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talian

www.italiansarcomagroup.org. I. I. talian. Activated June 1997. S. S. arcoma. G. G. roup. Formalized October 2002. 9. 1. 1. 1. 1. 1. 1. 2. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 3. 3. 2. 2. 2. 1. Italian Sarcoma Group. 1. BELGIO. 53 Centers

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talian

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  1. www.italiansarcomagroup.org I I talian Activated June 1997 S S arcoma G G roup Formalized October 2002

  2. 9 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 3 3 2 2 2 1 Italian Sarcoma Group 1 BELGIO 53 Centers • 10 I.R.C.C.S. • 12 Universities • 25 Public Hospitals • 6 Private Hospitals 1 1 8 172 Members at 24 March 2004

  3. Osteosarcoma ISG/SSG I - Localized disease PRE-OP MTX-CDP1/ADM1-IFO X 2 POST-OP ADM2-IFO-MTX-CDP2 X 3 (4 IN POOR) MTX: Methotrexate 12 g/m2 as 4 hours i.v. infusion, increase by 2 g/m2 if 4 hours serum MTX in previous course was < 1000 µmol/l CDP1: Cisplatin 60 mg/m2/24 hour as 48 hours continuous i.v. infusion CDP2: Cisplatin 75 mg/m2/24 hour as 48 hours continuous i.v. infusion ADM1: Adriamycin (Doxorubicin) 75 mg/m2 as 24 hours continuous i.v. Infusion ADM2: Adriamycin (Doxorubicin) 90 mg/m2 as 24 hours continuous i.v. infusion Ifo: Ifosfamide 3 g/m2/24 hour as 120 hours (5 day) continuous i.v. infusion

  4. ISG/SSG I (localized osteosarcoma) March 1997 – May 2000 Total cases: 182 OS EFS Manuscript ready for submission

  5. Osteosarcoma ISG/SSG II - Metastases at diagnosis Postoperative treatment 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 week ADM2: Adriamycin (Doxorubicin) 90 mg/m2 as 24 hours continuous i.v. infusion Cy: Cyclofosfamide 4000 mg/m2 as 3 hour continuous i.v. infusion E1: Etoposide 200 mg/m2/day as 72 hour (3 day ) continuous i.v. infusion HDEC+PBSC rescue: Etoposide 450 mg/m2/day as 4 day continuous i.v. infusion Carboplatin 375 mg/m2/day for 4 days (2 hour infusion) Peripheral blood stem cell (PBSC) rescue at 72 hours after and of chemotherapy

  6. ISG/SSG II (metastatic osteosarcoma) March 1998 – December 2003 Total cases: 47 Abstract to be presented ASCO 2005

  7. LOCALIZED OSTEOSARCOMA ISG/OS-1 April 2001 – Ongoing At october 2004: 166 pts. Necrosis ≥ 90% A-M-P Necrosis < 90% A-I-M-P Arm A (M-P/A) x 2 RANDOM Arm B M-P/A- M-I/P- M-I/A P/A-M-M-I/P-I/A Pts. expected: 264 in 5 yrs.

  8. Italian Sarcoma Group Cooperative OSteosarcoma Study Scandinavian Sarcoma Group EURO-B.O.S.S.EUROpean Bone Over40 Sarcoma Study CDP-ADM-IFO as adjuvant or neoadjuvant treatment (MTX only in selected patients) December 2002-ongoing At october 2004: 30 patients ISG

  9. ISG/SSG III and IV (Ewing family tumors) Standard L O C A L T H E R A P Y VACA-IE R 1 Necrosis VAC+IE HDT HiperVAI+CE VAC+IE HDT R 2 Mini-allo VAC+IE HiperCE R 3 HDT

  10. ISG/SSG III (Standard risk) June 1999 – ongoing At October 2004: 223 patients GOOD RESPONDERS 53% RESPONSE 183 pts. POOR RESPONDERS 47% 70 pts. completed HD treatment • No major organ toxicity • No toxic death

  11. ISG/SSG IV (High risk) June 1999 – ongoing At October 2004: 72 patients - 10 progression disease - 1 toxic death 41 PTS completed HD treatment 3 year OS 54% (38-69) Median FU 19 months (1-62) Abstract to be presented at ASCO 2005

  12. Italian Sarcoma Group Localized High Risk STS Protocol (ISG/STS1) R A N D O M IFO + EPI x 2 IFO + EPI x 3 CONTROL • IFO 9 g/m2 in 3 days • EPI120 mg/m2 2 days • MESNA 3000 mg/m2 3 days • G-CSF 300 mcg days + 5 +15

  13. l l l l l l l l l Milano INT 38 Bologna IOR 36 Milano ICH 11 Torino Gradenigo 9 Aviano/Gorizia 8 Brescia 6 Milano IEO 2 Napoli INT 2 Torino IRCC 2 Ravenna 1 ------ 115 l

  14. Jan 2002 ISG 115 GEIS Jan 200422 137

  15. Adult soft tissue sarcoma… • ISG/STS1 (neoadjuvant EpiDOX+IFX, in localized high-risk disease) • HD-IFX cont inf (2nd-4th line) • Gemcytabine in leiomyosarcoma (2nd-3rd line) • Paclitaxel in angiosarcoma (2nd line) • Miniallogenic transplant (advanced disease, responsive patients)

  16. GIST… • GIOTTO (observational study, 2004, in collaboration with Novartis) • REGISTER (pathology retrospective study) • 62024 (adjuvant Imatinib), intergroup EORTC-led trial • SU11248 (company’s sponsored international study) • PTK787 (international study)

  17. ITALIAN SARCOMA GROUP POTENTIAL OF ACCRUAL Italian Population: 57 Million OSTEOSARCOMA: 90/120 = 75% EWING’S FAMILY: 50/60 > 80% SOFT TISSUE SARCOMAS: 700/1400 = 50%

  18. A European Project within the VI framework

  19. Dr. Piero Picci (Co-ordinator) *Partner 1Istituti Ortopedici Rizzoli (IOR, Italy) Dr.ssa Katia Scotlandi *Partner 2 Institut National de la Santé et de la Recherche Médicale (INSERM, France) Pr. Alain Bernard *Partner 3 Laboratory for Experimental Orthopaedic Research (UKM, Germany) Dr. Frans van Valen *Partner 4 University of Helsinki (UH.DMG, Finland) Prof. Sakari Knuutila *Partner 5 Department of Pathology, University of Valencia (UVEG, Spain) Prof. Antonio Lombart-Bosch *Partner 6 Children´s Cancer Research Institute (CCRI, Austria) Assoc. Prof. Dr. Heinrich Kovar *Partner 7 Université Paris 7 Denis-Diderot (UP7 DD, France) Dr. Bernard Perbal *Partner 8 Centre National de la Recherche Scientifique (CNRS, France) Dr. Claude Malvy *Partner 9 Belozersky Inst. of Physico-Chemical Biology of the Moscow State Univ. (BI.MSU) Dr.ssa Marina Gottikh *Partner 10 GenX Laboratories srl (GENX, Italy) Dr. Alessandro Borsatti *Partner 11MABGENE S.A. (MABG, France) Agnès Leconte

  20. PROTHETS - OBJECTIVES • Prognostic factors: fusion transcripts, secondary cytogenetic and molecular alterations, CD99, IGF-IR, NOVH, erbB-2, TTF1 • Targeted therapeutic approaches: EWS/FLI1, CD99, erbB-2, IGF-IR, (TRAIL) • Genomic profiles for evaluation of tumor progression and response to chemotherapy

  21. Graphical presentation of work packages

  22. Starting January 1st, 2005 - 3 year project Total grant: 2.530.500,00 Euro Website: WWW.PROTHETS.ORG

  23. May 24-25 ISG Annual Meeting • May 27 • Meeting of • European • Sarcoma • Groups • ISG • SSG • GEIS • EORTC • France • Poland • Germany • etc.

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