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Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO)

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Summary

Malignant solitary fibrous tumors are rare soft-tissue sarcomas. They are considered as low-grade malignancies, but may display metastatic potential in 20 % of the cases. In case of metastatic or locally advanced, unresectable disease, standard treatments, like anthracycline-based regimens, are poorly effective. Previous studies suggested that antiangiogenic drugs, such as sorafenib, could be efficient to treat vascular sarcomas and solitary fibrous tumors. Five patients with progressive SFT were included in this phase 2 study, and treated with sorafenib at a dose of 800 mg daily. Two patients out of the five achieved a 9 months disease control with sorafenib, while their disease had progressed within the month preceding their inclusion. Consequently, our data suggest a potential efficacy of sorafenib in SFT, Further investigation is needed to confirm these data.

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Funding

This work was supported by Institut National du Cancer (PHRC-2009/grant) and Bayer HealthCare France

Ethical and regulatory considerations

Study investigations were conducted after approval by the regional Ethics Committee (“Comité de Protection des Patients Nord-Ouest III”, date of approval: 16 June 2009) and after declaration to the French Health Products Safety Agency (“Agence Française de Sécurité Sanitaire et des Produits de Santé”, date of approval: 1 June 2009). Informed consent was obtained from each patient. This study was registered in the European Clinical Trials Register (EudraCT N° 2007-004651-10). This study had been registered in the ClinicalTrial.gov site (Number: NCT 00874874). The study was conducted in agreement with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice guidelines.

(http://www.cancer.gov/clinicaltrials/search/view?cdrid=633547&version=healthprofessional).

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The authors have no conflicts of interest to declare.

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Correspondence to T. Valentin.

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Valentin, T., Fournier, C., Penel, N. et al. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs 31, 1626–1627 (2013). https://doi.org/10.1007/s10637-013-0023-z

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  • DOI: https://doi.org/10.1007/s10637-013-0023-z

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