Implementation and Effectiveness of Novel Therapeutic Substances for Advanced Malignant Melanoma in Saxony, Germany, 2010–2020—Cohort Study Based on Administrative Data
by
, ,
Thomas Datzmann
1,2,3,4,5,*, 
Jochen Schmitt
1,2,3,4,5,
Saskia Fuhrmann
5,6,
Martin Roessler
5,
Friedegund Meier
1,2,3,4,7 and
Olaf Schoffer
5 1
National Center for Tumor Diseases, 01307 Dresden, Germany
2
German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany
3
Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, 01307 Dresden, Germany
4
Helmholtz-Zentrum Dresden-Rossendorf (HZDR), 01328 Dresden, Germany
5
Medizinische Fakultät Carl Gustav Carus, Center for Evidence-Based Healthcare, TU Dresden, 01307 Dresden, Germany
6
Hospital Pharmacy, University Hospital Carl Gustav Carus, 01307 Dresden, Germany
7
Medizinische Fakultät Carl Gustav Carus, Skin Cancer Center at the University Cancer Centre Dresden, Department of Dermatology, University Hospital Carl Gustav Carus, 01307 Dresden, Germany
*
Author to whom correspondence should be addressed.
Cancers 2021, 13(24), 6150; https://doi.org/10.3390/cancers13246150
Submission received: 12 November 2021
/
Revised: 30 November 2021
/
Accepted: 3 December 2021
/
Published: 7 December 2021
(This article belongs to the Special Issue Novel Therapeutic Targets in Melanoma)
Simple Summary
Novel 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.
Abstract
(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.
