Abstract 734P
Background
Identifying prognostic biomarkers of Olaparib (OLA) plus PLD efficacy is relevant to optimize the clinical benefit of this therapy in PROC pts. Neutrophil/lymphocyte (NLR), Lymphocyte/monocyte (LMR) and Platelet/lymphocyte (PLR) ratios have been identified as prognostic factors for survival but evidence at PROC is scarce.
Methods
ROLANDO is a single arm phase II trial that enrolled pts with high-grade serous or endometrioid and at least one previous PROC recurrence regardless of BRCA status. Pts received 6 cycles of PLD every 28 days + OLA 300 mg b.i.d. followed by OLA 300 mg b.i.d. monotherapy until progression or unacceptable toxicity. The objective of this study was to identify prognostic factors of overall survival (OS) in the cohort of PROC patients prospectively included in the ROLANDO trial. Prognostic factors analysed were the total number of previous and platinum-containing lines, BRCA mutation status, previous bevacizumab, CA 125 levels, and the ratios NLR, LMR and PLR calculated at inclusion. Logistic regression and COX models were used post hoc to analyze the association of baseline characteristics with treatment and disease outcomes. Cut-off points for stratified analysis were validated in previous reports.
Results
From 2017 to 2020, 31 PROC pts were included. Median age was 57-y , ECOG 0/1: 32.3%/67.7% and BRCA mutated: 16.1%. Prior treatment lines were >2 lines 14 (45.2%) pts, ≥ 2 platinum lines 21 (67.7%) and previous bevacizumab 19 (61.3%). CA-125 was > 2 Upper limit normal (ULN) in 24 (77.4%) pts. Baseline lab. blood counts were used to calculate NLR, LMR and PLR ratios, with NLR ≥ 2 and LMR < 4 in 20 (65%) pts and PLR ≥ 125 in 18 (58%). NLR and number of previous lines were the only significantly associated factors with OS by Cox Model at univariate (p=0.023 for NLR and p=0.024 for number of previous lines). In the multivariate analysis, depressed levels of NLR were the only independent factor showing a strong association with higher OS (HR 11.18; 95%CI: 1.1-114.5; p=0.042).
Conclusions
NLR <2 performed at PROC relapse correlates with higher OS in pts treated with OLA plus PLD in our series.
Clinical trial identification
EudraCT 2016-004850-14, NCT03161132.
Editorial acknowledgement
We acknowledge the assistance in the confection of this communication to MFAR Clinical Research Team.
Legal entity responsible for the study
Grupo Español de Investigación en Cáncer de Ovario (GEICO).
Funding
AstraZeneca.
Disclosure
J.A. Perez Fidalgo: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: PharmaMar; Financial Interests, Personal, Advisory Role: Clovis; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Ability Pharma; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: GSK; Financial Interests, Personal, Speaker’s Bureau: PharmaMar; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Personal, Expert Testimony: Samsung Bioepis; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: AstraZeneca. Y. García: Financial Interests, Personal, Other, Advisory, Speakers bureau: Roche; Financial Interests, Personal, Other, Advisory, Speakers bureau: AstraZeneca; Financial Interests, Personal, Other, Advisory, Speakers bureau: GSK-Tesaro; Financial Interests, Personal, Advisory Role: Clovis; Other, Personal, Other, Travel expenses and CME activities fees: Roche; Other, Personal, Other, Travel expenses and CME activities fees: AstraZeneca; Other, Personal, Other, Travel expenses and CME activities fees: GSK-Tesaro; Other, Personal, Other, Travel expenses and CME activities fees: Clovis. A. Oaknin: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: Inmunogen; Financial Interests, Personal, Advisory Board: Genmab; Financial Interests, Personal, Advisory Board: Mersana Therapeutic; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Deciphera Pharmaceutical; Financial Interests, Personal, Other, Travel or accomodation support: Roche; Financial Interests, Personal, Other, Travel or accomodation support: AstraZeneca; Financial Interests, Personal, Other, Travel or accomodation support: PharmaMar; Financial Interests, Institutional, Other: Abbvie Deutshland; Financial Interests, Institutional, Other: Ability Pharmaceuticals; Financial Interests, Institutional, Other: Advaxis Inc; Financial Interests, Institutional, Other: Aeterna Zentaris; Financial Interests, Institutional, Other: Amgen; Financial Interests, Institutional, Other: Aprea Therapeutics AB; Financial Interests, Institutional, Other: Clovis Oncology Inc; Financial Interests, Institutional, Other: Eisai Limited Ltd; Financial Interests, Institutional, Other: F. Hoffmann - La Roche Ltd; Financial Interests, Institutional, Other: Regeneron Pharmaceuticals; Financial Interests, Institutional, Other: Immunogen Inc; Financial Interests, Institutional, Other: Merck, Sharp & Dohme de España SA; Financial Interests, Institutional, Other: Millennium Pharmaceuticals Inc; Financial Interests, Institutional, Other: PharmaMar SA; Financial Interests, Institutional, Other: Tesaro Inc; Financial Interests, Institutional, Other: BMS, Bristrol Meyers Squibb. A. Redondo: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Clovis; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: PharmaMar; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Speaker’s Bureau: GSK; Financial Interests, Personal, Speaker’s Bureau: PharmaMar; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Personal, Other, Travel/Accomodations/Expenses: Roche; Financial Interests, Personal, Other, Travel/Accomodations/Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel/Accomodations/Expenses: Tesaro (GSK). All other authors have declared no conflicts of interest.