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@ARTICLE{Schumann:300825,
author = {K. Schumann$^*$ and K. C. Klespe and C. Mauch and C. Loquai
and U. Schultheis and S. Börger and A. Thiem and S. Emmert
and M. Hoellwerth and P. Koelbinger and V. A. Nguyen and M.
Wanner and E. Richtig and W. K. Peitsch and W. Harth and V.
Zenderowski and A. D. Braun and M. Mengoni and R. Dummer and
J. Mangana and L. V. Maul and F. Meis and K. Rappersberger
and O. D. Persa$^*$ and T. Biedermann$^*$ and C. Posch$^*$},
title = {{S}witching {PD}-1 to {BRAF} + {MEK} inhibition improves
recurrence-free survival in patients receiving a second
course of adjuvant melanoma therapy.},
journal = {Journal of the European Academy of Dermatology and
Venereology},
volume = {nn},
issn = {0926-9959},
address = {Oxford [u.a.]},
publisher = {Wiley-Blackwell},
reportid = {DKFZ-2025-00939},
pages = {nn},
year = {2025},
note = {epub},
abstract = {PD-1 or BRAF + MEK inhibition is considered the current
gold standard in adjuvant melanoma therapy. Little is known
if, after the recurrence of the disease and surgery, a
second course of adjuvant therapy might be beneficial.A
multicenter, retrospective study investigating a second
course of adjuvant therapy after recurrence and surgery in
stage III-IV melanoma patients. Patients received nivolumab
(NIV), pembrolizumab (PEM) or dabrafenib plus trametinib (D
+ T) between 01/2017 and 10/2021. The primary endpoint was
12-month recurrence-free survival (RFS2). Further analyses
included descriptive and correlative statistics.Sixty-six
patients from 22 centers in Germany, Austria and Switzerland
were included. Thirty-two patients received D + T as
second-course adjuvant therapy, 9 patients received PEM and
25 patients received NIV. Recurrence-free survival for the
second-course adjuvant treatment (RFS2) was assessed after
12 and 24 months and showed a superiority of adjuvant BRAF +
MEK over PD-1 therapy (12-months RFS2: $90.6\%$ vs.
$70.6\%,$ HR 4.226 $[95\%$ CI 1.154-15.48]; p = 0.030;
24-months RFS2 $71.9\%$ vs. $52.9\%,$ HR 3.154 $[95\%$ CI
1.374-7.242]; p = 0.007). There was no significant decrease
in OS with either BRAF + MEK or PD-1 treatment (12-months
OS: $100\%$ both, 24-months OS: $100\%$ vs. $93.8\%).$
Furthermore, therapy sequences were investigated. For better
comparability, only BRAF V600 mutated patients were
assessed: RFS2 was significantly better for patients with a
class switch from PD-1 to BRAF + MEK compared to BRAF + MEK
to PD-1 (HR 4.401 (1.04-18.63), p = 0.044). No new safety
signals were detected.In the investigated cohort, a second
course of adjuvant melanoma treatment is feasible and
provides similar RFS compared to an initial course of
adjuvant therapy using BRAF + MEK inhibitors; however, RFS2
is reduced for PD-1 antibodies. In addition, both treatments
were convincing with a 24-month OS of almost $100\%.$
Switching from adjuvant PD-1 to BRAF + MEK treatment
provided better overall RFS compared to switching from
adjuvant BRAF + MEK to PD-1 treatment.},
cin = {MU01},
ddc = {610},
cid = {I:(DE-He78)MU01-20160331},
pnm = {899 - ohne Topic (POF4-899)},
pid = {G:(DE-HGF)POF4-899},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:40331873},
doi = {10.1111/jdv.20708},
url = {https://inrepo02.dkfz.de/record/300825},
}