- 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.
- 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.
- 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%).
- Open label.