Long-Term Real-World Outcomes and Safety of Vemurafenib and Vemurafenib + Cobimetinib Therapy in Patients with BRAF-Mutated Melanoma

• DOI: 10.1007/s11523-023-00954-w
• Publication Date: 2023-03-11T17:02:40Z
• Authors: Karolina Piejko; Bożena Cybulska-S...; Marcin Ziętek; Robert Dziura; Łukasz Galus; Natasza Kempa-Kam...; Barbara Ziółkowska; Ewa Rutkowska; Tomasz Kopciński; Tomasz Kubiatowski; Wiesław Bal; Rafał Suwiński; Jacek Mackiewicz; Grażyna Kamińska-...; Anna M. Czarnecka; Piotr Rutkowski
• Keywords: Proto-Oncogene Proteins B-raf; Skin Neoplasms; Vemurafenib; Antineoplastic Combined Chemotherapy Protocols; Mutation; Humans; Original Research Article; Melanoma; 3. Good health

Combined treatment with BRAFi and/or MEK inhibitors (MEKi) improves outcomes in advanced melanoma patients comparison monotherapy.We aim to report real-world efficacy and safety of vemurafenib (V) + cobimetinib (V C) from 10 years practice.A total 275 consecutive unresectable or metastatic BRAF mutated started first-line V C between 1 October 2013 31 December 2020. Survival analyses were performed using the Kaplan-Meier method, Log-rank Chi-square tests used for groups.The estimated median overall survival (mOS) was 10.3 months group, 12.3 group (p = 0.0005; HR 1.58, 95% CI 1.2-2.1), although latter had lactate dehydrogenase elevated numerically more often. Estimated progression-free (mPFS) 5.5 8.3 0.0002; 1.62, 1.3-2.1). Complete response, partial stable disease, progressive disease as best responses recorded V/V groups 7%/10%, 52%/46%, 26%/28%, 15%/16% patients, respectively. The numbers any grade adverse effects similar both groups.We confirmed significant improvement mOS mPFS mutated-melanoma treated outside clinical trials compared V, no major increase toxicity combination.