ASCO Annual Meeting
June 2, 2014
Results from a large clinical study show that treatment with ipilimumab (Yervoy) decreases the risk of melanoma coming back after surgery by roughly 25% for people diagnosed with high-risk stage III disease. However, this treatment causes serious side effects.
Nine hundred fifty-one (951) people who had already had surgery to treat stage III melanoma volunteered to participate in this study. They were considered to be at high risk for the cancer coming back (recurrence) because the cancer had spread to the lymph nodes. The volunteers were randomly assigned to one of two groups. One group received ipilimumab, a drug that works by taking the brakes off the immune system to destroy cancer cells. The other group received an inactive treatment called a placebo.
Nearly three years after treatment, the researchers found that ipilimumab therapy greatly reduced the risk of melanoma recurrence. During this time, there were 234 recurrences reported in the ipilimumab group compared with 294 recurrences in the placebo group. This means that 47% of people who received ipilimumab remained melanoma-free after three years compared with 35% of people who received the placebo. Overall, ipilimumab reduced the risk of recurrence by 25% compared with placebo.
Despite its effectiveness, treatment with ipilimumab often caused serious side effects. More than half (52%) of people in the ipilimumab group stopped treatment because of side effects, most within the first 12 to 16 weeks. These side effects included rash and inflammation of the colon (colitis), thyroid, and pituitary gland. There were also five treatment-related deaths reported during this study. However, most of these side effects can be prevented and managed by watching closely for symptoms before they become more serious. Still, more research is needed to better understand whether the benefits outweigh the risks associated with this treatment.
What this means for patients
“This is a promising treatment—we saw substantially fewer recurrences among patients who are at high risk of relapse,” said lead study author Professor Alexander Eggermont, MD, PhD, Director General of the Gustave Roussy Cancer Campus Grand Paris in France. “We’ve seen many impressive new treatments for advanced melanoma in recent years. This trial with ipilimumab is the first to show we may be able to give these new drugs earlier in the course of disease, where it can do more good and potentially cure more patients.”
Ipilimumab is approved by the U.S. Food and Drug Administration for the treatment of stage IV melanoma, as well as stage III melanoma that cannot be removed with surgery. However, it is not currently approved to reduce the risk of recurrence after surgery. Talk with your doctor about all of your treatment options, including clinical trials.
Questions to ask your doctor
- What stage of melanoma do I have?
- What are my treatment options?
- Can the melanoma be removed using surgery?
- Will I need to have additional treatment after surgery? Why or why not?
- Will immunotherapy be part of my treatment plan?
- What are the possible side effects of each treatment option, both in the short term and the long term? How can they be managed?
- Is the cancer likely to come back after treatment?