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Are Elderly Patients With Clinically Localized Prostate Cancer Overtreated? Exploring Heterogeneity in Survival Effects.

ABSTRACT: Clinical trial evidence shows minimal survival gains and higher complication rates from radical prostatectomy (RP) versus watchful waiting (WW) for elderly men with localized prostate cancer (PCa). It is believed that these patients are overtreated. The current analyses aim to explore patient-level heterogeneity in survival effects, examine matching of patients to treatments in practice, and identify patient characteristics driving heterogenous effects, in order to present more comprehensive evidence about the concerns of overtreatment.Eleven-year all-cause and PCa-specific survival among SEER-Medicare patients diagnosed during 1996-2002 were analyzed using local instrumental variable approaches.A total of 8462 (77%) of 11,036 patients received RP. The average effects of RP over WW on 11-year overall and cancer-specific survival were 1.1 months (95%CI, -25, 28; P=0.94) and 1.7 months (95%CI, -25, 29; P=0.90) respectively; effects did not differ significantly according to age, race, grade, and stage. Fewer than 1% of patients had significant cancer-specific survival benefit from RP at the 10% level; 6% were expected to gain over 15 months from RP. However, patients with larger expected survival gains from RP were much more likely to receive RP in practice. Such positive self-selection was driven by PCa-specific survival than overall survival. Several comorbidities may play a critical role in predicting who could benefit from RP.Our analyses corroborate concerns about PCa overtreatment. A small fraction of screen-detected PCa patients derive survival benefits from RP. Prediction tools should account for patient comorbidities to accurately predict survival benefits of RP over WW.

SUBMITTER: Basu A

PROVIDER: S-EPMC5845767 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Are Elderly Patients With Clinically Localized Prostate Cancer Overtreated? Exploring Heterogeneity in Survival Effects.

Basu Anirban A Gore John L JL

Medical care 20150101 1

<h4>Background</h4>Clinical trial evidence shows minimal survival gains and higher complication rates from radical prostatectomy (RP) versus watchful waiting (WW) for elderly men with localized prostate cancer (PCa). It is believed that these patients are overtreated. The current analyses aim to explore patient-level heterogeneity in survival effects, examine matching of patients to treatments in practice, and identify patient characteristics driving heterogenous effects, in order to present mor ...[more]

PMID: 25397964

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Project description:PurposeAndrogen deprivation therapy may increase diabetes risk. As the benefits of primary androgen deprivation therapy for localized prostate cancer are controversial, and most prostate cancer survivors are of advanced age with comorbidities, it is important to determine if primary androgen deprivation therapy increases the risk of diabetes and to determine the susceptibility factors.Materials and methodsWe conducted a retrospective cohort study of 12,191 men diagnosed with incident localized prostate cancer during 1995 to 2008, age 35 to 100 years, and without diabetes or receipt of prostatectomy or radiation 1 year after diagnosis. Patients were enrolled in 1 of 3 managed health plans and followed through 2010. Primary androgen deprivation therapy was defined as androgen deprivation therapy within 1 year after diagnosis. Incident diabetes was ascertained using inpatient and outpatient diagnosis codes, diabetes medications and hemoglobin A1c values. We estimated primary androgen deprivation therapy associated diabetes risk using Cox proportional hazard models in conventional and propensity score analyses.ResultsDiabetes developed in 1,203 (9.9%) patients during followup (median 4.8 years) with incidence rates of 2.5 and 1.6 events per 100 person-years in the primary androgen deprivation therapy and nonprimary androgen deprivation therapy groups, respectively. Primary androgen deprivation therapy was associated with a 1.61-fold increased diabetes risk (95% CI 1.38-1.88). The number needed to harm was 29. The association was stronger in men age 70 or younger than in older men (HR 2.25 vs 1.40, p value for interaction=0.008).ConclusionsPrimary androgen deprivation therapy may increase diabetes risk by 60% and should be used with caution when managing localized prostate cancer. Because of the consistent association between androgen deprivation therapy and greater diabetes risk across disease states, we recommend routine screening and lifestyle interventions to reduce the risk of diabetes in men receiving androgen deprivation therapy.

Project description:IntroductionRadiotherapy can diminish quality of life (QoL) for prostate cancer patients. Our objective was to evaluate the effect of radiotherapy on QoL in men aged 75 years or older treated with radiotherapy for a localized prostate cancer, and to identify predictors of reduced QoL.Patients and methodsWe prospectively administered a battery of geriatric (MNA, GDS, Get up and Go Test, CIRS-G, ADL, IADL, MMSE), toxicity (IPSS; IIEF 5), and QoL (QLQ C30) screening tests in 100 elderly patients before and two months after prostate cancer radiotherapy (NCT 02876237). Patients ≥ 75 years undergoing radiotherapy with a curative intent for localized prostate cancer with or without androgen deprivation therapy (ADL) were eligible for study inclusion. Correlations between patient-assessed QoL and tumor characteristics, radiotherapy treatment or CGA parameters were sought using the Fisher or the Mann and Whitney tests. Changes in QoL parameters over time were analyzed using the Wilcoxon signed-rank test.ResultsAt study entry, scores for IADL impairments were present in 51%, reduced autonomy in activities of daily living in 16%, cognitive impairment found in 20%, depression-related symptoms in 31%, and 66% of patients had significant co-morbidities. Eight percent were judged to be at risk of fall and 2% were found to be undernourished. Severely impaired (IPSS ≥ 20) urinary function was observed in 11.2% and 13.5% of patients before and two months after completion of radiotherapy respectively. Significantly decreased QoL (> 20 points) at two months after treatment was found in 13% of patients and a moderate but clinically relevant reduction (10 to 20 points) in 17% of patients. No tumor characteristic, treatment, or oncogeriatric parameter was predictive of reduced QoL following prostate cancer radiotherapy.ConclusionDespite sometimes markedly diminished oncogeriatric parameters, prostate cancer radiotherapy was generally well tolerated in these elderly patients. We found no predictive factor to determine which patients would experience impaired quality of life following radiotherapy.

Project description:Radical prostatectomy and radiotherapy are currently the main treatment options for localized prostate cancer. However, no large cohort study comparing surgery and radiation has been performed in Japan or Asia. The objective of the current study was to compare the survival outcomes of patients with clinically localized prostate cancer and in elderly and young patients receiving surgery and radiotherapy. The survival outcomes of patients with localized prostate cancer (age at diagnosis ?79 years, clinical T1-3) initially treated with surgery or radiotherapy were retrospectively analyzed. Data were collected from the population-based cancer registry of the Kanagawa Prefecture, Japan. A 1:1 coarsened exact matching of age at diagnosis, clinical T stage and cancer differentiation was performed between the two treatment groups. Patients were also categorized into two subgroups by age using a cutoff of 70 years for analysis. The cohort comprised 4,810 patients aged 50-79 years. No significant difference in cancer-specific survival (CSS) was observed between the two groups (P=0.612). However, the surgery group had significantly better overall survival (OS; P=0.004). When stratified for age, similar tendencies were observed in the elderly group (aged 70-79 years; CSS, P=0.961 and OS, P=0.007). No significant difference in either CSS or OS was identified in the younger group (P=0.550 and P=0.408, respectively). Intrinsic deaths were more likely to occur in elderly patients treated with radiotherapy than those undergoing surgery (69.3 vs. 78.2%; P=0.128). The results indicated that surgery provided significantly better OS than radiotherapy, particularly among the elderly. However, no significant difference was observed in CSS. These results should be interpreted with caution, given that some important factors were unavailable in the present study, such as prostate-specific antigen values and Gleason scores. Prospective trials evaluating these therapies are warranted.

Project description:ImportanceThere is a lack of data evaluating the association of surgical delay time (SDT) with outcomes in patients with localized, high-risk prostate cancer.ObjectiveTo investigate the association of SDT of radical prostatectomy and final pathological and survival outcomes.Design, setting, and participantsThis cohort study used data from the US National Cancer Database (NCDB) and identified all patients with clinically localized (cT1-2cN0cM0) high-risk prostate adenocarcinoma diagnosed between 2006 and 2016 who underwent radical prostatectomy. Data analyses were performed from April 1 to April 12, 2020.ExposuresSDT was defined as the number of days between the initial cancer diagnosis and radical prostatectomy. SDT was categorized into 5 groups: 31 to 60, 61 to 90, 91 to 120, 121 to 150, and 151 to 180 days.Main outcomes and measuresThe primary outcomes were predetermined as adverse pathological outcomes after radical prostatectomy, including pT3-T4 disease, pN-positive disease, and positive surgical margin. The adverse pathological score (APS) was defined as an accumulated score of the 3 outcomes (0-3). An APS of 2 or higher was considered a separate outcome to capture cases with more aggressive pathological features. The secondary outcome was overall survival.ResultsOf the 32 184 patients included in the study, the median (interquartile range) age was 64 (59-68) years, and 25 548 (79.4%) were non-Hispanic White. Compared with an SDT of 31 to 60 days, longer SDTs were not associated with higher risks of having any adverse pathological outcomes (odds ratio [OR], 0.95; 95% CI, 0.80-1.12; P = .53), pT3-T4 disease (OR, 0.99; 95% CI, 0.83-1.17; P = .87), pN-positive disease (OR, 0.79; 95% CI, 0.59-1.06; P = .12), positive surgical margin (OR, 0.88; 95% CI, 0.74-1.05; P = .17), or APS greater than or equal to 2 (OR, 0.90; 95% CI, 0.74-1.05; P = .17). Longer SDT was also not associated with worse overall survival (for SDT of 151-180 days, hazard ratio, 1.12; 95% CI, 0.79-1.59, P = .53). Subgroup analyses performed for patients with very high-risk disease (primary Gleason score 5) and sensitivity analyses with SDT considered as a continuous variable yielded similar results.Conclusions and relevanceIn this cohort study of patients who underwent radical prostatectomy within 180 days of diagnosis for high-risk prostate cancer, radical prostatectomy for high-risk prostate cancer could be safely delayed up to 6 months after diagnosis.

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Are Elderly Patients With Clinically Localized Prostate Cancer Overtreated? Exploring Heterogeneity in Survival Effects.

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Are Elderly Patients With Clinically Localized Prostate Cancer Overtreated? Exploring Heterogeneity in Survival Effects.

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