Regorafenib as maintenance therapy significantly extends progression-free survival (5.6 vs 3.5 months) after doxorubicin-based chemotherapy in advanced non-adipocytic soft tissue sarcoma (STS) patients.
The phase II EREMISS trial enrolled 126 patients with predominantly leiomyosarcoma, demonstrating a favorable hazard ratio (HR=0.53) for progression-free survival.
Overall survival improvement showed a positive trend but was not statistically significant (27.6 vs 20.5 months; HR=0.78; P=0.28).
Toxicity was considerable with regorafenib, with over half experiencing grade ≥3 adverse events; common severe side effects included asthenia, hypertension, and rash.
