Purpose
The non‐interventional, propective NIMES‐ROC phase IV study (NCT02825420) evaluated trabectedin plus pegylated liposomal doxorubicin (PLD) in real‐life clinical practice.
Patients and Methods
Eligible were adults with platinum‐sensitive recurrent ovarian cancer (PS‐ROC) who have received ≥1 cycle of trabectedin/PLD before inclusion according to the marketing authorization. The primary endpoint was progression‐free survival (PFS) according to investigator criteria.
Results
218 patients from five European countries were evaluated, 72.5% of whom were pre‐treated with ≥2 prior chemotherapy lines and received a median of 6 cycles of trabectedin/PLD (range: 1‐24). Median PFS was 9.46 months (95% confidence interval [CI]: 7.9‐10.9), whereas median overall survival (OS) was 23.56 months (95% CI: 18.1‐34.1). Patients not pretreated with an antiangiogenic drug obtained larger median PFS (p<0.007) and OS (p<0.048), largely owning to differences between the two populations. Twenty‐four patients (11.0%) had a complete response and 57 patients (26.1%) achieved a partial response for an objective response rate (ORR) of 37.2%. 59 patients (27.1%) had disease stabilization for a disease control rate of 64.2%. No statistically significant difference in PFS, OS and ORR was observed by BRCA1/2 status and platinum sensitivity. Most common grade 3/4 adverse events (AEs) were neutropenia (30.3%), anemia (6.4%), thrombocytopenia (5.5%) and asthenia (5.0%). No deaths attributed to treatment‐related AEs or unexpected AEs occurred.
Conclusion
The combination of trabectedin/PLD represents clinically meaningful and safe option for patients with PS‐ROC regardless of prior treatment with an antiangiogenic drug, being comparable with previously observed outcomes in selected and less pre‐treated patients from clinical trials.