Real-world treatment practice in patients with advanced melanoma

Abstract

Introduction The treatment outcomes of patients with advanced/metastatic melanoma were poor before the use of new therapeutic options. Material and methods A retrospective analysis was conducted among 287 patients with unresectable stage III and stage IV melanoma treated at the Maria Sklodowska-Curie National Research Institute of Oncology Cracow Branch, from 2013 to 2019. All enrolled patients were treated with immunotherapy (IT; consisting of pembrolizumab/nivolumab, or ipilimumab) or target therapy (TT; consisting of vemurafenib ±cobimetinib or dabrafenib ±trametinib) in at least one treatment line. Results mutation was detected in 152 (55%) patients. In general, the majority of patients (92%) were in very good or good condition (Eastern Cooperative Oncology Group [ECOG] 0 or 1). Brain metastasis was detected in 64 (22%) patients. Median OS and PFS in the experimental group from the beginning of the first-line treatment were 14.9 and 6.7 months, respectively. Across the study population, as a first-line treatment patients received IT, TT as well as CHT, and the median OS was 19.2, 12.6 and 15.9 months, respectively. Multivariate analysis confirmed that normal LDH levels, no brain metastases, ECOG 0, and objective response to the treatment were strong predictors of longer OS. For PFS, absence of brain metastases, ECOG 0, and treatment response were found to be predictive factors on multivariate analysis. Conclusions The administration of new therapies for the treatment of patients with advanced/disseminated melanoma significantly prolonged survival in this group of patients. Nevertheless, further studies should be conducted to assess the effectiveness of various sequences of treatment.

Cost-Utility of Nivolumab Plus Ipilimumab in First-Line Treatment of Advanced Melanoma in the United States: An Analysis Using Long-Term Overall Survival Data from Checkmate 067

“…This duration was based on mean second-line PFS data for patients previously treated with PD-1 therapies reported by Zimmer et al [ 33 ]. The median PFS from this study is broadly aligned with similar second-line PFS estimates from the literature based on real-world data [ 38 ]. Despite the limitations in our approach to estimating costs related to subsequent treatments, the economic evaluations presented here are generally consistent with the findings from a prior economic evaluation based on a treatment sequencing analysis, which demonstrated that first-line therapy with NIVO + IPI (followed by BRAF + MEK inhibitor therapy) was most cost effective at thresholds greater than $80,000 per QALY [ 32 ].…”

Real-World Experience with Targeted Therapy in BRAF Mutant Advanced Melanoma Patients: Results from a Multicenter Retrospective Observational Study Advanced Melanoma in Russia (Experience) (ADMIRE)

“…Thus, the few available studies with real-world data showed positive achievements of targeted therapy for the cohort of BRAF-mutant melanoma patients. Moreover, our study of real-world clinical practice was the largest and included 2.5-fold more patients with BRAF-mutant advanced melanoma compared to those of the above-mentioned study (382 vs. 152 patients) and demonstrated increased median OS (22.6 months) and 2-year OS (47.2%) compared to the earlier reported study [ 30 ] in patients receiving the first-line targeted therapy. In addition, even though the patients included in the ADMIRE study had poorer prognostic factors, the data showed essentially higher effectiveness in a real-world setting, which may correspond to phase 3 clinical trials.…”

“…Median OS and PFS in the experimental group from the start of the first-line treatment were 14.9 and 6.7 months, respectively. The first-line treatment of patients involved IT, TT, or chemotherapy, and the median OS reached 19.2, 12.6, and 15.9 months, respectively [ 30 ]. Thus, the few available studies with real-world data showed positive achievements of targeted therapy for the cohort of BRAF-mutant melanoma patients.…”

Real-world treatment patterns and outcomes in patients with metastatic melanoma

“…Brain metastases were detected in 64 (22%) patients. The first-line treatment of patients involved immunotherapy, targeted therapy, or chemotherapy, and the median OS reached 19.2, 12.6, and 15.9 months, respectively [9]. In this analysis the unexpected finding was that the median OS for targeted therapy is lower than that in chemotherapy group.…”