Real-world survival of men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with abiraterone acetate (Abi) or docetaxel (Doc) and comparison with clinical trial outcomes.

Authors

Daniel Geynisman

Daniel M. Geynisman

Fox Chase Cancer Center, Philadelphia, PA

Daniel M. Geynisman , Andres F Correa , Chethan Ramamurthy , J Robert Beck , Elizabeth A. Handorf

Organizations

Fox Chase Cancer Center, Philadelphia, PA, Mays Cancer Center, Philadelphia, PA

Research Funding

No funding received
None

Background: Multiple phase III trials have proven that Abi and Doc both improve overall survival (OS) in men with mHSPC. No randomized trials have compared the two approaches. Methods: We conducted a retrospective, observational study to compare OS in de novo M1 men, treated with Abi vs. Doc using patient-level data from the Flatiron health EHR-derived de-identified database. We also compared this real-world OS to trial level data using extracted data points along the OS curves from CHAARTED and LATITUDE trials. OS was compared via Kaplan-Meier curves. Analyses were adjusted via propensity score weighting for age, Gleason score, PSA at diagnosis, race, ethnicity, ECOG PS, insurance type and treatment setting. Results: The cohort included 418 Abi pts and 807 Doc pts (Table). Median follow-up was 13.5 mo for Abi and 31.6 mo for Doc. Unadjusted median OS for Abi and Doc were 31.6 mo (95% CI 28.1-NA) and 41.8 mo (95% CI 37.4-46.3) respectively (P=0.09). Twelve mo and 24 mo OS for Abi was 86.3% and 69%; for Doc it was 89.8% and 72.1 %. Median adjusted OS for Abi and Doc were 31.6 mo (95% CI 28.0-undefined) and 38.8 mo (95% CI 33.1-46.3) respectively (P=0.4). Twelve mo and 24 mo adjusted OS for Abi was 86.6% and 69.4%; for Doc it was 87.9% and 69.2%. Based on extracted trial data, in LATITUDE, Abi treated pts had 12 mo and 24 mo OS of 93.5% and 77.0%; in CHAARTED, Doc treated pts had 12 mo and 24 mo OS of 94.3% and 83.6%. Conclusions: Utilizing real-world data, we demonstrate that 12 and 24-months OS are clinically and statistically similar between Abi and Doc in men with mHSPC. Median OS is also similar, although due to limited follow-up, the estimate of median OS for Abi has large variability. In addition, we show that clinical trial pts had superior outcomes to those in a real-world clinic population. Recent meta-analyses of trial data have not found significant differences in OS for Abi vs. Doc; this analysis of real-world data confirms these findings and indicates that they may be generalizable to a broader patient population. Although this observational study is subject to residual confounding and missing data, it provides further evidence to support the use of both Abi and Doc in men with mHSPC. Differentiating costs, side-effects and QOL can thus become more prominent when making decisions about therapy.

Patient characteristics.

Abiraterone (N=418)Docetaxel (N=807)p value
Gleason Score<824 (5.7%)39 (4.8%)0.262
855 (13.2%)135 (16.7%)
9-10191 (45.7%)378 (46.8%)
Age at metastatic diagnosisMean (SD)71.354 (8.777)65.670 (8.718)< 0.001
Practice TypeACADEMIC69 (16.5%)53 (6.6%)< 0.001
COMMUNITY349 (83.5%)754 (93.4%)
M-StageM1a/M1NOS275 (65.8%)564 (69.9%)0.028
M1b104 (24.9%)150 (18.6%)
M1c39 (9.3%)93 (11.5%)

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

2021 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Prostate Cancer - Advanced Disease

Track

Prostate Cancer - Advanced

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 39, 2021 (suppl 6; abstr 53)

DOI

10.1200/JCO.2021.39.6_suppl.53

Abstract #

53

Poster Bd #

Online Only

Abstract Disclosures

Similar Abstracts

First Author: Neal D. Shore

Abstract

2024 ASCO Genitourinary Cancers Symposium

Cost-effectiveness of triplet therapies in metastatic hormone-sensitive prostate cancer used in PEACE-1 and ARASENS.

First Author: Nataniel Hernan Lester-Coll