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See Latest ArticlesEfficacy of sequential high-dose doxorubicin and ifosfamide compared with standard-dose doxorubicin in patients with advanced soft tissue sarcoma: An open-label randomized phase ii study of the spanish group for research on sarcomas
Journal of Clinical Oncology, 03/16/09
Maurel J et al – Data suggest that single-agent doxorubicin remains the standard treatment in fit patients with advanced soft tissue sarcoma.
Methods- Study to assess PFS and antitumor response to standard-dose doxorubicin vs sequential dose-dense doxorubicin and ifosfamide in first-line treatment of advanced soft tissue sarcoma
- Pts (n=132) from ECOG PS < 2, between the ages 18-65 yrs, and with adequate bone marrow, liver, and renal function
- Pts were randomly assigned to either doxorubicin 75 mg/m2 given as a bolus injection/3 wks for 6 cycles (arm A) or doxorubicin at 30 mg/m2/d for 3 consecutive days x1/2 wks for 3 cycles followed by ifosfamide at 12.5 g/m2 delivered by continuous infusion over 5 d x1/3 wks for 3 cycles with filgastrim or pegfilgastrim support (arm B)
- Febrile neutropenia, asthenia, and mucositis were more frequent in the arm B
- The interim preplanned analysis for futility allowed the premature closure
- OR were observed in 23.4% of assessable pts in arm A and 24.1% in arm B
- PFS was 26 wks in the arm A and 24 wks in arm B
- OS did not differ between the two therapeutic arms
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