Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Combined anti-PD-1 and anti-CTLA-4 Treatment in Stage IV Melanoma Patients: Bicentric Analysis of Real-world Data

Version 1 : Received: 9 November 2023 / Approved: 10 November 2023 / Online: 10 November 2023 (11:05:56 CET)

A peer-reviewed article of this Preprint also exists.

Silași, A.D.A.; Sievert, A.C.; Danciu, P.; Lefter, A.V.; Afrasanie, V.A.; Sur, D. Combined Anti-PD-1 and Anti-CTLA-4 Treatment in Stage IV Melanoma Patients: A Bicentric Analysis of Real-World Data and a Modern Treatment Scenario Proving Lactate Dehydrogenase’s Usefulness. Diagnostics 2024, 14, 654. Silași, A.D.A.; Sievert, A.C.; Danciu, P.; Lefter, A.V.; Afrasanie, V.A.; Sur, D. Combined Anti-PD-1 and Anti-CTLA-4 Treatment in Stage IV Melanoma Patients: A Bicentric Analysis of Real-World Data and a Modern Treatment Scenario Proving Lactate Dehydrogenase’s Usefulness. Diagnostics 2024, 14, 654.

Abstract

Background: This study retrospective evaluates patients with stage IV melanoma treated with Nivolumab and Ipilimumab combination therapy from two regional oncology centers from Romania between the years of 2019 up to the end of 2022. Methods: The data were analyzed in SAS for Windows, V9.4. The survival curves were estimated using the Kaplan-Meier method, and survival distributions were compared with log-rank test. The effects of the main clinical and pathological variables on OS and PFS were investigated with Cox regression. Results: Kaplan-Meier curve of OS in all evaluable patients enrolled in the study resulted in a median OS of 346 days (95% CI: 150-NA) and a median PFS of 211 days (95% CI: 113-430). 45.3% of the patients experienced adverse events during the Nivolumab + Ipilimumab treatment with some of them having multiple organ systems involved. Discussion: The OS values were lower than that reported in approval clinical trials, but the results show a marked improvement when comparing to results obtained by chemotherapy regimens previously used in these scenarios. Conclusion: This study provides real-world insights into the survival data and safety profiles of combination therapy with anti-PD-1 antibodies and anti-CTLA-4 antibodies.

Keywords

melanoma; metastasis; overall survival; progression-free survival; side effects; Nivolumab; Ipilimumab; anti-programmed death-1 antibodies; anti-cytotoxic T-lymphocyte antigen-4 antibodies.

Subject

Biology and Life Sciences, Biochemistry and Molecular Biology

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