Bayer HealthCare, Whippany, NJ
Nasreen Khan , Rana R. McKay , Daniel Eidelberg Spratt , Niculae Constantinovici , Guifang Chen , Jorge A. Ortiz , Shankar Srinivasan , Zdravko Vassilev , Julie Xu , Neal D. Shore
Background: RP is often the primary treatment option for pts with clinically localized PC. Despite its frequent success, more than 30% of pts eventually present with BCR, defined as detectable prostate-specific antigen (PSA) after RP. BCR is associated with a higher risk of developing distant metastasis and ultimately death. Current patterns of BCR and the impact of BCR on treatment choice and clinical outcomes are not well characterized. Methods: This retrospective cohort study uses nationally representative Optum© Electronic Medical Records (EMR) data from 1/2010 to 9/2021. Eligible pts were adults who underwent RP after PC diagnosis, had ≥ 3 available PSA values after RP, and had EMR activity for at least 6 mo before and 12 mo after RP. Pts with prior malignancy except nonmelanoma skin cancers and pts with metastatic PC at baseline (BL) or within 3 months after RP were excluded. The BL period was 6 mo before RP. Primary outcome was frequency of BCR (defined as PSA ≥ 0.2 ng/mL); secondary analyses included % of pts who progressed to metastasis, castration-resistant PC (CRPC), and death after BCR, and factors associated with time to BCR. Results: 15,198 pts who underwent RP were included in this analysis. Key pt characteristics/outcomes are shown in the Table. Median (range) age was 63.0 (36-88) y, 85.9% of pts were White, and 10.0% were African American. Median (Q1-Q3) follow-up was 3.9 (2.4-5.7) y, and 14.3% of pts had subsequent adjuvant/salvage radiation therapy (RT). Overall, 19.8% of all pts and 61.4% of the subgroup of 2,178 pts with subsequent RT developed BCR. Among pts with BCR (n = 3,016), 16.3% had a PSA doubling time ≤ 10 mo, 17.1% developed metastasis, 13.8% developed CRPC, and 9.7% died. In multivariate Cox regression models (Table), the BL factors associated with an increased risk of developing BCR were PSA 10- < 20 or ≥ 20 ng/mL, Charlson comorbidity index (CCI) > 0, age ≥ 65, African American race, public insurance, and living in the US South region. Conclusions: This real-world (RW) study evaluates the occurrence of BCR in pts who underwent RP with a curative intent from a large US database. This study confirms BL PSA as an important prognostic marker for BCR. A considerable % of pts with BCR developed metastatic PC (17%) or died (10%) during the study period. Novel treatment strategies are needed to delay BCR and further progression to advanced PC among pts with high-risk localized disease.
Pts with RP (n = 15,198) | |
---|---|
PSA in last 12 mo, median (Q1-Q3), ng/mL (n = 12,181) | 6.1 (4.6-8.8) |
Select factors impacting time to BCR (Cox regression model), HR (95% CI) (reference groups in footnotes) | |
BL PSA ≥ 20 ng/mL* | 3.99 (3.39-4.69) |
US South† | 1.29 (1.16-1.42) |
CCI 1‡ | 1.20 (1.10-1.31) |
Public health insurance§ | 1.18 (1.05-1.32) |
Age 55-64¶ | 0.74 (0.68-0.81) |
*BL PSA 0- < 4. †US Midwest. ‡CCI 0. §Commercial health insurance. ¶Age ≥65.
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