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Ann Oncol. 2015 Oct;26(10):2168-73. doi: 10.1093/annonc/mdv300. Epub 2015 Jul 22.

Sorafenib in patients with locally advanced and metastatic chordomas: a phase II trial of the French Sarcoma Group (GSF/GETO).

Author information

1
Department of Medical Oncology, Centre René Gauducheau, Nantes.
2
Department of Medical Oncology, Institut Gustave Roussy, Villejuif.
3
Methodology and Biostatistics Unit.
4
Department of General Oncology, Centre Oscar Lambret, Lille.
5
Department of Medical Oncology, Institut Curie, Paris.
6
Department of Medical Oncology, Institut de Cancérologie de la Loire, Lucien Neuwirth, Saint Priest en Jarez.
7
Department of Medical Oncology, Centre Antoine Lacassagne, Nice.
8
Department of Medical Oncology, Centre GF Leclerc, Dijon.
9
Department of Medical Oncology, Centre Léon Bérard, Lyon.
10
Department of Medical Oncology, Hopital La Timone, Marseille.
11
Department of Medical Oncology, Institut Claudius Regaud, Toulouse.
12
Department of Medical Oncology, Institut Paoli Calmette, Marseille.
13
Department of Medical Oncology, Institut Bergonié, Bordeaux.
14
Clinical Research Unit, Centre Oscar Lambret, Lille.
15
Department of General Oncology, Centre Oscar Lambret, Lille Clinical Research and Methodology Platform, SIRIC OncoLille Consortium, Lille, France n-penel@o-lambret.fr.

Abstract

BACKGROUND:

There is no consensual treatment of locally advanced or metastatic chordomas.

PATIENTS AND METHODS:

We conducted a multicenter, open-label, uncontrolled phase II trial of sorafenib (800 mg/day). The primary end point was the 9-month progression-free rate according to RECIST 1.1. All patients had documented progressive disease at the time of study entry.

RESULTS:

Twenty-seven patients were enrolled between May 2011 and January 2014. The median age was 64 (range, 30-86) years. There were 17 men and 10 women. Twelve patients had been previously treated with chemotherapy and molecularly targeted agents. The maximum toxicity grade per patient was grade 3 in 21 cases (77.8%) and grade 4 in 4 cases (14.8%). Sorafenib provided an intent-to-treat best objective response of 1/27 [3.7%; 95% confidence interval (CI) 0.1% to 19.0%], a 9-month progression-free rate of 73.0% (95% CI 46.1-88.0) and a 12-month overall survival rate of 86.5% (95% CI 55.8-96.5). Survival curves were similar in pretreated and not pretreated patients.

DISCUSSION:

Additional clinical trials further exploring sorafenib as a treatment of locally advanced or metastatic chordomas are warranted.

KEYWORDS:

chordoma; phase II trial; sorafenib

PMID:
26202596
PMCID:
PMC4576908
DOI:
10.1093/annonc/mdv300
[Indexed for MEDLINE]
Free PMC Article

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