Recurrent ovarian cancer: add-on pazopanib improved response, survival

  • Duska LR & et al.
  • Gynecol Oncol
  • 30 Mar 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Adding pazopanib to gemcitabine in patients with recurrent epithelial ovarian cancer improves response and survival.

Why this matters

  • Patients with platinum-resistant disease can derive PFS benefit from adding pazopanib.
  • Phase 3 evaluation is warranted.

Study design

  • Phase 2 study: 148 patients (median age, 63 years) with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were randomly assigned to gemcitabine with or without pazopanib.
  • Primary endpoint: PFS.
  • Funding: Glaxo SmithKline/Novartis.

Key results

  • 60% of the patients had platinum-resistant disease.
  • Median follow-up, 13 months.
  • Adding pazopanib significantly improved median PFS (5.3 [95% CI, 4.2-5.8] months vs 2.9 [95% CI, 2.1-4.1] months) vs gemcitabine alone.
  • The PFS benefit was observed in the platinum-resistant disease group (5.32 vs 2.33 months; Tarone-Ware P<.001 but not in the platinum-sensitive group>
  • There was no difference in OS.
  • Pazopanib+gemcitabine significantly improved overall response rate (20% vs 11%; chi-square P=.023) and disease control rate (80% vs 60%; chi-square P<.001>
  • Grade ≥3 adverse event rate was higher with pazopanib+gemcitabine.
  • The most common toxicities were anemia, neutropenia, thrombocytopenia, elevation in AST, fatigue, and hypertension.
  • The pazopanib group showed a higher discontinuation rate (40% vs 14%).

Limitations

  • Open label.