TY - JOUR
T1 - Adjuvant BRAF/MEK versus anti-PD-1 in BRAF-mutant melanoma
T2 - a propensity score matched survival analysis
AU - Bloem, M.
AU - de Meza, M. M.
AU - van den Eertwegh, A. J. M.
AU - Aarts, M. J. B.
AU - van den Berkmortel, F. W. P. J.
AU - Blank, C. U.
AU - Blokx, W. A. M.
AU - Boers-Sonderen, M. J.
AU - Bonenkamp, J. J.
AU - Boreel, C. D. M.
AU - de Groot, J. W. B.
AU - Haanen, J. B. A. G.
AU - Hospers, G. A. P.
AU - Kapiteijn, E.
AU - van Not, O. J.
AU - Piersma, D.
AU - Rikhof, B.
AU - Stevense-den Boer, A. M.
AU - van der Veldt, A. A. M.
AU - Vreugdenhil, G.
AU - Suijkerbuijk, K. P. M.
AU - Wouters, M. W. J. M.
PY - 2025/6/29
Y1 - 2025/6/29
N2 - Background: Adjuvant BRAF/MEK inhibitors (BRAF/MEK) and anti-PD-1 therapy have become the standard care in resected stage III/IV melanoma. A head-to-head clinical trial comparison is lacking. Methods: All stage III BRAF-mutant melanoma patients who received adjuvant BRAF/MEK or anti-PD-1 (2018-2022) were included from the Dutch Melanoma Treatment Registry. Propensity score matching (PSM) was used to compare 1- and 2-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS), and toxicity rates. Findings: Among 952 patients (226 BRAF/MEK and 726 anti-PD-1), BRAF/MEK-treated patients had lower disease stages (16·4% versus 9·9% stage IIIA; p < 0·01) and more often comorbidities (75·2% versus 63·4%; p < 0·01). Median follow-up was 29 months. PSM created two similar groups of 223 patients. RFS, DMFS, and OS were not significantly different before and after PSM. Two-year RFS was 62% (95% CI 55–71) for BRAF/MEK and 65% (95% CI 58–72) for anti-PD-1; 2-year DMFS was 81% (95% CI 74–87) versus 81% (95% CI 75–86); 2-year OS was 86% (95% CI 81–92) versus 89% (95% CI 85–94), respectively. Grade ≥ 3 toxicity was reported in 11·7% (BRAF/MEK) and 13·4% (anti-PD-1). Conclusion: After PSM, no significant differences in outcomes were observed between adjuvant anti-PD-1 and BRAF/MEK-treated patients with stage III BRAF-mutant melanoma.
AB - Background: Adjuvant BRAF/MEK inhibitors (BRAF/MEK) and anti-PD-1 therapy have become the standard care in resected stage III/IV melanoma. A head-to-head clinical trial comparison is lacking. Methods: All stage III BRAF-mutant melanoma patients who received adjuvant BRAF/MEK or anti-PD-1 (2018-2022) were included from the Dutch Melanoma Treatment Registry. Propensity score matching (PSM) was used to compare 1- and 2-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS), and toxicity rates. Findings: Among 952 patients (226 BRAF/MEK and 726 anti-PD-1), BRAF/MEK-treated patients had lower disease stages (16·4% versus 9·9% stage IIIA; p < 0·01) and more often comorbidities (75·2% versus 63·4%; p < 0·01). Median follow-up was 29 months. PSM created two similar groups of 223 patients. RFS, DMFS, and OS were not significantly different before and after PSM. Two-year RFS was 62% (95% CI 55–71) for BRAF/MEK and 65% (95% CI 58–72) for anti-PD-1; 2-year DMFS was 81% (95% CI 74–87) versus 81% (95% CI 75–86); 2-year OS was 86% (95% CI 81–92) versus 89% (95% CI 85–94), respectively. Grade ≥ 3 toxicity was reported in 11·7% (BRAF/MEK) and 13·4% (anti-PD-1). Conclusion: After PSM, no significant differences in outcomes were observed between adjuvant anti-PD-1 and BRAF/MEK-treated patients with stage III BRAF-mutant melanoma.
KW - RESECTED STAGE-III
KW - FOLLOW-UP
KW - IPILIMUMAB
KW - NIVOLUMAB
KW - OUTCOMES
KW - TIME
U2 - 10.1038/s41416-025-03021-5
DO - 10.1038/s41416-025-03021-5
M3 - Article
SN - 0007-0920
VL - 132
SP - 1124
EP - 1130
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 12
M1 - 102290
ER -