title: Efficacy of consolidation high-dose chemotherapy with ifosfamide, carboplatin and etoposide (HD-ICE) followed by autologous peripheral blood stem cell rescue in chemosensitive patients with metastatic soft tissue sarcomas.
abstract: BACKGROUND
  Prognosis of patients with metastatic soft tissue sarcomas (MSTS) is poor even after response to doxorubicin-based chemotherapy. We report phase II data of high-dose chemotherapy and peripheral blood stem cell (PBSC) rescue in patients with MSTS responding to AI-G chemotherapy.
  
  
  METHODS
  From 1997 to 2002, 55 patients with MSTS were prospectively treated with 4 cycles of AI-G (doxorubicin 75 mg/m(2), ifosfamide 6 g/m(2) with G-CSF support). Responders received 2 further cycles of AI-G with collection of PBSCs. High-dose chemotherapy consisted of ifosfamide 12 g/m(2), carboplatin 1.2 g/m(2) and etoposide 1.2 g/m(2) (HD-ICE) followed by reinfusion of PBSCs.
  
  
  RESULTS
  Twenty-one of 55 patients (38%) were assessed as responders (3 complete response, 18 partial response). All but 2 patients refusing treatment received high-dose chemotherapy with PBSC rescue leading to grade IV hematologic toxicity without severe infections in all patients. No toxic death occurred. After a median follow-up time of 30 months, the median progression-free time was 12 months and survival time was 22 months for the entire group. By intent-to-treat analysis the probability of 5-year progression-free survival was significantly higher for patients allocated to HD-ICE compared to patients receiving second-line chemotherapy after failure of AI-G (14 vs. 3%; p = 0.003). The estimated 5-year overall survival between the 2 groups was different (27% vs. not reached) but did not reach significance (p = 0.08).
  
  
  CONCLUSIONS
  HD-ICE is feasible and promising in patients with chemosensitive MSTS. A randomized phase III trial is warranted to further define the role of HD-ICE as consolidation treatment in these patients.
authors.affiliation: Department of Internal Medicine III, Klinikum Grosshadern Medical Center, Munich, Germany. Marcus.Schlemmer@med.uni-muenchen.de
authors.forename: Marcus
authors.initials: M
authors.lastname: Schlemmer
authors.forename: Clemens-Martin
authors.initials: CM
authors.lastname: Wendtner
authors.forename: Martin
authors.initials: M
authors.lastname: Falk
authors.forename: Sultan
authors.initials: S
authors.lastname: Abdel-Rahman
authors.forename: Thomas
authors.initials: T
authors.lastname: Licht
authors.forename: Jens
authors.initials: J
authors.lastname: Baumert
authors.forename: Christian
authors.initials: C
authors.lastname: Straka
authors.forename: Marcus
authors.initials: M
authors.lastname: Hentrich
authors.forename: Christoph
authors.initials: C
authors.lastname: Salat
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hiddemann
authors.forename: Rolf-Dieter
authors.initials: RD
authors.lastname: Issels
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016190:Carboplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005047:Etoposide / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation; D011446:Prospective Studies; D016879:Salvage Therapy; D012509:Sarcoma / Q000556:secondary / Q000628:therapy*; D012983:Soft Tissue Neoplasms / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D014182:Transplantation, Autologous
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D016190:Carboplatin; D007069:Ifosfamide