No abstract

10547 Background: Chemotherapy (CT) with ifosfamide, carboplatin, and etoposide (ICE) is effective in refractory solid tumors. The aim of this trial was to determine the efficacy and safety of ICE as front line therapy for patients (pts) with newly-diagnosed EFT. Methods: Induction with 2 courses of ICE (ifosfamide 3g/m2/d ×3, carboplatin 450mg/m2 ×1, etoposide 150mg/m2/d ×3) plus 2 of VDC (vincristine 1,5mg/m2/d ×1, doxorubicin 60mg/m2/d ×1, cyclophosphamide 1,5g/m2/d ×1) was followed by surgery and/or radiotherapy. After induction, pts were allocated to low (LR) or high-risk (HR) according to LDH (<or>1,5×NL), site (pelvic/non-pelvic) and resection (complete/unresectable) or metastatic (mets). Postoperative CT included 10 alternating courses of IE and VDC for LR and 12 alternating courses of ICE and VDC for HR. Toxicity was assessed following 523, 648, 268 and 114 courses of ICE, VDC, IE and VC, respectively; 35 site visits were carried out for data quality control. Results: From 10/2003 to 10/2008, 150 of 159 enrolled pts were evaluable; median age 13y (0.2–29.3y). 44 pts were classified as LR and 101 as HR, 56 mts. Toxicity was mainly grade III-IV neutropenia, thrombocytopenia and febrile neutropenia, and was significantly higher following ICE. The 3y EFS and OS were 65% and 27% for localized pts and 80% and 43% for mets pts. 3y EFS for lung and non-lung mets were 40% and 19% (P=0.013). Multivariate analysis showed that mets disease was the only independent prognostic factor (P=0.006) for the entire group. However, when mts pts were analyzed separately, high LDH (P=0.01) and extra-lung site (P=0.016) had significant negative impact on survival. Conclusions: ICE regimen is safe and despite a high proportion of pts with advanced disease the survival are similar to larger series. Elevated LDH and the presence of extra-lung mets were significant negative prognostic factors in mets pts. Randomized trials to identify pts who may benefit from more intensive CT are warranted. No significant financial relationships to disclose.