Dataset Information

Adverse Pathologic Findings for Men Electing Immediate Radical Prostatectomy: Defining a Favorable Intermediate-Risk Group.

ABSTRACT:

Importance

Active surveillance is recommended for patients with very low-risk (VLR) and low-risk (LR) prostate cancer. Despite controversy, recent clinical guidelines state surveillance may be considered for men with low-volume intermediate-risk (LVIR) disease.

Objective

To compare rates of adverse pathologic findings among VLR, LR, and LVIR men electing immediate radical prostatectomy and evaluate criteria to define if a favorable intermediate-risk group minimizing risk exists.

Design, setting, and participants

This was a cohort study of men (2005-July 2016) with clinically localized VLR (1264 patients), LR (4849 patients), and LVIR (608 patients) (1-2 cores, Gleason 3?+?4?=?7, prostate-specific antigen [PSA] level <20 ng/mL) prostate cancer undergoing radical prostatectomy evaluated retrospectively at Johns Hopkins Hospital.

Interventions

Radical prostatectomy.

Main outcomes and measures

The proportions of men found to have at least Gleason 4?+?3?=?7 disease and other adverse pathologic features were compared by risk group. Log-binomial regression calculated relative risk (RR) of adverse pathologic findings in the LVIR cohort compared with VLR and LR cohorts. Analyses were repeated in subgroups of the LVIR population who otherwise met criteria for VLR (T1c, PSA density [PSAD] <0.15 ng/mL/cm3, ?50% cancer in any core) and LR (?T2a, PSA level <10 ng/mL) disease. Rates of adverse pathologic findings within the LVIR group were calculated based on various clinical thresholds, and univariable and multivariable logistic regression analyses were performed to identify predictors of adverse pathologic findings.

Results

The rate of adverse pathologic findings was significantly higher for LVIR disease (150 of 608 patients [24.7%]; RR, 4.50; 95% CI, 3.73-5.43; P?Conclusions and relevanceNearly 25% of men (150 of 608) electing immediate radical prostatectomy with low-volume, Gleason 3?+?4 prostate cancer on biopsy are found to harbor adverse surgical pathologic findings. These data do not support the presence of a "favorable" subgroup among included patients and could have important implications for active surveillance in similar patients with Gleason 3?+?4?=?7 prostate cancer.

SUBMITTER: Patel HD

PROVIDER: S-EPMC5833628 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adverse Pathologic Findings for Men Electing Immediate Radical Prostatectomy: Defining a Favorable Intermediate-Risk Group.

Patel Hiten D HD Tosoian Jeffrey J JJ Carter H Ballentine HB Epstein Jonathan I JI

JAMA oncology 20180101 1

<h4>Importance</h4>Active surveillance is recommended for patients with very low-risk (VLR) and low-risk (LR) prostate cancer. Despite controversy, recent clinical guidelines state surveillance may be considered for men with low-volume intermediate-risk (LVIR) disease.<h4>Objective</h4>To compare rates of adverse pathologic findings among VLR, LR, and LVIR men electing immediate radical prostatectomy and evaluate criteria to define if a favorable intermediate-risk group minimizing risk exists.<h ...[more]

PMID: 28715578

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Project description:BackgroundCurrent National Comprehensive Cancer Network guidelines recommend postoperative radiation therapy based only on adverse pathologic findings (APFs), irrespective of preoperative risk group. We assessed whether a model incorporating both the preoperative risk group and APFs could predict long-term oncologic outcomes better than a model based on APFs alone.MethodsWe retrospectively reviewed 4,404 men who underwent radical prostatectomy (RP) at our institution between 1992 and 2014. After excluding patients receiving neoadjuvant therapy or with incomplete pathological or follow-up data, 3,092 men were included in the final analysis. APFs were defined as extraprostatic extension (EPE), seminal vesicle invasion (SVI), or a positive surgical margin (PSM). The adequacy of model fit to the data was compared using the likelihood-ratio test between the models with and without risk groups, and model discrimination was compared with the concordance index (c-index) for predicting biochemical recurrence (BCR) and prostate cancer-specific mortality (PCSM). We performed multivariate Cox proportional hazard model and competing risk regression analyses to identify predictors of BCR and PCSM in the total patient group and each of the risk groups.ResultsAdding risk groups to the model containing only APFs significantly improved the fit to the data (likelihood-ratio test, p <0.001) and the c-index increased from 0.693 to 0.732 for BCR and from 0.707 to 0.747 for PCSM. A RP Gleason score (GS) ?8 and a PSM were independently associated with BCR in the total patient group and also each risk group. However, only a GS ?8 and SVI were associated with PCSM in the total patient group (GS ?8: hazard ratio [HR] 5.39 and SVI: HR 3.36) and the high-risk group (GS ?8: HR 6.31 and SVI: HR 4.05).ConclusionThe postoperative estimation of oncologic outcomes in men with APFs at RP was improved by considering preoperative risk group stratification. Although a PSM was an independent predictor for BCR, only a RP GS ?8 and SVI were associated with PCSM in the total patient and high-risk groups.

Project description:Background: Patients undergoing surgery for prostate cancer who have adverse pathological findings experience high rates of recurrence. While there are data supporting adjuvant radiotherapy compared to a wait-and-watch strategy to reduce recurrence rates, there are no randomized controlled trials comparing adjuvant radiotherapy with the other standard of care, salvage radiotherapy (radiotherapy administered at the time of recurrence). Methods: We constructed a health state transition (Markov) model employing two-dimensional Monte Carlo simulation using a lifetime horizon to compare the quality-adjusted survival associated with postoperative strategies using adjuvant or salvage radiotherapy. Prior to analysis, we calibrated and validated our model using the results of previous randomized controlled trials. We considered clinically important oncological health states from immediately postoperative to prostate cancer-specific death, commonly described complications from prostate cancer treatment, and other causes of mortality. Transition probabilities and utilities for disease states were derived from a literature search of MEDLINE and expert consensus. Results: Salvage radiotherapy was associated with an increased quality-adjusted life expectancy (QALE) (58.3 months) as compared with adjuvant radiotherapy (53.7 months), a difference of 4.6 months (standard deviation 8.8). Salvage radiotherapy had higher QALE in 53% of hypothetical cohorts. There was a minimal difference in overall life expectancy (-0.1 months). Examining recurrence rates, our model showed validity when compared with available randomized controlled data. Conclusions: A salvage radiotherapy strategy appears to provide improved QALE for patients with adverse pathological findings following radical prostatectomy, compared with adjuvant radiotherapy. As these findings reflect, population averages, specific patient and tumor factors, and patient preferences remain central for individualized management.

Project description:BackgroundIn order to improve postoperative functional outcome, including urinary continence and erectile function, nerve sparing surgery is recommended for patients with clinically localized prostate cancer (PCa). However, due to poor diagnosis accuracy at the preoperative stage, upstaging occurs in a considerable proportion of patients. Multiparametric magnetic resonance imaging (mpMRI) and the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) have recently shown excellent performance in diagnosis and staging of PCa. The aim of this study was to develop a predictive model based on PI-RADS v2 for postoperative upstaging in patients with low-intermediate risk PCa.MethodsThe medical records of 314 patients with low-intermediate risk PCa [prostate-specific antigen (PSA) level ≤20 ng/mL, Gleason score (GS) <8, and clinical stage < T3] who underwent preoperative mpMRI and radical prostatectomy in the Department of Urology, Peking University First Hospital between January 2012 and July 2019 were reviewed retrospectively. Clinicopathological characteristics were collected. All MRI reports were done at our institution as part of routine clinical practice before prostate biopsy and there was no re-reporting occurred. Using PI-RADS v2, the mpMRI results were assigned to three groups: "negative", "suspicious", and "positive". Multivariate logistic regression analysis was used to assess factors associated with postoperative pathological upstaging, defined as the presence of pT3 at final pathology. A regression coefﬁcient based model for predicting postoperative upstaging was constructed and internally validated using 1,000 bootstrap resamples. The performance of the model was assessed using the area under the receiver operating characteristic curve (AUC). With the optimal cutoff point the performance of the model was assessed through analysis of sensitivity, specificity, positive predictive value, and negative predictive value.ResultsUpstaging was observed in 119 (37.9%) patients. The univariate and multivariate analyses revealed that PSA density, biopsy Gleason grade group (GGG), and mpMRI findings were significantly independent predictors for postoperative upstaging (all P<0.05). A predictive model showing very favorable calibration characteristics and higher accuracy than the single variables was constructed (AUC =0.74; P<0.001). At the optimal cutoff point, the model demonstrated a sensitivity and negative predictive value of 87.4% and 87.0%, respectively.ConclusionsPI-RADS v2 assessment proved to be one of the most valuable predictors for postoperative upstaging in patients with low-intermediate risk PCa. The predictive model, based on PI-RADS v2 assessment, PSA density, and biopsy GGG, may help to select suitable candidates for nerve sparing radical prostatectomy among patients with low-intermediate risk PCa.

Dataset Information

Adverse Pathologic Findings for Men Electing Immediate Radical Prostatectomy: Defining a Favorable Intermediate-Risk Group.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Publications

Adverse Pathologic Findings for Men Electing Immediate Radical Prostatectomy: Defining a Favorable Intermediate-Risk Group.

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