% 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{Kennedy:276423, author = {O. J. Kennedy and M. Kicinski and S. Valpione and S. Gandini and S. Suciu and C. U. Blank and G. V. Long and V. G. Atkinson and S. Dalle and A. M. Haydon and A. Meshcheryakov and A. Khattak and M. S. Carlino and S. Sandhu and J. Larkin and S. Puig and P. A. Ascierto and P. Rutkowski and D. Schadendorf$^*$ and M. Boers-Sonderen and A. M. Di Giacomo and A. J. M. van den Eertwegh and J.-J. Grob and R. Gutzmer and R. Jamal and A. C. J. van Akkooi and C. Robert and A. M. M. Eggermont and P. Lorigan and M. Mandala}, title = {{P}rognostic and predictive value of metformin in the {E}uropean {O}rganisation for {R}esearch and {T}reatment of {C}ancer 1325/{KEYNOTE}-054 phase {III} trial of pembrolizumab versus placebo in resected high-risk stage {III} melanoma.}, journal = {European journal of cancer}, volume = {189}, issn = {0014-2964}, address = {Amsterdam [u.a.]}, publisher = {Elsevier}, reportid = {DKFZ-2023-01106}, pages = {112900}, year = {2023}, note = {2023 Aug;189:112900}, abstract = {Metformin is a commonly prescribed and well-tolerated medication. In laboratory studies, metformin suppresses BRAF wild-type melanoma cells but accelerates the growth of BRAF-mutated cells. This study investigated the prognostic and predictive value of metformin, including with respect to BRAF mutation status, in the European Organisation for Research and Treatment of Cancer 1325/KEYNOTE-054 randomised controlled trial.Patients with resected high-risk stage IIIA, IIIB, or IIIC melanoma received 200 mg of pembrolizumab (n = 514) or placebo (n = 505) every 3 weeks for twelve months. Pembrolizumab prolonged recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) at approximately 42 months median follow-up (Eggermont et al., TLO, 2021). Multivariable Cox regression was used to estimate associations of metformin with RFS and DMFS. Interaction terms were used to model effect modification by treatment and BRAF mutation.Fifty-four patients $(0.5\%)$ used metformin at baseline. Metformin was not significantly associated with RFS (hazard ratio [HR] 0.87, $95\%$ confidence interval [CI] 0.52-1.45) and DMFS (HR 0.82, $95\%$ CI 0.47-1.44). The interaction between metformin and the treatment arm was not significant for either RFS (p = 0.92) or DMFS (p = 0.93). Among patients with mutated BRAF, the association of metformin with RFS (HR 0.70, $95\%$ CI 0.37-1.33) was greater in magnitude though not significantly different to those without mutated BRAF (HR 0.98, $95\%$ CI 0.56-1.69).There was no significant impact of metformin use on pembrolizumab efficacy in resected high-risk stage III melanoma. However, larger studies or pooled analyses are needed, particularly to explore a possible effect of metformin in BRAF-mutated melanoma.}, keywords = {BRAF (Other) / Immunomodulation (Other) / Immunotherapy (Other) / Melanoma (Other) / Metformin (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:37277264}, doi = {10.1016/j.ejca.2023.04.016}, url = {https://inrepo02.dkfz.de/record/276423}, }