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Interferon therapy not recommended for patients with minimal cancer in one lymph node.
The final results of a clinical trial showed that most patients with minimal stage 3 melanoma do not see any benefits from interferon treatment.
Researchers conducted the study using stage 3 patients with melanoma detected in a single lymph node by SLN biopsy. These patients had a lower risk of disease recurrence than other stage 3 patients due to lesser amounts of cancer detected.
Researchers also looked at patients with a small amount of cancer in a lymph node that could only be detected on a molecular level using polymerase chain reaction (PCR).
Over a 10 year span, researchers monitored more than 3600 patients across 79 institutions in North America. Patients with a small amount of melanoma detected in a lymph node were either given high dose interferon or were observed.
Researchers were looking to explore the long term outcomes of overall survival and cancer free survival.
"We started the Sunbelt Melanoma Trial to determine whether interferon therapy was warranted in this relatively lower risk group of stage 3 patients," said principal investigator Kelly McMasters, MD, PhD. "What we found was that there was no evidence that interferon was necessary or helpful for this substantial group of melanoma patients. That saves many patients the toxicity and expense of interferon therapy, which is like having the flu, only worse, for a whole year.
“While the study did not quite meet its accrual goals and was underpowered to detect very small differences in survival, there was not even a trend for improvement in survival with interferon. Based on these findings, it would be hard to recommend interferon therapy for patients with minimal cancer in just one lymph node."
Interferon was approved in 1995 and is 1 out of 2 drugs that is FDA approved for adjuvant therapy in high risk melanoma patients.
"Newer studies of melanoma adjuvant therapy using immune checkpoint agents, such as PD-1 inhibitors, show much promise," McMasters said. "I think more work needs to be performed to understand the significance of molecular detection of melanoma cells in the lymph nodes and in the circulating bloodstream. We now suspect that melanoma, as with other cancers, routinely sheds cancer cells into the lymphatic system and bloodstream, and that a small minority of these cells that have the ability to evade the immune system, attach, invade, develop their own blood supply and grow, will become metastatic tumors."