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Paris- RP

Lille. Rouen. Caen. Reims. Paris- RP. Nancy. Strasbourg. Angers. Rennes. Tours. Nantes. Dijon. Besançon. Poitiers. Lyon. Bordeaux. Toulouse. Nice. Montpellier. Marseille. GSF: Groupe Sarcome Français GETO: Groupe d’Etudes des Tumeurs Osseuses. N = 36 institutions

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Paris- RP

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  1. Lille Rouen Caen Reims Paris- RP Nancy Strasbourg Angers Rennes Tours Nantes Dijon Besançon Poitiers Lyon Bordeaux Toulouse Nice Montpellier Marseille GSF: Groupe Sarcome Français GETO: Groupe d’Etudes des Tumeurs Osseuses N = 36 institutions Sarcoma Database: 3300 pts Frozen tissue bank: 1300 sarcomas Villejuif Clermont-Ferrand

  2. Sarcome 01 Euro-Ewing 99 PI :Dr O. Oberlin – Villejuif Molecular analysis on Iry: 448 patients (79 %) BM: 326 patients (57%) 30 sept 06 Suspension of R1 randomization

  3. Sarcome 02 PALSAR II PI :Dr N B BUI – Bordeaux Main end-point: overall survival Statistical hypothesis: 3-yr OS: 40% vs 15% (N® per arm: 50) October 06: N = 207 patients N® = 65/100 patients

  4. Sarcome 03 Osteosarcoma PI :A Le Cesne – Villejuif Localized operable osteosarcoma API-AI regimen 4 CT courses Main end-point: histological response rate Good histological response: 37% ASCO 06 2-yr overall survival: 86% 2-yr PFS 74% Follow-up

  5. Sarcome 04 EWING 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 2006 = 44/45 ASCO 07

  6. Sarcome 05 Desminib 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 (at least 7 patients not PD) At 3 month: 1 CR, 1 PR, 31 SD, 5 PD ASCO 06 6-m PFS 73%; 1-yr PFS 69% Translational research ongoing imatinib Random NSAID

  7. Sarcome 06: Angiotax 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 ASCO 2007

  8. Sarcome 07 Taxogem 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 N = 13/80

  9. Sarcome 08:Adjuvant GIST EORTC 62024 PI (FSG) :A Le Cesne – Villejuif Participating French centers : 42 Mutational analysis: 70% October 2006 N = 418

  10. Sarcome 09 OS 2006 PI :F Duffaud – Curie / L Brugieres - Villejuif Intergroup SFCE/GSF/GETO Adult/children OS – phase III Zoledronate N = 470 3-yr EFS > 13% in exp arm Translational research

  11. Sarc-Gyn 1 Adjuvant CT PI:P Pautier – Villejuif Uterine leiomyoS, carcinoS, high grade endometrial S N = 52 / 256 3-yr EFS > 20% in experimental arm Arm A 4 x API RTE 45 Gy + Brachytherapy 15 Gy A (50), I ( 6), C (75) Surgery < 6 wR • RTE 45 Gy + Brachytherapy 15 Gy • Arm B

  12. BFR 14 trial - Advanced GIST(June 2002) PI :J.Y Blay – Lyon A. Le Cesne - Villejuif Stop Imatinib Non PD R Imatinib N patients included in October 2005:271 1) N randomized (interrupted) pts at 1 year: 58 (ASCO 04,05) Stop imatinib arm: 32 imatinib arm: 26 2) N randomized (ongoing) pts at 3 years: 32 (ASCO 07)

  13. AB1010 first line - Advanced GIST PI :A. Le Cesne - Villejuif Day 1 Preclinical efficacy profile > to IM IC50 < 0.005 µM vs IC50 = 0.02 µM Phase II AB1010: 7.5 mg/kg 4 centers N = 25 (06/05 to 11/06) ASCO 2007 Day 1 M6 M1

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