A Randomized, Double-Blind Phase 3 Trial of Maintenance Therapy With Niraparib vs Placebo in Patients With Platinum-Sensitive Recurrent Ovarian Cancer (ENGOT-OV16/NOVA Trial)

Improving the response rate to neoadjuvant chemotherapy by adding antiangiogenic therapy could increase the rate of complete resection at interval debulking surgery. However, the use of bevacizumab raises concerns regarding wound healing. The phase 2 CHIVA study (Vargatef in Addition to First Line Chemotherapy With Interval De bulking Surgery in Patients With Ovarian Cancer) evaluated the safety and effcacy of nintedanib, an oral antiangiogenic tyrosine kinase inhibitor with a short half-life (Abstract 859PD). The trial enrolled patients with International Federation of Gynecology and Obstetrics stage IIIC to IV cancer of the ovary, fallopian tube, or primary peritoneum. Patients were randomized 2: 1 to receive nintedanib or placebo in addition to chemotherapy before and after interval debulking surgery. All patients received 3 cycles of neoadjuvant chemotherapy before interval debulking surgery and 3 cycles of chemotherapy after. There were 72 patients in the nintedanib arm and 49 in the placebo arm. The majority of patients had serous/papillary disease of histologic grade 3. The rates of complications during surgery were 13% in patients receiving nintedanib vs 18% in those receiving placebo. The addition of nintedanib to neoadjuvant chemotherapy did not increase the rate of postoperative complications. In the placebo vs nintedanib cohorts, rates of grade 1/2 AEs were 52% vs 54%, respectively, and rates of grade 3/4 AEs were 18% vs 13%.