Cortisone]]
+
*[[Cladribine (Leustatin)]] 12 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 2 (total dose: 60 mg/m<sup>2</sup>)
 +
*[[Cytarabine (Ara-C)]] 1000 mg/m<sup>2</sup> IV over 2 hours once per day on days 1, 3, 4, 5, 6
 +
'''21-day cycle, repeated once if PR/CR; see text for definition of PR'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Miller GM, Hinman F Jr. Cortisone treatment in advanced carcinoma of the prostate. J Urol. 1954 Sep;72(3):485-96. [https://doi.org/10.1016/s0022-5347(17)67614-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/13202237 PubMed]
+
# Jabbour E, Verstovsek S, Giles F, Gandhi V, Cortes J, O'Brien S, Plunkett W, Garcia-Manero G, Jackson CE, Kantarjian H, Andreeff M. 2-Chlorodeoxyadenosine and cytarabine combination therapy for idiopathic hypereosinophilic syndrome. Cancer. 2005 Aug 1;104(3):541-6. [https://doi.org/10.1002/cncr.21186 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/15977212 PubMed]
−
==Cyproterone acetate monotherapy {{#subobject:785019 |Regimen=1}}==
+
==Hydroxyurea monotherapy {{#subobject:e819ce|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:e1ee02 |Variant=1}}===
+
===Regimen {{#subobject:4e5567|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable" style="width: 40%; text-align:center;"  
−
!style="width: 20%"|Study
+
!style="width: 25%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1111/j.1464-410X.1980.tb02961.x Jacobi et al. 1980]
 
−
|NR
 
−
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
−
|[[#Estradiol_undecylate_monotherapy_88|Estradiol undecylate]]
 
−
| style="background-color:#91cf60" |Seems to have superior ORR
 
−
|-
 
−
|rowspan=2|[https://doi.org/10.1016/s0022-5347(17)44996-2 Pavone-Macaluso et al. 1986 (EORTC 30761)]
 
−
|rowspan=2|1977-1981
 
−
|rowspan=2 style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
−
|1. [[#DES_monotherapy|DES]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|-
 
−
|2. [[#Medroxyprogesterone_monotherapy_88|MPA]]
 
−
| style="background-color:#91cf60" |Seems to have superior OS
 
 
|-
 
|-
−
|[https://doi.org/10.1016/S0090-4295(98)00129-0 Debruyne et al. 1998]
+
|[https://doi.org/10.7326/0003-4819-89-2-167 Parrillo et al. 1978]
−
|1992-1994
+
|style="background-color:#ffffbe"|Non-randomized, <20 pts
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Liarozole_monotherapy_77|Liarozole]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
 
|-
 
|-
 
|}
 
|}
 +
''Note: treatment details are not available in the abstract.''
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Endocrine therapy====
+
====Chemotherapy====
−
*[[Cyproterone acetate (Androcur)]]
+
*[[Hydroxyurea (Hydrea)]]
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Jacobi GH, Altwein JE, Kurth KH, Basting R, Hohenfellner R. Treatment of advanced prostatic cancer with parenteral cyproterone acetate: a phase III randomised trial. Br J Urol. 1980 Jun;52(3):208-15. [https://doi.org/10.1111/j.1464-410X.1980.tb02961.x link to original article] [https://pubmed.ncbi.nlm.nih.gov/7000222 PubMed]
+
# Parrillo JE, Fauci AS, Wolff SM. Therapy of the hypereosinophilic syndrome. Ann Intern Med. 1978 Aug;89(2):167-72. [https://doi.org/10.7326/0003-4819-89-2-167 link to original article] [https://pubmed.ncbi.nlm.nih.gov/677578 PubMed]
−
# '''EORTC 30761:''' Pavone-Macaluso M, de Voogt HJ, Viggiano G, Barasolo E, Lardennois B, de Pauw M, Sylvester R. Comparison of diethylstilbestrol, cyproterone acetate and medroxyprogesterone acetate in the treatment of advanced prostatic cancer: final analysis of a randomized phase III trial of the European Organisation for Research on Treatment of Cancer Urological Group. J Urol. 1986 Sep;136(3):624-31. [https://doi.org/10.1016/s0022-5347(17)44996-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2942707 PubMed]
+
==Imatinib monotherapy {{#subobject:77c7b0|Regimen=1}}==
−
# Debruyne FJ, Murray R, Fradet Y, Johansson JE, Tyrrell C, Boccardo F, Denis L, Marberger JM, Brune D, Rassweiler J, Vangeneugden T, Bruynseels J, Janssens M, De Porre P; Liarozole Study Group. Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Urology. 1998 Jul;52(1):72-81. [https://doi.org/10.1016/S0090-4295(98)00129-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9671874 PubMed]
 
−
==DES monotherapy {{#subobject:0a1860|Regimen=1}}==
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:128a40|Variant=1}}===
+
===Regimen {{#subobject:0be8cc|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable" style="color:white; background-color:#404040"
−
!style="width: 20%"|Study
+
|<small>'''FDA-recommended dose'''</small>
−
!style="width: 20%"|Years of enrollment
+
|-
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
|}
−
!style="width: 20%"|Comparator
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 33%"|Study
 +
!style="width: 33%"|Years of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://doi.org/10.1016/S0140-6736(02)08505-7 Gleich et al. 2002]
 +
|NR in abstract
 +
|style="background-color:#ffffbe"|Non-randomized, <20 pts
 
|-
 
|-
−
|[https://www.auajournals.org/doi/abs/10.1016/S0022-5347%2817%2944995-0 Smith et al. 1986 (EORTC 30762)]
+
|[https://doi.org/10.1056/NEJMoa020150 Apperley et al. 2002 (STIB2225)]
−
|1976-1980
+
|NR
−
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
+
|style="background-color:#ffffbe"|Phase 2, <20 pts
−
|[[#Estramustine_monotherapy_88|Estramustine]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
 
|-
 
|-
−
|[https://doi.org/10.1200/JCO.1990.8.10.1675 Osborne et al. 1990 (SWOG S8219)]
+
|[http://www.bloodjournal.org/content/101/9/3391.long Pardanani et al. 2002]
−
|1982-1986
+
|NR
−
| style="background-color:#1a9851" |Phase 3 (C)
+
|style="background-color:#ffffbe"|Phase 2, <20 pts
−
|[[#AC_.26_Orchiectomy_99|AC & Orchiectomy]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
 
|-
 
|-
−
|[https://doi.org/10.1111/j.1464-410X.1992.tb15633.x Waymont et al. 1992]
+
|[http://www.bloodjournal.org/content/101/12/4714.long Cortes et al. 2003]
−
|1985-1987
+
|2001-2002
−
| style="background-color:#1a9851" |Phase 3 (C)
+
|style="background-color:#ffffbe"|Phase 2, <20 pts
−
|[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior TTFR
 
 
|-
 
|-
−
|}
+
|[https://doi.org/10.1056/NEJMoa025217 Cools et al. 2003]
−
''No longer used, but of historical interest.''
+
|2001-2002
−
====Endocrine therapy====
+
|style="background-color:#ffffbe"|Non-randomized, <20 pts
−
*[[Diethylstilbestrol (DES)]]
 
−
</div></div>
 
−
===References===
 
−
# '''EORTC 30762:''' Smith PH, Suciu S, Robinson MR, Richards B, Bastable JR, Glashan RW, Bouffioux C, Lardennois B, Williams RE, de Pauw M, Sylvester R. A comparison of the effect of diethylstilbestrol with low dose estramustine phosphate in the treatment of advanced prostatic cancer: final analysis of a phase III trial of the European Organisation for Research on Treatment of Cancer. J Urol. 1986 Sep;136(3):619-23. [https://www.auajournals.org/doi/abs/10.1016/S0022-5347%2817%2944995-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3525866 PubMed]
 
−
# '''SWOG S8219:''' Osborne CK, Blumenstein B, Crawford ED, Coltman CA Jr, Smith AY, Lambuth BW, Chapman RA. Combined versus sequential chemo-endocrine therapy in advanced prostate cancer: final results of a randomized Southwest Oncology Group study. J Clin Oncol. 1990 Oct;8(10):1675-82. [https://doi.org/10.1200/JCO.1990.8.10.1675 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2213104 PubMed]
 
−
# Waymont B, Lynch TH, Dunn JA, Emtage LA, Arkell DG, Wallace DM, Blackledge GR. Phase III randomised study of zoladex versus stilboestrol in the treatment of advanced prostate cancer. Br J Urol. 1992 Jun;69(6):614-20. [https://doi.org/10.1111/j.1464-410X.1992.tb15633.x link to original article] [https://pubmed.ncbi.nlm.nih.gov/1386272 PubMed]
 
−
=Chemotherapy for metastatic disease=
 
−
==CMF {{#subobject:25 |Regimen=1}}==
 
−
CMF: '''<u>C</u>'''yclophosphamide, '''<u>M</u>'''ethotrexate, 5-'''<u>F</u>'''luorouracil
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:25 |Variant=1}}===
 
−
{| class="wikitable" style="width: 40%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
 
|-
 
|-
−
|[https://doi.org/10.1002/1097-0142(19930615)71:12%3C3975::AID-CNCR2820711229%3E3.0.CO;2-D Wozniak et al. 1993]
+
|[http://www.haematologica.org/content/92/9/1173.long Baccarani et al. 2007]
 +
|2001-2007
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
−
|}
+
|[http://www.bloodjournal.org/content/103/2/473.long Klion et al. 2003]
−
''This regimen is "minimally active in hormone-refractory metastatic prostate cancer" per Wozniak et al. 1993 and is included for historical reference only.''
+
|2003
−
====Chemotherapy====
+
|style="background-color:#ffffbe"|Non-randomized, <20 pts
−
*[[Cyclophosphamide (Cytoxan)]] 100 mg/m<sup>2</sup> PO once per day on days 1 to 7
 
−
*[[Methotrexate (MTX)]] 15 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Fluorouracil (5-FU)]] 300 mg/m<sup>2</sup> IV once on day 1
 
−
'''7-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
# Wozniak AJ, Blumenstein BA, Crawford ED, Boileau M, Rivkin SE, Fletcher WS; [[Study_Groups#SWOG|SWOG]]. Cyclophosphamide, methotrexate, and 5-fluorouracil in the treatment of metastatic prostate cancer: a Southwest Oncology Group study. Cancer. 1993 Jun 15;71(12):3975-8. [https://doi.org/10.1002/1097-0142(19930615)71:12%3C3975::AID-CNCR2820711229%3E3.0.CO;2-D link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8508363 PubMed]
 
−
==Suramin monotherapy{{#subobject:1d9f88 |Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:gd1534 |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
 
|-
 
|-
−
|[https://doi.org/10.1200/jco.2002.10.022 Small et al. 2002 (CALGB 9480)]
+
|[https://doi.org/10.1111/j.1365-2141.2008.07033.x Helbig et al. 2008]
−
|1995-1996
+
|NR
−
| style="background-color:#1a9851" |Phase 3 (C)
+
|style="background-color:#ffffbe"|Non-randomized, <20 pts
−
|[[#Suramin_monotherapy|Suramin]]; other doses
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of RR
 
 
|-
 
|-
−
|}
+
|[https://doi.org/10.1111/j.1365-2141.2008.07294.x Metzgeroth et al. 2008]
−
<div class="toccolours" style="background-color:#b3e2cd">
+
|NR
−
====Chemotherapy====
+
|style="background-color:#91cf61"|Phase 2
−
*[[Suramin (Antrypol)]]
 
−
</div></div>
 
−
===References===
 
−
#'''CALGB 9480:''' Small EJ, Halabi S, Ratain MJ, Rosner G, Stadler W, Palchak D, Marshall E, Rago R, Hars V, Wilding G, Petrylak D, Vogelzang NJ. Randomized study of three different doses of suramin administered with a fixed dosing schedule in patients with advanced prostate cancer: results of intergroup 0159, cancer and leukemia group B 9480. J Clin Oncol. 2002 Aug 15;20(16):3369-75. [https://doi.org/10.1200/jco.2002.10.022 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12177096/ PubMed] NCT00002723
 
−
=Therapy for metastatic castrate-resistant disease=
 
−
==Aspirin & Dexamethasone {{#subobject:bd6fcb |Regimen=1}}==
 
−
DA: '''<u>D</u>'''examethasone & '''<u>A</u>'''spirin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:bae48c |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049603/ Shamash et al. 2011 (BARTS-DAVDAS)]
 
−
|2001-2008
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Aspirin.2C_Dexamethasone.2C_Diethylstilbestrol_99|Aspirin, Dexamethasone, Diethylstilbestrol]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
 
|-
 
|-
 
|}
 
|}
 +
''Note: Dosing is as described in the Metzgeroth et al. 2008 paper.''
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Endocrine therapy====
+
====Targeted therapy====
−
*[[Dexamethasone (Decadron)]] 2 mg PO once per day
+
*[[Imatinib (Gleevec)]] by the following mutation-specific criteria:
−
====Supportive therapy====
+
**FIP1L1-PDGFRA positive patients: 100 mg PO once per day
−
*[[Aspirin]] 75 mg PO once per day
+
**PDGFRB fusion positive or without known molecular aberration: 400 mg PO once per day
−
*[[Ranitidine (Zantac)]] 150 mg PO twice per day
+
'''28-day cycle for 13 or more cycles'''
−
'''Continued indefinitely'''
+
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*Helbig et al. 2008: Patients proceeded to a maintenance phase after 3 to 6 months of therapy which consisted of weekly dosing; dose not specified in the manuscript
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# '''BARTS-DAVDAS:''' Shamash J, Powles T, Sarker SJ, Protheroe A, Mithal N, Mills R, Beard R, Wilson P, Tranter N, O'Brien N, McFaul S, Oliver T. A multi-centre randomised phase III trial of dexamethasone vs dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred diethylstilbestrol. Br J Cancer. 2011 Feb 15;104(4):620-8. Epub 2011 Feb 1. [https://www.nature.com/articles/bjc20117 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049603/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21285990 PubMed] NCT00316927
+
# Gleich GJ, Leiferman KM, Pardanani A, Tefferi A, Butterfield JH. Treatment of hypereosinophilic syndrome with imatinib mesilate. Lancet. 2002 May 4;359(9317):1577-8. [https://doi.org/10.1016/S0140-6736(02)08505-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12047970 PubMed]
−
==Cyclophosphamide monotherapy {{#subobject:8e2679 |Regimen=1}}==
+
# '''STIB2225:''' Apperley JF, Gardembas M, Melo JV, Russell-Jones R, Bain BJ, Baxter EJ, Chase A, Chessells JM, Colombat M, Dearden CE, Dimitrijevic S, Mahon FX, Marin D, Nikolova Z, Olavarria E, Silberman S, Schultheis B, Cross NC, Goldman JM. Response to imatinib mesylate in patients with chronic myeloproliferative diseases with rearrangements of the platelet-derived growth factor receptor beta. N Engl J Med. 2002 Aug 15;347(7):481-7. [https://doi.org/10.1056/NEJMoa020150 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/12181402 PubMed]
 +
## '''Pooled update:''' Cheah CY, Burbury K, Apperley JF, Huguet F, Pitini V, Gardembas M, Ross DM, Forrest D, Genet P, Rousselot P, Patton N, Smith G, Dunbar CE, Ito S, Aguiar RC, Odenike O, Gimelfarb A, Cross NC, Seymour JF. Patients with myeloid malignancies bearing PDGFRB fusion genes achieve durable long-term remissions with imatinib. Blood. 2014 Jun 5;123(23):3574-7. Epub 2014 Mar 31. [http://www.bloodjournal.org/content/123/23/3574.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047496/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24687085 PubMed]PubMed PMID: 24687085
 +
# Pardanani A, Reeder T, Porrata LF, Li CY, Tazelaar HD, Baxter EJ, Witzig TE, Cross NC, Tefferi A. Imatinib therapy for hypereosinophilic syndrome and other eosinophilic disorders. Blood. 2003 May 1;101(9):3391-7. Epub 2002 Dec 27. [http://www.bloodjournal.org/content/101/9/3391.long link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/12506022 PubMed]
 +
# Cortes J, Ault P, Koller C, Thomas D, Ferrajoli A, Wierda W, Rios MB, Letvak L, Kaled ES, Kantarjian H. Efficacy of imatinib mesylate in the treatment of idiopathic hypereosinophilic syndrome. Blood. 2003 Jun 15;101(12):4714-6. Epub 2003 Feb 20. [http://www.bloodjournal.org/content/101/12/4714.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/12595304 PubMed]
 +
# Cools J, DeAngelo DJ, Gotlib J, Stover EH, Legare RD, Cortes J, Kutok J, Clark J, Galinsky I, Griffin JD, Cross NC, Tefferi A, Malone J, Alam R, Schrier SL, Schmid J, Rose M, Vandenberghe P, Verhoef G, Boogaerts M, Wlodarska I, Kantarjian H, Marynen P, Coutre SE, Stone R, Gilliland DG. A tyrosine kinase created by fusion of the PDGFRA and FIP1L1 genes as a therapeutic target of imatinib in idiopathic hypereosinophilic syndrome. N Engl J Med. 2003 Mar 27;348(13):1201-14. [https://doi.org/10.1056/NEJMoa025217 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/12660384 PubMed]
 +
# Klion AD, Robyn J, Akin C, Noel P, Brown M, Law M, Metcalfe DD, Dunbar C, Nutman TB. Molecular remission and reversal of myelofibrosis in response to imatinib mesylate treatment in patients with the myeloproliferative variant of hypereosinophilic syndrome. Blood. 2004 Jan 15;103(2):473-8. Epub 2003 Sep 22. [http://www.bloodjournal.org/content/103/2/473.long link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/14504092 PubMed]
 +
# Baccarani M, Cilloni D, Rondoni M, Ottaviani E, Messa F, Merante S, Tiribelli M, Buccisano F, Testoni N, Gottardi E, de Vivo A, Giugliano E, Iacobucci I, Paolini S, Soverini S, Rosti G, Rancati F, Astolfi C, Pane F, Saglio G, Martinelli G. The efficacy of imatinib mesylate in patients with FIP1L1-PDGFRalpha-positive hypereosinophilic syndrome: results of a multicenter prospective study. Haematologica. 2007 Sep;92(9):1173-9. Epub 2007 Aug 1. [http://www.haematologica.org/content/92/9/1173.long link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/17666373 PubMed] NCT00276929
 +
# Helbig G, Stella-Hołowiecka B, Majewski M, Całbecka M, Gajkowska J, Klimkiewicz R, Moskwa A, Grzegorczyk J, Lewandowska M, Hołowiecki J. A single weekly dose of imatinib is sufficient to induce and maintain remission of chronic eosinophilic leukaemia in FIP1L1-PDGFRA-expressing patients. Br J Haematol. 2008 Apr;141(2):200-4. Epub 2008 Feb 26. [https://doi.org/10.1111/j.1365-2141.2008.07033.x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/18307562 PubMed]
 +
# Metzgeroth G, Walz C, Erben P, Popp H, Schmitt-Graeff A, Haferlach C, Fabarius A, Schnittger S, Grimwade D, Cross NC, Hehlmann R, Hochhaus A, Reiter A. Safety and efficacy of imatinib in chronic eosinophilic leukaemia and hypereosinophilic syndrome: a phase-II study. Br J Haematol. 2008 Dec;143(5):707-15. Epub 2008 Oct 17. [https://doi.org/10.1111/j.1365-2141.2008.07294.x link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18950453 PubMed]
 +
==Mepolizumab monotherapy {{#subobject:39b7a4|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:f36bde |Variant=1}}===
+
===Regimen {{#subobject:2ef22d|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
 
!style="width: 20%"|Years of enrollment
 
!style="width: 20%"|Years of enrollment
Line 392: Line 184:
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://doi.org/10.1002/1097-0142(19921115)70:10%3C2488::AID-CNCR2820701016%3E3.0.CO;2-9 Saxman et al. 1992]
+
|[https://doi.org/10.1056/NEJMoa070812 Rothenberg et al. 2008 (GSK 100185)]
−
|1984-1989
+
|2004-2006
−
| style="background-color:#1a9851" |Phase 3 (C)
+
| style="background-color:#1a9851" |Phase 3 (E-esc)
−
|[[#CAM_99|CAM]]
+
|[[#Placebo_88|Placebo]]
−
| style="background-color:#ffffbf" |Seems not superior
+
| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
 
|}
 
|}
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Chemotherapy====
+
====Immunosuppressive therapy====
−
*[[Cyclophosphamide (Cytoxan)]]
+
*[[Mepolizumab (Nucala)]] 750 mg IV once on day 1
 +
'''21-day cycle for 8 cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Saxman S, Ansari R, Drasga R, Miller M, Wheeler B, McClean J, Einhorn L; Hoosier Oncology Group. Phase III trial of cyclophosphamide versus cyclophosphamide, doxorubicin, and methotrexate in hormone-refractory prostatic cancer: a Hoosier Oncology Group study. Cancer. 1992 Nov 15;70(10):2488-92. [https://doi.org/10.1002/1097-0142(19921115)70:10%3C2488::AID-CNCR2820701016%3E3.0.CO;2-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/1423178 PubMed]
+
# '''GSK 100185:''' Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. Epub 2008 Mar 16. Erratum in: N Engl J Med. 2008 Jun 5;358(23): 2530. [https://doi.org/10.1056/NEJMoa070812 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18344568 PubMed] NCT00086658
−
==Cyclophosphamide, Prednisone, Diethylstilbestrol {{#subobject:26 |Regimen=1}}==
+
## '''Update:''' Roufosse FE, Kahn JE, Gleich GJ, Schwartz LB, Singh AD, Rosenwasser LJ, Denburg JA, Ring J, Rothenberg ME, Sheikh J, Haig AE, Mallett SA, Templeton DN, Ortega HG, Klion AD. Long-term safety of mepolizumab for the treatment of hypereosinophilic syndromes. J Allergy Clin Immunol. 2013 Feb;131(2):461-7.e1-5. Epub 2012 Oct 4. [https://doi.org/10.1016/j.jaci.2012.07.055 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23040887 PubMed]
−
CPD: '''<u>C</u>'''yclophosphamide, '''<u>P</u>'''rednisone, '''<u>D</u>'''iethylstilbestrol
+
==Nilotinib monotherapy {{#subobject:007581|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:26 |Variant=1}}===
+
===Regimen {{#subobject:267a4e|Variant=1}}===
−
{| class="wikitable" style="width: 60%; text-align:center;"  
+
{| class="wikitable" style="width: 40%; text-align:center;"  
−
! style="width: 33%" |Study
+
!style="width: 25%"|Study
−
! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
 
|-
 
|-
−
|[https://doi.org/10.1002/cncr.11686 Hellerstedt et al. 2003]
+
|[https://doi.org/10.1056/NEJMoa055104 Kantarjian et al. 2006 (A2101)]
−
| style="background-color:#91cf61" |Phase 2
+
|style="background-color:#ffffbe"|Phase 1/2, <20 pts of this subtype
−
|50% or greater decline in PSA: 42%
 
 
|-
 
|-
 
|}
 
|}
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Chemotherapy====
+
====Targeted therapy====
−
*[[Cyclophosphamide (Cytoxan)]] 100 mg PO once per day on days 1 to 20
+
*[[Nilotinib (Tasigna)]] 400 mg PO twice per day
−
====Endocrine therapy====
 
−
*[[Prednisone (Sterapred)]] 10 mg PO once per day
 
−
*[[Diethylstilbestrol (DES)]] 1 mg PO once per day
 
−
====Supportive therapy====
 
−
*[[Warfarin (Coumadin)]] 1 mg PO once per day to decrease risk of DVT
 
−
'''30-day cycles'''
 
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
#Hellerstedt B, Pienta KJ, Redman BG, Esper P, Dunn R, Fardig J, Olson K, Smith DC. Phase II trial of oral cyclophosphamide, prednisone, and diethylstilbestrol for androgen-independent prostate carcinoma. Cancer. 2003 Oct 15;98(8):1603-10. [https://doi.org/10.1002/cncr.11686 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14534875 PubMed]
+
# '''A2101:''' Kantarjian H, Giles F, Wunderle L, Bhalla K, O'Brien S, Wassmann B, Tanaka C, Manley P, Rae P, Mietlowski W, Bochinski K, Hochhaus A, Griffin JD, Hoelzer D, Albitar M, Dugan M, Cortes J, Alland L, Ottmann OG. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. N Engl J Med. 2006 Jun 15;354(24):2542-51. [https://doi.org/10.1056/NEJMoa055104 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16775235 PubMed] NCT00109707
−
==Doxorubicin monotherapy {{#subobject:061c25 |Regimen=1}}==
+
## '''Subgroup analysis:''' Hochhaus A, le Coutre PD, Kantarjian HM, Baccarani M, Erben P, Reiter A, McCulloch T, Fan X, Novick S, Giles FJ. Effect of the tyrosine kinase inhibitor nilotinib in patients with hypereosinophilic syndrome/chronic eosinophilic leukemia: analysis of the phase 2, open-label, single-arm A2101 study. J Cancer Res Clin Oncol. 2013 Dec;139(12):1985-93. Epub 2013 Sep 22. [http://link.springer.com/article/10.1007/s00432-013-1529-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24057647 PubMed]
 +
==Peginterferon alfa-2a monotherapy {{#subobject:010d91|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:472ea8 |Variant=1}}===
+
===Regimen {{#subobject:72ed60|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable" style="width: 40%; text-align:center;"  
−
!style="width: 20%"|Study
+
!style="width: 25%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
 
|-
 
|-
−
|[https://link.springer.com/article/10.1385%2FMO%3A20%3A2%3A137 Leaf et al. 2003 (ECOG E3882)]
+
|[http://www.lrjournal.com/article/S0145-2126(11)00469-3 Butterfield et al. 2011]
−
|1983-1986
+
|style="background-color:#ffffbe"|Case series
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Doxorubicin_.26_DES_99|Doxorubicin & DES]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|-
 
−
|[https://doi.org/10.1016/s0140-6736(00)03639-4 Tu et al. 2001]
 
−
|1996-1999
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 
−
|[[#Doxorubicin_.26_Strontium-89|Doxorubicin & Strontium-89]]
 
−
| style="background-color:#d73027" |Inferior OS
 
 
|-
 
|-
 
|}
 
|}
 +
''Note: The authors describe using peginterferon alfa-2b initially but switched to peginterferon alfa-2a when the first was "no longer available. Dosing details are not available in the abstract."
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Chemotherapy====
+
====Immunotherapy====
−
*[[Doxorubicin (Adriamycin)]]
+
*[[Peginterferon alfa-2a (Pegasys)]]
 
</div></div>
 
</div></div>
 
===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://doi.org/10.1016/s0140-6736(00)03639-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11210994 PubMed]
+
# '''Case series:''' Butterfield JH, Weiler CR. Use of pegylated interferon in hypereosinophilic syndrome. Leuk Res. 2012 Feb;36(2):192-7. Epub 2011 Nov 26. [http://www.lrjournal.com/article/S0145-2126(11)00469-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22118911 PubMed]
−
# '''ECOG E3882:''' Leaf AN, Propert K, Corcoran C, Catalano PJ, Trump DL, Harris JE, Davis TE. Phase III study of combined chemohormonal therapy in metastatic prostate cancer (ECOG 3882): an Eastern Cooperative Oncology Group study. Med Oncol. 2003;20(2):137-46. [https://link.springer.com/article/10.1385%2FMO%3A20%3A2%3A137 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12835516 PubMed]
+
==Ruxolitinib monotherapy {{#subobject:87790c|Regimen=1}}==
−
==Doxorubicin & Strontium-89 {{#subobject:9b4d29 |Regimen=1}}==
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:083cec |Variant=1}}===
+
===Regimen {{#subobject:f86a11|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable" style="width: 40%; text-align:center;"  
−
!style="width: 20%"|Study
+
!style="width: 25%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
 
|-
 
|-
−
|[https://doi.org/10.1016/s0140-6736(00)03639-4 Tu et al. 2001]
+
|[https://doi.org/10.1200/jco.2012.46.4370 Rumi et al. 2013]
−
|1996-1999
+
|style="background-color:#ffffbe"|Case report
−
| style="background-color:#1a9851" |Randomized Phase 2 (E-esc)
 
−
|[[#Doxorubicin_monotherapy|Doxorubicin]]
 
−
| style="background-color:#1a9850" |Superior OS
 
 
|-
 
|-
 
|}
 
|}
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[#Doxorubicin_.26_Ketoconazole.2FEstramustine_.26_Vinblastine_99|Doxorubicin & Ketoconazole alternating with Estramustine & Vinblastine]]
 
−
</div>
 
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Chemotherapy====
+
====Targeted therapy====
−
*[[Doxorubicin (Adriamycin)]]
+
*[[Ruxolitinib (Jakafi)]] 15 mg PO twice per day
−
====Radiotherapy====
+
'''Duration not specified'''
−
*[[Strontium-89 (Metastron)]]
 
−
</div></div>
 
−
===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://doi.org/10.1016/s0140-6736(00)03639-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11210994 PubMed]
 
−
==Vinblastine monotherapy {{#subobject:1d9e22 |Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:81db34 |Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.1999.17.10.3160 Hudes et al. 1999]
 
−
|1993-1995
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Estramustine_.26_Vinblastine_88|Estramustine & Vinblastine]]
 
−
| style="background-color:#fee08b" |Might have inferior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Vinblastine (Velban)]]
 
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Hudes G, Einhorn L, Ross E, Balsham A, Loehrer P, Ramsey H, Sprandio J, Entmacher M, Dugan W, Ansari R, Monaco F, Hanna M, Roth B; Hoosier Oncology Group; Fox Chase Network. Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer: A Hoosier Oncology Group and Fox Chase Network phase III trial. J Clin Oncol. 1999 Oct;17(10):3160-6. [https://doi.org/10.1200/JCO.1999.17.10.3160 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10506613 PubMed]
+
# '''Case report:''' Rumi E, Milosevic JD, Casetti I, Dambruoso I, Pietra D, Boveri E, Boni M, Bernasconi P, Passamonti F, Kralovics R, Cazzola M. Efficacy of ruxolitinib in chronic eosinophilic leukemia associated with a PCM1-JAK2 fusion gene. J Clin Oncol. 2013 Jun 10;31(17):e269-71. Epub 2013 Apr 29. [https://doi.org/10.1200/jco.2012.46.4370 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23630205 PubMed]
−
[[Category:Prostate cancer regimens]]
+
[[Category:Hypereosinophilic syndrome regimens]]
−
[[Category:Historical regimens]]
 
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
−
[[Category:Genitourinary cancers]]
+
[[Category:Myeloproliferative neoplasms]]
 +
[[Category:Clinical pharmacology]]

Revision as of 12:52, 2 January 2023

Back to Top

Section editor
Sanjay mohan.png
 Sanjay R. Mohan, MD, MSCI
Vanderbilt University
Nashville, TN
0 regimens on this page
0 variants on this page


Guidelines

NCCN

All lines of therapy

Alemtuzumab monotherapy

Regimen

Study Evidence
Wagner et al. 2009 Case report

Note: treatment is to be given bi-weekly, exact days not specified; below is an example. Duration also not specified.

Targeted therapy

7-day cycles

References

  1. Case report: Wagner LA, Speckart S, Cutter B, Gleich GJ. Treatment of FIP1L1/PDGFRA-negative hypereosinophilic syndrome with alemtuzumab, an anti-CD52 antibody. J Allergy Clin Immunol. 2009 Jun;123(6):1407-8. Epub 2009 Apr 1. link to original article contains dosing details in abstract PubMed
  2. Retrospective: Strati P, Cortes J, Faderl S, Kantarjian H, Verstovsek S. Long-term follow-up of patients with hypereosinophilic syndrome treated with Alemtuzumab, an anti-CD52 antibody. Clin Lymphoma Myeloma Leuk. 2013 Jun;13(3):287-91. Epub 2012 Nov 1. link to original article link to PMC article PubMed

Benralizumab monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Kuang et al. 2019 (NIAID 14-I-0081) 2014-2017 Randomized Phase 2, <20 pts (E-esc) Placebo Seems to have superior primary endpoint

Immunosuppressive therapy

28-day cycle for 6 or more cycles

References

  1. NIAID 14-I-0081: Kuang FL, Legrand F, Makiya M, Ware J, Wetzler L, Brown T, Magee T, Piligian B, Yoon P, Ellis JH, Sun X, Panch SR, Powers A, Alao H, Kumar S, Quezado M, Yan L, Lee N, Kolbeck R, Newbold P, Goldman M, Fay MP, Khoury P, Maric I, Klion AD. Benralizumab for PDGFRA-negative hypereosinophilic syndrome. N Engl J Med. 2019 Apr 4;380(14):1336-1346. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00001406

Cladribine & Cytarabine

Regimen

Study Evidence
Jabbour et al. 2005 Phase 2, <20 pts

Note: the timing of drug administration is in hours in the manuscript, starting at t = 0 hours.

Chemotherapy

21-day cycle, repeated once if PR/CR; see text for definition of PR

References

  1. Jabbour E, Verstovsek S, Giles F, Gandhi V, Cortes J, O'Brien S, Plunkett W, Garcia-Manero G, Jackson CE, Kantarjian H, Andreeff M. 2-Chlorodeoxyadenosine and cytarabine combination therapy for idiopathic hypereosinophilic syndrome. Cancer. 2005 Aug 1;104(3):541-6. link to original article contains dosing details in manuscript PubMed

Hydroxyurea monotherapy

Regimen

Study Evidence
Parrillo et al. 1978 Non-randomized, <20 pts

Note: treatment details are not available in the abstract.

Chemotherapy

References

  1. Parrillo JE, Fauci AS, Wolff SM. Therapy of the hypereosinophilic syndrome. Ann Intern Med. 1978 Aug;89(2):167-72. link to original article PubMed

Imatinib monotherapy

Regimen

FDA-recommended dose
Study Years of enrollment Evidence
Gleich et al. 2002 NR in abstract Non-randomized, <20 pts
Apperley et al. 2002 (STIB2225) NR Phase 2, <20 pts
Pardanani et al. 2002 NR Phase 2, <20 pts
Cortes et al. 2003 2001-2002 Phase 2, <20 pts
Cools et al. 2003 2001-2002 Non-randomized, <20 pts
Baccarani et al. 2007 2001-2007 Phase 2
Klion et al. 2003 2003 Non-randomized, <20 pts
Helbig et al. 2008 NR Non-randomized, <20 pts
Metzgeroth et al. 2008 NR Phase 2

Note: Dosing is as described in the Metzgeroth et al. 2008 paper.

Targeted therapy

  • Imatinib (Gleevec) by the following mutation-specific criteria:
    • FIP1L1-PDGFRA positive patients: 100 mg PO once per day
    • PDGFRB fusion positive or without known molecular aberration: 400 mg PO once per day

28-day cycle for 13 or more cycles

Subsequent treatment

  • Helbig et al. 2008: Patients proceeded to a maintenance phase after 3 to 6 months of therapy which consisted of weekly dosing; dose not specified in the manuscript

References

  1. Gleich GJ, Leiferman KM, Pardanani A, Tefferi A, Butterfield JH. Treatment of hypereosinophilic syndrome with imatinib mesilate. Lancet. 2002 May 4;359(9317):1577-8. link to original article PubMed
  2. STIB2225: Apperley JF, Gardembas M, Melo JV, Russell-Jones R, Bain BJ, Baxter EJ, Chase A, Chessells JM, Colombat M, Dearden CE, Dimitrijevic S, Mahon FX, Marin D, Nikolova Z, Olavarria E, Silberman S, Schultheis B, Cross NC, Goldman JM. Response to imatinib mesylate in patients with chronic myeloproliferative diseases with rearrangements of the platelet-derived growth factor receptor beta. N Engl J Med. 2002 Aug 15;347(7):481-7. link to original article contains dosing details in abstract PubMed
    1. Pooled update: Cheah CY, Burbury K, Apperley JF, Huguet F, Pitini V, Gardembas M, Ross DM, Forrest D, Genet P, Rousselot P, Patton N, Smith G, Dunbar CE, Ito S, Aguiar RC, Odenike O, Gimelfarb A, Cross NC, Seymour JF. Patients with myeloid malignancies bearing PDGFRB fusion genes achieve durable long-term remissions with imatinib. Blood. 2014 Jun 5;123(23):3574-7. Epub 2014 Mar 31. link to original article link to PMC article PubMedPubMed PMID: 24687085
  3. Pardanani A, Reeder T, Porrata LF, Li CY, Tazelaar HD, Baxter EJ, Witzig TE, Cross NC, Tefferi A. Imatinib therapy for hypereosinophilic syndrome and other eosinophilic disorders. Blood. 2003 May 1;101(9):3391-7. Epub 2002 Dec 27. link to original article contains dosing details in abstract PubMed
  4. Cortes J, Ault P, Koller C, Thomas D, Ferrajoli A, Wierda W, Rios MB, Letvak L, Kaled ES, Kantarjian H. Efficacy of imatinib mesylate in the treatment of idiopathic hypereosinophilic syndrome. Blood. 2003 Jun 15;101(12):4714-6. Epub 2003 Feb 20. link to original article contains dosing details in manuscript PubMed
  5. Cools J, DeAngelo DJ, Gotlib J, Stover EH, Legare RD, Cortes J, Kutok J, Clark J, Galinsky I, Griffin JD, Cross NC, Tefferi A, Malone J, Alam R, Schrier SL, Schmid J, Rose M, Vandenberghe P, Verhoef G, Boogaerts M, Wlodarska I, Kantarjian H, Marynen P, Coutre SE, Stone R, Gilliland DG. A tyrosine kinase created by fusion of the PDGFRA and FIP1L1 genes as a therapeutic target of imatinib in idiopathic hypereosinophilic syndrome. N Engl J Med. 2003 Mar 27;348(13):1201-14. link to original article contains dosing details in abstract PubMed
  6. Klion AD, Robyn J, Akin C, Noel P, Brown M, Law M, Metcalfe DD, Dunbar C, Nutman TB. Molecular remission and reversal of myelofibrosis in response to imatinib mesylate treatment in patients with the myeloproliferative variant of hypereosinophilic syndrome. Blood. 2004 Jan 15;103(2):473-8. Epub 2003 Sep 22. link to original article contains dosing details in abstract PubMed
  7. Baccarani M, Cilloni D, Rondoni M, Ottaviani E, Messa F, Merante S, Tiribelli M, Buccisano F, Testoni N, Gottardi E, de Vivo A, Giugliano E, Iacobucci I, Paolini S, Soverini S, Rosti G, Rancati F, Astolfi C, Pane F, Saglio G, Martinelli G. The efficacy of imatinib mesylate in patients with FIP1L1-PDGFRalpha-positive hypereosinophilic syndrome: results of a multicenter prospective study. Haematologica. 2007 Sep;92(9):1173-9. Epub 2007 Aug 1. link to original article contains dosing details in abstract PubMed NCT00276929
  8. Helbig G, Stella-Hołowiecka B, Majewski M, Całbecka M, Gajkowska J, Klimkiewicz R, Moskwa A, Grzegorczyk J, Lewandowska M, Hołowiecki J. A single weekly dose of imatinib is sufficient to induce and maintain remission of chronic eosinophilic leukaemia in FIP1L1-PDGFRA-expressing patients. Br J Haematol. 2008 Apr;141(2):200-4. Epub 2008 Feb 26. link to original article contains dosing details in abstract PubMed
  9. Metzgeroth G, Walz C, Erben P, Popp H, Schmitt-Graeff A, Haferlach C, Fabarius A, Schnittger S, Grimwade D, Cross NC, Hehlmann R, Hochhaus A, Reiter A. Safety and efficacy of imatinib in chronic eosinophilic leukaemia and hypereosinophilic syndrome: a phase-II study. Br J Haematol. 2008 Dec;143(5):707-15. Epub 2008 Oct 17. link to original article contains dosing details in manuscript PubMed

Mepolizumab monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Rothenberg et al. 2008 (GSK 100185) 2004-2006 Phase 3 (E-esc) Placebo Superior primary endpoint

Immunosuppressive therapy

21-day cycle for 8 cycles

References

  1. GSK 100185: Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. Epub 2008 Mar 16. Erratum in: N Engl J Med. 2008 Jun 5;358(23): 2530. link to original article contains dosing details in manuscript PubMed NCT00086658
    1. Update: Roufosse FE, Kahn JE, Gleich GJ, Schwartz LB, Singh AD, Rosenwasser LJ, Denburg JA, Ring J, Rothenberg ME, Sheikh J, Haig AE, Mallett SA, Templeton DN, Ortega HG, Klion AD. Long-term safety of mepolizumab for the treatment of hypereosinophilic syndromes. J Allergy Clin Immunol. 2013 Feb;131(2):461-7.e1-5. Epub 2012 Oct 4. link to original article PubMed

Nilotinib monotherapy

Regimen

Study Evidence
Kantarjian et al. 2006 (A2101) Phase 1/2, <20 pts of this subtype

Targeted therapy

References

  1. A2101: Kantarjian H, Giles F, Wunderle L, Bhalla K, O'Brien S, Wassmann B, Tanaka C, Manley P, Rae P, Mietlowski W, Bochinski K, Hochhaus A, Griffin JD, Hoelzer D, Albitar M, Dugan M, Cortes J, Alland L, Ottmann OG. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. N Engl J Med. 2006 Jun 15;354(24):2542-51. link to original article PubMed NCT00109707
    1. Subgroup analysis: Hochhaus A, le Coutre PD, Kantarjian HM, Baccarani M, Erben P, Reiter A, McCulloch T, Fan X, Novick S, Giles FJ. Effect of the tyrosine kinase inhibitor nilotinib in patients with hypereosinophilic syndrome/chronic eosinophilic leukemia: analysis of the phase 2, open-label, single-arm A2101 study. J Cancer Res Clin Oncol. 2013 Dec;139(12):1985-93. Epub 2013 Sep 22. link to original article PubMed

Peginterferon alfa-2a monotherapy

Regimen

Study Evidence
Butterfield et al. 2011 Case series

Note: The authors describe using peginterferon alfa-2b initially but switched to peginterferon alfa-2a when the first was "no longer available. Dosing details are not available in the abstract."

Immunotherapy

References

  1. Case series: Butterfield JH, Weiler CR. Use of pegylated interferon in hypereosinophilic syndrome. Leuk Res. 2012 Feb;36(2):192-7. Epub 2011 Nov 26. link to original article PubMed

Ruxolitinib monotherapy

Regimen

Study Evidence
Rumi et al. 2013 Case report

Targeted therapy

Duration not specified

References

  1. Case report: Rumi E, Milosevic JD, Casetti I, Dambruoso I, Pietra D, Boveri E, Boni M, Bernasconi P, Passamonti F, Kralovics R, Cazzola M. Efficacy of ruxolitinib in chronic eosinophilic leukemia associated with a PCM1-JAK2 fusion gene. J Clin Oncol. 2013 Jun 10;31(17):e269-71. Epub 2013 Apr 29. link to original article contains dosing details in abstract PubMed
Retrieved from "https://hemonc.org/w/index.php?title=Staging_page&oldid=65307"