Discussion
resected stage IIIB-C, resected melanoma, melanoma
RECURRENCE, MELANOMA, DISEASE, CUTANEOUS MELANOMA, MELANOMA STAGING
This post hoc ITC, which used pooled, long-term follow-up data from the phase 3 EORTC 18,071 and CheckMate 238 trials [Despite emerging evidence for the benefits of novel adjuvant melanoma treatments, the historical standard approach of surveillance alone may be an option in certain clinical situations and used in real-world practice [Although this study suggests that adjuvant nivolumab has an OS benefit compared with placebo in high-risk stage IIIB-C cutaneous melanoma, additional studies are needed that evaluate OS with adjuvant nivolumab or other anti-PD-1 antibodies versus placebo in other melanoma subpopulations. Currently, two ongoing trials, CheckMate 76 K (NCT04099251) and KEYNOTE-716 (NCT03553836), are evaluating RFS and OS with adjuvant nivolumab or pembrolizumab versus placebo in patients with stage IIB-C melanoma [In addition to survival outcomes, NNT is an intuitive and simple metric used to summarize the investment of time, energy, and resources that clinicians and patients must make to achieve a specific therapeutic goal [In addition to nivolumab, pembrolizumab (another anti-PD-1 antibody) and the combination of dabrafenib plus trametinib (for patients with This study had certain limitations, some of which are inherent in clinical trials. First, melanoma staging in the two trials was defined based on different editions of the AJCC staging system (i.e., sixth edition in EORTC 18,071 and seventh edition in CheckMate 238); however, given that the main difference between the two editions is in the definition of stage IIIA disease, which was not assessed in this study, this factor is unlikely to influence the comparison. Second, disease recurrence was assessed by an independent review committee in EORTC 18,071 [In conclusion, this post hoc ITC provides comparative RFS and OS data for an anti-PD-1 antibody and routine surveillance in the adjuvant melanoma setting. The analysis used long-term follow-up data from the pivotal EORTC 18,071 and Checkmate 238 trials and showed that treatment with nivolumab improved RFS compared with ipilimumab and routine surveillance in the weighted population of patients with resected stage IIIB-C melanoma. After adjusting for post-recurrence therapy, patients treated with nivolumab demonstrated improvements in OS compared with placebo. During a 4-year follow-up period, approximately 8.9 patients needed to be treated with nivolumab compared with ipilimumab in order to obtain one additional recurrence-free survivor, approximately 4.2 patients needed to be treated with nivolumab compared with placebo (i.e., no treatment) to obtain one additional recurrence-free survivor, and 8.5 patients needed to be treated to obtain one additional overall survivor after adjusting for the post-recurrence survival difference. Longer follow-up data from other placebo-controlled adjuvant trials are needed to confirm these findings. With the advent of multiple adjuvant treatment options, the results of this study provide important data for optimal treatment decision-making among healthcare providers who treat patients with resected melanoma.