% IMPORTANT: The following is UTF-8 encoded. This means that in the presence % of non-ASCII characters, it will not work with BibTeX 0.99 or older. % Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or % “biber”. @ARTICLE{Haist:282917, author = {M. Haist and H. Stege and F. Rogall and Y. Tan and I. von Wasielewski and K. C. Klespe and F. Meier and P. Mohr and K. C. Kähler and M. Weichenthal and A. Hauschild and D. Schadendorf$^*$ and S. Ugurel$^*$ and G. Lodde$^*$ and L. Zimmer$^*$ and R. Gutzmer and D. Debus and B. Schilling and A. Kreuter and J. Ulrich and F. Meiss and R. Herbst and A. Forschner and U. Leiter and C. Pfoehler and M. Kaatz and F. Ziller and J. C. Hassel and M. Tronnier and M. Sachse and E. Dippel and P. Terheyden and C. Berking and M. V. Heppt and F. Kiecker and S. Haferkamp and C. Gebhardt and J. C. Simon and S. Grabbe and C. Loquai}, title = {{T}reatment management for {BRAF}-mutant melanoma patients with tumor recurrence on adjuvant therapy: a multicenter study from the prospective skin cancer registry {ADOREG}.}, journal = {Journal for ImmunoTherapy of Cancer}, volume = {11}, number = {9}, issn = {2051-1426}, address = {London}, publisher = {BioMed Central}, reportid = {DKFZ-2023-01906}, pages = {e007630}, year = {2023}, abstract = {Adjuvant therapy with immune-checkpoint inhibitors (CPI) or BRAF/MEK-directed targeted therapy (TT) improves recurrence-free survival (RFS) for patients with advanced, BRAFV600-mutant (BRAFmut) resected melanoma. However, $40\%$ of these patients will develop distant metastases (DM) within 5 years, which require systemic therapy. Little data exist to guide the choice of upfront adjuvant therapy or treatment management upon DM. This study evaluated the efficacy of subsequent treatments following tumor recurrence upon upfront adjuvant therapy.For this multicenter cohort study, we identified 515 BRAFmut patients with resected stage III melanoma who were treated with PD-1 inhibitors (anti-PD1) or TT in the adjuvant setting. Disease characteristics, treatment regimens, details on tumor recurrence, subsequent treatment management, and survival outcomes were collected within the prospective, real-world skin cancer registry ADOReg. Primary endpoints included progression-free survival (PFS) following DM and best tumor response to first-line (1L) treatments.Among 515 eligible patients, 273 patients received adjuvant anti-PD1 and 242 adjuvant TT. At a median follow-up of 21 months, $54.6\%$ of anti-PD1 patients and $36.4\%$ of TT patients recurred, while $39.6\%$ (anti-PD1) and $29.3\%$ (TT) developed DM. Risk of recurrence was significantly reduced in patients treated with TT compared with anti-PD1 (adjusted HR 0.52; $95\%$ CI 0.40 to 0.68, p<0.001). Likewise, median RFS was significantly longer in TT-treated patients (31 vs 17 months, p<0.001). Patients who received TT as second adjuvant treatment upon locoregional recurrence had a longer RFS2 as compared with adjuvant CPI (41 vs 6 months, p=0.009). Patients who recurred at distant sites following adjuvant TT showed favorable response rates $(42.9\%)$ after switching to 1L ipilimumab+nivolumab (ipi+nivo). Patients with DM during adjuvant anti-PD1 achieved response rates of $58.7\%$ after switching to 1L TT and $35.3\%$ for 1L ipi+nivo. Overall, median PFS was significantly longer in patients who switched treatments for stage IV disease (median PFS 9 vs 5 months, p=0.004).BRAFmut melanoma patients who developed DM upon upfront adjuvant therapy achieve favorable tumor control and prolonged PFS after switching treatment modalities in the first-line setting of stage IV disease. Patients with locoregional recurrence benefit from complete resection of recurrence followed by a second adjuvant treatment with TT.}, keywords = {Adjuvant Drug Therapy (Other) / Immune Checkpoint Inhibitors (Other) / Melanoma (Other) / Molecular Targeted Therapy (Other) / Recurrence (Other)}, cin = {ED01}, ddc = {610}, cid = {I:(DE-He78)ED01-20160331}, pnm = {899 - ohne Topic (POF4-899)}, pid = {G:(DE-HGF)POF4-899}, typ = {PUB:(DE-HGF)16}, pubmed = {pmid:37730278}, doi = {10.1136/jitc-2023-007630}, url = {https://inrepo02.dkfz.de/record/282917}, }