Abstract 746P
Background
PARP inhibitors (PARPi) demonstrated improvement in progression-free survival (PFS) following first-line (1L) platinum-based chemotherapy (Pt-CT) for advanced ovarian carcinoma (OC) patients (pts). Here we describe real-world clinical outcomes in pts with de novo high-grade epithelial OC (HGEOC) eligible for niraparib per EMEA approval (PRIMA trial).
Methods
Data were extracted from the Epidemio-Strategy and Medical Economics (ESME) OC Data Platform (NCT03275298), a centralized deidentified structured database derived from electronic health records of consecutive pts managed at one of the 18 French comprehensive cancer centres since 2011. All pts with de novo FIGO stage III/IV HGEOC diagnosed in 2015-2017, with a documented response to a 1L Pt-CT were eligible. Survival endpoints were estimated since the first CT cycle using the Kaplan-Meier method.
Results
Of 10,263 OC cases in the ESME OC cohort, 488 pts with a median follow-up of 36 months were analysed. Median age was 65 years (q1-q3: 58-70), 335 pts (69%) had a FIGO stage III, 418 pts (86%) had a debulking surgery in 1L and 178 pts (36%) received bevacizumab in 1L induction. BRCA deleterious mutations were present in 72/396 pts (18%). Overall 283 pts met the PRIMA inclusion criteria defined by a FIGO stage III/IV (excluding stage III upfront CC0 cytoreductive surgery) HGEOC pts not receiving bevacizumab in L1 maintenance. In these 283 pts, 72% received neoadjuvant CT. Median PFS since first CT cycle was 15.5 months (95% CI: 14.5-16.5), comparable to the control arm of PRIMA when considering the difference in the PFS definition (from first CT versus from randomization). Median PFS in the BRCA-mutated and BRCA-wild type subsets were 19.1 (95% CI: 15.9-25.0) and 15.2 (95% CI: 14.3-17.0) months, respectively. Estimated 36-month overall survival rate was 65.6% (95% CI: 59.1-72.1).
Conclusions
Analyses of large real-world cohorts with structured data such as the French ESME OC database are powerful tools to confirm clinical outcomes in HGEOC pts. Our results are in line with those reported in clinical trials for de novo HGEOC pts with a documented response to a 1L Pt-CT without maintenance therapy (bevacizumab or PARPi).
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Unicancer.
Funding
The ESME Ovarian Cancer database is supported by an industrial consortium (AstraZeneca and GlaxoSmithKline). Data collection, analyses and publications are totally managed by Unicancer independently of the industrial consortium.
Disclosure
M. Rodrigues: Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Product Samples: MSD; Financial Interests, Sponsor/Funding: BMS. I.L. Ray-Coquard: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Advisory Role: Roche. J. Classe: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Pharmamar. T. De La Motte Rouge: Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Tesaro-GSK; Financial Interests, Personal, Other: Clovis oncology; Financial Interests, Personal, Other: Mylan. P. Colombo: Financial Interests, Personal, Advisory Role: Tesaro; Financial Interests, Personal, Advisory Role: AstraZeneca. C. Pomel: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Expert Testimony: GSK; Financial Interests, Personal, Expert Testimony: Clovis; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Roche. T. Petit: Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Expert Testimony: Lilly; Financial Interests, Personal, Expert Testimony: Pfizer; Financial Interests, Personal, Expert Testimony: Mylan; Financial Interests, Personal, Expert Testimony: Daiichi; Financial Interests, Personal, Expert Testimony: Pierre Fabre Oncology. L. Gladieff: Financial Interests, Personal, Expert Testimony: GSK; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Sponsor/Funding: Clovis Oncology; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Sponsor/Funding: MSD. All other authors have declared no conflicts of interest.