Merkel cell carcinoma
Revision as of 17:35, 12 February 2022 by Warner-admin (talk | contribs) (Text replacement - "|Phase II" to "|Phase 2")
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Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA |
3 regimens on this page
3 variants on this page
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Guidelines
Alberta Health Services
- 2019: Merkel Cell Carcinoma
NCCN
Metastatic or advanced disease, all lines of therapy
Avelumab monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Kaufman et al. 2016 (JAVELIN Merkel 200) | 2014-2015 | Phase 2 (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 NCT02155647
- 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
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Regimen
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Nghiem et al. 2016 (KEYNOTE-017) | 2015 | Phase 2 (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 NCT02267603