title: Sequential dose-dense Doxorubicin and Ifosfamide in advanced soft-tissue sarcoma patients in an out-patient-basis schedule.
abstract: Aims. This phase II study explored activity/safety of front-line dose-dense chemotherapy in high-grade STS (soft tissue sarcoma) patients and tested ezrin as prognostic factor. Patients and Methods. The protocol consisted of three cycles of doxorubicin (DOXO) 30 mg/m(2) on days 1-3 every 2 weeks, followed by three cycles of ifosfamide (IFO) 2.5 g/m(2) two hours a day on days 1-5 every 3 weeks, with GCSF support. Ezrin was assessed immunohistochemically. Results. Twenty patients, 13 metastatic and 7 locally advanced, were enrolled. Median age was 39 years (25-60). Median dose intensities were 42 mg/m(2)/week and 3.6 g/m(2)/week for DOXO and IFO, respectively. Grade 3/4 toxicities occurred in 18 patients. Response rate was 15% (3 of 20) by RECIST. Patients younger than 45 years with locally advanced disease and synovial histology presented longer survival. A trend towards longer survival was observed among ezrin-positive patients. Conclusions. This dose-dense schedule should not be routinely used due to its high frequency of toxic events; however, a sequential strategy with DOXO and IFO may benefit selected patients and should be further explored with lower doses. The role of ezrin as a prognostic marker should be confirmed in a larger group of patients.
authors.affiliation: Servico de Oncologia Clinica, Instituto de Radiologia, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, 05403-900 Sao Paulo, SP, Brazil.
authors.forename: G F G
authors.initials: GF
authors.lastname: Almeida
authors.forename: G
authors.initials: G
authors.lastname: Castro
authors.forename: I M L
authors.initials: IM
authors.lastname: Snitcovsky
authors.forename: S A
authors.initials: SA
authors.lastname: Siqueira
authors.forename: E H
authors.initials: EH
authors.lastname: Akaishi
authors.forename: O P
authors.initials: OP
authors.lastname: Camargo
authors.forename: C R G C M
authors.initials: CR
authors.lastname: Oliveira
authors.forename: M H H
authors.initials: MH
authors.lastname: Federico