Abstract
Simple SummaryNovel therapies have become available in the routine care of metastatic melanoma in recent years. We conducted a retrospective cohort study based on SHI data from Germany (2010–2020) to investigate overall mortality between patients that received different substance classes. We included 463 patients with distant metastases in the main analysis. Classical chemotherapeutics (CTx) as well as targeted therapeutics (TT) and immune checkpoint inhibitors (ICI) showed protective effects after treatment initiation, which decreased over time. Predicted survival of an average patient over five years since first metastasis was best by sequential treatment with ICI and TT. The worst survival was seen in patients treated with TT alone. However, it is conceivable that the observed high survival differences were overestimated due to bias, such as confounding by indication. It is likely that patients treated exclusively with TT were in an extremely serious condition and died before they could have received an ICI.(1) Background: Targeted (TT) and immune checkpoint inhibitor (ICI) therapies have become available in the routine care of metastatic melanoma in recent years. (2) Objective: We compared mortality in patients with metastatic melanoma and different systemic therapies. (3) Methods: A retrospective cohort study, based on pseudonymized health insurance data of about two million individuals from Saxony, Germany, was conducted for the years 2010 to 2020. Only patients with an advanced stage, i.e., distant metastases were considered for the main analysis. Relative survival since metastasis and predicted survivor curves derived from a Cox model were used to assess potential differences in mortality. (4) Results: Relative survival was highest in the subgroup with sequential use of ICI and TT. All treatments except interferon had significant hazard ratios (HR) in the Cox model with time-dependent effects indicating a protective effect after treatment initiation (HR 0.01–0.146) but decreasing over time (HR 1.351–2.310). The predicted survivor curves revealed best survival under ICI-TT treatment and worst survival under TT treatment alone. (5) Conclusions: We found real-world evidence for survival benefits of patients with metastatic melanoma who received sequential ICI and TT treatment. It is conceivable that the observed high survival differences were overestimated due to bias, such as confounding by indication.
Highlights
In the treatment of metastatic melanoma novel approaches including the use of targeted therapies (TT) and immune checkpoint inhibitors (ICI) have become increasingly available in routine care in recent years [1]
Promising targeted therapies with BRAF (v-raf murine sarcoma viral oncogene homolog B1) inhibitors like vemurafenib and dabrafenib and immune checkpoint inhibitors like nivolumab and pembrolizumab have been approved for treatment of metastatic melanoma in the last decade [2,3,4,5]
To find out how the different therapeutic approaches compare in routine care of patients with metastatic melanoma, we aimed at assessing differences in overall survival with TT and ICI compared with chemotherapy and interferon therapy
Summary
In the treatment of metastatic melanoma novel approaches including the use of targeted therapies (TT) and immune checkpoint inhibitors (ICI) have become increasingly available in routine care in recent years [1]. Promising targeted therapies with BRAF (v-raf murine sarcoma viral oncogene homolog B1) inhibitors like vemurafenib and dabrafenib and immune checkpoint inhibitors like nivolumab and pembrolizumab have been approved for treatment of metastatic melanoma in the last decade [2,3,4,5]. To find out how the different therapeutic approaches compare in routine care of patients with metastatic melanoma, we aimed at assessing differences in overall survival with TT and ICI compared with chemotherapy and interferon therapy. The robustness of the results was assessed by sensitivity analyses
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