Difference between revisions of "Castleman disease"
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=Multicentric Castleman’s disease= | =Multicentric Castleman’s disease= | ||
| + | |||
| + | ==Placebo {{#subobject:00417d|Regimen=1}}== | ||
| + | |||
| + | ===Regimen {{#subobject:10a1bd|Variant=1}}=== | ||
| + | {| border="1" style="text-align:center;" !align="left" | ||
| + | |'''Study''' | ||
| + | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
| + | |'''Comparator''' | ||
| + | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
| + | |- | ||
| + | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70319-5/fulltext van Rhee et al. 2014] | ||
| + | |<span | ||
| + | style="background:#00CD00; | ||
| + | padding:3px 6px 3px 6px; | ||
| + | border-color:black; | ||
| + | border-width:2px; | ||
| + | border-style:solid;">Phase III</span> | ||
| + | |[[Castleman’s_disease#Siltuximab_.28Sylvant.29|Siltuximab]] | ||
| + | |<span | ||
| + | style="background:#ff0000; | ||
| + | padding:3px 6px 3px 6px; | ||
| + | border-color:black; | ||
| + | border-width:2px; | ||
| + | border-style:solid;">Inferior durable tumor and symptomatic response for at least 18 weeks</span> | ||
| + | |- | ||
| + | |} | ||
| + | |||
| + | ''No active treatment; all patients did receive "best supportive care."'' | ||
| + | |||
| + | ===References=== | ||
| + | <!-- # '''Abstract:''' Raymond S Wong, Corey Casper, Nikhil Munshi, Xiaoyan Ke, Alexander Fosså, David Simpson, Marcelo Capra, Ting Liu, Ruey Kuen Hsieh, Yeow Tee Goh, Jun Zhu, Seok-Goo Cho, Hanyun Ren, James Cavet, Rajesh Bandekar, Margaret Rothman, Thomas A Puchalski, Shalini Chaturvedi, Helgi van de Velde, Jessica Vermeulen, and Frits van Rhee. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy and Safety Of Siltuximab, An Anti-Interleukin-6 Monoclonal Antibody, In Patients With Multicentric Castleman’s Disease. 2013 ASH Annual Meeting abstract 505. [http://bloodjournal.hematologylibrary.org/content/122/21/505 link to abstract] --> | ||
| + | # van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fosså A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. Epub 2014 Jul 17. Erratum in: Lancet Oncol. 2014 Sep;15(10):417. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70319-5/fulltext link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25042199 PubMed] | ||
==Siltuximab (Sylvant) {{#subobject:9fe1e6|Regimen=1}}== | ==Siltuximab (Sylvant) {{#subobject:9fe1e6|Regimen=1}}== | ||
| Line 18: | Line 50: | ||
|} | |} | ||
| − | ===Regimen #1 | + | ===Regimen #1 {{#subobject:c9d934|Variant=1}}=== |
| − | <span | + | {| border="1" style="text-align:center;" !align="left" |
| − | style="background:# | + | |'''Study''' |
| + | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
| + | |'''Comparator''' | ||
| + | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
| + | |- | ||
| + | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70319-5/fulltext van Rhee et al. 2014] | ||
| + | |<span | ||
| + | style="background:#00CD00; | ||
| + | padding:3px 6px 3px 6px; | ||
| + | border-color:black; | ||
| + | border-width:2px; | ||
| + | border-style:solid;">Phase III</span> | ||
| + | |[[Castleman’s_disease#Placebo|Placebo]] | ||
| + | |<span | ||
| + | style="background:#00cd00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
border-color:black; | border-color:black; | ||
border-width:2px; | border-width:2px; | ||
| − | border-style:solid;"> | + | border-style:solid;">Superior durable tumor and symptomatic response for at least 18 weeks</span> |
| + | |- | ||
| + | |} | ||
| + | ''Patients had symptomatic, measurable, HIV-negative, and HHV-8-negative multicentric Castleman’s disease (MCD).'' | ||
| − | + | *[[Siltuximab (Sylvant)]] 11 mg/kg IV over 1 hour once on day 1 | |
| − | * | + | Supportive medications: |
| + | *All patients received "best supportive care" | ||
'''21-day cycles, given until treatment failure''' | '''21-day cycles, given until treatment failure''' | ||
| − | ===Regimen #2 | + | ===Regimen #2 {{#subobject:8a874b|Variant=1}}=== |
| − | <span style="background:#ff0000; padding:3px 6px 3px 6px; border-color:black; border-width:2px; border-style:solid;">Phase I</span> | + | {| border="1" style="text-align:center;" !align="left" |
| + | |'''Study''' | ||
| + | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
| + | |- | ||
| + | |[http://clincancerres.aacrjournals.org/content/19/13/3659.long Kurzrock et al. 2013] | ||
| + | |<span | ||
| + | style="background:#ff0000; | ||
| + | padding:3px 6px 3px 6px; | ||
| + | border-color:black; | ||
| + | border-width:2px; | ||
| + | border-style:solid;">Phase I</span> | ||
| + | |- | ||
| + | |} | ||
| − | ''This dose was the recommended dose after the dose-finding study Kurzrock et al. 2013. | + | ''This dose was the recommended dose after the dose-finding study Kurzrock et al. 2013. Note that this is different from the FDA-approved dose, which is 11 mg/kg.'' |
*[[Siltuximab (Sylvant)]] 12 mg/kg IV over 1 hour once on day 1 | *[[Siltuximab (Sylvant)]] 12 mg/kg IV over 1 hour once on day 1 | ||
| Line 43: | Line 105: | ||
===References=== | ===References=== | ||
# Kurzrock R, Voorhees PM, Casper C, Furman RR, Fayad L, Lonial S, Borghaei H, Jagannath S, Sokol L, Usmani SZ, van de Velde H, Qin X, Puchalski TA, Hall B, Reddy M, Qi M, van Rhee F. A phase I, open-label study of siltuximab, an anti-IL-6 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma, multiple myeloma, or Castleman disease. Clin Cancer Res. 2013 Jul 1;19(13):3659-70. [http://clincancerres.aacrjournals.org/content/19/13/3659.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/23659971 PubMed] content property of [http://hemonc.org HemOnc.org] | # Kurzrock R, Voorhees PM, Casper C, Furman RR, Fayad L, Lonial S, Borghaei H, Jagannath S, Sokol L, Usmani SZ, van de Velde H, Qin X, Puchalski TA, Hall B, Reddy M, Qi M, van Rhee F. A phase I, open-label study of siltuximab, an anti-IL-6 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma, multiple myeloma, or Castleman disease. Clin Cancer Res. 2013 Jul 1;19(13):3659-70. [http://clincancerres.aacrjournals.org/content/19/13/3659.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/23659971 PubMed] content property of [http://hemonc.org HemOnc.org] | ||
| − | # '''Abstract:''' Raymond S Wong, Corey Casper, Nikhil Munshi, Xiaoyan Ke, Alexander Fosså, David Simpson, Marcelo Capra, Ting Liu, Ruey Kuen Hsieh, Yeow Tee Goh, Jun Zhu, Seok-Goo Cho, Hanyun Ren, James Cavet, Rajesh Bandekar, Margaret Rothman, Thomas A Puchalski, Shalini Chaturvedi, Helgi van de Velde, Jessica Vermeulen, and Frits van Rhee. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy and Safety Of Siltuximab, An Anti-Interleukin-6 Monoclonal Antibody, In Patients With Multicentric Castleman’s Disease. 2013 ASH Annual Meeting abstract 505. [http://bloodjournal.hematologylibrary.org/content/122/21/505 link to abstract] | + | <!-- # '''Abstract:''' Raymond S Wong, Corey Casper, Nikhil Munshi, Xiaoyan Ke, Alexander Fosså, David Simpson, Marcelo Capra, Ting Liu, Ruey Kuen Hsieh, Yeow Tee Goh, Jun Zhu, Seok-Goo Cho, Hanyun Ren, James Cavet, Rajesh Bandekar, Margaret Rothman, Thomas A Puchalski, Shalini Chaturvedi, Helgi van de Velde, Jessica Vermeulen, and Frits van Rhee. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy and Safety Of Siltuximab, An Anti-Interleukin-6 Monoclonal Antibody, In Patients With Multicentric Castleman’s Disease. 2013 ASH Annual Meeting abstract 505. [http://bloodjournal.hematologylibrary.org/content/122/21/505 link to abstract] --> |
| + | # van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fosså A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. Epub 2014 Jul 17. Erratum in: Lancet Oncol. 2014 Sep;15(10):417. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70319-5/fulltext link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25042199 PubMed] | ||
| + | |||
| + | ==Tocilizumab (Actemra) {{#subobject:dd12c2|Regimen=1}}== | ||
| + | |||
| + | ===Regimen {{#subobject:c5ac9b|Variant=1}}=== | ||
| + | {| border="1" style="text-align:center;" !align="left" | ||
| + | |'''Study''' | ||
| + | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
| + | |- | ||
| + | |[http://www.bloodjournal.org/content/106/8/2627.long Nishimoto et al. 2005] | ||
| + | |<span | ||
| + | style="background:#EEEE00; | ||
| + | padding:3px 6px 3px 6px; | ||
| + | border-color:black; | ||
| + | border-width:2px; | ||
| + | border-style:solid;">Phase II</span> | ||
| + | |- | ||
| + | |} | ||
| + | |||
| + | *[[Tocilizumab (Actemra)]] 8 mg/kg IV every 2 weeks | ||
| + | |||
| + | '''16-week course; could be extended at physician discretion''' | ||
| + | |||
| + | ===References=== | ||
| + | # Nishimoto N, Kanakura Y, Aozasa K, Johkoh T, Nakamura M, Nakano S, Nakano N, Ikeda Y, Sasaki T, Nishioka K, Hara M, Taguchi H, Kimura Y, Kato Y, Asaoku H, Kumagai S, Kodama F, Nakahara H, Hagihara K, Yoshizaki K, Kishimoto T. Humanized anti-interleukin-6 receptor antibody treatment of multicentric Castleman disease. Blood. 2005 Oct 15;106(8):2627-32. Epub 2005 Jul 5. [http://www.bloodjournal.org/content/106/8/2627.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15998837 PubMed] | ||
Revision as of 15:27, 11 March 2015
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9 regimens on this page
9 variants on this page
|
Multicentric Castleman’s disease
Placebo
Regimen
| Study | Evidence | Comparator | Efficacy |
| van Rhee et al. 2014 | Phase III | Siltuximab | Inferior durable tumor and symptomatic response for at least 18 weeks |
No active treatment; all patients did receive "best supportive care."
References
- van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fosså A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. Epub 2014 Jul 17. Erratum in: Lancet Oncol. 2014 Sep;15(10):417. link to original article PubMed
Siltuximab (Sylvant)
| back to top |
Regimen #1
| Study | Evidence | Comparator | Efficacy |
| van Rhee et al. 2014 | Phase III | Placebo | Superior durable tumor and symptomatic response for at least 18 weeks |
Patients had symptomatic, measurable, HIV-negative, and HHV-8-negative multicentric Castleman’s disease (MCD).
- Siltuximab (Sylvant) 11 mg/kg IV over 1 hour once on day 1
Supportive medications:
- All patients received "best supportive care"
21-day cycles, given until treatment failure
Regimen #2
| Study | Evidence |
| Kurzrock et al. 2013 | Phase I |
This dose was the recommended dose after the dose-finding study Kurzrock et al. 2013. Note that this is different from the FDA-approved dose, which is 11 mg/kg.
- Siltuximab (Sylvant) 12 mg/kg IV over 1 hour once on day 1
21-day cycles, given until progression of disease or unacceptable toxicity
References
- Kurzrock R, Voorhees PM, Casper C, Furman RR, Fayad L, Lonial S, Borghaei H, Jagannath S, Sokol L, Usmani SZ, van de Velde H, Qin X, Puchalski TA, Hall B, Reddy M, Qi M, van Rhee F. A phase I, open-label study of siltuximab, an anti-IL-6 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma, multiple myeloma, or Castleman disease. Clin Cancer Res. 2013 Jul 1;19(13):3659-70. link to original article contains verified protocol PubMed content property of HemOnc.org
- van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fosså A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. Epub 2014 Jul 17. Erratum in: Lancet Oncol. 2014 Sep;15(10):417. link to original article PubMed
Tocilizumab (Actemra)
Regimen
| Study | Evidence |
| Nishimoto et al. 2005 | Phase II |
- Tocilizumab (Actemra) 8 mg/kg IV every 2 weeks
16-week course; could be extended at physician discretion
References
- Nishimoto N, Kanakura Y, Aozasa K, Johkoh T, Nakamura M, Nakano S, Nakano N, Ikeda Y, Sasaki T, Nishioka K, Hara M, Taguchi H, Kimura Y, Kato Y, Asaoku H, Kumagai S, Kodama F, Nakahara H, Hagihara K, Yoshizaki K, Kishimoto T. Humanized anti-interleukin-6 receptor antibody treatment of multicentric Castleman disease. Blood. 2005 Oct 15;106(8):2627-32. Epub 2005 Jul 5. link to original article contains verified protocol PubMed