Recurrent ovarian cancer: cabozantinib fails phase 2 trial

  • Matulonis UA & et al.
  • Gynecol Oncol
  • 23 Dec 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In patients with recurrent ovarian cancer, daily cabozantinib yields PFS similar to weekly paclitaxel, but worse OS, event-free survival (EFS), and overall response rate (ORR).
  • Gastrointestinal toxicities were more frequent with cabozantinib.

Why this matters

  • Trials evaluating combination treatment with cabozantinib are ongoing.

Study design

  • Phase 2 NRG Oncology/Gynecologic Oncology Group study: 111 patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were randomly assigned 1:1 to daily 60 mg cabozantinib or weekly paclitaxel.
  • Primary endpoint: PFS.
  • Funding: National Cancer Institute.

Key results

  • Median follow-up time was 13.9 months for cabozantinib and 14.5 months for paclitaxel group.
  • Median PFS was not significantly different between cabozantinib and paclitaxel (5.3 vs 5.5 months; HR, 1.1; P=.64).
  • Cabozantinib was associated with significantly worse median OS (19.4 months vs not reached; HR, 2.27; P=.04) and EFS (3.5 vs 5.0 months; HR, 1.81; P=.01) vs paclitaxel.
  • ORR was lower for cabozantinib compared with weekly paclitaxel (7% vs 24.1%).
  • Gastrointestinal toxicities (nausea, diarrhea, and abdominal pain) were more frequent with cabozantinib.

Limitations

  • Open-label design.

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