title: Non-pegylated liposomal doxorubicin plus ifosfamide in metastatic soft tissue sarcoma: results from a phase-II trial.
abstract: OBJECTIVE
  Non-pegylated liposomal doxorubicin (NPLD) has demonstrated antitumour activity equivalent to conventional doxorubicin and a significantly lower risk of cardiotoxicity. This phase II trial was performed to evaluate the activity and the safety of NPLD and ifosfamide combination in patients with metastatic soft tissue sarcoma.
  
  
  METHODS
  Thirty-four patients received NPLD 40 mg/m(2) (d1) and ifosfamide 3 g/m(2)/day (d1-3) every three weeks as first-line therapy of metastatic soft tissue sarcoma. The treatment was planned for a maximum of six cycles.
  
  
  RESULTS
  The objective response (OR) rate among response-assessable patients was 55.9%. The median progression-free survival (PFS) was 4.2 months and the median overall survival (OS) was 11.2 months. Symptomatic grade 3 cardiotoxicity occurred in one patient (3%).
  
  
  CONCLUSIONS
  The combination of NPLD and ifosfamide reported in a population of metastatic soft tissue sarcoma patients at risk for developing heart failure encourage antitumour activity, similar to that of classical doxorubicin.
authors.affiliation: Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy rita.de_sanctis@cancercenter.humanitas.it.
authors.forename: Rita
authors.initials: R
authors.lastname: De Sanctis
authors.affiliation: Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy Department of Medical Oncology, Adelaide & Meath Hospital, incorporating the National Children's Hospital (AMNCH), Dublin, Ireland.
authors.forename: Alexia
authors.initials: A
authors.lastname: Bertuzzi
authors.affiliation: Medical Oncology Unit 1, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
authors.affiliation: Department of Oncology, Gradenigo Hospital, Turin, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Comandone
authors.affiliation: Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Marchetti
authors.affiliation: Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Marrari
authors.affiliation: Department of Pathology, Humanitas Cancer Center, IRCCS, Milan, Italy.
authors.forename: Piergiuseppe
authors.initials: P
authors.lastname: Colombo
authors.affiliation: Department of Radiology, Humanitas Cancer Center, IRCCS, Milan, Italy.
authors.forename: Romano Fabio
authors.initials: RF
authors.lastname: Lutman
authors.affiliation: Biostatics Unit, Humanitas Cancer Center, IRCCS, Milan, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Giordano
authors.affiliation: Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Santoro
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D016896:Treatment Outcome
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D007069:Ifosfamide
keywords: Non-pegylated liposomal doxorubicin; Phase II; soft tissue sarcoma