Researchers, including Australians, have developed a tool to predict patient-specific outcomes in people with stage II or III melanoma and ultimately help inform decisions regarding their need for adjuvant therapy.
Writing in The Lancet Oncology [link here], the researchers said the goal was to ensure patients at highest risk of recurrence benefit from adjuvant treatment while those at lower risk were not overtreated considering the potential for treatment-related adverse events.
The model was developed using data from more then 4,000 patients ≥ 13 years of age who underwent sentinel lymph node biopsy (SLNB) at four melanoma centres in Germany, Poland and The Netherlands between 1997 and 2013.
The model was then validated in a cohort of almost 5,000 patients of any age with confirmed primary melanoma who underwent SLNB at the Melanoma Institute Australia (MIA) during the same time period.
The final model included six independent prognostic factors: age at SLNB, melanoma location (upper limb, lower limb, trunk, or head or neck), presence of ulceration, increased Breslow thickness, positive sentinel node status, and sentinel node tumour burden.
“All the data needed to use the model and nomogram are commonly collected and easily ascertainable in hospitals worldwide,” the study coauthored by MIA co-medical directors Professor Georgina Long and Professor Richard Scolyer said.
“For the model’s prediction of the composite recurrence outcome, the AUC was 0·80 (95% CI 0·78–0·81); for prediction of melanoma-specific survival, the AUC was 0·81 (0·79–0·84),” it said.
“Because our model can provide absolute estimates before treatment with adjuvant therapy, and the relative risk reduction in recurrence or death due to immunotherapy is known (ie, the hazard ratio), the potential absolute risk reduction after adjuvant therapy can now be calculated.”
To facilitate clinical use, an online calculator has been developed [link here].
“Our prediction model and nomogram accurately predicted patient-specific risk probabilities for 5-year recurrence-free and melanoma-specific survival. These tools could have important implications for clinical decision making when considering adjuvant treatments in patients with high-risk melanomas,” it said.
An accompanying Comment in the journal [link here] said a limitation of the model was that it was based on patients treated at highly specialised melanoma centres rather than population-based.
“However, we anticipate that future external validations could confirm the robustness of the model,” it said.
“Unlike the other calculators of the risk of melanoma recurrence that are available, Stassen and colleagues’ model includes patients with both sentinel lymph node-positive and sentinel lymph node-negative disease, and calculates both recurrence-free survival and melanoma-specific survival, which means that the absolute benefit of adjuvant treatments can be estimated.”
It said the work was a “fundamental first step towards a new era in which adjuvant treatment recommendations are more personalised and precise.”
“The next question to address is the risk level at which adjuvant treatment for melanoma should be recommended.”