The OVA-YOND prospective non-interventional phase IV study evaluated trabectedin plus PLD in real-life clinical practice to assess the toxicity and efficacy of the combination when given in accordance with the marketing authorization to women with PSROC.
Data from patients treated with PLD 30 mg/m2 and immediately followed by trabectedin 1.1 mg/m2 3-h i.v. infusion every 3 weeks have been collected.
From 02/2013 to 12/2016, 77 enrolled patients from 31 sites across Germany who received at least one cycle of trabectedin plus PLD were evaluated. All patients had a platinum-sensitive relapse with a median platinum-free interval of 12 months (range: 6-86 months). Median age of patients was 66 years (range: 40-78) and 80.5% had ECOG performance status 0/1. Serous carcinoma was the most prevalent histological type (n = 54; 70.1%), tumor was localized at the ovary in 88.3% of patients and 38 patients (49.4%) were diagnosed with FIGO IIIC stage. Median number of trabectedin plus PLD cycles received per patient was 6, with 39 patients (50.6%) receiving ≥6 cycles and up to a maximum of 21 cycles. Median treatment duration was 4.24 months, mostly on an outpatient basis (≥66.7-100% of cases). Five patients (6.5%) had a complete response and 19 patients (24.7%) achieved a partial response for an ORR of 31.2% with a median duration of 6.25 months. Additionally, 16 patients (20.8%) had disease stabilization for a disease control rate of 51.9%. With 64 PFS events recorded, median PFS was 6.3 months (CI95%: 5.1-7.3) and median OS was 16.4 months (CI95%: 11.3-19.3). A total of 278 trabectedin-related adverse events (TRAE) occurred in 57.1% of the patients who recovered in 70.9% cases. Most common grade 3/4 TRAE were leukopenia (18.2% of patients), neutropenia (15.6%), thrombocytopenia (9.1%), ALT (7.8%) and AST (6.5%) increase, and nausea/vomiting (5.2% each). No grade 5 or unexpected TRAE occurred.
Trabectedin plus PLD confer clinically meaningful benefit to patients with PSROC, being either comparable or better to those previously observed in selected population from clinical trials or other real-life studies, and with a manageable safety profile.
Clinical trial identification
Legal entity responsible for the study
P. Wimberger: Honoraria for scientific talks from Pharma Mar. All other authors have declared no conflicts of interest.