Connective Tissue Oncology Society 11th Annual Meeting NON METASTATIC EWING’ FAMILY TUMORS: HIGH DOSE CHEMOTHERAPY WITH PERIPHERAL BLOOD STEM CELL RESCUE.

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Presentation transcript:

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. 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 or in case of inadequate surgical margins Maintenance treatment According to the response to induction therapy

ISG/SSG III Evaluation of response Good Response Surgery: Surgery: histologic response G II-III (Picci) RxT: RxT: CR to soft tissue Poor response Surgery: Surgery: histologic response G I (Picci) RxT: RxT: persistent disease in soft tissue

VACVIDVACIE VACVIDIEVACVIDVACVID IEVACCEBuMel Local treatment GR PR PBSC harvest ISG SSG III VAC 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 GENDERMaleFemale 152 (63%) 88 (37%) FEVER Available in 225 YesNo 29 (13%) 196 (87%) FATIGUE Available in 216 YesNo 17 (8%) 199 (92%) Weightloss Available in 214 YesNo 11 (5%) 203 (95%) SAP Available in 209 NormalHigh 185 (89%) 24 (11%) 24 (11%) LDH Available in 207 NormalHigh 145 (70%) 62 (30%) SiteExtremityCentralPelvis 130 (54%) 65 (27%) 45 (19%) 45 (19%) Median age (years): 15 (3-40) Median duration of symptoms (months): 4 ( ) June September patients 240 patients ISG: 203 (85%) SSG: 37 (15%)

ISG/SSG III Local treatment Surgery 134 (59%) Surgery + RxT 49 (21%) RxT 45 (20%) 228 patients

ISG/SSG III Local treatment by site P <

ISG/SSG III SURGERY 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 Response 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 by site P=0.043

ISG/SSG III Histologic response by site P=0.4

ISG/SSG III ISG/SSG % (95% CI) % (95% CI) 3-year PFS 67 (60-75) 3-year OS 78 (72-85) Median FU 29 months (1-75) Progression-free survivalOverall survival

ISG/SSG III Progression-free survival SITE 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 survival Local 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 survival RESPONSE GR 3 yrs PFS 70% (61-80) PR 3 yrs PFS 62% (51-73) P=0.19

ISG/SSG III No High Dose Chemotherapy 22/110 poor responder patients did not get HDC PD6 Poor harvest2 Medical contraindication4 Refusal/medical decision10

ISG/SSG III Progression-free survival RESPONSE GR 3 yrs PFS 70% (61-80) PR 3 yrs PFS 68% (57-80) P=0.7

ISG/SSG III Progression-free survival HISTOLOGIC 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 PDLRLR+otherBoneLungBone+Lung 6 (11%) 10 (18%) 8 (14%) 18 (32%) 6 (11%) G4 cardiotox, Pneumonia, Septic emboli 10 months after chemo completion AML 2 patients

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 ISG SSG III