No Overall Survival Benefit of First-Line Doxorubicin Plus Ifosfamide vs Doxorubicin Alone in Advanced Soft-Tissue Sarcoma .
By Matthew Stenger . March 2014 .
In the open-label, phase III EORTC 62012 trial reported in The Lancet Oncology, Judson et al found that doxorubicin plus ifosfamide was not associated with any overall survival advantage compared with doxorubicin alone in patients with advanced or metastatic soft-tissue sarcoma. Progression-free survival and objective response rate were improved with the intensified regimen, suggesting a role in cases where tumor shrinkage is the goal of treatment.
Study Details
In the trial, 455 patients with locally advanced unresectable or metastatic high-grade soft-tissue sarcoma aged 18 to 60 years with WHO performance status of 0 or 1 were randomly assigned between April 2003 and May 2010 to receive intensified doxorubicin (75 mg/m2 at 25 mg/m2 per day on days 1–3) plus ifosfamide (n = 227; 10 g/m2 over 4 days with mesna and pegfilgrastim [Neulasta]) or doxorubicin alone (n = 228; 75 mg/m2 by bolus on day 1 or 72-hour continuous infusion) every 3 weeks until disease progression or unacceptable toxicity for up to a maximum of six cycles. The primary endpoint was overall survival.
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