Difference between revisions of "Merkel cell carcinoma"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
 
(94 intermediate revisions by 5 users not shown)
Line 1: Line 1:
−
'''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].'''
+
<span id="BackToTop"></span>
−
 
+
<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
−
Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen?  Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].
+
[[#top|Back to Top]]
−
 
+
</div>
 +
{{#lst:Editorial board transclusions|derm}}
 +
''For placebo or observational studies in this condition, please visit [[Merkel cell carcinoma - null regimens|this page]].''
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
|-
 
|-
−
|<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Regimen |limit=10000|format=sum}} 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: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} 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}}
 +
=Guidelines=
 +
'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
 +
==Alberta Health Services==
 +
*2019: [https://www.albertahealthservices.ca/assets/info/hp/cancer/if-hp-cancer-guide-cu004-merkel-cell.pdf Merkel Cell Carcinoma] [https://www.ncbi.nlm.nih.gov/pubmed/31084721 PubMed]
  
−
=Primary Treatment=
+
==NCCN==
 +
*[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1444 NCCN Guidelines - Merkel Cell Carcinoma]
 +
**'''2018:''' Bichakjian et al. [https://doi.org/10.6004/Jnccn.2018.0055 Merkel Cell Carcinoma, Version 1.2018, NCCN Clinical Practice Guidelines in Oncology.] [https://pubmed.ncbi.nlm.nih.gov/29891526/ PubMed]
 +
**'''2014:''' Bichakjian et al. [https://doi.org/10.6004/Jnccn.2014.0041 Merkel cell carcinoma, version 1.2014.] [https://pubmed.ncbi.nlm.nih.gov/24616545/ PubMed]
 +
**'''2009:''' Miller et al. [https://doi.org/10.6004/Jnccn.2009.0024 Merkel cell carcinoma.] [https://pubmed.ncbi.nlm.nih.gov/19401064/ PubMed]
 +
**'''2006:''' Miller et al. [https://doi.org/10.6004/Jnccn.2006.0060 Merkel cell carcinoma.] [https://pubmed.ncbi.nlm.nih.gov/16884672/ PubMed]
 +
**'''2004:''' No authors listed. [https://doi.org/10.6004/Jnccn.2004.0007 Merkel cell carcinoma. Clinical practice guidelines in oncology.] [https://pubmed.ncbi.nlm.nih.gov/19777698/ PubMed]
  
−
==Pembrolizumab (Keytruda) {{#subobject:515cc4|Regimen=1}}==
+
==SITC==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
*'''2022:''' Silk et al. [https://doi.org/10.1136/jitc-2021-004434 Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer] [https://www.ncbi.nlm.nih.gov/pubmed/35902131 PubMed]
−
|-
 
−
|[[#toc|back to top]]
 
−
|}
 
  
 +
=Metastatic or advanced disease, first-line therapy=
 +
==Pembrolizumab monotherapy {{#subobject:515cc4|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:0b8a79|Variant=1}}===
 
===Regimen {{#subobject:0b8a79|Variant=1}}===
−
{| border="1" style="text-align:center;" !align="left"  
+
{| class="wikitable sortable" style="width: 80%; text-align:center;"  
−
|'''Study'''
+
!style="width: 25%"|Study
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
!style="width: 25%"|Dates of enrollment
−
|[[Overall response rate|'''ORR''']]
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
−
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1603702 Nghiem al. 2016]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927341/ Nghiem et al. 2016 (KEYNOTE-017)]
−
|<span
+
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
−
style="background:#EEEE00;
+
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-326-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
−
padding:3px 6px 3px 6px;
+
|-
−
border-color:black;
+
|} -->
−
border-width:2px;
+
|2015-01 to 2015-12
−
border-style:solid;">Phase II</span>
+
|style="background-color:#91cf61"|Phase 2 (RT)
−
|56% (95% CI 35-76%)
+
|ORR: 58% (95% CI 43-72%)<sup>1</sup>
 
|-
 
|-
 
|}
 
|}
 +
''<sup>1</sup>Reported efficacy is based on the 2021 update.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
 
*[[Pembrolizumab (Keytruda)]] 2 mg/kg IV once on day 1
 
*[[Pembrolizumab (Keytruda)]] 2 mg/kg IV once on day 1
 +
'''21-day cycle for up to 35 cycles (2 years) or until CR'''
 +
</div></div>
 +
===References===
 +
# '''KEYNOTE-017:''' Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 blockade with pembrolizumab in advanced Merkel-cell carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. Epub 2016 Apr 19. [https://doi.org/10.1056/NEJMoa1603702 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927341/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/27093365/ PubMed] [https://clinicaltrials.gov/study/NCT02267603 NCT02267603]
 +
##'''Update:''' Nghiem P, Bhatia S, Lipson EJ, Sharfman WH, Kudchadkar RR, Brohl AS, Friedlander PA, Daud A, Kluger HM, Reddy SA, Boulmay BC, Riker AI, Burgess MA, Hanks BA, Olencki T, Margolin K, Lundgren LM, Soni A, Ramchurren N, Church C, Park SY, Shinohara MM, Salim B, Taube JM, Bird SR, Ibrahim N, Fling SP, Homet Moreno B, Sharon E, Cheever MA, Topalian SL. Durable Tumor Regression and Overall Survival in Patients With Advanced Merkel Cell Carcinoma Receiving Pembrolizumab as First-Line Therapy. J Clin Oncol. 2019 Mar 20;37(9):693-702. Epub 2019 Feb 6. [https://doi.org/10.1200/jco.18.01896 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6424137/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30726175/ PubMed]
 +
##'''Update:''' Nghiem P, Bhatia S, Lipson EJ, Sharfman WH, Kudchadkar RR, Brohl AS, Friedlander PA, Daud A, Kluger HM, Reddy SA, Boulmay BC, Riker A, Burgess MA, Hanks BA, Olencki T, Kendra K, Church C, Akaike T, Ramchurren N, Shinohara MM, Salim B, Taube JM, Jensen E, Kalabis M, Fling SP, Homet Moreno B, Sharon E, Cheever MA, Topalian SL. Three-year survival, correlates and salvage therapies in patients receiving first-line pembrolizumab for advanced Merkel cell carcinoma. J Immunother Cancer. 2021 Apr;9(4):e002478. [https://doi.org/10.1136/jitc-2021-002478 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8061836/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33879601/ PubMed]
  
−
'''21-day cycles for up to 2 years or until CR, progression, or intolerable toxicity'''
+
==Retifanlimab monotherapy {{#subobject:gb33c4|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:0bhy234|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://clinicaltrials.gov/study/NCT03599713 Awaiting publication (POD1UM-201)]
 +
|2019-2022
 +
| style="background-color:#91cf61" |Phase 2 (RT)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Immunotherapy====
 +
*[[Retifanlimab (Zynyz)]] 500 mg IV over 30 minutes once on day 1
 +
'''28-day cycle for up to 24 cycles (2 years)'''
 +
</div></div>
 +
===References===
 +
#'''POD1UM-201:''' [https://clinicaltrials.gov/study/NCT03599713 NCT03599713]
  
 +
=Metastatic or advanced disease, subsequent lines of therapy=
 +
==Avelumab monotherapy {{#subobject:41b46c|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:bcebae|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 80%; text-align:center;"
 +
!style="width: 25%"|Study
 +
!style="width: 25%"|Dates of enrollment
 +
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587154/ Kaufman et al. 2016 (JAVELIN Merkel 200)]
 +
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-248-1 <span style="color:white;">ESMO-MCBS (4)</span>]'''
 +
|-
 +
|} -->
 +
|2014-07-25 to 2015-09-03
 +
|style="background-color:#91cf61"|Phase 2 (RT)
 +
|33% (95% CI: 23–44)<sup>1</sup>
 +
|-
 +
|}
 +
''<sup>1</sup>Reported efficacy is based on the 2020 update.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 +
====Prior treatment criteria====
 +
*Failure of at least one previous line of chemotherapy for metastatic disease.
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Immunotherapy====
 +
*[[Avelumab (Bavencio)]] 10 mg/kg IV over 60 minutes once on day 1
 +
====Supportive therapy====
 +
*[[:Category:Antihistamines|H1-antihistamine]], such as [[Diphenhydramine (Benadryl)|diphenhydramine]] (dose & route not given) once on day 1, 30 to 60 minutes prior to avelumab
 +
*[[Acetaminophen (Tylenol)|Paracetamol/acetaminophen]] (dose not given) once on day 1, 30 to 60 minutes prior to avelumab
 +
*The Bavencio package insert suggests "Premedicate with acetaminophen and an antihistamine for the first 4 infusions and subsequently as needed."
 +
'''14-day cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. Epub 2016 Apr 19. [http://www.nejm.org/doi/full/10.1056/NEJMoa1603702 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927341/ link to PMC article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/27093365 PubMed] content property of [http://hemonc.org HemOnc.org]
+
<!-- # '''Abstract:''' Howard Kaufman, Jeffery Scott Russell, Omid Hamid, Shailender Bhatia, Patrick Terheyden, Sandra P. D'Angelo, Kent C. Shih, Celeste Lebbe, Gerald P Linette, Michele Milella, Isaac Brownell, Karl D. Lewis, Jochen H. Lorch, Kevin M. Chin, Lisa Mahnke, Anja von Heydebreck, Jean-Marie Cuillerot, Paul Nghiem. Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell carcinoma previously treated with chemotherapy: Results of the phase 2 JAVELIN Merkel 200 trial. 2016 ASCO Annual Meeting abstract 9508. -->
−
 
+
# '''JAVELIN Merkel 200:''' Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. Epub 2016 Sep 1. [https://doi.org/10.1016/s1470-2045(16)30364-3 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587154/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27592805/ PubMed] content property of [https://hemonc.org HemOnc.org] [https://clinicaltrials.gov/study/NCT02155647 NCT02155647]
−
[[Category:Chemotherapy regimens]]
+
## '''Update:''' Kaufman HL, Russell JS, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Milella M, Brownell I, Lewis KD, Lorch JH, von Heydebreck A, Hennessy M, Nghiem P. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018 Jan 19;6(1):7. [https://doi.org/10.1186/s40425-017-0310-x link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774167/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29347993/ PubMed]
−
[[Category:Solid oncology regimens]]
+
## '''Update:''' D'Angelo SP, Russell J, Lebbé C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL. Efficacy and safety of first-line avelumab treatment in patients with stage IV metastatic Merkel cell carcinoma: a preplanned interim analysis of a clinical trial. JAMA Oncol. 2018 Sep 1;4(9):e180077. Epub 2018 Sep 13. [https://doi.org/10.1001/jamaoncol.2018.0077 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885245/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29566106/ PubMed]
 +
##'''Update:''' D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbé C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Güzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1):e000674. [https://doi.org/10.1136/jitc-2020-000674 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7239697/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32414862/ PubMed]
 +
##'''Update:''' D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbé C, Lewis KD, Linette GP, Milella M, Xiong H, Guezel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma (JAVELIN Merkel 200): updated overall survival data after >5 years of follow-up. ESMO Open. 2021 Dec;6(6):100290. Epub 2021 Oct 26. [https://doi.org/10.1016/j.esmoop.2021.100290 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8564559/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34715570/ PubMed]
 +
[[Category:Merkel cell carcinoma regimens]]
 +
[[Category:Disease-specific pages]]
 +
[[Category:Non-melanoma skin cancers]]

Latest revision as of 21:05, 29 June 2024

Back to Top

Section editor
Bethbuchbinder.jpg
 Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA, USA
LinkedIn

For placebo or observational studies in this condition, please visit this page.

3 regimens on this page
3 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

Alberta Health Services

NCCN

SITC

Metastatic or advanced disease, first-line therapy

Pembrolizumab monotherapy

Regimen

Study Dates of enrollment Evidence Efficacy
Nghiem et al. 2016 (KEYNOTE-017) 2015-01 to 2015-12 Phase 2 (RT) ORR: 58% (95% CI 43-72%)1

1Reported efficacy is based on the 2021 update.

Immunotherapy

21-day cycle for up to 35 cycles (2 years) or until CR

References

  1. KEYNOTE-017: Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 blockade with pembrolizumab in advanced Merkel-cell carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. Epub 2016 Apr 19. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02267603
    1. Update: Nghiem P, Bhatia S, Lipson EJ, Sharfman WH, Kudchadkar RR, Brohl AS, Friedlander PA, Daud A, Kluger HM, Reddy SA, Boulmay BC, Riker AI, Burgess MA, Hanks BA, Olencki T, Margolin K, Lundgren LM, Soni A, Ramchurren N, Church C, Park SY, Shinohara MM, Salim B, Taube JM, Bird SR, Ibrahim N, Fling SP, Homet Moreno B, Sharon E, Cheever MA, Topalian SL. Durable Tumor Regression and Overall Survival in Patients With Advanced Merkel Cell Carcinoma Receiving Pembrolizumab as First-Line Therapy. J Clin Oncol. 2019 Mar 20;37(9):693-702. Epub 2019 Feb 6. link to original article link to PMC article PubMed
    2. Update: Nghiem P, Bhatia S, Lipson EJ, Sharfman WH, Kudchadkar RR, Brohl AS, Friedlander PA, Daud A, Kluger HM, Reddy SA, Boulmay BC, Riker A, Burgess MA, Hanks BA, Olencki T, Kendra K, Church C, Akaike T, Ramchurren N, Shinohara MM, Salim B, Taube JM, Jensen E, Kalabis M, Fling SP, Homet Moreno B, Sharon E, Cheever MA, Topalian SL. Three-year survival, correlates and salvage therapies in patients receiving first-line pembrolizumab for advanced Merkel cell carcinoma. J Immunother Cancer. 2021 Apr;9(4):e002478. link to original article link to PMC article PubMed

Retifanlimab monotherapy

Regimen

Study Dates of enrollment Evidence
Awaiting publication (POD1UM-201) 2019-2022 Phase 2 (RT)

Immunotherapy

28-day cycle for up to 24 cycles (2 years)

References

  1. POD1UM-201: NCT03599713

Metastatic or advanced disease, subsequent lines of therapy

Avelumab monotherapy

Regimen

Study Dates of enrollment Evidence Efficacy
Kaufman et al. 2016 (JAVELIN Merkel 200) 2014-07-25 to 2015-09-03 Phase 2 (RT) 33% (95% CI: 23–44)1

1Reported efficacy is based on the 2020 update.

Prior treatment criteria

  • Failure of at least one previous line of chemotherapy for metastatic disease.

Immunotherapy

Supportive therapy

  • H1-antihistamine, such as diphenhydramine (dose & route not given) once on day 1, 30 to 60 minutes prior to avelumab
  • Paracetamol/acetaminophen (dose not given) once on day 1, 30 to 60 minutes prior to avelumab
  • The Bavencio package insert suggests "Premedicate with acetaminophen and an antihistamine for the first 4 infusions and subsequently as needed."

14-day cycles

References

  1. JAVELIN Merkel 200: Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. Epub 2016 Sep 1. link to original article contains dosing details in manuscript link to PMC article PubMed content property of HemOnc.org NCT02155647
    1. Update: Kaufman HL, Russell JS, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Milella M, Brownell I, Lewis KD, Lorch JH, von Heydebreck A, Hennessy M, Nghiem P. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018 Jan 19;6(1):7. link to original article link to PMC article PubMed
    2. Update: D'Angelo SP, Russell J, Lebbé C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL. Efficacy and safety of first-line avelumab treatment in patients with stage IV metastatic Merkel cell carcinoma: a preplanned interim analysis of a clinical trial. JAMA Oncol. 2018 Sep 1;4(9):e180077. Epub 2018 Sep 13. link to original article link to PMC article PubMed
    3. Update: D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbé C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Güzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1):e000674. link to original article link to PMC article PubMed
    4. Update: D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbé C, Lewis KD, Linette GP, Milella M, Xiong H, Guezel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma (JAVELIN Merkel 200): updated overall survival data after >5 years of follow-up. ESMO Open. 2021 Dec;6(6):100290. Epub 2021 Oct 26. link to original article link to PMC article PubMed
Retrieved from "https://hemonc.org/w/index.php?title=Merkel_cell_carcinoma&oldid=87830"