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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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slide1

www.italiansarcomagroup.org

I

I

talian

Activated

June 1997

S

S

arcoma

G

G

roup

Formalized

October 2002

slide2

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

slide3

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

slide4

ISG/SSG I (localized osteosarcoma)

March 1997 – May 2000

Total cases: 182

OS

EFS

Manuscript ready for submission

slide5

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

slide6

ISG/SSG II

(metastatic osteosarcoma)

March 1998 – December 2003

Total cases: 47

Abstract to be presented ASCO 2005

slide7

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.

euro b o s s euro pean b one o ver 40 s arcoma s tudy
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

slide9

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

slide10

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
slide11

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

slide12

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

slide13

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

slide14

Jan 2002

ISG 115

GEIS Jan 200422

137

adult soft tissue sarcoma
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)
slide16
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)
slide17

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%

slide19

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

slide20

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
slide21

Graphical presentation

of work packages

slide22

Starting January 1st, 2005 - 3 year project

Total grant: 2.530.500,00 Euro

Website: WWW.PROTHETS.ORG

slide23

May 24-25

ISG

Annual

Meeting

  • May 27
  • Meeting of
  • European
  • Sarcoma
  • Groups
  • ISG
  • SSG
  • GEIS
  • EORTC
  • France
  • Poland
  • Germany
  • etc.