Real-world effectiveness of first-line maintenance olaparib in women with BRCA-mutated advanced ovarian cancer: U.S. retrospective cohort study.

Authors

Ramez Eskander

Ramez Nassef Eskander

UC San Diego Moores Cancer Center, San Diego, CA

Ramez Nassef Eskander , Naufil Alam , Grainne H. Long , Ozan Ozgoren , Will Ambler , Stephanie Volpe , Kathleen N. Moore

Organizations

UC San Diego Moores Cancer Center, San Diego, CA, AstraZeneca Pharmaceuticals LP, Cambridge, United Kingdom, Astra Zeneca Turkey, Istanbul, Turkey, Adelphi Real World, Bollington, United Kingdom, AstraZeneca, Cambridge, United Kingdom, Division of Obstetrics and Gynecology, Department of Gynecologic Oncology, University of Oklahoma Health Science Center, Stephenson Cancer Center, Oklahoma City, OK

Research Funding

Pharmaceutical/Biotech Company

Background: Following cytoreductive surgery and first-line (1L) platinum based chemotherapy, 70% of patients (pts) with newly diagnosed advanced ovarian cancer (AOC) experience relapse within 3 years. 1L maintenance treatment (tx) with olaparib monotherapy, a poly (ADP-ribose) polymerase inhibitor, extended progression free survival in pts with BRCA mutated (BRCAm) AOC in the SOLO-1 (NCT01844986) randomized controlled trial (RCT). We aimed to describe real world characteristics, tx patterns, and clinical outcomes of pts with newly diagnosed, BRCAm AOC. Methods: Data were collected from 457 pts via electronic case report forms in the US. Pt eligibility criteria were positive BRCAm test result between Jan-June 2019 (6 months post 1L olaparib FDA approval), newly diagnosed AOC (no maintenance tx prior to index), aged ≥18 years, no RCT enrollment, no active neoplasia, no prior tx for metastatic/stage IV cancer. Pt follow up was until July 2021. Kaplan-Meier (KM) estimation was used for time to event analysis using progression proxies: Time to subsequent therapy and discontinuation (or death for both) from initiation of 1L maintenance olaparib monotherapy. Results: Pt mean age (±SD) at index was 62 (±10) years, 64% of pts were white and 18% African American; further clinical characteristics are in the table. 95% of pts received ≥1 pharmacological tx. At 1L, 36% of pts (156/433) received maintenance tx after chemotherapy, with 64% of pts (277/433) receiving routine surveillance (no maintenance tx). Olaparib was the most common maintenance tx (67%, 105/156), with 67% of pts (70/105) prescribed olaparib monotherapy. At 24 months, the KM model estimated 91% of pts (95% confidence interval: 82, 96) would not progress to their subsequent therapy, with a median discontinuation of olaparib monotherapy of 25.0 (interquartile range [IQR]: 21.0, not estimable) months, over a median follow-up of 22.0 (IQR: 20.6, 24.0) months. Conclusions: This real world study complements SOLO-1 RCT data by demonstrating prolonged benefit of 1L olaparib in newly diagnosed pts with BRCAm AOC in terms of lower likelihood of progression (tx switch/death). To assess real world tx effectiveness globally, data collection across further eight countries is due to be completed in 2022.

Selected clinical characteristics of pts with newly diagnosed BRCAm AOC.

Base
Olaparib monotherapy
Any olaparib
Routine surveillance
n=457
n=70
n=105
n=277
Stage at AOC diagnosis, n (%)
Stage III
258 (56)
48 (69)
61 (58)
142 (51)
Stage IV (a and b)
199 (44)
22 (31)
44 (42)
135 (49)
ECOG score at AOC diagnosis, n (%)
0
99 (22)
23 (33)
38 (36)
51 (18)
1
259 (57)
42 (60)
57 (54)
163 (59)
2+
99 (22)
5 (7)
10 (10)
63 (23)
Surgery status, n (%)
No surgery
157 (34)
12 (17)
19 (18)
117 (42)
At least 1 surgery
300 (66)
58 (83)
86 (82)
160 (58)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 5518)

DOI

10.1200/JCO.2022.40.16_suppl.5518

Abstract #

5518

Poster Bd #

397

Abstract Disclosures