Adjuvant Therapies in Melanoma- update

Adjuvant therapies are given before the Melanoma has widely spread, so in Melanoma Stage 3.

work in progress

Sophie Piperno- Neumann on 
FOTEADJ: randomised adjuvant Phase 3 clinical trial of fotemustine versus observations in high-risk UM patients


Uveal Melanoma (Melanoma of the eye)

• 3-5% of all Melanoma cases
• 20% of patients will develop mestastasis within 5 years after being diagnosed, median OS is 12 months
• TNM staging is important as important for prognosis

aim: 5 year progression-free survival

Reason for the study:

previous EORTC study had shown that Fotemustine given directly to the liver improved OS in Stage 4 patients (find study) 

(pic study design)

The trial was stopped for futility- no difference between chemo (fotemustine) and observations. The study was therefore stopped and changed to an intensive surveillance program.

Peter Mohr discussing adjuvant therapies in Melanoma-

What is the standard of adjuvant therapy in Melanoma?

After 25 randomised adjuvant Interferon trials-

Michael Atkins ASCO 2016: only 30% Stage 3 patients today get adjuvant therapy in US (Interferon)
Even less in Europe.

No agreement on treatment in adjuvant setting- guidelines internationally do not agree 

(pic)

What is the right endpoint for adjuvant trial?

so what should we be looking for?

- relapse free survival benefit?

- distant met free survival?

- overall survival (most likely today as we have effective therapies in Stage 4)

'chemotherapy should no longer be applied in the adjuvant setting' P. Mohr

Intergroup E1609

EORTC 18071  65% vs 54% 5 yrs OS adjuvant Ipi 10mg/kg

(presented by Lex Eggermont at ESMO2016)

OS in Stage 4 - Ipi 10mg vs 3mg begins to differ after one year, with patients on Ipi 10mg/kg - so we need to wait for OS data in the adjuvant setting

Up to now NO STANDARD based on efficacy, toxicity and cost

upcoming: PD1- based adjuvant therapies

(pic)

Eggermont: 'I see no future for Ipi/Nivo in the adjuvant setting'