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


CONCLUSIONS
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.
Medicine Department, Institut Gustave Roussy, Villejuif, France. Electronic address: Axel.LECESNE@gustaveroussy.fr.
Axel
A
Le Cesne
Department of Medical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: isabelle.ray-coquard@lyon.unicancer.fr.
Isabelle
I
Ray-Coquard
Department of Medical Oncology, Hôpital de la Timone, Marseille, France. Electronic address: florence.duffaud@mail.ap-hm.fr.
Florence
F
Duffaud
Medicine Department, Institut Claudius Régaud, Toulouse, France. Electronic address: Chevreau.Christine@claudiusregaud.fr.
Christine
C
Chevreau
Medical Oncology Department, Centre Oscar Lambret, Lille, France. Electronic address: n-penel@o-lambret.fr.
Nicolas
N
Penel
Department of Medical Oncology, Institut Bergonié, Bordeaux, France. Electronic address: b.bui@bordeaux.unicancer.fr.
Binh
B
Bui Nguyen
Department of Medical Oncology, Institut Curie, Paris, France. Electronic address: sophie.pipernoneumann@curie.fr.
Sophie
S
Piperno-Neumann
Medical Oncology Department, Centre François Baclesse, Caen, France. Electronic address: c.delcambre@baclesse.fr.
Corinne
C
Delcambre
Department of Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandoeuvre-les-Nancy, France. Electronic address: m.rios@nancy.unicancer.fr.
Maria
M
Rios
Department of Medical Oncology, CHRU Jean Minjoz, Besançon, France. Electronic address: lchaigneau@chu-besancon.fr.
Loic
L
Chaigneau
Medical Oncology Department, Hôpital Saint-Louis, Paris, France. Electronic address: christine.lemaignan@sls.aphp.fr.
Christine
C
Le Maignan
Medicine Department, CRLCC Henri Becquerel, Rouen, France. Electronic address: cecile.guillemet@rouen.fnclcc.fr.
Cecile
C
Guillemet
Department of Medical and Molecular Oncology, Institut Paoli-Calmettes, Marseille, France. Electronic address: bertuccif@ipc.unicancer.fr.
François
F
Bertucci
Department of Medical Oncology, Institut de cancérologie de l'Ouest René Gauducheau, Nantes St-Herblain Cedex, France. Electronic address: Emmanuelle.Bompas@ico.unicancer.fr.
Emmanuelle
E
Bompas
Department of Medical Oncology, CHRU Tours Bretonneau, Tours Cedex, France. Electronic address: linassier@med.univ-tours.fr.
Claude
C
Linassier
Medical Oncology Department, Centre Val D'Aurelle, Montpellier, France. Electronic address: timothee.olivier@montpellier.unicancer.fr.
Thimotée
T
Olivier
Department of Medical Oncology and Hematology, Hôpitaux Civils Universitaires Strasbourg, Strasbourg, France. Electronic address: j-emmanuel.kurtz@chru-strasbourg.fr.
Jean-Emmanuel
JE
Kurtz
Medicine Department, Institut Gustave Roussy, Villejuif, France. Electronic address: frcaroline.even@igr.fr.
Caroline
C
Even
Department of Medical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: philippe.cousin@lyon.unicancer.fr.
Philippe
P
Cousin
Department of Medical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.
Jean
J
Yves Blay
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D002648:Child; D004149:Dioxoles / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy*; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use*; D000077606:Trabectedin; D016896:Treatment Outcome; D055815:Young Adult
D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
Advanced; Metastasis; RetrospectYon; Sarcoma; Trabectedin