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Connective Tissue Oncology Society 11th Annual Meeting. NON METASTATIC EWING’ FAMILY TUMORS: HIGH DOSE CHEMOTHERAPY WITH PERIPHERAL BLOOD STEM CELL RESCUE IN POOR RESPONDER PATIENTS: PRELIMINARY RESULTS OF ISG/SSG III PROTOCOL .
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Connective Tissue Oncology Society11th Annual Meeting NON METASTATIC EWING’ FAMILY TUMORS: HIGH DOSE CHEMOTHERAPY WITH PERIPHERAL BLOOD STEM CELL RESCUE IN POOR RESPONDER PATIENTS: PRELIMINARY RESULTS OF ISG/SSG III PROTOCOL. S.Ferrari, A.Tienghi, M.Mercuri, F.Bertoni, E.Barbieri, F.Fossati Bellani, R. Luksch, G. Bernini, A. Brach del Prever, F.Fagioli, P.Picci and G. Bacci Italian Sarcoma Group (ISG); S. Smeland, T. Bohling, O. Brosjo, G Saeter, T. Wiebe, T Alvegaard Scandinavian Sarcoma Group (SSG)
Diagnosis of Ewing/PNET Sarcoma No metastases at diagnosis Age between 3-40 years Non-randomized clinical study Induction treatment V-Ac-C-A-I-E Local treatment Surgery whenever possible, Radiotherapy, when surgery is not feasible, or in case of inadequate surgical margins Maintenance treatment According to the response to induction therapy
ISG SSG III VAC VID IE VAC VID IE VAC VID IE GR Local treatment VAC VID VAC IE VAC CE VAC IE BuMel PR PBSC harvest V=vincristine 1.5mg/m2 A=doxorubicin 80mg/m2 C=cyclophosphamide 1200 mg/m2 I = ifosfamide 3g/m2/day x 3 D=dactinomycin 1.5mg/m2 E=etoposide 150mg/m2/day x3 C=cyclophosphamide 4000mg/m2 E=etoposide 200mg/m2x3 Bu=busulfan 16mg/kg Mel=melphalan 140mg/m2
ISG/SSG III Clinical Characteristics June 1999 - September 2005 240 patients ISG: 203 (85%) SSG: 37 (15%) Median age (years): 15 (3-40) Median duration of symptoms (months): 4 (0.5-38 )
ISG/SSG IIILocal treatment Surgery 134 (59%) Surgery + RxT 49 (21%) RxT 45 (20%) 228 patients
ISG/SSG III Local treatment by site P < 0.0001
Surgery Resection 175 (95%) Amputation 9 (5%) 184 patients Margins Wide 128 (80%) Radical 6 (4%) Marginal 18 (11%) Intralesional 8 (5%) 160 patients ISG/SSG III SURGERY
Response Good 111 (50%) Poor 110 (50%) 221 patients Necrosis I 77 (49%) II 38 (24%) III 43 (27%) 158 patients ISG/SSG III Response
ISG/SSG III Response by site P=0.043
ISG/SSG III Progression-free survival Overall survival Median FU 29 months (1-75)
ISG/SSG III Progression-free survivalSITE Extremity 3 yrs PFS 70% (61-80) Central 3 yrs PFS 62% (46-77) Pelvis 3 yrs PFS 60% (43-76) P=0.3
ISG/SSG III Progression-free survivalLocal treatment Surgery 3 yrs PFS 72% (63-81) Surgery+RxT 3 yrs PFS 68% (52-83) RxT 3 yrs PFS 51% (33-68) RxT No PD 3 yrs PFS 57% (39-76) P =0.09
ISG/SSG III Progression-free survivalRESPONSE GR 3 yrs PFS 70% (61-80) PR 3 yrs PFS 62% (51-73) P=0.19
ISG/SSG IIINo High Dose Chemotherapy 22/110 poor responder patients did not get HDC PD 6 Poor harvest 2 Medical contraindication 4 Refusal/medical decision 10
ISG/SSG III Progression-free survivalRESPONSE GR 3 yrs PFS 70% (61-80) PR 3 yrs PFS 68% (57-80) P=0.7
ISG/SSG III Progression-free survivalHISTOLOGIC RESPONSE I 3 yrs PFS 66% (54-79) II 3 yrs PFS 70% (55-86) III 3 yrs PFS 83% (70-95) P=0.18
ISG/SSG III Events G4 cardiotox, Pneumonia, Septic emboli 10 months after chemo completion AML 2 patients
ISG SSG III The treatment is feasible and well tolerated Results are encouraging The strategy for poor responders seems to improve their prognosis Longer follow-up is needed to confirm its efficacy