Abstract | CONTEXT: OBJECTIVES: DESIGN, SETTING, AND PATIENTS: Single-center, phase 2 trial with national recruitment from the French HHT Network. Patients were 18 to 70 years old and had confirmed HHT, severe liver involvement, and a high cardiac index related to HHT. INTERVENTION:
Bevacizumab, 5 mg per kg, every 14 days for a total of 6 injections. The total duration of the treatment was 2.5 months; patients were followed up for 6 months after the beginning of the treatment. MAIN OUTCOME MEASURE: Decrease in cardiac output at 3 months after the first injection, evaluated by echocardiography. RESULTS: A total of 25 patients were included between March 2009 and November 2010. Of the 24 patients who had echocardiograms available for reread, there was a response in 20 of 24 patients with normalization of cardiac index (complete response [CR]) in 3 of 24, partial response (PR) in 17 of 24, and no response in 4 cases. Median cardiac index at beginning of the treatment was 5.05 L/min/m(2) (range, 4.1-6.2) and significantly decreased at 3 months after the beginning of the treatment with a median cardiac index of 4.2 L/min/m(2) (range, 2.9-5.2; P < .001). Median cardiac index at 6 months was significantly lower than before treatment (4.1 L/min/m(2); range, 3.0-5.1). Among 23 patients with available data at 6 months, we observed CR in 5 cases, PR in 15 cases, and no response in 3 cases. Mean duration of epistaxis, which was 221 minutes per month (range, 0-947) at inclusion, had significantly decreased at 3 months (134 minutes; range, 0-656) and 6 months (43 minutes; range, 0-310) (P = .008). Quality of life had significantly improved. The most severe adverse events were 2 cases of grade 3 systemic hypertension, which were successfully treated. CONCLUSION: TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00843440.
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Authors | Sophie Dupuis-Girod, Isabelle Ginon, Jean-Christophe Saurin, Denis Marion, Elsa Guillot, Evelyne Decullier, Adeline Roux, Marie-France Carette, Brigitte Gilbert-Dussardier, Pierre-Yves Hatron, Pascal Lacombe, Bernard Lorcerie, Sophie Rivière, Romain Corre, Sophie Giraud, Sabine Bailly, Gilles Paintaud, David Ternant, Pierre-Jean Valette, Henri Plauchu, Frédéric Faure |
Journal | JAMA
(JAMA)
Vol. 307
Issue 9
Pg. 948-55
(Mar 07 2012)
ISSN: 1538-3598 [Electronic] United States |
PMID | 22396517
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal, Humanized
- Bevacizumab
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Topics |
- Angiogenesis Inhibitors
(therapeutic use)
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Arteriovenous Malformations
(etiology, physiopathology)
- Bevacizumab
- Cardiac Output
(drug effects)
- Epistaxis
(etiology, prevention & control)
- Female
- Heart Failure
- Humans
- Liver
(blood supply)
- Male
- Middle Aged
- Prospective Studies
- Telangiectasia, Hereditary Hemorrhagic
(complications, drug therapy, physiopathology)
- Treatment Outcome
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