Axel Le Cesne1, Isabelle Ray-Coquard2, Florence Duffaud3, Christine Chevreau4, Nicolas Penel5, Binh Bui Nguyen6, Sophie Piperno-Neumann7, Corinne Delcambre8, Maria Rios9, Loic Chaigneau10, Christine Le Maignan11, Cecile Guillemet12, François Bertucci13, Emmanuelle Bompas14, Claude Linassier15, Thimotée Olivier16, Jean-Emmanuel Kurtz17, Caroline Even18, Philippe Cousin19, Jean Yves Blay20. 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.
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.
Authors: George D Demetri; Margaret von Mehren; Robin L Jones; Martee L Hensley; Scott M Schuetze; Arthur Staddon; Mohammed Milhem; Anthony Elias; Kristen Ganjoo; Hussein Tawbi; Brian A Van Tine; Alexander Spira; Andrew Dean; Nushmia Z Khokhar; Youn Choi Park; Roland E Knoblauch; Trilok V Parekh; Robert G Maki; Shreyaskumar R Patel Journal: J Clin Oncol Date: 2015-09-14 Impact factor: 44.544
Authors: Magda Cordeiro; José Manuel Casanova; Joana Rodrigues; João Freitas; Ruben Fonseca; Rui Caetano de Oliveira; Paulo Freitas Tavares Journal: Case Rep Oncol Date: 2020-02-11