Trabectedin in patients with advanced soft tissue sarcoma: A retrospective national analysis of the French Sarcoma Group |
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| Institution: | 1. Medicine Department, Institut Gustave Roussy, Villejuif, France;2. Department of Medical Oncology, Centre Léon Bérard, Lyon, France;3. Department of Medical Oncology, Hôpital de la Timone, Marseille, France;4. Medicine Department, Institut Claudius Régaud, Toulouse, France;5. Medical Oncology Department, Centre Oscar Lambret, Lille, France;6. Department of Medical Oncology, Institut Bergonié, Bordeaux, France;7. Department of Medical Oncology, Institut Curie, Paris, France;8. Medical Oncology Department, Centre François Baclesse, Caen, France;9. Department of Medical Oncology, Institut de Cancérologie de Lorraine – Alexis Vautrin, Vandoeuvre-les-Nancy, France;10. Department of Medical Oncology, CHRU Jean Minjoz, Besançon, France;11. Medical Oncology Department, Hôpital Saint-Louis, Paris, France;12. Medicine Department, CRLCC Henri Becquerel, Rouen, France;13. Department of Medical and Molecular Oncology, Institut Paoli-Calmettes, Marseille, France;14. Department of Medical Oncology, Institut de cancérologie de l’Ouest René Gauducheau, Nantes St-Herblain Cedex, France;15. Department of Medical Oncology, CHRU Tours Bretonneau, Tours Cedex, France;p. Medical Oncology Department, Centre Val D’Aurelle, Montpellier, France;q. Department of Medical Oncology and Hematology, Hôpitaux Civils Universitaires Strasbourg, Strasbourg, France;1. Department of Clinical Sciences at Danderyd’s Hospital, Karolinska Institutet, S-182 88 Stockholm, Sweden;2. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, S-171 77 Stockholm, Sweden;3. Department of Clinical Science, Intervention and Technology, Karolinska Institutet, S-171 77 Stockholm, Sweden;1. Department of Medical Oncology, Institut Bergonié, Bordeaux, France;2. Department of Pathology, Institut Bergonié, Bordeaux, France;3. Department of Radiotherapy, Institut Bergonié, Bordeaux, France;4. Department of Radiology, Institut Bergonié, Bordeaux, France;5. Department of Surgery, Institut Bergonié, Bordeaux, France;1. Área Clínica de Oncología Ginecológica, Fundación Instituto Valenciano de Oncología, Prof. Baguena, 19, 46009 Valencia, Spain;2. Département d’Oncologie Médicale Adulte, Centre Léon Bérard, 28 rue Laennec, 69008 Lyon, France;3. Laboratorio de Biología Molecular, Fundación Instituto Valenciano de Oncología, Prof. Baguena, 19, 46009 Valencia, Spain;4. Dipartimento di Medicina e Chirurgia Interdisciplinare, Università Milano-Bicocca and Divisione di Ginecologia Oncologica Medica, Via Ripamonti, 435-20141 Milano, Italy;1. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden;2. Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden;3. Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden;4. Department of Integrative Biology, University of California, Berkeley, United States;1. Department of Gynecologyic Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, PR China;2. Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, 200032, PR China;3. Department of Obstetrics & Gynecology, Shengjing Hospital of China Medical University, Shenyang, 110004, PR China;4. Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, PR China |
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| Abstract: | AimThe 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/m2 as a 24-h infusion every three weeks.MethodsPatients who achieved non-progressive disease after six initial cycles could receive long-term trabectedin treatment until disease progression.ResultsOverall, 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.ConclusionThe 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. |
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| Keywords: | Trabectedin Sarcoma Metastasis Advanced RetrospectYon |
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