Multiple hepatic arterial injections of recombinant adenovirus p53 and 5-fluorouracil after transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: a pilot phase II trial.
Anticancer Drugs
; 20(5): 389-95, 2009 Jun.
Article
em En
| MEDLINE
| ID: mdl-19287305
ABSTRACT
This pilot phase II study was designed to determine the efficacy, toxicities, and biological activity of multiple hepatic arterial injections of recombinant adenovirus p53 (rAd-p53) and 5-fluorouracil (5-FU) after transcatheter arterial chemoembolization (TACE) when compared with TACE alone in patients with unresectable hepatocellular carcinoma (HCC). Forty-six patients with unresectable HCC were randomized in either group 1 [23 patients, multiple hepatic arterial injections of Ad-p53 (1x10 viral particles) and 5-FU (500-750 mg), after TACE] or group 2 (23 patients, TACE alone). In group 1, the number of Ad-p53/5-FU courses administered was 166 (median 7, range 3-12). In group 2, the number of TACE courses administered was 47 (median 2, range 1-3). Partial response and stable disease were 69.5% in group 1 and 65.2% in group 2. Times to progression were 9.6 months (range 2.1-21.7) in group 1 and 8.3 months (range 2.1-16.8) in group 2. Overall survivals were 12.8 months (range 2.7-26.2) in group 1 and 10.4 months (range 2.7-22.5) in group 2. Toxicities in both groups were generally mild and reversible. The most common Ad-p53-related toxicity was a transient fever. Specific p53 transgene expression was detected using reverse-transcriptase polymerase chain reaction in biopsied tumor tissues. Distribution studies revealed that the vector was detected in the plasma, but rarely in the gargle and urine. This study shows that multiple hepatic arterial injections of Ad-p53 and 5-FU after TACE can be active and safe as a treatment for patients with unresectable HCC.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Adenovírus Humanos
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Genes p53
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Quimioembolização Terapêutica
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Carcinoma Hepatocelular
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Fluoruracila
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Vetores Genéticos
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Neoplasias Hepáticas
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Antimetabólitos Antineoplásicos
Tipo de estudo:
Clinical_trials
Limite:
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
Revista:
Anticancer Drugs
Assunto da revista:
ANTINEOPLASICOS
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
China