Merkel cell carcinoma

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Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA

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2 regimens on this page
2 variants on this page


Guidelines

NCCN

Metastatic or advanced disease, all lines of therapy

Avelumab monotherapy

Source: Avelumab (Bavencio) for merkel cell carcinoma

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Regimen

Study Evidence Efficacy
Kaufman et al. 2016 (JAVELIN Merkel 200) Phase II (RT) 32% (95% CI: 22–43)

Immunotherapy

Supportive medications

Per Kaufman et al. 2016:

  • H1-antihistamine, such as diphenhydramine (dose & route not given) once on day 1, 30 to 60 minutes prior to immunotherapy
  • Paracetamol/acetaminophen (dose not given) once on day 1, 30 to 60 minutes prior to immunotherapy
  • 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. link to original article contains verified protocol PubMed content property of HemOnc.org
    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

Pembrolizumab monotherapy

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Regimen

Study Evidence Efficacy
Nghiem et al. 2016 (KEYNOTE-017) Phase II (RT) 56% (95% CI 35-76%)

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 verified protocol PubMed