Background and Purpose:
Proton radiation has been used for the treatment of uveal melanoma since 1975, but few studies have been conducted to assess its efficacy and safety. This paper aims to systematically review the effects and side effects of proton therapy for any indication of the eye.
Material and Methods:
A range of databases were searched from inception to 2007. All studies that included at least ten patients and that assessed the efficacy or safety of proton therapy for any indication of the eye were included.
Results:
The search generated 2,385 references, of which 37 met the inclusion criteria. Five controlled trials, two comparative studies and 30 case series were found, most often reporting on uveal melanoma, choroidal melanoma and age-related macular degeneration (AMD). Methodological quality of these studies was poor. Studies were characterized by large differences in radiation techniques applied within the studies, and by variation in patient characteristics within and between studies. Results for uveal melanoma and choroidal melanoma suggest favorable survival, with, however, significant rates of side effects. Results for choroidal hemangioma and AMD did not reveal beneficial effects from proton radiation.
Conclusion:
There is limited evidence on the effectiveness and safety of proton radiation due to the lack of well-designed and well-reported studies. There is a need to lift evidence on proton therapy to a higher level by performing dose-finding randomized controlled trials (RCTs), comparative studies of proton radiation versus standard given alternatives and prospective case studies enrolling only patients treated with up-to-date techniques, allowing extrapolation of results to similar patient groups.
Hintergrund und Ziel:
Protonenstrahlen werden seit 1975 zur Behandlung von Uveamelanomen eingesetzt, aber nur wenige Studien haben die Wirksamkeit und Verträglichkeit der Behandlung untersucht. Ziel dieser Studie war die Erstellung einer systematischen Übersicht der Wirksamkeit und Verträglichkeit von Protonenstrahltherapien für alle ophthalmologischen Indikationen.
Material und Methodik:
Suche in diversen Databanken über den Zeitraum von der Einführung bis zum Jahr 2007. Einbezogen wurden alle Studien, in die mindestens zehn Patienten eingeschlossen wurden und deren Ziel es war, die Wirksamkeit oder Verträglichkeit der Protonenstrahltherapie für beliebige ophthalmologische Indikationen zu untersuchen.
Ergebnisse:
Die Suche ergab 2 385 Treffer; davon erfüllten 37 Studien die Selektionskriterien. Es handelte sich um fünf kontrollierte Studien, zwei vergleichende Studien und 30 Fallstudien. Die meisten Arbeiten betrafen Uveamelanome, Aderhautmelanome und altersbedingte Makuladegeneration (AMD). Die methodische Qualität dieser Studien war niedrig. Es bestanden große Unterschiede bei den angewendeten Strahlungsprotokollen und den Patienteneigenschaften, nicht nur zwischen, sondern auch innerhalb der Studien. Die Resultate für Uveamelanome und Aderhautmelanome wiesen auf einen positiven Effekt bezüglich der Überlebensrate hin, allerdings in Verbindung mit beachtlichen Komplikationsraten. Die Ergebnisse für Aderhautmelanome und AMD zeigten keine günstigen Auswirkungen der Protonstrahlbehandlung.
Schlussfolgerung:
Aufgrund des Mangels an gut geplanten und gut dokumentierten Studien ist die Evidenz für die Wirksamkeit und Sicherheit der Protonenstrahlbehandlung gering. Um einen höheren Evidenzgrad zu erreichen, ist es erforderlich, randomisierte, kontrollierte Studien (RCTs) zur Dosisfindung und zum Vergleich zwischen Standard- und Protonenstrahltherapie in einem prospektiven Design unter Anwendung moderner Techniken durchzuführen, was die Extrapolation der Daten auf ähnliche Patientengruppen zulässt.
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Bekkering, G.E., Rutjes, A.W.S., Vlassov, V.V. et al. The Effectiveness and Safety of Proton Radiation Therapy for Indications of the Eye. Strahlenther Onkol 185, 211–221 (2009). https://doi.org/10.1007/s00066-009-1900-4
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DOI: https://doi.org/10.1007/s00066-009-1900-4