GSF: Groupe Sarcome Français

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Presentation transcript:

GSF: Groupe Sarcome Français GETO: Groupe d’Etudes des Tumeurs Osseuses Paris- RP Reims Rennes Tours Marseille Montpellier Lyon Nice Lille Strasbourg Bordeaux Dijon Besançon Nantes Toulouse Poitiers Angers Nancy Caen Rouen N = 40 institutions Sarcoma Database: 2500 pts Frozen tissue bank: 1000 sarcomas Villejuif Clermont-Ferrand

Sarcome 01 Euro-Ewing 99 EORTC SFCE GPOH UKCCSG Total N 83 475 673 332 PI : Dr O. Oberlin – Villejuif EORTC SFCE GPOH UKCCSG Total N 83 475 673 332 1563 % ® Patients 53 % 40 % 37 % 50 100 150 200 250 300 350 400 450 500 Jan-00 Apr-00 Jul-00 Oct-00 Jan-01 Apr-01 Jul-01 Oct-01 Jan-02 Actual R1 Expected R1 R1 randomization May-02 Aug-02 Nov-02 Feb-03 May-03 Aug-03 Nov-03 Feb-04 May-04 Aug-04 Nov-04 Feb-05 May-05 Aug-05

Sarcome 02 PALSAR II Main end-point: overall survival PI : Dr N B BUI – Bordeaux Main end-point: overall survival Statistical hypothesis: 3-yr OS: 40% vs 15% (N per arm: 50) October 05: N = 184 pts N® = 60 patients

Sarcome 03 Osteosarcoma Localized operable osteosarcoma API-AI regimen PI : A Le Cesne – Villejuif Localized operable osteosarcoma API-AI regimen 4 CT courses N = 39 evaluable pts Main end-point: histological response rate Statistical hypothesis: Simon two step at least 14/39 good histological response Analysis ongoing ASCO 06

Sarcome 04 EWING D1 D8 D15 D21 D28/1 D8 D15 D21 D28 October 2005 = 25 PI : O Oberlin – Villejuif D1 D8 D15 D21 D28/1 D8 D15 D21 D28 CDDP VP-16 Main end-point: Objective response rate Statistical hypothesis: Simon: at least 6/29 OR October 2005 = 25

Sarcome 05 Desminib Progressive AF/Desmoid T Glivec®: 400 mg/d PI : JY Blay – Lyon Progressive AF/Desmoid T Glivec®: 400 mg/d 800 mg/d if PD Duration: one year Main end-point: 3-month PFS Statistical hypothesis: Simon two step: 18 + 17 patients at least 7 patients not PD at 3 months Secondary end-point: 12-m PFS, OS, tolerance, OR Analysis ongoing ASCO 06

Sarcome 06: Angiotax Angiosarcoma 2nd/3rd CT line PI : N Penel – Lille Angiosarcoma 2nd/3rd CT line Weekly taxol: 80 mg/w 3 weeks on, 1 off Main end-point: Objective response rate Statistical hypothesis: Simon two step: 15 + 10 patients at least 6/25 OR Secondary end-point: PFS, OS, tolerance Translational research

Sarcome 07 Taxogem ® phase II Leiomyosarcoma Uterine vs other PI : F. Duffaud – Marseille P. Pautier - Villejuif ® phase II Leiomyosarcoma Uterine vs other 2nd CT line N = 40 + 40 Main end-point: OR Secondary end-point: PFS, OS, tolerance, QOL

Sarcome 08:Adjuvant GIST EORTC 62024 PI (FSG) : A Le Cesne – Villejuif Participating French centers : 42 November 2005 N = 121

Advanced GIST – BFR 14 trial French Sarcoma Group (June 2002) PI : J.Y Blay – Lyon A. Le Cesne - Villejuif Stop Gleevec® Gleevec® R Gleevec® Day 1 12 months +/- surgery N patients included in October 2005: 268 N randomized patients (after 1 year) 58 (early interruption) Stop imatinib arm: 32 imatinib arm: 26 N randomized patients (after 3 years) 12 1 2