Иммунотерапия метастатической меланомы: опыт шестилетнего наблюдения

Abstract

Purpose – to evaluate the efficacy of nivolumab in oncologic patients with advanced cutaneous melanoma after six-year follow-up in real-life clinical practice. Materials and methods. In the St. Petersburg ‘City Clinical Oncology Dispensary’, under our supervision in the period from 2015 to 2022, 12 patients with a diagnosis of metastatic or recurrent skin melanoma were prescribed nivolumab. The study included patients aged 40 to 84 years (average age 59.66 ± 12.91 (95% CI 51.46–67.87). Among the 12 patients diagnosed with advanced melanoma included in this analysis, there were 8 women (66.7%) and 4 men (33.3%). The mean time from the moment of melanoma diagnosis to the development of the metastatic stage was 59.83 ± 15.1 months (95% CI 26.61–93.06). The number of metastatically affected organs varied from 1 to 4. Results. The duration of treatment of patients with nivolumab ranged from 5 to 32 months. The median duration of treatment with nivolumab was 6 months. Long-term results of treatment with nivolumab were as follows: 6-year PFS was 40%, 6-year OS was 50%. The median progression-free time and median overall survival in this group were comparable and amounted to 64 months (95% CI 63.0–80.0). A subgroup analysis revealed that in the group of patients with an objective response achieved on the background of nivolumab therapy, 6-year PFS and OS were better. The six-year PFS in the objective response and stabilization groups was 60% and 25%, respectively (p = 0.0040). Overall survival at 6 years was 75% in the group of patients with an objective response and 25% in patients with a maximum response to stabilization therapy (p = 0.0032). Conclusion. Our results (median overal survival 64 months, 6-year OS 50%) are consistent with the results of the CheckMate 067 study, as well as with other standard drug approaches in first-line treatment of metastatic melanoma, such as pembrolizumab, for which a 5-year OS is 43.2%, or the combination of BRAF and MEK inhibitors, in the presence of a BRAF mutation, with a 5-year OS of 31% to 35%. 6-year follow-up results in real clinical practice demonstrate sustained, improved clinical outcomes with nivolumab in patients with metastatic melanoma.