Avelumab for advanced Merkel cell carcinoma in the Netherlands: a real-world cohort.

Autor:	Levy S; Department of Medical Oncology, Antoni van Leeuwenhoek Netherlands Cancer Institute, Amsterdam, The Netherlands so.levy@nki.nl., Aarts MJB; Department of Medical Oncology, Maastricht University Medical Center+, Maastricht, Limburg, The Netherlands., Eskens FALM; Department of Medical Oncology, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands., Keymeulen KBMI; Department of Surgery, Maastricht University Medical Center+, Maastricht, Limburg, The Netherlands., Been LB; Department of Surgical Oncology, University Medical Center Groningen, Groningen, The Netherlands., Grünhagen D; Department of General Surgery, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands., van Akkooi A; Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Jalving M; Department of Medical Oncology, University Medical Center Groningen, Groningen, The Netherlands., Tesselaar MET; Department of Medical Oncology, Antoni van Leeuwenhoek Netherlands Cancer Institute, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	Journal for immunotherapy of cancer [J Immunother Cancer] 2020 Sep; Vol. 8 (2).
DOI:	10.1136/jitc-2020-001076
Abstrakt:	Background: Merkel cell carcinoma (MCC) is associated with high recurrence rates and poor survival when metastatic disease is present. The immune checkpoint inhibitor avelumab has shown high response rates (RRs) and durable responses in patients with advanced MCC (aMCC) in clinical trials. To date, only results from clinical trials, patients treated in an expanded access program and very small numbers of patients have been reported. In this study, detailed real-world efficacy and toxicity data of avelumab in patients with aMCC are reported. Methods: Patients with aMCC treated in four dedicated referral centers in the Netherlands were analyzed from February 2017 until December 2019. Patients were included if they had received at least one administration of avelumab, regardless of previous lines of therapy. Patient data were collected retrospectively from patient records. Primary endpoints were response rate (RR) and duration of response (DOR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. Results: Fifty-four patients received avelumab. Eight (15%) patients had locally advanced disease (laMCC). In 40 (74%) patients, avelumab was first-line treatment, these included all patients with laMCC. The median follow-up was 8.9 (range 0.5-35.9) months. RR was 57% (n=31) with 24% (n=13) of patients achieving a complete response. The median DOR was 8.4 (range 1.3-22.1) months and 23 (43%) patients had an ongoing response at the end of the study. The median PFS was 8.6 (95% CI 1.6-15.5) months, and the median OS was 25.8 (95% CI 9.1-42.4) months. Six (11%) patients experienced grade 3 toxicity. No grade 4-5 toxicity was seen. Conclusions: In this real-world cohort, clinical efficacy and toxicity outcomes in clinical practice were in line with results from clinical trials and showed relatively high RRs and durable responses in patients with aMCC. Competing Interests: Competing interests: MJBA, FALME, KBMIK, LBB, DG, AvA, MJ and METT report to hold a position on an advisory board for Merck. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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