Abstract | BACKGROUND: There is no standard treatment for progressive epithelioid hemangioendothelioma (EHE). To investigate the significant vascularization of EHE, the activity/toxicity of sorafenib in patients with progressive EHE was explored. METHODS: In this multicenter, 1-stage, phase 2 trial of sorafenib (800 mg daily), the primary endpoint, which was chosen by default, was the 9-month progression-free rate. All patients had documented progressive disease at the time of study entry. RESULTS: Fifteen patients were enrolled between June 2009 and February 2011. The median age was 57 years (range, 31-76 years), and the ratio of men to women was 9:6. The performance status was zero in 10 patients and 1 in 5 patients. Twelve patients had metastases, mainly in the lung (12 patients), liver (5 patients), and bone (3 patients). Five patients had received prior chemotherapy ( doxorubicin in 5 patients and taxane in 3 patients). The median sorafenib treatment duration was 124 days (range, from 27 to >271 days). Seven patients required dose reductions or transient treatment discontinuation. The 9-month progression-free rate was 30.7% (4 of 13 patients). The 2-month, 4-month, and 6-month progression-free rate was 84.6% (11 of 13 patients), 46.4% (6 of 13 patients), and 38.4% (5 of 13 patients), respectively. Two partial responses were observed that lasted 2 months and 9 months. CONCLUSIONS: Further clinical trials exploring sorafenib as treatment of progressive EHE are needed.
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Authors | Christine Chevreau, Axel Le Cesne, Isabelle Ray-Coquard, Antoine Italiano, Angela Cioffi, Nicolas Isambert, Yves Marie Robin, Charles Fournier, Stéphanie Clisant, Loic Chaigneau, Jacques-Olivier Bay, Emmanuelle Bompas, Eric Gauthier, Jean Y Blay, Nicolas Penel |
Journal | Cancer
(Cancer)
Vol. 119
Issue 14
Pg. 2639-44
(Jul 15 2013)
ISSN: 1097-0142 [Electronic] United States |
PMID | 23589078
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | © 2013 American Cancer Society. |
Chemical References |
- Antineoplastic Agents
- Phenylurea Compounds
- Protein Kinase Inhibitors
- Niacinamide
- Sorafenib
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Topics |
- Adult
- Aged
- Antineoplastic Agents
(administration & dosage, adverse effects, therapeutic use)
- Disease Progression
- Disease-Free Survival
- Drug Administration Schedule
- Female
- France
- Head and Neck Neoplasms
(drug therapy)
- Hemangioendothelioma, Epithelioid
(drug therapy, secondary)
- Humans
- Liver Neoplasms
(drug therapy)
- Male
- Middle Aged
- Niacinamide
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Phenylurea Compounds
(administration & dosage, adverse effects, therapeutic use)
- Protein Kinase Inhibitors
(therapeutic use)
- Rare Diseases
- Sorafenib
- Time Factors
- Treatment Outcome
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