Somatostatin-based radiotherapy with [90Y-DOTA]-TOC in neuroendocrine tumors: long-term outcome of a phase I dose escalation study.
J Transl Med
; 11: 17, 2013 Jan 15.
Article
em En
| MEDLINE
| ID: mdl-23320604
ABSTRACT
BACKGROUND:
We 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.METHODS:
In 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.RESULTS:
Overall, 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).CONCLUSIONS:
Increasing [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. (ClinicalTrials.gov number NCT00978211).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Radioterapia
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Radioisótopos de Ítrio
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Somatostatina
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Octreotida
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Tumores Neuroendócrinos
Tipo de estudo:
Guideline
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article