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The New England Journal of MedicineFinal Results for Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma

Extended Follow-Up in Stage III Melanoma Reveals Sustained Benefits of Dabrafenib and Trametinib Therapy

This comprehensive study presents the final results after nearly a decade of follow-up for patients with stage III melanoma treated with adjuvant dabrafenib plus trametinib. The findings offer critical insights into the long-term effects of BRAF inhibition on relapse-free survival and distant metastasis-free survival, with implications for the management of melanoma patients harboring BRAF V600 mutations.

Study Design:

  • Participants: 870 patients with resected stage III melanoma and BRAF V600 mutations were enrolled.
  • Intervention: Patients were randomized to receive either 12 months of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) or matched placebos.
  • Duration of Follow-Up: Median follow-up times were 8.33 years for the treatment group and 6.87 years for the placebo group.

Key Findings:

  • Overall Survival: The overall survival rate showed a non-significant 20% lower risk of death with dabrafenib plus trametinib (HR 0.80; 95% CI, 0.62 to 1.01; P=0.06).
  • Subgroup Analysis: In patients with BRAF V600E mutations, the risk of death was significantly reduced by 25% (HR 0.75; 95% CI, 0.58 to 0.96).
  • Relapse-Free and Distant Metastasis-Free Survival: Both metrics significantly favored the treatment group (HR for relapse or death, 0.52; HR for distant metastasis or death, 0.56).
  • Safety: No new safety concerns were identified, maintaining consistency with previous reports from earlier phases of the trial.

HCN Medical Memo
As we approach a decade of follow-up, the consistent advantage in relapse-free and distant metastasis-free survival underscores the enduring efficacy of dabrafenib and trametinib in treating stage III melanoma. Physicians should consider these outcomes when strategizing long-term treatment plans for patients with BRAF V600 mutations.

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