Porównanie pośrednie wyników leczenia chorych na zaawansowane/przerzutowe czerniaki za pomocą niwolumabu lub pembrolizumabu – analiza wieloośrodkowa

Introduction. The development of a new class of drug — checkpoint inhibitors has changed the prognosis of cancer patients. A particular class of drugs are antibodies against the programmed cell death type 1 receptor/ligand of the programmed cell death type 1 receptor (nivolumab and pembrolizumab). There are, however, no trials with a random selection of the patients which directly compare nivolumab and pembrolizumab. Because of the development of immunotherapy and many new drugs registered as anti-PD-1, it is important to determine whether there are differences in respect to effectiveness and safety in using nivolumab and pembrolizumab. Material and method. 499 patients with non-resectable or metastatic melanoma treated in the years 2016–2019 in five oncological reference centers in Poland (Cracow, Gliwice, Lublin, Poznań, Wrocław) were included in the analysis. The criterion for inclusion in the analysis was first-line treatment with anti-PD-1 (nivolumab or pembrolizumab). Results. Median OS and PFS in the whole analyzed group were 19.9 and 7.9 months, respectively. Estimated median OS and PFS were 20.1 and 18.1 months and 8.5 and 6.0 months for nivolumab and pembrolizumab, respectively. No statistically significant difference was observed in median OS and PFS in the group of patients receiving nivolumab and pembrolizumab (respectively P = 0.6291 [HR = 1.06; Cl 95% 0.8–1.4] and P = 0.0956 [HR = 1.20; Cl 95% 0.97–1.48]). The percentage of grade G3 or/and G4 irAEs was similar in both groups treated with nivolumab or pembrolizumab, 5.8 and 5.2%, respectively. Conclusions. No differences in the range of OS, PFS and ORR was observed between therapy with nivolumab and pembrolizumab in previously untreated patients with advanced/metastatic melanoma. No differences were found in the frequency of irAEs of grade G3 or G4. The treatment with a specific preparation should be based on the preferences of the patient and the clinician.