Неоадъювантная терапия резектабельной меланомы кожи в России: опыт трех онкологических центров

Abstract

Introduction. Neoadjuvant therapy of skin melanoma is a relatively new and dynamically developing area in the treatment of this malignant tumor. This article represents the results of an analysis of the clinical outcomes of patients receiving neoadjuvant systemic immunotherapy (NST) in 3 research centers in Russia. Material and methods. A combined analysis of the blinded individual patient data was performed in January 2024. The criteria for including data in the analysis were the availability of information about the disease and its prevalence, the course of NST, the pathomorphological response and treatment outcomes. Results. Data were obtained from three research centers on 77 patients who started receiving therapy in the period from Oct. 2020 to Jul. 2023. NST with prolgolimab was performed in 59 (76.6%) pts, pembrolizumab in 13 (16.9%) pts and ipilimumab 3 mg/kg + nivolumab 1 mg/kg in 5 (6.5%) pts. The average number of cycles was 3.6 (95%CI 3.2–4.0), the average duration of HCT was 45.5 days (95% CI 39.3–51.6). The pathomorphological response to treatment in accordance with INMC criteria was assessed in 61 patients: 25 (41.0%) had a complete response, 6 (9.8%) had an almost complete response, 7 (11.5%) had a partial response and 23 (37.7%) had no response or disease progression. With a median follow-up period of 10.2 months (95% CI from 7.1 to 13.2 months) median relapse-free survival in patients with complete, near-to- complete and partial pathomorphological response to treatment was not achieved, while in the group of non-responders was 14.4 months (95% CI 4.3 to 24.6 months), p = 0.014. Subsequent adjuvant therapy was performed in 46 (59.7%) patients, while adjuvant therapy had a statistically significant effect on survival only in patients with non-response. Conclusions. The results of our study confirm the significant potential of NST in the treatment of resectable stage IIIB-D skin melanoma. Prospective well-organized studies are required to address the issue of de-escalation of surgery and adjuvant therapy.