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Observation versus initial treatment for men with localized, low-risk prostate cancer: a cost-effectiveness analysis.

ABSTRACT: Observation is underutilized among men with localized, low-risk prostate cancer.To assess the costs and benefits of observation versus initial treatment.Decision analysis simulating treatment or observation.Medicare schedules, published literature.Men aged 65 and 75 years who had newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 µg/L, stage ?T2a, Gleason score ?3 + 3).Lifetime.Societal.Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]).Quality-adjusted life expectancy and costs.Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15,374 ($24,520 vs. $39,894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11,746 ($18,302 vs. $30,048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment.Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses.Results depend on outcomes reported in the published literature, which is limited.Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios.National Cancer Institute, U.S. Department of Defense, Prostate Cancer Foundation, and Institute for Clinical and Economic Review.

SUBMITTER: Hayes JH

PROVIDER: S-EPMC4487888 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Observation versus initial treatment for men with localized, low-risk prostate cancer: a cost-effectiveness analysis.

Hayes Julia H JH Ollendorf Daniel A DA Pearson Steven D SD Barry Michael J MJ Kantoff Philip W PW Lee Pablo A PA McMahon Pamela M PM

Annals of internal medicine 20130601 12

<h4>Background</h4>Observation is underutilized among men with localized, low-risk prostate cancer.<h4>Objective</h4>To assess the costs and benefits of observation versus initial treatment.<h4>Design</h4>Decision analysis simulating treatment or observation.<h4>Data sources</h4>Medicare schedules, published literature.<h4>Target population</h4>Men aged 65 and 75 years who had newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 µg/L, stage ≤T2a, Gleason score ≤3 + 3).<h ...[more]

PMID: 23778902

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Project description:BackgroundThe effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known.MethodsFrom November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality.ResultsDuring the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P=0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P=0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P=0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P=0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death.ConclusionsAmong men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.).

Project description:ImportanceProstate radiation therapy (PRT) is a treatment option in men with low-volume metastatic prostate cancer based on the results of the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy Arm H (STAMPEDE-H) trial. However, the cost-effectiveness of this treatment remains unaddressed.ObjectiveTo assess the cost-effectiveness of PRT when added to androgen deprivation therapy (ADT) for men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC).Design, setting, and participantsThis economic evaluation used microsimulation modeling to evaluate the cost-effectiveness of adding PRT to ADT. A simulated cohort of 10 000 individuals with low-volume mHSPC was created. Data from men with low-volume mHSPC were extracted and analyzed from January 18, 2019, through July 4, 2020. Transition probabilities were extracted from the STAMPEDE-H study. Health states included stable disease, progression, second progression, and death. Individual grade 2 or higher genitourinary and gastrointestinal toxic events associated with PRT were tracked. Univariable deterministic and probabilistic sensitivity analyses explored uncertainty with regard to the model assumptions. Health state utility estimates were based on the published literature.ExposuresThe combination of PRT and ADT using regimens of 20 fractions and 6 weekly fractions.Main outcomes and measuresOutcomes included net quality-adjusted life-years (QALYs), costs in US dollars, and incremental cost-effectiveness ratios. A strategy was classified as dominant if it was associated with higher QALYs at lower costs than the alternative and dominated if it was associated with fewer QALYs at higher costs than the alternative.ResultsFor the base case scenario of men 68 years of age with low-volume mHSPC, the modeled outcomes were similar to the target clinical data for overall survival, failure-free survival, and rates of PRT-related toxic effects. The addition of PRT was a dominant strategy compared with ADT alone, with a gain of 0.16 QALYs (95% CI, 0.15-0.17 QALYs) and a reduction in net costs by $19 472 (95% CI, $23 096-$37 362) at 37 months of follow-up and a gain of 0.81 QALYs (95% CI, 0.73-0.89 QALYs) and savings of $30 229 (95% CI, $23 096-$37 362) with lifetime follow-up.Conclusions and relevanceIn the economic evaluation, PRT was a dominant treatment strategy compared with ADT alone. These findings suggest that addition of PRT to ADT is a cost-effective treatment for men with low-volume mHSPC.

Project description:In the United States, 192,000 men were diagnosed as having prostate cancer in 2009, the majority with low-risk, clinically localized disease. Treatment of these cancers is associated with substantial morbidity. Active surveillance is an alternative to initial treatment, but long-term outcomes and effect on quality of life have not been well characterized.To examine the quality-of-life benefits and risks of active surveillance compared with initial treatment for men with low-risk, clinically localized prostate cancer.Decision analysis using a simulation model was performed: men were treated at diagnosis with brachytherapy, intensity-modulated radiation therapy (IMRT), or radical prostatectomy or followed up by active surveillance (a strategy of close monitoring of newly diagnosed patients with serial prostate-specific antigen measurements, digital rectal examinations, and biopsies, with treatment at disease progression or patient choice). Probabilities and utilities were derived from previous studies and literature review. In the base case, the relative risk of prostate cancer-specific death for initial treatment vs active surveillance was assumed to be 0.83. Men incurred short- and long-term adverse effects of treatment.Hypothetical cohorts of 65-year-old men newly diagnosed as having clinically localized, low-risk prostate cancer (prostate-specific antigen level <10 ng/mL, stage ?T2a disease, and Gleason score ?6).Quality-adjusted life expectancy (QALE).Active surveillance was associated with the greatest QALE (11.07 quality-adjusted life-years [QALYs]), followed by brachytherapy (10.57 QALYs), IMRT (10.51 QALYs), and radical prostatectomy (10.23 QALYs). Active surveillance remained associated with the highest QALE even if the relative risk of prostate cancer-specific death for initial treatment vs active surveillance was as low as 0.6. However, the QALE gains and the optimal strategy were highly dependent on individual preferences for living under active surveillance and for having been treated.Under a wide range of assumptions, for a 65-year-old man, active surveillance is a reasonable approach to low-risk prostate cancer based on QALE compared with initial treatment. However, individual preferences play a central role in the decision whether to treat or to pursue active surveillance.

Project description:BackgroundExternal beam radiotherapy is the recommended but expensive treatment option for localized prostate cancer. Prostate cancer is the most common cancer in men worldwide. A cost-effectiveness study is needed given the excessive cost of radiotherapy treatment and the high prevalence of prostate cancer. The aim of this systematic review was to assess and identify studies that examined model based economic evaluation of external beam radiation therapy for the treatment of localized prostate cancer.MethodsA systematic review of the published literature was conducted through MEDLINE, NHS EED (NHS Economic Evaluation Database), and Cochrane databases with a specific search strategy. The literatures were searched according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. At first 1046 citations were identified. The extracted files were imported into the Rayyan systematic review site for inclusion or exclusion based on the defined criteria. Studies included in this review were articles published between 2003 and 2017, and that conducted full-economic evaluations of the modality of external beam radiotherapy for the treatment of localized prostate cancer.ResultsThere were 12 studies that satisfied the inclusion and exclusion criteria. Seven studies compared intensity modulated radiation therapy (IMRT) with three-dimensional conformal radiation therapy (3D-CRT), two compared IMRT with stereotactic body radiation therapy (SBRT) another two-paper assessed IMRT with proton beam therapy (PBT). One paper compared the three external-beam radio therapy options of IMRT, SBRT and PBT. Most of the studies were originated from the US and analyzed the cost data from the payer's perspective. Most studies were supported that IMRT was cost effective when it compared with 3D-CRT. Compared with IMRT, SBRT was found to be cost-effective.ConclusionsThere are limited number of studies exist on the cost effectiveness of radiation therapy options for the treatment of localize prostate cancer across Europe. Most studies are originated from the US Medicare payer Perspective. Further research is need that investigate the cost effectiveness of these radiation therapy options from the societal perspective in Europe.

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Observation versus initial treatment for men with localized, low-risk prostate cancer: a cost-effectiveness analysis.

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Observation versus initial treatment for men with localized, low-risk prostate cancer: a cost-effectiveness analysis.

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