In a nutshell
This study wanted to find out what the best timing is for treating patients with stage 3 melanoma with ipilimumab (Yervoy) and nivolumab (Opdivo). The study found that the best timing was two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg every three weeks.
Ipilimumab and nivolumab are medications used to treat melanoma. Using these medications in patients with stage 3 melanoma usually works well to kill the cancer. However, these medications can have some serious side effects. How bad the side effects are can depend on the timing of the treatment. It is not known what the best timing is for treating melanoma with ipilimumab and nivolumab to have the best outcome, with the least side effects.
Methods & findings
This study had 86 patients. All of the patients had stage 3 melanoma that could be operated on. All of the patients received treatment with ipilimumab and nivolumab. The patients were split into three groups. Group 1 had two cycles of ipilimumab 3 mg/kg combined with nivolumab 1 mg/kg every three weeks. Group 2 had two cycles of ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg every three weeks. Group 3 had two cycles of ipilimumab 3 mg/kg every 3 weeks, immediately followed by two cycles of nivolumab 3 mg/kg every 2 weeks.
After 12 weeks, the occurrence of side effects was measured. Group 3 had to stop treatment early. This was because too many side effects were happening in this group. 40% of patients in group 1 had serious side effects. 20% of patients in group 2 had side effects. 50% of patients in group 3 had side effects. Common side effects included inflammation of the large intestine (group 3), and elevated liver enzymes (group 1).
In group 1, 63% of patients had the tumor shrink significantly. In group 2, 57% of patients had the tumor shrink significantly. In group 3, 35% of patients had the tumor shrink significantly.
All patients received surgery after ipilimumab and nivolumab. In group 1, 80% of patients had a tumor response after surgery (pathological response). 47% of these patients had no cancer left after surgery. In group 2, 77% of patients had a pathological response. Of these, 57% had no cancer left after surgery. In group 3, 65% of patients had a pathological response with 23% with no signs of cancer left in the body after treatment.
The bottom line
The study concluded that group 2 had the least side effects and the best response to treatment with ipilimumab and nivolumab.
The fine print
This is a small study. A number of patients had to stop treatment because they got too sick. Further research is needed.
Talk to your oncologist if you are concerned about side effects to immunotherapy.
Published By :
The Lancet. Oncology
May 31, 2019