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Eur J Cancer. 2015 Apr;51(6):742-50. doi: 10.1016/j.ejca.2015.01.006. Epub 2015 Feb 23.

Trabectedin in patients with advanced soft tissue sarcoma: a retrospective national analysis of the French Sarcoma Group.

Author information

1
Medicine Department, Institut Gustave Roussy, Villejuif, France. Electronic address: Axel.LECESNE@gustaveroussy.fr.
2
Department of Medical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: isabelle.ray-coquard@lyon.unicancer.fr.
3
Department of Medical Oncology, Hôpital de la Timone, Marseille, France. Electronic address: florence.duffaud@mail.ap-hm.fr.
4
Medicine Department, Institut Claudius Régaud, Toulouse, France. Electronic address: Chevreau.Christine@claudiusregaud.fr.
5
Medical Oncology Department, Centre Oscar Lambret, Lille, France. Electronic address: n-penel@o-lambret.fr.
6
Department of Medical Oncology, Institut Bergonié, Bordeaux, France. Electronic address: b.bui@bordeaux.unicancer.fr.
7
Department of Medical Oncology, Institut Curie, Paris, France. Electronic address: sophie.pipernoneumann@curie.fr.
8
Medical Oncology Department, Centre François Baclesse, Caen, France. Electronic address: c.delcambre@baclesse.fr.
9
Department of Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandoeuvre-les-Nancy, France. Electronic address: m.rios@nancy.unicancer.fr.
10
Department of Medical Oncology, CHRU Jean Minjoz, Besançon, France. Electronic address: lchaigneau@chu-besancon.fr.
11
Medical Oncology Department, Hôpital Saint-Louis, Paris, France. Electronic address: christine.lemaignan@sls.aphp.fr.
12
Medicine Department, CRLCC Henri Becquerel, Rouen, France. Electronic address: cecile.guillemet@rouen.fnclcc.fr.
13
Department of Medical and Molecular Oncology, Institut Paoli-Calmettes, Marseille, France. Electronic address: bertuccif@ipc.unicancer.fr.
14
Department of Medical Oncology, Institut de cancérologie de l'Ouest René Gauducheau, Nantes St-Herblain Cedex, France. Electronic address: Emmanuelle.Bompas@ico.unicancer.fr.
15
Department of Medical Oncology, CHRU Tours Bretonneau, Tours Cedex, France. Electronic address: linassier@med.univ-tours.fr.
16
Medical Oncology Department, Centre Val D'Aurelle, Montpellier, France. Electronic address: timothee.olivier@montpellier.unicancer.fr.
17
Department of Medical Oncology and Hematology, Hôpitaux Civils Universitaires Strasbourg, Strasbourg, France. Electronic address: j-emmanuel.kurtz@chru-strasbourg.fr.
18
Medicine Department, Institut Gustave Roussy, Villejuif, France. Electronic address: frcaroline.even@igr.fr.
19
Department of Medical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: philippe.cousin@lyon.unicancer.fr.
20
Department of Medical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.

Abstract

AIM:

The French Sarcoma Group performed this retrospective analysis of the 'RetrospectYon' database with data of patients with recurrent advanced soft tissue sarcoma (STS) treated with trabectedin 1.5 mg/m(2) as a 24-h infusion every three weeks.

METHODS:

Patients who achieved non-progressive disease after six initial cycles could receive long-term trabectedin treatment until disease progression.

RESULTS:

Overall, 885 patients from 25 French centres were included. Patients received a median of four trabectedin cycles (range: 1-28). The objective response rate was 17% (six complete/127 partial responses) and 50% (n = 403) of patients had stable disease for a disease control rate of 67%. After a median follow-up of 22.0 months, median progression-free survival (PFS) and overall survival (OS) were 4.4 and 12.2 months, respectively. After six cycles, 227/304 patients with non-progressive disease received trabectedin until disease progression and obtained a significantly superior median PFS (11.7 versus 7.6 months, P<0.003) and OS (24.9 versus 16.9 months, P < 0.001) compared with those who stopped trabectedin treatment. Deaths and unscheduled hospitalisation attributed to drug-related events occurred in 0.5% and 9.4% of patients, respectively.

CONCLUSION:

The results of this real-life study demonstrate that treatment with trabectedin of patients with STS yielded comparable or improved efficacy outcomes versus those observed in clinical trials. A long-term treatment with trabectedin given until disease progression is associated with significantly improved PFS and OS.

KEYWORDS:

Advanced; Metastasis; RetrospectYon; Sarcoma; Trabectedin

PMID:
25727882
DOI:
10.1016/j.ejca.2015.01.006
[Indexed for MEDLINE]
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