Document Detail


Sorafenib for patients with advanced angiosarcoma: a phase II Trial from the French Sarcoma Group (GSF/GETO).
MedLine Citation:
PMID:  22285963     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Angiosarcomas account for <2% of all soft tissue sarcomas. This subtype is one of the most aggressive forms of soft tissue sarcoma. The prognosis for angiosarcoma patients in the advanced phase remains poor with current cytotoxic agents (progression-free survival [PFS] time of ∼4 months and overall survival [OS] time of ∼8 months). We investigated the antitumor activity of sorafenib in patients with metastatic or advanced angiosarcomas in a phase II trial.
METHODS: We conducted a stratified phase II trial. The primary endpoint was the progression-free rate (PFR) at 9 months according to the Response Evaluation Criteria in Solid Tumors. A two-stage design (optimal Simon design) was used. Patients received sorafenib (400 mg twice daily) for 9 months until unacceptable toxicity or tumor progression. Central pathological and radiological reviews were performed. Data on stratum A (superficial angiosarcoma) and stratum B (visceral angiosarcoma) are currently available. This trial is registered with ClinicalTrials.gov (identifier, NCT00874874).
FINDINGS: Strata A and B recruited 26 and 15 patients, respectively. The median age was 63 years (range, 31-82 years), with 17 male and 24 female patients. Fourteen cases arose in irradiated fields. Thirty patients (73.0%) had been pretreated with conventional chemotherapy. No unexpected toxicity occurred. The PFR at 9 months was 3.8% in stratum A and 0.0% in stratum B. The median PFS times were 1.8 months and 3.8 months, respectively, whereas the median OS times were 12.0 months and 9.0 months, respectively. No responses were observed in chemotherapy-naïve patients, whereas a 40% tumor control rate and 23% response rate were observed in the pretreated population. In this cohort, no activating mutation of the KDR gene (exons 15, 16, 24) was detected.
INTERPRETATION: Sorafenib showed limited antitumor activity in pretreated patients only, for both visceral and superficial angiosarcoma, but tumor control was of short duration.
Authors:
Isabelle Ray-Coquard; Antoine Italiano; Emmanuelle Bompas; Axel Le Cesne; Yves-Marie Robin; Christine Chevreau; Jacques-Olivier Bay; Guilhem Bousquet; Sophie Piperno-Neumann; Nicolas Isambert; Laurent Lemaitre; Charles Fournier; Eric Gauthier; Olivier Collard; Didier Cupissol; Stéphanie Clisant; Jean-Yves Blay; Nicolas Penel;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-01-27
Journal Detail:
Title:  The oncologist     Volume:  17     ISSN:  1549-490X     ISO Abbreviation:  Oncologist     Publication Date:  2012  
Date Detail:
Created Date:  2012-02-27     Completed Date:  2012-06-25     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  9607837     Medline TA:  Oncologist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  260-6     Citation Subset:  IM    
Affiliation:
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00874874
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Antineoplastic Agents / adverse effects,  therapeutic use*
Benzenesulfonates / adverse effects,  therapeutic use*
Endpoint Determination
Female
Hemangiosarcoma / drug therapy*,  mortality
Humans
Male
Middle Aged
Pyridines / adverse effects,  therapeutic use*
Vascular Endothelial Growth Factor Receptor-2 / genetics
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Benzenesulfonates; 0/Pyridines; 0/sorafenib; EC 2.7.10.1/Vascular Endothelial Growth Factor Receptor-2
Comments/Corrections
Comment In:
Oncologist. 2012;17(2):154-6   [PMID:  22285964 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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