Patients with high-risk melanoma who underwent a course of pembrolizumab after surgery spent a longer time before the disease reappeared than patients who received ipilimumab or interfered with high doses after surgery. These results of a major clinical trial of the SWOG Cancer Research Network, S1404, will be presented at the ASCO annual meeting on June 6, 2021.
The researchers also measured overall survival and found no statistically significant differences in overall survival rates between the two groups. patients three and a half years after the last patient enrolled in the trial. However, they found that patients taking pembrolizumab had fewer serious side effects than those treated with high-dose interferon or ipilimumab.
Trial S1404 is sponsored by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), designed and led by the SWOG Cancer Research Network, and conducted by the National Clinical Trials Network ( NCTN) funded by NIH.
Kenneth F. Grossmann, MD, Ph.D., of the Huntsman Cancer Institute at the University of Utah Medical Center and chair of the SWOG Melanoma Committee, was the study’s lead researcher. He spoke about the pembrolizumab treatment that was tested: “The recurrence-free survival advantage and improved safety profile over the previous care standard make this therapy an ongoing standard for the treatment of patients with resected melanoma. high risk. “
Noting that overall survival measures were not significantly different between the two arms, Grossmann said, “The overall survival analysis was performed at a predefined time point with only about 50% of the events required for an analysis. We suspect that effective use of PD-1 blockade and other improved therapies for stage IV disease improved the outcomes of recurrent patients in the control arm, so overall survival was no different between the two groups. ” .
Grossmann added that more data from this trial will include studies to assess pre-treatment predictors of whether patients will benefit from treatment and quality-of-life studies to better understand the impact of relapse in patients with resectable melanoma. high risk.
The study randomized 1,345 adult patients with stage III or IV melanoma who had been operated on to remove their tumors. Patients were randomly assigned to the pembrolizumab arm or control arm. Those in the control arm decided with their doctors whether to follow a high-dose interferon course or an ipilimumab, both FDA-approved for treatment in these patients.
Pembrolizumab, an immunotherapy drug known as a PD-1 inhibitor, was chosen for the trial because of its comparatively low toxicity and activity in metastatic diseases. Another trial has since also shown a recurrence-free survival benefit for the drug compared to a placebo. High-dose interferon and ipilimumab, which were standard treatments for the care of these patients at the start of the study, often have serious side effects. As expected by S1404 researchers, toxicity was lower in patients in the pembrolizumab arm. Among patients taking interferon at high doses, approximately 72% had severe side effects (grade 3 or higher adverse events). The rate of these side effects was approximately 58% for those taking ipilimumab, but it was only 32% for patients. pembrolizumab.
Provided by SWOG Cancer Research Network
Citation: Immunotherapy after surgery reduces the risk of relapse in patients with high-risk melanoma (2021, June 3) recovered on June 4, 2021 at https://medicalxpress.com/news/2021-06- immune-therapy-surgery-lowers-relapse. html
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