Adjuvant interferon alfa-2a treatment in resected primary stage II cutaneous melanoma

Pehamberger, H, Soyer, HP, Steiner, A, Kofler, R, Binder, M, Mischer, P, Pachinger, W, Aubock, J, Fritsch, P, Kerl, H and Wolff, K (1998) Adjuvant interferon alfa-2a treatment in resected primary stage II cutaneous melanoma. Journal of Clinical Oncology, 16 4: 1425-1429. doi:10.1200/JCO.1998.16.4.1425

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Author Pehamberger, H
Soyer, HP
Steiner, A
Kofler, R
Binder, M
Mischer, P
Pachinger, W
Aubock, J
Fritsch, P
Kerl, H
Wolff, K
Title Adjuvant interferon alfa-2a treatment in resected primary stage II cutaneous melanoma
Journal name Journal of Clinical Oncology   Check publisher's open access policy
ISSN 0732-183X
1527-7755
Publication date 1998-04-01
Sub-type Article (original research)
DOI 10.1200/JCO.1998.16.4.1425
Open Access Status File (Publisher version)
Volume 16
Issue 4
Start page 1425
End page 1429
Total pages 5
Place of publication Alexandria, VA, United States
Publisher American Society of Clinical Oncology
Language eng
Abstract Background Combination therapy with the BRAF inhibitor dabrafenib plus the MEK inhibitor trametinib improved survival in patients with advanced melanoma with BRAF V600 mutations. We sought to determine whether adjuvant dabrafenib plus trametinib would improve outcomes in patients with resected, stage III melanoma with BRAF V600 mutations. Methods In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 870 patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations to receive oral dabrafenib at a dose of 150 mg twice daily plus trametinib at a dose of 2 mg once daily (combination therapy, 438 patients) or two matched placebo tablets (432 patients) for 12 months. The primary end point was relapse-free survival. Secondary end points included overall survival, distant metastasis-free survival, freedom from relapse, and safety. Results At a median follow-up of 2.8 years, the estimated 3-year rate of relapse-free survival was 58% in the combination-therapy group and 39% in the placebo group (hazard ratio for relapse or death, 0.47; 95% confidence interval [CI], 0.39 to 0.58; P<0.001). The 3-year overall survival rate was 86% in the combination-therapy group and 77% in the placebo group (hazard ratio for death, 0.57; 95% CI, 0.42 to 0.79; P=0.0006), but this level of improvement did not cross the prespecified interim analysis boundary of P=0.000019. Rates of distant metastasis-free survival and freedom from relapse were also higher in the combination-therapy group than in the placebo group. The safety profile of dabrafenib plus trametinib was consistent with that observed with the combination in patients with metastatic melanoma. Conclusions Adjuvant use of combination therapy with dabrafenib plus trametinib resulted in a significantly lower risk of recurrence in patients with stage III melanoma with BRAF V600E or V600K mutations than the adjuvant use of placebo and was not associated with new toxic effects. (Funded by GlaxoSmithKline and Novartis; COMBI-AD ClinicalTrials.gov, NCT01682083 ; EudraCT number, 2012-001266-15 .).
Keyword Lymph-Node Dissection
Malignant-Melanoma
Current Therapy
Trial
Efficacy
Program
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: UQ Diamantina Institute Publications
 
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