Abstract
Background. To explore the tolerance and the activity of high-dose ifosfamide (IFOS) combined with doxorubicin (DXR) at 50 mg/m2 every 4 weeks in patients with soft tissue sarcomas. Methods. DXR was given IV bolus and IFOS by continuous infusion at 2 g/m2/day. Initial IFOS dose (12 g/m2) was adjusted to 10, 13, or 14 g/m2 according to toxicity. Results. Seventy patients received 277 cycles (median 3 cycles, range 1–10), 34% with IFOS dose increased, 30% decreased, and 48% delivered at 12 g/m2. Toxicity grade 4 occurred on granulocytes (67% of patients) or platelets (19%), 54% had febrile neutropenia, 31% grade 3/4 asthenia, and 26% abandoned the study due to toxicity. Three toxic deaths occurred. In 57 non-GIST patients objective activity was 45.6% (95% CI, 32 to 58%). Conclusion. At least 4 cycles were tolerated by 71% of patients, most receiving DXR 50 mg/m2 plus IFOS 10–12 g/m2, with substantial toxicity.
Highlights
Doxorubicin (DXR) and ifosfamide (IFOS) are two active agents against advanced soft tissue sarcomas (ASTS), which have been combined in an attempt to improve therapeutic efficacy [1]
Two were considered ineligible
ASTS patients were treated with IFOS at an initial dose of 12 g/m2 combined with DXR 50 mg/m2 every 4 weeks, with the dose of IFOS adjusted in the 10–14 g/m2 range according to the hematologic nadir
Summary
Doxorubicin (DXR) and ifosfamide (IFOS) are two active agents against advanced soft tissue sarcomas (ASTS), which have been combined in an attempt to improve therapeutic efficacy [1]. The combination of 12.5 g/m2 IFOS with 4epidoxorubicin (EPI) at 90 mg/m2 induced grade 4 thrombocytopenia in 35% of patients [10], while EPI at 110 mg/m2 plus IFOS 10 g/m2 were the doses recommended after a Phase I trial [11] In those trials, grade 4 neutropenia occurred in 70–100% of patients, a toxicity that was not considered limiting. Grade 4 neutropenia occurred in 70–100% of patients, a toxicity that was not considered limiting Objective activity of those regimens, usually delivered every 3 weeks, varied from 52% to 69%, randomized studies comparing their efficacy with that of single agent DXR or standard-dose combinations are still lacking. At least 4 cycles were tolerated by 71% of patients, most receiving DXR 50 mg/m2 plus IFOS 10–12 g/m2, with substantial toxicity
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