Long-term outcome and effect of maintenance therapy in patients with advanced sarcoma treated with trabectedin: an analysis of 181 patients of the French ATU compassionate use program
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- 作者：Jean-Yves Blay (1)
Antoine Italiano (2)
Isabelle Ray-Coquard (1)
Axel Le Cesne (3)
Florence Duffaud (4)
Maria Rios (5)
Olivier Collard (6)
Fran?ois Bertucci (7)
Emmanuelle Bompas (8)
Nicolas Isambert (9)
Loic Chaigneau (10)
Philippe Cassier (1)
Binh Bui (2)
Gauthier Decanter (11)
Olfa Derbel (1)
Jean-Michel Coindre (2)
Patrick Zintl (11)
Nadia Badri (11)
Nicolas Penel (12) - 刊名：BMC Cancer
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：13
- 期：1
- 全文大小：323KB
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29. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2407/13/64/prepub - 作者单位：Jean-Yves Blay (1)
Antoine Italiano (2)
Isabelle Ray-Coquard (1)
Axel Le Cesne (3)
Florence Duffaud (4)
Maria Rios (5)
Olivier Collard (6)
Fran?ois Bertucci (7)
Emmanuelle Bompas (8)
Nicolas Isambert (9)
Loic Chaigneau (10)
Philippe Cassier (1)
Binh Bui (2)
Gauthier Decanter (11)
Olfa Derbel (1)
Jean-Michel Coindre (2)
Patrick Zintl (11)
Nadia Badri (11)
Nicolas Penel (12)
1. Centre Leon Berard, Lyon, France
2. Institut Bergonie, Bordeaux, France
3. Institut Gustave Roussy, Villejuif, France
4. Hopital de La Timone, Marseille, France
5. Centre Alexis Vautrin, Nancy, France
6. Institut de Cancérologie de la Loire, Saint Etienne, France
7. Institut Paoli-Calmettes Calmette, Marseille, France
8. Centre René Gauducheau, Nantes, France
9. Centre GF Leclerc, Dijon, France
10. CHU Besan?on, Besan?on, France
11. Pharmamar, Madrid, Spain
12. Centre Oscar Lambret, Lille, France - ISSN：1471-2407
文摘
Background The long term outcome of advanced sarcoma patients treated with trabectedin outside of clinical trials and the utility of maintenance treatment has not been reported. Methods Between 2003 and 2008, patients with advanced sarcoma failing doxorubicin could be treated within a compassionate use program (ATU, Temporary Use Authorization) of trabectedin in France using the standard 3-weekly regimen. Data from 181 patients (55%) were collected from 11 centres and analyzed. Results Trabectedin was given in first, second, third or fourth line in metastatic phase in 6%, 37%, 33% and 23% of patients respectively. With a median follow-up of 6 years, median PFS and OS were 3.6 months and 16.1 months respectively. The median number of cycles was 3 (range 1-9). Best response were partial response (PR, n--8, 10%), stable disease (SD, n--9, 39%) and progressive disease (PD, n--3, 46%), non evaluable (NE, n--, 5%). Thirty patients (17%) had to be hospitalized for treatment- related side effects. Independent prognostic factors in multivariate analysis (Cox model) were myxoid LPS and line of trabectedin for PFS, and myxoid LPS and retroperitoneal sarcomas for OS. Patients in PR or SD after 6 cycles continuing treatment had a better PFS (median 5.3 vs 10.5 months, p--.001) and OS (median 13.9 vs 33.4 months, p--.009) as compared to patients who stopped after 6 cycles. Conclusions In this compassionate use program, trabectedin yielded similar or better PFS and OS than in clinical trials. Maintenance treatment beyond 6 cycles was associated with an improved survival.