Abstract 1076P
Background
Immune checkpoint inhibitors are effective for metastatic melanoma, but little is known about how is the efficacy and toxicity of this therapy in Turkish patients with metastatic melanoma. Here we present real-world efficacy and safety data of immune checkpoint inhibitors in Turkish patients with metastatic melanoma.
Methods
In this retrospective multi-institutional trial, patients with metastatic cutaneous melanoma who received immune checkpoint inhibitors between Jun 2013 and April 2021 were analyzed. Primary endpoints were objective response rate (ORR) and overall survival (OS). Secondary endpoints were progression free survival (PFS) and toxicity. For survival analysis, Log rank test and Cox regression analysis were used.
Results
249 patients were included from 23 centers in Turkey for this trial. Median age was 59. 64% male, 28% BRAF mutant and 26% had brain metastases. 107 patients (43%) had metastasis at presentation (de novo metastasis). Overall, 173 (69%), 70 (28%) and 6 (3%) patients received Nivolumab, İpilimumab, and İpilimumab plus Nivolumab, respectively. At a median follow-up of 95 months, ORR of all patients was 37.7%. 28 patients (11.2%) had complete response, 66 patients (26.5%) had partial response and 29 patients (11.6%) had stable disease. Disease control rate was 49.3%. Median OS was 61 months (95% CI 47-74.9). Median PFS was 7 months (95% CI 5.9-8). On multivariate analysis, survival statistically favored patients without brain metastasis when compared to patients with brain metastasis (p=0.003) and patients with metastasis which occured after diagnosis when compared to patients with de novo metastasis (p<0.001). Grade 3-4 Immunotherapy-related adverse effects were reported in 38 patients (15.3%), more frequently represented by colitis, dermatitis, hypothyroidism and hypophysitis.
Conclusions
In this large real-life cohort showed that immune check point inhibitors were effective and prolonged survival of Turkish patients with metastatic melanoma. Also this trial demonstrated that brain metastasis and de novo metastasis were independent poor prognostic factors in Turkish patients with metastatic melanoma. irAE were mild and manageable.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
M.A. Ozgun.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.