english.prescrire.org > Spotlight > Archives : 2020 > Dabrafenib (Tafinlar°) and trametinib (Mekinist°) combined, as adjuvant therapy for stage III melanoma with a BRAF V600 mutation

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2020 : 1 | 30 | 60

Dabrafenib (Tafinlar°) and trametinib (Mekinist°) combined, as adjuvant therapy for stage III melanoma with a BRAF V600 mutation

FEATURED REVIEW This combination has now been authorised in the European Union for the adjuvant treatment of patients with melanoma and lymph node involvement but no other metastases, when the tumour cells express a BRAF V600 mutation. Does this combination extend survival in this situation? Does it reduce the incidence of recurrence? What more is known about its adverse effects?
Full review (3 pages) available for download by subscribers.

Prescrire's rating

  •  POSSIBLY HELPFUL  In patients treated surgically for melanoma with lymph node involvement but no distant metastases and with a BRAF V600 mutation, adjuvant treatment with the combination of dabrafenib and trametinib reduced the 3-year recurrence rate by about 20 percentage points in a single double-blind randomised placebo-controlled trial in 870 patients. Interim results suggest that this combination extends survival, although confirmation from longer-term follow-up is required. These potential benefits must be weighed against the increased incidence of serious adverse events reported with dabrafenib + trametinib (36% of patients versus 10% in the placebo group). In the absence of head-to-head trials, it is not known whether this combination is superior to nivolumab or pembrolizumab. When dabrafenib + trametinib is chosen, patients should be closely monitored, in particular for cutaneous, visual, renal, hepatic and cardiac harms.

©Prescrire 1 June 2020

Source: "Dabrafenib - Tafinlar° and trametinib - Mekinist° combined, as adjuvant therapy for stage III melanoma with a BRAF V600 mutation. Lower risk of recurrence, but more adverse effects and no comparison with other antineoplastics" Prescrire International 2020; 29 (216): 147-149. Subscribers only.

Enjoy full access to Prescrire International, and support independent information

Share on  Facebook Share on  Twitter

Prescrire's rating:

Prescrire's rating

See also:

"Pembrolizumab (Keytruda°)
as adjuvant therapy for
stage III melanoma"
Prescrire Int 2020;
29 (216): 149.
Pdf, subscribers only

"Nivolumab (Opdivo°) as
adjuvant therapy for stage III
and stage IV melanoma"
Prescrire Int 2020;
29 (216): 150-151.
Pdf, subscribers only

"Advanced melanoma.
Risks from combining
two immunostimulants"
Prescrire Int 2018;
27 (190): 50.
Pdf, subscribers only

Read more:

All the subjects in
Prescrire's Spotlight
Free >