In patients with soft tissue sarcoma pretreated with doxorubicin, treatment with regorafenib significantly reduced the risk of progression symptoms or toxicity compared with placebo, a study published in the journal Cancer has shown.1
The ongoing, international, double-blind, placebo-controlled, phase 2 REGOSARC study (ClinicalTrials.gov Identifier: NCT01900743) demonstrated a significant improvement in progression-free survival with regorafenib vs placebo for patients with advanced nonapidocytic sarcoma previously treated with doxorubicin.
To provide an integrated measure of regorafenib’s clinical benefit, investigators conducted a post hoc exploratory analysis of quality-adjusted time without symptoms of progression or toxicity.
Among patients with nonapidocytic sarcoma, results showed that median progression-free survival was 4.0 months (95% CI, 2.6-5.5) with regorafenib compared with 1.0 month (95% CI, 0.9-1.8) for placebo, suggesting that regorafenib was associated with 64% reduced risk of progression or death vs placebo (hazard ratio [HR], 0.36; 95% CI, 0.25-0.53; P <.0001).
However, there was no significant difference in the risk of mortality between the 2 treatment arms (HR, 0.67; 95% CI, 0.44-1.02). Median overall survival was 13.4 months (95% CI, 8.6-17.3) with regorafenib and 9.0 months (95% CI, 6.8-12.5) with placebo.
Researchers also found that patients treated with regorafenib had a grade 3 to 4 adverse events for 8.0 months (95% CI, 7.0-9.0), on average, vs 5.7 months (95% CI, 4.9-6.4) with placebo (P <.001).
The findings contribute to the growing evidence that regorafenib is efficacious and improves quality of life in patients with advanced soft tissue sarcomas.
The REGOSARC trial enrolled 182 patients with advanced soft tissue sarcomas who had received previous doxorubicin or other anthracycline treatment. Patients were classified as having liposarcoma, leiomyosarcoma, synovial sarcoma, or other sarcomas and then randomly assigned to receive oral regorafenib 160 mg daily on days 1 to 21 of each 28-day cycle or placebo.
1. Berry V, Basson L, Bogart E, et al. REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma—A quality-adjusted time without symptoms of progression or toxicity analysis. Cancer. 2017 March 10. doi: 10.1002/cncr.30661 [Epub ahead of print]