Efficacy and safety of adjuvant systemic therapies in trial non-eligible resected stages III and IV melanoma patients

BACKGROUND: Adjuvant immunotherapy and targeted therapy are now the standard of care for patients with resected stage IIIA-IV melanoma. However, little is known regarding its efficacy in real-world patients who were not represented in these landmark trials. METHODS: This retrospective study included all patients with resected stage IIIA-IV melanoma who received adjuvant systemic therapy between January 1 2018 and December 31 2020, in two Canadian academic cancer. Primary outcome was the proportion of trial non-eligible patients in the real-world setting. Survival and safety analyses were also conducted. RESULTS: Of the total 113 patient, 99 (88%) were trial non-eligible patients. Most common reasons for trial non-eligible criteria was having no baseline CLND (72%), followed by outside of treatment window >12 weeks (30%), stage IIIA (14%), unknown primary (9%), stage IV (14%), and baseline AD on immunosuppressants (3%). There were no significant RFS (P = 0.731) or OS (P = 0.110) differences in the overall population of trial eligible vs. non-eligible. Safety profiles were similar between the trial eligible vs. non-eligible groups. CONCLUSION: Our study suggested a high proportion of real-world patients would have been deemed non-eligible for clinical trials. Regardless, adjuvant systemic therapy delivered similar survival and toxicity outcomes in both groups.