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Attia, Steven; Bolejack, Vanessa; Ganjoo, Kristen N.; George, Suzanne; Agulnik, Mark; Rushing, Daniel; Loggers, Elizabeth T.; Livingston, Michael B.; Wright, Jennifer; Chawla, Sant P.; Okuno, Scott H.; Reinke, Denise K.; Riedel, Richard F.; Davis, Lara E.; Ryan, Christopher W.; Maki, Robert G.

A phase II trial of regorafenib in patients with advanced Ewing sarcoma and related tumors of soft tissue and bone: SARC024 trial results

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  • Media type: E-Article
  • Title: A phase II trial of regorafenib in patients with advanced Ewing sarcoma and related tumors of soft tissue and bone: SARC024 trial results
  • Contributor: Attia, Steven; Bolejack, Vanessa; Ganjoo, Kristen N.; George, Suzanne; Agulnik, Mark; Rushing, Daniel; Loggers, Elizabeth T.; Livingston, Michael B.; Wright, Jennifer; Chawla, Sant P.; Okuno, Scott H.; Reinke, Denise K.; Riedel, Richard F.; Davis, Lara E.; Ryan, Christopher W.; Maki, Robert G.
  • imprint: Wiley, 2023
  • Published in: Cancer Medicine
  • Language: English
  • DOI: 10.1002/cam4.5044
  • ISSN: 2045-7634
  • Keywords: Cancer Research ; Radiology, Nuclear Medicine and imaging ; Oncology
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Regorafenib is one of several FDA‐approved cancer therapies targeting multiple tyrosine kinases. However, there are few subtype‐specific data regarding kinase inhibitor activity in sarcomas. We report results of a single arm, phase II trial of regorafenib in advanced Ewing family sarcomas.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients with metastatic Ewing family sarcomas (age ≥ 18, ECOG 0–2, good organ function) who had received at least one line of therapy and experienced progression within 6 months of registration were eligible. Prior kinase inhibitors were not allowed. The initial dose of regorafenib was 160 mg oral days 1–21 of a 28‐day cycle. The primary endpoint was estimating progression‐free rate (PFR) at 8 weeks employing RECIST 1.1.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Thirty patients (median age, 32 years; 33% women [10 patients]; bone primary, 40%; extraskeletal primary, 60%) enrolled at 14 sites. The most common grade 3 or higher toxicities were hypophosphatemia (5 grade 3, 1 grade 4), hypertension (2 grade 3), elevated ALT (2 grade 3). Sixteen patients required dose reductions, most often for hypophosphatemia (<jats:italic>n</jats:italic> = 7 reductions in 6 patients); two stopped regorafenib for toxicity. There was one death unrelated to treatment in the 30‐day post‐study period. Median progression‐free survival (PFS) was 14.8 weeks (95% CI 7.3–15.9); PFR at 8 weeks by Kaplan–Meier analysis was 63% (95% CI 46–81%). The RECIST 1.1 response rate was 10%. Median OS was 53 weeks (95% CI 37–106 weeks).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Regorafenib has modest activity in the Ewing family sarcomas. Toxicity was similar to that seen in approval studies.</jats:p></jats:sec>
  • Access State: Open Access