Nintedanib in combination with carboplatin and paclitaxel is an active first-line treatment that significantly improves progression-free survival for women with advanced ovarian cancer, according to a new study published online ahead of print in the journal The Lancet Oncology. However, the regimen is associated with more gastrointestinal adverse events.1
For the double-blind, phase 3 trial, researchers enrolled 1366 chemotherapy-naïve patients with stage 2B to 4 ovarian cancer who underwent upfront debulking surgery.
Patients were randomly assigned 2:1 to receive 6 cycles of carboplatin AUC 5 or 6 mg/mL per minute plus paclitaxel 175 mg/m2 with nintedanib 200 mg or placebo twice daily on days 2 to 21 of every 3-week cycle for up to 120 weeks.
Results showed that median progression-free survival was 17.2 months (95% CI, 16.6 – 19.9) in the nintedanib group compared with 16.6 months (95% CI, 13.9 – 19.1) in the placebo group (HR, 0.84; 95% CI, 0.72 – 0.98; P = .024). A total of 53% of patients in the nintedanib group experienced disease progression or death vs 58% of those in the placebo group.
In regard to safety, grade 3 to 4 diarrhea was experienced by nearly 22% of patients in the nintedanib arm compared with 2% of those in the placebo arm.
Other common adverse events were neutropenia, thrombocytopenia, and anemia. Of note, 3 patients in the nintedanib and 1 in the placebo group died to due to drug-related adverse events.
“Future studies should focus on improving patient selection and optimization tolerability,” the authors concluded.
- du Bois A, Kristensen G, Ray-Coquard I, et al. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial [published online ahead of print on November 15, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00366-6.