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. 2023 Dec;41(12):3535-3542.
doi: 10.1007/s00345-023-04680-w. Epub 2023 Nov 15.

A US real-world study of treatment patterns and outcomes in localized or locally advanced prostate cancer patients

Stephen J Freedland  1   2 , Sandhya Nair  3 , Xiwu Lin  4 , Lawrence Karsh  5 , Christopher Pieczonka  6 , Ravi Potluri  7 , Sabine D Brookman-May  8   9 , Suneel D Mundle  10 , Sarah Fleming  11 , Neeraj Agarwal  12
Affiliations

A US real-world study of treatment patterns and outcomes in localized or locally advanced prostate cancer patients

Stephen J Freedland et al. World J Urol. 2023 Dec.

Abstract

Purpose: Men with localized or locally advanced prostate cancer (LPC/LAPC) are at risk of progression after radiotherapy (RT) or radical prostatectomy (RP). Using real-world data, we evaluated patient characteristics, treatment patterns, and outcomes in LPC/LAPC.

Methods: Optum claims and electronic health records (EHR) data from January 2010 to December 2021 were queried for men with LPC/LAPC who received primary RT, RP, or androgen deprivation therapy alone within 180 days after diagnosis. Survival outcomes were analyzed using descriptive statistics and Kaplan-Meier curves. Real-world overall survival (rwOS) was compared in patients with and without evidence of disease (i.e., disease recurrence, metastasis, diagnosis of castration-resistant PC) at defined time points.

Results: 61,772 and 62,361 men in claims and EHR cohorts met the inclusion criteria. Median follow-up was 719 and 901 days, respectively. Most men received primary RT (51.0% claims, 35.0% EHR) or RP (39.4% claims, 53.8% EHR). Survival was greatest among men treated with RP, followed by RT. Adjusted for age and comorbidity, rwOS was shorter among men with evidence of disease within 1, 3, 4, and 5 years after primary treatment than those without at the same time points.

Conclusion: Real-world claims and EHR data show that survival among men with LPC/LAPC differs by primary treatment and time point of disease recurrence thereafter. Poor outcomes in men with LPC/LAPC who progress early indicate an unmet medical need for more effective primary treatment. If validated for surrogacy, no evidence of disease at specific time points could represent an intermediate efficacy endpoint in future trials.

Keywords: Androgen deprivation therapy; Disease trajectories; Prostate cancer; Prostatectomy; Radiotherapy; Survival outcomes.

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Conflict of interest statement

Stephen Freedland has had consulting or advisory roles for Astellas Pharma, AstraZeneca, Janssen Biotech, Bayer, Pfizer, Sanofi, Myovant Sciences, Merck, and Exact Sciences; has received compensation for travel from Sanofi; and has had speakers bureau role for Sanofi and AstraZeneca. Sandhya Nair has employment from Janssen Research & Development. Xiwu Lin has employment from Janssen Research & Development, and has stock and ownership interests in Johnson & Johnson. Lawrence Karsh has had consulting or advisory roles for Astellas, AstraZeneca, Bayer, Dendreon, Ferring, Janssen, Merck, Pfizer, Sanofi and Daiichi-Sankyo; has had speakers bureau roles for Astellas, AstraZeneca, Bayer, Dendreon, Janssen, Merck, Myovant, and Pfizer; has stock and ownership interests in Swan Valley Medical; and receives research funding to his institution from Astellas, Bayer, Bristol Myers Squibb, Dendreon, FKD, Janssen, KDx, Myovant, Oncocell, Pfizer, and Tavanta. Christopher Pieczonka has employment from Associated Medical Professionals of New York; has had consulting or advisory roles for Pfizer/Astellas, Bayer, Janssen Oncology, Tolmar, Sun Pharma, Dendreon, AstraZeneca, Merck, and Bristol Myers Squibb; has a leadership role for Associated Medical Professionals of New York; has had speakers bureau roles for Bayer, Dendreon, Pfizer, Astellas Pharma, Sun Pharma, Myovant Sciences, Janssen Oncology, and Foundation Medicine; has stock and ownership interests in US Urology Partners; has received honoraria from Janssen, Dendreon, Pfizer, Astellas, Bayer, Sun Pharma, Myovant Sciences, Merck, AstraZeneca, and Bristol Myers Squibb; and has received research funding from Bayer, Pfizer, Astellas Pharma, Merck, AstraZeneca, Advantagene, Dendreon, and Janssen Oncology. Ravi Potluri reports institutional consulting fees received by his employer Putnam Associates. Sabine D. Brookman-May has employment from Janssen Research & Development; has a leadership role at Janssen Research & Development; has stock and ownership interests in Johnson & Johnson; and has a consulting role for Wellster Healthtech. Suneel Mundle has employment from Janssen Research & Development. Neeraj Agarwal has received consulting fees from Astellas, AstraZeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics, and Seattle Genetics over his lifetime; and his institution has received payment (for clinical trials) from Arnivas, Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Crispr, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, Glaxo Smith Kline, Immunomedics, Janssen, Lava, Medivation, Merck, Nektar, Neoleukin, New Link Genetics, Novartis, Oric, Pfizer, Prometheus, Rexahn, Roche, Sanofi, Seattle Genetics, Takeda, and Tracon. Sarah Fleming has employment from Janssen Research & Development; and has stock and ownership interests in Johnson & Johnson.

Figures

Fig. 1
Fig. 1
Real-world survival outcomes, rwOS (a), rwPFS (b), rwEFS (c), and rwMFS (d), among men with LPC/LAPC identified from claims data following primary treatment. 95% confidence intervals shown in shading around plotted lines. ADT androgen deprivation therapy, CI confidence interval, rwEFS real-world event-free survival, rwMFS real-world metastasis-free survival, rwOS real-world overall survival; rwPFS real-world progression-free survival; EHR electronic health records, LAPC locally advanced prostate cancer, LPC localized prostate cancer, RP radical prostatectomy, RT radiotherapy
Fig. 2
Fig. 2
Real-world survival outcomes, rwOS (a), rwPFS (b), rwEFS (c), and rwMFS (d), among men with LPC/LAPC identified from EHR data following primary treatment. 95% confidence intervals shown in shading around plotted lines. ADT androgen deprivation therapy, CI confidence interval, rwEFS real-world event-free survival, rwMFS real-world metastasis-free survival, rwOS real-world overall survival; rwPFS real-world progression-free survival; EHR electronic health records, LAPC locally advanced prostate cancer, LPC localized prostate cancer, RP radical prostatectomy, RT radiotherapy
Fig. 3
Fig. 3
Real-world overall survival among men with LPC/LAPC identified from claims and EHR data with and without evidence of disease within 4 years of primary treatment using claims (a) and EHR (b) data. 95% confidence intervals shown in shading around plotted lines. CI confidence interval, EHR electronic health records, HR hazard ratio, LAPC locally advanced prostate cancer, LPC localized prostate cancer, rwOS real-world overall survival
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