Found 1 Presentation For Request "739P"
739P - Efficacy and safety of maintenance olaparib and bevacizumab (bev) in ovarian cancer (OC) patients (pts) aged ≥65 years (y) from the PAOLA-1/ENGOT-ov25 first-line trial
- Renaud Sabatier (Marseille, CEDEX 9, France)
Abstract
Background
The randomized phase III PAOLA-1 study (NCT02477644) showed that addition of olaparib to bev maintenance improved progression-free survival (PFS) in pts with advanced OC (Ray-Coquard
Methods
We collected clinical and molecular data from older pts (≥65 y). PFS in older pts was compared with younger pts (<65 y) and predictive factors explored. Safety was assessed in these subgroups.
Results
Of 806 randomized pts, 292 (36%) were ≥65 y (Table). Median age: older pts, 69 y (range 65–87 y); younger pts, 56 y (range 26–64 y). A lower proportion of older vs younger pts had an ECOG performance status of 0 (62% vs 75%), upfront surgery (39% vs 57%) and, of pts who had upfront surgery, a lower proportion had complete macroscopic resection (54% vs 62%). Older pts were less likely to have a ∗Including primary and interval debulking surgery; BRCA wt, BRCA wild type; CI, confidence interval; HR, hazard ratio; NE, not evaluable.
Subgroups Pts, n Olaparib + bev (N=537) Placebo + bev (N=269) ≥65 y 292 205 (38%) 87 (32%) <65 y 514 332 (62%) 182 (68%) ≥65 y 292 21.6 16.6 0.55 (0.41–0.75) <65 y 514 22.9 16.9 0.61 (0.49–0.77) HRD positive 104 NE 16.7 0.21 (0.12–0.39) BRCAm 51 NE 20.3 0.22 (0.07–0.62) HRD positive/BRCA wt 51 NE 16.5 0.23 (0.10–0.52) HRD negative 133 16.6 16.5 0.80 (0.52–1.25) Complete debulking surgery* 157 NE 18.8 0.43 (0.27–0.69) Residual disease after surgery or no surgery 135 16.6 11.4 0.67 (0.45–1.01)
Conclusions
Despite a lower rate of complete surgical debulking, older pts achieved a similar PFS benefit vs younger pts (including in the BRCAm and both HRD positive cohorts) when olaparib was added to first-line maintenance bev, with a comparable safety profile.
Clinical trial identification
NCT02477644.
Editorial acknowledgement
Editorial assistance was provided by Esmie Wescott, PhD, from Mudskipper Business Limited, funded by AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
AstraZeneca.
Funding
ARCAGY Research, AstraZeneca, Merck & Co., Inc. and Hoffmann-La Roche Ltd.
Disclosure
R. Sabatier: Financial Interests, Personal, Research Grant: ESAI and AstraZeneca; Financial Interests, Personal, Advisory Role: GSK, Pfizer, Roche and Novartis; Non-Financial Interests, Personal, Other: Pfizer, Roche, GSK, Novartis and AstraZeneca. F. Joly: Financial Interests, Personal, Invited Speaker, Advisory board: GSK, Clovis, AstraZeneca, Janssen, BMS, MSD, Astellas, Sanofi, Ipsen, Amgen; Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, Astellas; Non-Financial Interests, Personal, Leadership Role: GSK, Clovis, Janssen, BMS; Non-Financial Interests, Personal, Advisory Role: GSK, Clovis, Janssen, BMS. E.M. Guerra-Alia: Financial Interests, Personal, Advisory Role, advisory or consultancy honorarium: AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; Financial Interests, Personal, Expert Testimony: AstraZeneca, PharmaMar, Roche, GSK; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, PharmaMar, Roche, GSK; Financial Interests, Personal, Other, Travel grant: Roche, Tesaro, a GSK Company and Baxter. G. Bogner: Financial Interests, Personal, Advisory Role: AstraZeneca, Roche and GSK; Financial Interests, Personal, Funding, Medical conferences: AstraZeneca, Roche and GSK. I. Vergote: Financial Interests, Institutional, Advisory Role: Amgen, AstraZeneca, Clovis Oncology, Carrick Therapeutics, Deciphera Pharmaceuticals, Elevar Therapeutics, F Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Mersana, Millenium Pharmaceuticals, Merck, Novocure, Octimet Oncology NV, Oncoinvent AS, S; Financial Interests, Personal, Other, Research contract: Oncoinvent AS and Genmab; Financial Interests, Personal, Sponsor/Funding: Amgen and Roche; Financial Interests, Personal, Other, Travel grant: Amgen, Merck, Roche, AstraZeneca and Tesaro. N. Colombo: Financial Interests, Personal, Other, Honoraria: Roche/Genentech, AstraZeneca, Tesaro and PharmaMar; Financial Interests, Personal, Advisory Role: Roche/Genentech, PharmaMar, AstraZeneca, Clovis Oncology, Pfizer, Merck Oncology, Takeda, Tesaro, and BioCadand GSK. S. Hietanen: Financial Interests, Personal, Advisory Board: GSK and AstraZeneca. U. Canzler: Financial Interests, Personal, Invited Speaker, Honoraria: Lilly. F. Marmé: Financial Interests, Personal, Other, Honoraria/expenses: AstraZeneca, GSK/Tesaro, Clovis, MSD, Novartis, Pfizer, Lilly, Roche, Gilead/Immunomedics, Eisai, Celgene, GenicHealth and Myriad Genetics; Financial Interests, Personal, Advisory Board: AstraZeneca, GSK/Tesaro, Clovis, MSD, Novartis, Pfizer, Lilly, Roche, Gilead/Immunomedics, Amgen, Eisai, Celgene, PharmaMar, Janssen-Cilag, GenicHealth, Myriad Genetics and Seagen; Financial Interests, Personal, Research Grant: AstraZeneca, GSK/Tesaro, Clovis, MSD, Novartis, Pfizer, Roche, Gilead/Immunomedics, PharmaMar, GBG and AGO Studiengruppe. E. Pujade-Lauraine: Financial Interests, Personal, Other, Personal fees: AstraZeneca, Tesaro, Clovis, Roche, Incyte, and Pfizer; Non-Financial Interests, Personal, Other: AstraZeneca, Tesaro, and Roche; Financial Interests, Personal, Full or part-time Employment: ARCAGY Research. I.L. Ray-Coquard: Financial Interests, Personal, Other, Honoraria: Abbvie, Agenus, Advaxis, BMS, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche, GSK, MSD, Deciphera, Mersena, Merck Sereno, Novartis, Amgen, Tesaro and Clovis; Financial Interests, Institutional, Other, Honoraria: GSK, MSD, Roche and BMS; Financial Interests, Personal, Advisory Role: Abbvie, Agenus, Advaxis, BMS, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche/Genentech, GSK, MSD, Deciphera, Mersena, Merck Sereno, Novartis, Amgen, Tesaro and Clovis; Financial Interests, Personal, Research Grant: MSD, Roche and BMS; Financial Interests, Institutional, Research Grant: MSD, Roche, BMS, Novartis, AstraZeneca and Merck Sereno; Financial Interests, Personal, Other, Travel grant: Roche and AstraZeneca and GSK. All other authors have declared no conflicts of interest.