Cediranib Prolongs Progression-free Survival in Alveolar Soft Part Sarcoma
Data suggest that cediranib-treatment of ASPS results in a substantial reduction in tumor burden and prolonged PFS.
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Cediranib prolonged progression-free survival (PFS) among patients with alveolar soft part sarcoma (ASPS), according to a study to be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
ASPS constitutes just 0.5 to 1% of soft tissue sarcomas and demonstrates poor response to chemotherapy. Cediranib — a VEGFR and other receptor tyrosine kinase inhibitor — showed activity in ASPS in previous single-arm phase 2 trials. The CASPS trial (Clinicaltrials.gov identifier: NCT01337401) evaluated cediranib with a placebo comparator.
The phase 2 trial randomly assigned 48 patients age 16 or older with metastatic ASPS 2:1 to receive 30 mg daily of cediranib or placebo.
The median age was 31 at baseline and 52% of patients were female. Patients who received placebo were switched to cediranib at 24 weeks, and all patients were unblinded.
The best response was partial response (21%) in the cediranib group compared with 0% in the placebo group at 24 weeks (P = .053). The change in the sum of target marker lesions was -8.3% (interquartile range [IQR], -26.2% to +5.9%) with cediranib compared with +13.4% (IQR, -0.6% to +21.3%) with placebo (P = .0013).
The median PFS was 10.8 months with cediranib compared with 3.7 months with placebo (hazard ratio [HR], 0.54; 90% CI, 0.30-0.97; P = .041).
The 1-year overall survival rate was 96% in the cediranib arm compared with 64.3% in the placebo arm.
The most common grade 3 or higher adverse effects were hypertension (23%), diarrhea (14%), and fatigue (9%).
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According to the investigators, these data suggest that cediranib-treatment of ASPS results in a substantial reduction in tumor burden and prolonged PFS. Future studies will assess tissue and serial blood samples to identify predictive and prognostic biomarkers.
Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Judson IR, Morden JP, Leahy MG, et al. Activity of cediranib in alveolar soft part sarcoma (ASPS) confirmed by CASPS (cediranib in ASPS), an international, randomised phase II trial (C2130/A12118). J Clin Oncol. 2017;35(suppl; abstr 11004).