AACR 2018 — CREATE data support crizotinib as SoC for ALK+ myofibroblastic tumor


  • Hao Cheng, MD
  • Univadis
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Takeaway

  • Among patients with inoperable, advanced, or metastatic ALK+ inflammatory myofibroblastic tumor (IMFT), 50% were confirmed to have partial or complete tumor shrinkage after treatment with the ALK-targeted anticancer therapeutic crizotinib.
  • Crizotinib should be considered as systemic treatment standard of care for this disease.

Why this matters:

  • IMFT can cause significant functional disabilities, organ dysfunction, and death. Surgery is often impossible or extremely debilitation and the tumor is resistant to conventional chemoradiation.
  • 50% of IMFTs have ALK gene rearrangements.
  • This study assesses the efficacy of ALK inhibitor crizotinib for patients with this disease.

Study design

  • Phase 2 CREATE study of 20 patients (median age, 45.5 years) with a local diagnosis of IMFT, receiving oral crizotinib 250 mg twice daily until disease progression.

Key Results

  • 12 evaluable patients with ALK+ IMET who received crizotinib had:
    • 100.0% disease control rate (complete response/partial response/stable disease as best response; 95% CI, 73.5-100.0%)
    • 50% response rate (2 complete, 4 partial).
    • 1-year progression free rate 73.3 % (95% CI, 37.9-90.6%).
    • 2-year OS rate 81.8% (95% CI, 44.7-95.1%).
  • 7 ALK-negative patients had a 14.3% response rate.

 Limitations

  • Noncomparative, single-arm study with a relatively small number of patients.

Expert comment:

“The CREATE study provides supportive data that sensitivity to crizotinib occurs in tumors with ALK gene rearrangements regardless of tissue site and provides plausibility for tissue site agnostic approval for targets like ALK gene fusions.”

Benjamin Solomon MBBS, PhD, FRACP – Peter McCallum Cancer Centre

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