Research in context
Systematic review
The final protocol for this trial was submitted in January, 2008. In the preceding 2 years we assessed the scientific literature, restricted to English language publications, on PubMed (1980–2007), on adjuvant therapy in melanoma in patients with high risk for recurrence. A simple literature search using the search terms “melanoma”, “adjuvant therapy”, and “randomised trial” provided all relevant studies.
Added value of the study
This trial is, to the best of our knowledge, the first to assess an approved drug with an effect on survival in advanced melanoma in the adjuvant setting, and the first to study an immune checkpoint inhibitor in this setting. Our findings show that adjuvant use of ipilimumab has a significant effect on recurrence-free survival in the intention-to-treat population. We noted efficacy of the treatment across subgroups including those with palpable lymph nodes. Nevertheless, our results show important side-effects, in particular grade 3–4 colitis and hypophysitis. Our data neither support nor refute the need for maintenance treatment with ipilimumab. However, the effect on recurrence-free survival is potentially better than that of adjuvant interferon.
Interpretation
Ipilimumab is an active drug in the adjuvant setting in patients with high-risk disease, although side-effects are significant. In view of its activity across subgroups including those with high tumour burden, it represents an option in the current adjuvant landscape for those who have experience with administering the drug. Overall survival data are not yet mature and will be reported in the future.