Eric Pujade-Lauraine, Anne Floquet, Jørn Herrstedt, Domenica Lorusso, Claire Falandry, Laurence Gladieff, F.l. De Piano, Fanny Pommeret, Fabien Tinquaut, Gilles Freyer, M.A. Mouret Reynier, S Abadie Lacourtoisie, Olivier Tredan, Laetitia Stefani, J-S. Frenel, Pierre-Emmanuel Brachet, D. Mollon-Grange, Frédérique Rousseau, T. Warkus, and Véronique D'Hondt
Background The GINECO previously developed the GVS to identify geriatric vulnerability in oOC pts (Falandry, 2013). The derivation cohort was EWOT-3 database of 111 oOC pts treated with first line carboplatin. The GVS combines albumin (≥ or Methods Pts ≥70 yrs diagnosed with FIGO stage III/IV epithelial OC and no organ failure were screened for GVS. Those with GVS≥3 were proposed EWOC-1 randomized trial, evaluating 3 treatment regimens in the vulnerable pts. Other pts’ data were collected in the “EWOC-1 registry”. External validation of GVS was performed in the whole population (V1), in the EWOC-1 registry subgroup (V2), and in the subgroup of pts treated with carboplatin paclitaxel regimens (V3). Cross-validation analyses (calibration, discrimination, and performance analysis) were performed according current recommendations (Steyerber, 2014). Results From 12/2013 to 11/2018, 447 elderly patients were included, 120 (27%) in EWOC-1 trial and 327 in EWOC-1 registry (V1: n = 447, V2: n = 327, V3: n = 324). Patients’ cancer characteristics were similar in the validation cohorts compared to the derivation one. Median follow up was 22 mo; missing values were limited ( Conclusions GVS provides a reproducible and robust prediction model of vulnerability in oOC pts, independent of geographic and historic effect (V1), as well as treatment patterns (V3), validated on an international population. Clinical trial identification PROTOCOL EWOC-1 - ENGOT OV-23 - 2013-000266-11. Legal entity responsible for the study Centre Hospitalier Lyon Sud. Funding Hospital Clinical Research Program (PHRC). Disclosure D. Lorusso: Honoraria (self), Honoraria (institution), Advisory / Consultancy: MERCK; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self): Clovis; Advisory / Consultancy: Immunogen; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Licensing / Royalties, Full / Part-time employment: PharmaMar; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Licensing / Royalties, Full / Part-time employment: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Licensing / Royalties, Full / Part-time employment: Tesaro; Officer / Board of Directors, Spouse / Financial dependant, Non-remunerated activity/ies: GCIG. A. Floquet: Advisory / Consultancy: Clovis; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: Roche. O. Tredan: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Lilly; Honoraria (self): BMS; Honoraria (self): MSD. E. Pujade-Lauraine: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder /: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Licensing / Royalties, Full: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self): Clovis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time e: Tesaro; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self): Genmab; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self): Incyte; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self): MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony, Leadership role, Research grant / Funding (self): Pfizer. C. Falandry: Honoraria (self): Leo Pharma; Honoraria (self), Honoraria (institution): Pfizer; Honoraria (self): MSD oncology; Honoraria (self): Teva; Honoraria (self): AstraZeneca; Honoraria (self): Baxter; Honoraria (self): Eisai; Honoraria (self): Janssen; Honoraria (self): Novartis; Honoraria (institution): Chugai Pharma; Honoraria (institution): Pierre Fabre; Honoraria (institution): Astellas Pharma. All other authors have declared no conflicts of interest.