News

First results from the EORTC 1208 MINITUB trial, presented by Professor Alexander C.J. van Akkooi, contribute  significantly to the body of evidence indicating that some melanoma  patients can be spared from drug treatments or an extensive surgery with  little impact on their risk of developing metastatic disease or dying  due to melanoma. In the past, patients with a melanoma that had spread  to the sentinel node – the first lymph node or groups of nodes to which  the cancer usually spreads – at the time of initial diagnosis underwent a  complete lymph node dissection in addition to surgery to remove the  skin lesion. Lymph node dissection carries significant toxicity and can  have a lifelong impact on the patient’s quality of life. Some studies  had suggested that the extent to which the sentinel nodes are affected  by melanoma might help to predict prognosis, and the objective of the  EORTC 1208 MINITUB study was to assess the outcomes of patients with a  minimal sentinel node tumour burden who did not undergo a complete lymph  node dissection.

The primary study endpoint was the proportion of patients who  developed metastatic melanoma after five years from the date of biopsy  of the sentinel node. The study was performed in 21 hospitals from nine  countries, and 296 patients were enrolled. A small number of patients (17) chose complete lymph node dissection while 279 chose observation.  Results showed that patients with minimal sentinel node tumour burden  who chose observation had a relatively low risk of developing metastatic  disease or dying due to melanoma, thus supporting the current practice  of omitting a complete lymph node dissection. The researchers also found  overdiagnosis leading to possibly unnecessary treatment in 7% of the  patients. They say that their results provide strong evidence that an  evaluation of the sentinel node tumour burden is helpful in evaluating  prognosis of each patient and that it would be useful to add it to  future cancer staging systems. This could help a better evaluation of  whether the benefits of melanoma treatments outweigh the risk of  toxicities, especially for patients with a relatively low risk of  developing metastatic disease. The researchers now intend to follow up  the longer-term outcomes for these patients.

Another presentation featured follow up data from the EORTC 1325/KEYNOTE-054 trial of the immunotherapy treatment pembrolizumab, presented by  Professor Alexander Eggermont, show that this treatment administered  after a full resection of high-risk stage III melanoma continues to  bring clinical benefits to patients in the longer term. The trial  enrolled patients in 2015 and 2016, and found that after five years of  follow-up, recurrence-free survival, distant metastasis-free survival,  and the time from randomisation until a second disease recurrence,  progression of the first recurrence, or death, were all significantly  improved in the patients who had received the active treatment rather  than placebo.

Now, at a median seven-year follow-up, researchers found that these  improvements remained present for all these endpoints for those who  received the active treatment. Because late recurrences in melanoma are  common, these results are important, they say.