Background <p>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.</p> Methods <p>All stage III <i>BRAF</i>-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.</p> Findings <p>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; <i>p</i> &lt; 0·01) and more often comorbidities (75·2% versus 63·4%; <i>p</i> &lt; 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).</p> Conclusion <p>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.</p>

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Adjuvant BRAF/MEK versus anti-PD-1 in BRAF-mutant melanoma: a propensity score matched survival analysis

  • M. Bloem,
  • M. M. de Meza,
  • A. J. M. van den Eertwegh,
  • M. J. B. Aarts,
  • F. W. P. J. van den Berkmortel,
  • C. U. Blank,
  • W. A. M. Blokx,
  • M. J. Boers-Sonderen,
  • J. J. Bonenkamp,
  • C. D. M. Boreel,
  • J. W. B. de Groot,
  • J. B. A. G. Haanen,
  • G. A. P. Hospers,
  • E. Kapiteijn,
  • O. J. van Not,
  • D. Piersma,
  • B. Rikhof,
  • A. M. Stevense-den Boer,
  • A. A. M. van der Veldt,
  • G. Vreugdenhil,
  • K. P. M. Suijkerbuijk,
  • M. W. J. M. Wouters

摘要

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.