Difference between revisions of "Merkel cell carcinoma"
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!style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587154/ Kaufman et al. 2016 (JAVELIN Merkel 200)] |
|style="background-color:#91cf61"|Phase II (RT) | |style="background-color:#91cf61"|Phase II (RT) | ||
|32% (95% CI: 22–43) | |32% (95% CI: 22–43) | ||
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====Supportive medications==== | ====Supportive medications==== | ||
| − | + | *[[:Category:Antihistamines|H1-antihistamine]], such as [[Diphenhydramine (Benadryl)|diphenhydramine]] (dose & route not given) once on day 1, 30 to 60 minutes prior to [[Avelumab (Bavencio)]] | |
| − | *[[:Category:Antihistamines|H1-antihistamine]], such as [[Diphenhydramine (Benadryl)|diphenhydramine]] (dose & route not given) once on day 1, 30 to 60 minutes prior to | + | *[[Acetaminophen (Tylenol)|Paracetamol/acetaminophen]] (dose not given) once on day 1, 30 to 60 minutes prior to [[Avelumab (Bavencio)]] |
| − | *[[Acetaminophen (Tylenol)|Paracetamol/acetaminophen]] (dose not given) once on day 1, 30 to 60 minutes prior to | ||
*The Bavencio package insert suggests "Premedicate with acetaminophen and an antihistamine for the first 4 infusions and subsequently as needed." | *The Bavencio package insert suggests "Premedicate with acetaminophen and an antihistamine for the first 4 infusions and subsequently as needed." | ||
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===References=== | ===References=== | ||
<!-- # '''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. [http://meetinglibrary.asco.org/content/168263-176 link to abstract] --> | <!-- # '''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. [http://meetinglibrary.asco.org/content/168263-176 link to abstract] --> | ||
| − | # '''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. [http://thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30364-3/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/27592805 PubMed] content property of [http://hemonc.org HemOnc.org] | + | # '''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. [http://thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30364-3/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587154/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27592805 PubMed] content property of [http://hemonc.org HemOnc.org] |
## '''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://jitc.biomedcentral.com/articles/10.1186/s40425-017-0310-x link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774167/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/29347993 PubMed] | ## '''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://jitc.biomedcentral.com/articles/10.1186/s40425-017-0310-x link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774167/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/29347993 PubMed] | ||
## '''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://jamanetwork.com/journals/jamaoncology/fullarticle/2675910 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885245/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/29566106 PubMed] | ## '''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://jamanetwork.com/journals/jamaoncology/fullarticle/2675910 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885245/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/29566106 PubMed] | ||
Revision as of 18:31, 29 January 2020
| Section editor | |
|---|---|
 |
Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA |
3 regimens on this page
3 variants on this page
|
Guidelines
Alberta Health Services
- 2019: Merkel Cell Carcinoma
NCCN
Metastatic or advanced disease, all lines of therapy
Avelumab monotherapy
| back to top |
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Kaufman et al. 2016 (JAVELIN Merkel 200) | Phase II (RT) | 32% (95% CI: 22–43) |
Immunotherapy
- Avelumab (Bavencio) 10 mg/kg IV over 60 minutes once on day 1
Supportive medications
- H1-antihistamine, such as diphenhydramine (dose & route not given) once on day 1, 30 to 60 minutes prior to Avelumab (Bavencio)
- Paracetamol/acetaminophen (dose not given) once on day 1, 30 to 60 minutes prior to Avelumab (Bavencio)
- The Bavencio package insert suggests "Premedicate with acetaminophen and an antihistamine for the first 4 infusions and subsequently as needed."
14-day cycles
References
- 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. link to original article contains verified protocol link to PMC article PubMed content property of HemOnc.org
- 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
- 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
Pembrolizumab monotherapy
| back to top |
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Nghiem et al. 2016 (KEYNOTE-017) | Phase II (RT) | 56% (95% CI 35-76%) |
Immunotherapy
- Pembrolizumab (Keytruda) 2 mg/kg IV once on day 1
21-day cycle for up to 35 cycles (2 years) or until CR
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. link to original article link to PMC article contains verified protocol PubMed