Our results suggest sstr as an independent prognostic marker in NETs. Sstr-immunohistochemistry correlates with sstr-imaging; however, sstr-imaging is more accurate for determining the individual prognosis.
BackgroundWe describe the long-term outcome after clinical introduction and dose escalation of somatostatin receptor targeted therapy with [90Y-DOTA]-TOC in patients with metastasized neuroendocrine tumors.MethodsIn a clinical phase I dose escalation study we treated patients with increasing [90Y-DOTA]-TOC activities. Multivariable Cox regression and competing risk regression were used to compare efficacy and toxicities of the different dosage protocols.ResultsOverall, 359 patients were recruited; 60 patients were enrolled for low dose (median: 2.4 GBq/cycle, range 0.9-7.8 GBq/cycle), 77 patients were enrolled for intermediate dose (median: 3.3 GBq/cycle, range: 2.0-7.4 GBq/cycle) and 222 patients were enrolled for high dose (median: 6.7 GBq/cycle, range: 3.7-8.1 GBq/cycle) [90Y-DOTA]-TOC treatment. The incidences of hematotoxicities grade 1–4 were 65.0%, 64.9% and 74.8%; the incidences of grade 4/5 kidney toxicities were 8.4%, 6.5% and 14.0%, and the median survival was 39 (range: 1–158) months, 34 (range: 1–118) months and 29 (range: 1–113) months. The high dose protocol was associated with an increased risk of kidney toxicity (Hazard Ratio: 3.12 (1.13-8.59) vs. intermediate dose, p = 0.03) and a shorter overall survival (Hazard Ratio: 2.50 (1.08-5.79) vs. low dose, p = 0.03).ConclusionsIncreasing [90Y-DOTA]-TOC activities may be associated with increasing hematological toxicities. The dose related hematotoxicity profile of [90Y-DOTA]-TOC could facilitate tailoring [90Y-DOTA]-TOC in patients with preexisting hematotoxicities. The results of the long-term outcome suggest that fractionated [90Y-DOTA]-TOC treatment might allow to reduce renal toxicity and to improve overall survival.Trial registrationClinicalTrials.gov number:NCT00978211
Zusammenfassung: In diesem Artikel wird zunächst erörtert, welche Hinweise und Vorgaben zur Beurteilung der Fahreignung bei neurologisch erkrankten Kraftfahrern der Fahrerlaubnis-Verordnung ( FeV, 1998 ), den Begutachtungs-Leitlinien zur Kraftfahrereignung ( Bundesanstalt für Straßenwesen, 2000 ) sowie dem Kommentar zu den Begutachtungs-Leitlinien ( Schubert et al., 2002 ) zu entnehmen sind. Diese Inhalte werden kritisch diskutiert. Nachfolgend wird beschrieben, welche Vorgehensweise bei der Untersuchung der Fahreignung zu empfehlen ist. Im einzelnen wird dabei auf die Diagnostik von Leistungen im Bereich der visuellen Wahrnehmung, der Aufmerksamkeit, der exekutiven und intellektuellen Funktionen, der motorischen Funktionen sowie von Persönlichkeitsfaktoren eingegangen. Ferner werden die Durchführung einer Fahrverhaltensprobe sowie Exploration und Verhaltensbeobachtung zur Urteilsbildung näher beschrieben.
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