Recurrent endometrial cancer: lenvatinib shows response in phase 2 study

  • Vergote I & et al.
  • Gynecol Oncol
  • 17 Jan 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Second-line lenvatinib is well-tolerated and shows modest antitumor response in patients with recurrent endometrial cancer.

Why this matters

  • Recurrent endometrial cancer is difficult to treat, and previous studies in this setting did not show improved survival.

Study design

  • Phase 2 study: 133 patients with unresectable endometrial cancer who relapsed after 1 previous platinum-based chemotherapy received lenvatinib.
  • Funding: Eisai Inc; MSD.

Key results

  • Objective response rate (ORR) was 14.3% (95% CI, 8.8%-21.4%).
  • The median duration of response was 7.2 months.
  • The median PFS was 5.6 months, and the median OS was 10.6 (95% CI, 8.9-14.9) months.
  • The most common grade ≥3 treatment-related adverse events were hypertension (33%), fatigue (12%), asthenia (10%), abdominal pain (6%), proteinuria (8%), and dehydration (6%).
  • Patients with lower baseline levels of angiopoietin-2 levels showed:
    • Longer PFS (highest vs lowest quartile): 225.0 vs 86.5 days. 
    • Longer OS (highest vs lowest quartile): 541.0 vs 173.0 days.
    • Higher ORR: 26.9% vs 5.7%.
  • Treatment-related discontinuation rate was 18%.

Limitations

  • Single-group, open-label design.