Cediranib May Be Effective in Alveolar Soft Part Sarcoma
In a randomized phase 2 trial, CASPS, researchers enrolled 48 patients with metastatic ASPS that progressed within the preceding 6 months. The primary endpoint was change in tumor size.
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Cediranib, a tyrosine kinase inhibitor, is effective in patients with alveolar soft part sarcoma (ASPS), according to an oral presentation at the Connective Tissue Oncology Society (CTOS) 2017 Annual Meeting.1
ASPS, a rare sarcoma that primarily affects young patients, was previously shown to respond to cediranib, which inhibits vascular endothelial growth factor receptors. In a randomized phase 2 trial (CASPS; ClinicalTrials.gov Identifier: NCT01337401) researchers enrolled 48 patients with metastatic disease that progressed within the preceding 6 months. The primary endpoint of the study was change in tumor size.
Patients were randomly assigned 2:1 to cediranib (32 patients) or placebo (16 patients). Crossover was allowed from the placebo group at 24 weeks or sooner if progression was detected. Most patients had primary tumors of the extremity; the median age was 31 years; some patients had received a prior tyrosine kinase inhibitor.
Among the 44 evaluable patients, those who received cediranib had a median change in tumor size of -8.3%, which contrasted with +13.4% in the placebo group (one-sided P = .001). At 24 weeks, 3 partial responses were noted and 14 patients had stable disease.
The median progression-free survival rate with cediranib was 10.8 months compared with 3.7 months with placebo. Despite crossover at 24 weeks, the 12-month overall survival rate was 94% with cediranib compared with 66% with placebo. Hazard ratios for progression-free survival and overall survival both missed significance.
Progression-free survival was not significantly worse among the 12 patients who previously received a tyrosine kinase inhibitor.
Grade 3 or worse adverse events observed with cediranib included hypertension, increased gamma glutamyltransferase, diarrhea, asthenia, and fatigue.
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- Judson I, Morden J, Leahy M, et al. CASPS (cediranib in alveolar soft part sarcoma), an international randomised phase II trial. Oral presentation at: Connective Tissue Oncology Society (CTOS) 2017 Annual Meeting. November 8-11, 2017; Maui, Hawaii.