Real-world experience of adjuvant immunotherapy for stages III–IV melanoma: A monocentric observational study

Abstract

Background

Adjuvant immunotherapy (AIO) improved recurrence-free survival (RFS) in patients with resected stages III–IV melanoma. Real-world data, especially in elderly patients, as well as optimal management of patients who relpases, are still limited.

Objectives

To evaluate real-world outcomes of AIO in a cohort of stages III–IV melanoma patients.

Methods

We conducted a monocentric, retrospective, observational study that included patients treated with AIO (nivolumab or pembrolizumab) for stages III/IV melanoma. The primary endpoint was RFS. Subgroup analyses were performed.

Results

A total of 76 patients were included, with a mean age of 64.6 years (51.3% and 31.6 age ≥65 and ≥75 years, respectively). Majority received nivolumab (67.1%). Median follow-up period was 26.4 months (interquartile range, 17.9–35.1 months). The RFS rates for the whole cohort were 75.8%, 66.0%, 52.9% and 52.9% for 1, 2, 3 and 4 years, respectively. Patients aged <75 years had a better RFS rate compare to those older ≥75 years (60.4% vs. 38.3% respectively, p = 0.02). A total of 41 patients (53.9%) experienced immune-related adverse events (irAEs) of any grade, and 22.3% of grade 3–5. irAEs ≥ 3 concerned 17.3% of patients aged <75 years and 33.3% for those aged ≥75 years. Thirteen patients (17.1%) had discontinued IO early due to severe irAEs after a median of 2 months (range 1–7). Median time to first recurrence from starting adjuvant programmed cell death 1 was 6.5 months (range, 1–35). Most patients recurred ON adjuvant IO (15/28 patients, 19.7%). Most of the time, first-line therapy after melanoma recurrence was ipilimumab plus nivolumab. Objective response rate was higher for patients with recurrence within 6 months of stopping adjuvant IO (33.3%).

Conclusions

Real-world outcomes of AIO for stages III/IV melanoma appeared comparable to clinical trial data. Immunotherapy appears less effective and less well tolerated in elderly patients.