The impact of technology diffusion on treatment for prostate cancer.
ABSTRACT: The use of local therapy for prostate cancer may increase because of the perceived advantages of new technologies such as intensity-modulated radiotherapy (IMRT) and robotic prostatectomy.To examine the association of market-level technological capacity with receipt of local therapy.Retrospective cohort.Patients with localized prostate cancer who were diagnosed between 2003 and 2007 (n=59,043) from the Surveillance Epidemiology and End Results-Medicare database.We measured the capacity for delivering treatment with new technology as the number of providers offering robotic prostatectomy or IMRT per population in a market (hospital referral region). The association of this measure with receipt of prostatectomy, radiotherapy, or observation was examined with multinomial logistic regression.For each 1000 patients diagnosed with prostate cancer, 174 underwent prostatectomy, 490 radiotherapy, and 336 were observed. Markets with high robotic prostatectomy capacity had higher use of prostatectomy (146 vs. 118 per 1000 men, P=0.008) but a trend toward decreased use of radiotherapy (574 vs. 601 per 1000 men, P=0.068), resulting in a stable rate of local therapy. High versus low IMRT capacity did not significantly impact the use of prostatectomy (129 vs. 129 per 1000 men, P=0.947) and radiotherapy (594 vs. 585 per 1000 men, P=0.579).Although there was a small shift from radiotherapy to prostatectomy in markets with high robotic prostatectomy capacity, increased capacity for both robotic prostatectomy and IMRT did not change the overall rate of local therapy. Our findings temper concerns that the new technology spurs additional therapy of prostate cancer.
Project description:The use of advanced treatment technologies (ie, intensity-modulated radiotherapy [IMRT] and robotic prostatectomy) for prostate cancer is increasing. The extent to which these advanced treatment technologies have disseminated among patients at low risk of dying from prostate cancer is uncertain.To assess the use of advanced treatment technologies, compared with prior standards (ie, traditional external beam radiation treatment [EBRT] and open radical prostatectomy) and observation, among men with a low risk of dying from prostate cancer.Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified a retrospective cohort of men diagnosed with prostate cancer between 2004 and 2009 who underwent IMRT (n = 23,633), EBRT (n = 3926), robotic prostatectomy (n = 5881), open radical prostatectomy (n = 6123), or observation (n = 16,384). Follow-up data were available through December 31, 2010.The use of advanced treatment technologies among men unlikely to die from prostate cancer, as assessed by low-risk disease (clinical stage ?T2a, biopsy Gleason score ?6, and prostate-specific antigen level ?10 ng/mL), high risk of noncancer mortality (based on the predicted probability of death within 10 years in the absence of a cancer diagnosis), or both.In our cohort, the use of advanced treatment technologies increased from 32% (95% CI, 30%-33%) to 44% (95% CI, 43%-46%) among men with low-risk disease (P < .001) and from 36% (95% CI, 35%-38%) to 57% (95% CI, 55%-59%) among men with high risk of noncancer mortality (P < .001). The use of these advanced treatment technologies among men with both low-risk disease and high risk of noncancer mortality increased from 25% (95% CI, 23%-28%) to 34% (95% CI, 31%-37%) (P < .001). Among all patients diagnosed in SEER, the use of advanced treatment technologies for men unlikely to die from prostate cancer increased from 13% (95% CI, 12%-14%), or 129.2 per 1000 patients diagnosed with prostate cancer, to 24% (95% CI, 24%-25%), or 244.2 per 1000 patients diagnosed with prostate cancer (P < .001).Among men diagnosed with prostate cancer between 2004 and 2009 who had low-risk disease, high risk of noncancer mortality, or both, the use of advanced treatment technologies has increased.
Project description:INTRODUCTION:Local coverage determinations (LCDs) are local decisions that regulate healthcare coverage. We evaluated the impact of LCDs as well as patient, tumor, and market characteristics on the adoption of stereotactic body radiation therapy (SBRT) for prostate cancer. METHODS:Using Surveillance, Epidemiology, and End Results (SEER)-Medicare, we identified men treated with SBRT, intensity-modulated radiotherapy (IMRT), and robotic prostatectomy. We compared demographics, clinical characteristics, and market factors among these three treatments. Our primary exposure was LCD policy; using the Medicare Coverage Database, we categorized LCDs as favorable (SBRT covered), neutral (SBRT covered in the context of a clinical trial or registry), unfavorable (SBRT not covered), or absent (i.e., SBRT not governed by an LCD at the time of treatment). We fit a multivariable multinomial logistic regression model and generated predicted probabilities to examine the relation between LCDs and SBRT. RESULTS:During this early period of SBRT adoption, IMRT was the most common of the three treatments followed by robotic prostatectomy and then SBRT. SBRT use was high when governed by favorable and neutral LCDs and lowest when governed by unfavorable LCDs. Compared with favorable LCDs, areas where LCDs were absent were associated with higher SBRT use compared with IMRT (odds ratio [OR] 1.56; 95%CI, 1.07-2.25) and robotic prostatectomy (OR 1.84; 95%CI, 1.25-2.69). CONCLUSIONS:When present, LCDs appear to regulate early SBRT adoption, but, when absent, are associated with increased SBRT use. Although SBRT use was uncommon, it varied across a wide range of patient, tumor, and market characteristics.
Project description:Stereotactic body radiotherapy (SBRT) is the precise external delivery of very high-dose radiotherapy to targets in the body, with treatment completed in one to five fractions. SBRT should be an ideal approach for organ-confined prostate cancer because (I) dose-escalation should yield improved rates of cancer control; (II) the unique radiobiology of prostate cancer favors hypofractionation; and (III) the conformal nature of SBRT minimizes high-dose radiation delivery to immediately adjacent organs, potentially reducing complications. This approach is also more convenient for patients, and is cheaper than intensity-modulated radiotherapy (IMRT). Several external beam platforms are capable of delivering SBRT for early-stage prostate cancer, although most of the mature reported series have employed a robotic non-coplanar platform (i.e., CyberKnife). Several large studies report 5-year biochemical relapse rates which compare favorably to IMRT. Rates of late GU toxicity are similar to those seen with IMRT, and rates of late rectal toxicity may be less than with IMRT and low-dose rate brachytherapy. Patient-reported quality of life (QOL) outcomes appear similar to IMRT in the urinary domain. Bowel QOL may be less adversely affected by SBRT than with other radiation modalities. After 5?years of follow-up, SBRT delivered on a robotic platform is yielding outcomes at least as favorable as IMRT, and may be considered appropriate therapy for stage I-II prostate cancer.
Project description:PURPOSE:Robotic assisted radical prostatectomy has largely replaced open radical prostatectomy for the surgical management of prostate cancer despite conflicting evidence of superiority with respect to disease control or functional sequelae. Using population cohort data, in this study we examined sexual and urinary function in men undergoing open radical prostatectomy vs those undergoing robotic assisted radical prostatectomy. MATERIALS AND METHODS:Subjects surgically treated for prostate cancer were selected from 2 large population based prospective cohort studies, the Prostate Cancer Outcomes Study (enrolled 1994 to 1995) and the Comparative Effectiveness Analysis of Surgery and Radiation (enrolled 2011 to 2012). Subjects completed baseline, 6-month and 12-month standardized patient reported outcome measures. Main outcomes were between-group differences in functional outcome scores at 6 and 12 months using linear regression, and adjusting for baseline function, sociodemographic and clinical characteristics. Sensitivity analyses were used to evaluate outcomes between patients undergoing open radical prostatectomy and robotic assisted radical prostatectomy within and across CEASAR and PCOS. RESULTS:The combined cohort consisted of 2,438 men, 1,505 of whom underwent open radical prostatectomy and 933 of whom underwent robotic assisted radical prostatectomy. Men treated with robotic assisted radical prostatectomy reported better urinary function at 6 months (mean difference 3.77 points, 95% CI 1.09-6.44) but not at 12 months (1.19, -1.32-3.71). Subjects treated with robotic assisted radical prostatectomy also reported superior sexual function at 6 months (8.31, 6.02-10.56) and at 12 months (7.64, 5.25-10.03). Sensitivity analyses largely supported the sexual function findings with inconsistent support for urinary function results. CONCLUSIONS:This population based study reveals that men undergoing robotic assisted radical prostatectomy likely experience less decline in early urinary continence and sexual function than those undergoing open radical prostatectomy. The clinical meaning of these differences is uncertain and longer followup will be required to establish whether these benefits are durable.
Project description:BACKGROUND:Men diagnosed with localised prostate cancer (LPC) wanting curative treatment face a highly preference-sensitive choice between prostatectomy and radiotherapy, which offer similar cure rates but different side effects. This study aims to determine the information, decision-making needs and preferences of men with LPC choosing between robotic prostatectomy and standard external beam or stereotactic radiotherapy. METHODS AND ANALYSIS:This study will be conducted at a large public teaching hospital in Australia offering the choice between robotic prostatectomy and radiotherapy from early 2017. Men (20-30) diagnosed with LPC who want curative treatment and meet criteria for either treatment will be invited to participate. In this mixed-methods study, patients will complete semistructured interviews before and after attending a combined clinic in which they consult a urologist and a radiation oncologist regarding treatment and four questionnaires (one before treatment decision-making and three after) assessing demographic and clinical characteristics, involvement in decision-making, decisional conflict, satisfaction and regret. Combined clinic consultations will also be audio-recorded and clinicians will report their perceptions regarding patients' suitability for, openness to and preferences for each treatment. Qualitative data will be transcribed verbatim and thematically analysed and descriptive statistical analyses will explore quantitative decision-making outcomes, with comparison according to treatment choice. DISCUSSION:Results from this study will inform how to best support men diagnosed with LPC deciding which curative treatment option best suits their needs and may identify the need for and content required in a decision aid to support these men. ETHICS AND DISSEMINATION:All participants will provide written informed consent. Data will be rigorously managed in accordance with national legislation. Results will be disseminated via presentations to both scientific and layperson audiences and publications in peer-reviewed scientific journals.
Project description:CONTEXT:Some of the high costs of robot-assisted radical prostatectomy (RARP), intensity-modulated radiotherapy (IMRT), and proton beam therapy may be offset by better outcomes or less resource use during the treatment episode. OBJECTIVE:To systematically review the literature to identify the key economic trade-offs implicit in a particular treatment choice for prostate cancer. EVIDENCE ACQUISITION:We systematically reviewed the literature according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement and protocol. We searched Medline, Embase, and Web of Science for articles published between January 2001 and July 2016, which compared the treatment costs of RARP, IMRT, or proton beam therapy to the standard treatment. We identified 37, nine, and three studies, respectively. EVIDENCE SYNTHESIS:RARP is costlier than radical retropubic prostatectomy for hospitals and payers. However, RARP has the potential for a moderate cost advantage for payers and society over a longer time horizon when optimal cancer and quality-of-life outcomes are achieved. IMRT is more expensive from a payer's perspective compared with three-dimensional conformal radiotherapy, but also more cost effective when defined by an incremental cost effectiveness ratio <$50 000 per quality-adjusted life year. Proton beam therapy is costlier than IMRT and its cost effectiveness remains unclear given the limited comparative data on outcomes. Using the Grades of Recommendation, Assessment, Development and Evaluation approach, the quality of evidence was low for RARP and IMRT, and very low for proton beam therapy. CONCLUSIONS:Treatment with new versus traditional technologies is costlier. However, given the low quality of evidence and the inconsistencies across studies, the precise difference in costs remains unclear. Attempts to estimate whether this increased cost is worth the expense are hampered by the uncertainty surrounding improvements in outcomes, such as cancer control and side effects of treatment. If the new technologies can consistently achieve better outcomes, then they may be cost effective. PATIENT SUMMARY:We review the cost and cost effectiveness of robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and proton beam therapy in prostate cancer treatment. These technologies are costlier than their traditional counterparts. It remains unclear whether their use is associated with improved cure and reduced morbidity, and whether the increased cost is worth the expense.
Project description:PURPOSE:Androgen deprivation therapy is often used as salvage treatment in men with rising prostate specific antigen after initial radical prostatectomy or radiotherapy for clinically localized prostate cancer. Given the lack of evidence from general practice, we examined the association of salvage androgen deprivation therapy with mortality in an observational cohort study. MATERIALS AND METHODS:From 3 managed care organizations we assembled a retrospective cohort of all 5,804 men with newly diagnosed localized prostate cancer from 1995 to 2009 who had a prostate specific antigen increase (biochemical recurrence) after primary radical prostatectomy or radiotherapy. The main outcomes were all-cause and prostate cancer specific mortality. We used Cox proportional hazards models to estimate mortality with salvage androgen deprivation therapy as a time dependent predictor. RESULTS:Overall salvage androgen deprivation therapy was not associated with all-cause or prostate cancer specific mortality in the prostatectomy cohort (HR 0.97, 95% CI 0.70-1.35 or HR 1.18, 95% CI 0.68-2.07) or in the radiotherapy cohort (HR 0.84, 95% CI 0.70-1.01 or HR 1.06, 95% CI 0.80-1.40, respectively). Among men with prostate specific antigen doubling time less than 9 months after the prostate specific antigen rise, salvage androgen deprivation therapy was statistically significantly associated with a decreased risk of all-cause and prostate cancer specific mortality in the prostatectomy cohort (HR 0.35, 95% CI 0.20-0.63 and HR 0.43, 95% CI 0.21-0.91) and in the radiotherapy cohort (HR 0.62, 95% CI 0.48-0.80 and HR 0.65, 95% CI 0.47-0.90, respectively). CONCLUSIONS:We found no association of salvage androgen deprivation therapy with all-cause or cause specific mortality in most men with biochemical recurrence after primary radical prostatectomy or radiotherapy for clinically localized prostate cancer. Men with quickly progressed disease may derive a clinical benefit from salvage androgen deprivation therapy.
Project description:The optimal field size of salvage radiotherapy (SRT) for biochemical recurrence, particularly for patients with high-risk prostate cancer, remains undefined. This retrospective analysis was performed to investigate oncological outcomes as well as treatment-related toxicity following salvage intensity-modulated radiotherapy (IMRT) to the whole pelvis and to compare the results with other studies implementing a small field size of the prostate bed.The medical records of 170 patients with high-risk prostate cancer who received SRT for biochemical recurrence following prostatectomy were reviewed. Whole-pelvic IMRT was administered with a median dose of 66 Gy in 30 fractions. To improve treatment accuracy, an endorectal balloon device and daily cone-beam computed tomography were utilized. Androgen-deprivation therapy combined with SRT was administered to 97 (57.1%) patients.Eventually, 68 (40.0%) patients showed biochemical progression (BCP) after SRT. With a median follow-up period of 56 months, the 5-year BCP-free survival was 38.6%. The overall and cause-specific survival rates were 90.9% and 96.7%, respectively. Regarding BCP-free survival analysis, pathological T stage, persistent prostate-specific antigen (PSA) elevation after prostatectomy, and preSRT PSA level were significant prognostic factors on univariate analysis. On multivariate analysis, pathological T stage and preSRT PSA value retained their significance. Acute and late grade-3 genitourinary toxicities were observed in one (0.6%) and five (2.9%) patients, respectively. One patient each developed acute and late grade-3 gastrointestinal toxicity.SRT to whole pelvis using IMRT and image guidance is as safe as SRT to the prostate bed, but its efficacy should be confirmed in ongoing randomized trials. PreSRT PSA was the only controllable prognostic factor, suggesting the benefit of early SRT.
Project description:To study the impact of new, expensive, and unproven therapies to treat prostate cancer, we investigated the dissemination of intensity-modulated radiotherapy (IMRT). IMRT is an innovative treatment for prostate cancer that delivers higher doses of radiation with improved precision compared to alternative radiotherapies. We observed rapid adoption of this new treatment among men diagnosed with prostate cancer from 2001 through 2007, despite uncertainty about its relative effectiveness. We compared patient and disease characteristics of those receiving IMRT and the previous radiation standard of care, three-dimensional conformal therapy; assessed intermediate-term outcomes; and examined potential factors associated with the increased use of IMRT. We found that in the early period of IMRT adoption (2001-03) men with high-risk disease were more likely to receive IMRT, whereas after IMRT's initial dissemination (2004-07) men with low-risk disease had fairly similar likelihoods of receiving IMRT as men with high-risk disease. This raises concerns about overtreatment, as well as considerable health care costs, because treatment with IMRT costs $15,000-$20,000 more than other standard therapies. As health care delivery reforms gain traction, policy makers must balance the promotion of new, yet unproven, technology with the risk of overuse.
Project description:BACKGROUND:Optimal management strategies for clinically localised prostate cancer are debated. Using median 10-year data from the largest randomised controlled trial to date (ProtecT), the lifetime cost-effectiveness of three major treatments (radical radiotherapy, radical prostatectomy and active monitoring) was explored according to age and risk subgroups. METHODS:A decision-analytic (Markov) model was developed and informed by clinical input. The economic evaluation adopted a UK NHS perspective and the outcome was cost per Quality-Adjusted Life Year (QALY) gained (reported in UK£), estimated using EQ-5D-3L. RESULTS:Costs and QALYs extrapolated over the lifetime were mostly similar between the three randomised strategies and their subgroups, but with some important differences. Across all analyses, active monitoring was associated with higher costs, probably associated with higher rates of metastatic disease and changes to radical treatments. When comparing the value of the strategies (QALY gains and costs) in monetary terms, for both low-risk prostate cancer subgroups, radiotherapy generated the greatest net monetary benefit (£293,446 [95% CI £282,811 to £299,451] by D'Amico and £292,736 [95% CI £284,074 to £297,719] by Grade group 1). However, the sensitivity analysis highlighted uncertainty in the finding when stratified by Grade group, as radiotherapy had 53% probability of cost-effectiveness and prostatectomy had 43%. In intermediate/high risk groups, using D'Amico and Grade group >?=?2, prostatectomy generated the greatest net monetary benefit (£275,977 [95% CI £258,630 to £285,474] by D'Amico and £271,933 [95% CI £237,864 to £287,784] by Grade group). This finding was supported by the sensitivity analysis. Prostatectomy had the greatest net benefit (£290,487 [95% CI £280,781 to £296,281]) for men younger than 65 and radical radiotherapy (£201,311 [95% CI £195,161 to £205,049]) for men older than 65, but sensitivity analysis showed considerable uncertainty in both findings. CONCLUSION:Over the lifetime, extrapolating from the ProtecT trial, radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates. Longer ProtecT trial follow-up is required to reduce uncertainty in the model. TRIAL REGISTRATION:Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).