Amyloid Positron Emission Tomography and Subsequent Health Care Use Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia.

Importance: Results of amyloid positron emission tomography (PET) have been shown to change the management of patients with mild cognitive impairment (MCI) or dementia who meet Appropriate Use Criteria (AUC). Objective: To determine if amyloid PET is associated with reduced hospitalizations and emergency department (ED) visits over 12 months in patients with MCI or dementia. Design, Setting, and Participants: This nonrandomized controlled trial analyzed participants in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, an open-label, multisite, longitudinal study that enrolled participants between February 2016 and December 2017 and followed up through December 2018. These participants were recruited at 595 clinical sites that provide specialty memory care across the US. Eligible participants were Medicare beneficiaries 65 years or older with a diagnosis of MCI or dementia within the past 24 months who met published AUC for amyloid PET. Each IDEAS study participant was matched to a control Medicare beneficiary who had not undergone amyloid PET. Data analysis was conducted on December 13, 2022. Exposure: Participants underwent amyloid PET at imaging centers. Main Outcomes and Measures: The primary end points were the proportions of patients with 12-month inpatient hospital admissions and ED visits. One of 4 secondary end points was the rate of hospitalizations and rate of ED visits in participants with positive vs negative amyloid PET results. Health care use was ascertained from Medicare claims data. Results: The 2 cohorts (IDEAS study participants and controls) each comprised 12 684 adults, including 6467 females (51.0%) with a median (IQR) age of 77 (73-81) years. Over 12 months, 24.0% of the IDEAS study participants were hospitalized, compared with 25.1% of the matched control cohort, for a relative reduction of -4.49% (97.5% CI, -9.09% to 0.34%). The 12-month ED visit rates were nearly identical between the 2 cohorts (44.8% in both IDEAS study and control cohorts) for a relative reduction of -0.12% (97.5% CI, -3.19% to 3.05%). Both outcomes fell short of the prespecified effect size of 10% or greater relative reduction. Overall, 1467 of 6848 participants (21.4%) with positive amyloid PET scans were hospitalized within 12 months compared with 1081 of 4209 participants (25.7%) with negative amyloid PET scans (adjusted odds ratio, 0.83; 95% CI, 0.78-0.89). Conclusions and Relevance: Results of this nonrandomized controlled trial showed that use of amyloid PET was not associated with a significant reduction in 12-month hospitalizations or ED visits. Rates of hospitalization were lower in patients with positive vs negative amyloid PET results.

Racial and Ethnic Differences in Amyloid PET Positivity in Individuals With Mild Cognitive Impairment or Dementia: A Secondary Analysis of the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Cohort Study.

Importance: Racial and ethnic groups with higher rates of clinical Alzheimer disease (AD) are underrepresented in studies of AD biomarkers, including amyloid positron emission tomography (PET). Objective: To compare amyloid PET positivity among a diverse cohort of individuals with mild cognitive impairment (MCI) or dementia. Design, Setting, and Participants: Secondary analysis of the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS), a single-arm multisite cohort study of Medicare beneficiaries who met appropriate-use criteria for amyloid PET imaging between February 2016 and September 2017 with follow-up through January 2018. Data were analyzed between April 2020 and January 2022. This study used 2 approaches: the McNemar test to compare amyloid PET positivity proportions between matched racial and ethnic groups and multivariable logistic regression to assess the odds of having a positive amyloid PET scan. IDEAS enrolled participants at 595 US dementia specialist practices. A total of 21 949 were enrolled and 4842 (22%) were excluded from the present analysis due to protocol violations, not receiving an amyloid PET scan, not having a positive or negative scan, or because of small numbers in some subgroups. Exposures: In the IDEAS study, participants underwent a single amyloid PET scan. Main Outcomes and Measures: The main outcomes were amyloid PET positivity proportions and odds. Results: Data from 17 107 individuals (321 Asian, 635 Black, 829 Hispanic, and 15 322 White) with MCI or dementia and amyloid PET were analyzed between April 2020 and January 2022. The median (range) age of participants was 75 (65-105) years; 8769 participants (51.3%) were female and 8338 (48.7%) were male. In the optimal 1:1 matching analysis (n = 3154), White participants had a greater proportion of positive amyloid PET scans compared with Asian participants (181 of 313; 57.8%; 95% CI, 52.3-63.2 vs 142 of 313; 45.4%; 95% CI, 39.9-50.9, respectively; P = .001) and Hispanic participants (482 of 780; 61.8%; 95% CI, 58.3-65.1 vs 425 of 780; 54.5%; 95% CI, 51.0-58.0, respectively; P = .003) but not Black participants (359 of 615; 58.4%; 95% CI, 54.4-62.2 vs 333 of 615; 54.1%; 95% CI, 50.2-58.0, respectively; P = .13). In the adjusted model, the odds of having a positive amyloid PET scan were lower for Asian participants (odds ratio [OR], 0.47; 95% CI, 0.37-0.59; P < .001), Black participants (OR, 0.71; 95% CI, 0.60-0.84; P < .001), and Hispanic participants (OR, 0.68; 95% CI, 0.59-0.79; P < .001) compared with White participants. Conclusions and Relevance: Racial and ethnic differences found in amyloid PET positivity among individuals with MCI and dementia in this study may indicate differences in underlying etiology of cognitive impairment and guide future treatment and prevention approaches.

rPOP: Robust PET-only processing of community acquired heterogeneous amyloid-PET data.

The reference standard for amyloid-PET quantification requires structural MRI (sMRI) for preprocessing in both multi-site research studies and clinical trials. Here we describe rPOP (robust PET-Only Processing), a MATLAB-based MRI-free pipeline implementing non-linear warping and differential smoothing of amyloid-PET scans performed with any of the FDA-approved radiotracers (18F-florbetapir/FBP, 18F-florbetaben/FBB or 18F-flutemetamol/FLUTE). Each image undergoes spatial normalization based on weighted PET templates and data-driven differential smoothing, then allowing users to perform their quantification of choice. Prior to normalization, users can choose whether to automatically reset the origin of the image to the center of mass or proceed with the pipeline with the image as it is. We validate rPOP with n = 740 (514 FBP, 182 FBB, 44 FLUTE) amyloid-PET scans from the Imaging Dementia-Evidence for Amyloid Scanning - Brain Health Registry sub-study (IDEAS-BHR) and n = 1,518 scans from the Alzheimer's Disease Neuroimaging Initiative (n = 1,249 FBP, n = 269 FBB), including heterogeneous acquisition and reconstruction protocols. After running rPOP, a standard quantification to extract Standardized Uptake Value ratios and the respective Centiloids conversion was performed. rPOP-based amyloid status (using an independent pathology-based threshold of ≥24.4 Centiloid units) was compared with either local visual reads (IDEAS-BHR, n = 663 with complete valid data and reads available) or with amyloid status derived from an MRI-based PET processing pipeline (ADNI, thresholds of >20/>18 Centiloids for FBP/FBB). Finally, within the ADNI dataset, we tested the linear associations between rPOP- and MRI-based Centiloid values. rPOP achieved accurate warping for N = 2,233/2,258 (98.9%) in the first pass. Of the N = 25 warping failures, 24 were rescued with manual reorientation and origin reset prior to warping. We observed high concordance between rPOP-based amyloid status and both visual reads (IDEAS-BHR, Cohen's k = 0.72 [0.7-0.74], ∼86% concordance) or MRI-pipeline based amyloid status (ADNI, k = 0.88 [0.87-0.89], ∼94% concordance). rPOP- and MRI-pipeline based Centiloids were strongly linearly related (R2:0.95, p<0.001), with this association being significantly modulated by estimated PET resolution (ß= -0.016, p<0.001). rPOP provides reliable MRI-free amyloid-PET warping and quantification, leveraging widely available software and only requiring an attenuation-corrected amyloid-PET image as input. The rPOP pipeline enables the comparison and merging of heterogeneous datasets and is publicly available at https://github.com/leoiacca/rPOP.

Association Between Ambient Air Pollution and Amyloid Positron Emission Tomography Positivity in Older Adults With Cognitive Impairment.

Importance: Amyloid-ß (Aß) deposition is a feature of Alzheimer disease (AD) and may be promoted by exogenous factors, such as ambient air quality. Objective: To examine the association between the likelihood of amyloid positron emission tomography (PET) scan positivity and ambient air quality in individuals with cognitive impairment. Design, Setting, and Participants: This cross-sectional study used data from the Imaging Dementia-Evidence for Amyloid Scanning Study, which included more than 18 000 US participants with cognitive impairment who received an amyloid PET scan with 1 of 3 Aß tracers (fluorine 18 [18F]-labeled florbetapir, 18F-labeled florbetaben, or 18F-labeled flutemetamol) between February 16, 2016, and January 10, 2018. A sample of older adults with mild cognitive impairment (MCI) or dementia was selected. Exposures: Air pollution was estimated at the patient residence using predicted fine particulate matter (PM2.5) and ground-level ozone (O3) concentrations from the Environmental Protection Agency Downscaler model. Air quality was estimated at 2002 to 2003 (early, or approximately 14 [range, 13-15] years before amyloid PET scan) and 2015 to 2016 (late, or approximately 1 [range, 0-2] years before amyloid PET scan). Main Outcomes and Measures: Primary outcome measure was the association between air pollution and the likelihood of amyloid PET scan positivity, which was measured as odds ratios (ORs) and marginal effects, adjusting for demographic, lifestyle, and socioeconomic factors and medical comorbidities, including respiratory, cardiovascular, cerebrovascular, psychiatric, and neurological conditions. Results: The data set included 18 178 patients, of which 10 991 (60.5%) had MCI and 7187 (39.5%) had dementia (mean [SD] age, 75.8 [6.3] years; 9333 women [51.3%]). Living in areas with higher estimated biennial PM2.5 concentrations in 2002 to 2003 was associated with a higher likelihood of amyloid PET scan positivity (adjusted OR, 1.10; 95% CI, 1.05-1.15; z score = 3.93; false discovery rate [FDR]-corrected P < .001; per 4-µg/m3 increments). Results were similar for 2015 to 2016 data (OR, 1.15; 95% CI, 1.05-1.26, z score = 3.14; FDR-corrected P = .003). An average marginal effect (AME) of +0.5% (SE = 0.1%; z score, 3.93; 95% CI, 0.3%-0.7%; FDR-corrected P < .001) probability of amyloid PET scan positivity for each 1-µg/m3 increase in PM2.5 was observed for 2002 to 2003, whereas an AME of +0.8% (SE = 0.2%; z score = 3.15; 95% CI, 0.3%-1.2%; FDR-corrected P = .002) probability was observed for 2015 to 2016. Post hoc analyses showed no effect modification by sex (2002-2003: interaction term ß = 1.01 [95% CI, 0.99-1.04; z score = 1.13; FDR-corrected P = .56]; 2015-2016: ß = 1.02 [95% CI, 0.98-1.07; z score = 0.91; FDR-corrected P = .56]) or clinical stage (2002-2003: interaction term ß = 1.01 [95% CI, 0.99-1.03; z score = 0.77; FDR-corrected P = .58]; 2015-2016: ß = 1.03; 95% CI, 0.99-1.08; z score = 1.46; FDR-corrected P = .47]). Exposure to higher O3 concentrations was not associated with amyloid PET scan positivity in both time windows. Conclusions and Relevance: This study found that higher PM2.5 concentrations appeared to be associated with brain Aß plaques. These findings suggest the need to consider airborne toxic pollutants associated with Aß pathology in public health policy decisions and to inform individual lifetime risk of developing AD and dementia.

Association of Amyloid Positron Emission Tomography With Subsequent Change in Clinical Management Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia.

Importance: Amyloid positron emission tomography (PET) detects amyloid plaques in the brain, a core neuropathological feature of Alzheimer disease. Objective: To determine if amyloid PET is associated with subsequent changes in the management of patients with mild cognitive impairment (MCI) or dementia of uncertain etiology. Design, Setting, and Participants: The Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study was a single-group, multisite longitudinal study that assessed the association between amyloid PET and subsequent changes in clinical management for Medicare beneficiaries with MCI or dementia. Participants were required to meet published appropriate use criteria stating that etiology of cognitive impairment was unknown, Alzheimer disease was a diagnostic consideration, and knowledge of PET results was expected to change diagnosis and management. A total of 946 dementia specialists at 595 US sites enrolled 16 008 patients between February 2016 and September 2017. Patients were followed up through January 2018. Dementia specialists documented their diagnosis and management plan before PET and again 90 (±30) days after PET. Exposures: Participants underwent amyloid PET at 343 imaging centers. Main Outcomes and Measures: The primary end point was change in management between the pre- and post-PET visits, as assessed by a composite outcome that included Alzheimer disease drug therapy, other drug therapy, and counseling about safety and future planning. The study was powered to detect a 30% or greater change in the MCI and dementia groups. One of 2 secondary end points is reported: the proportion of changes in diagnosis (from Alzheimer disease to non-Alzheimer disease and vice versa) between pre- and post-PET visits. Results: Among 16 008 registered participants, 11 409 (71.3%) completed study procedures and were included in the analysis (median age, 75 years [interquartile range, 71-80]; 50.9% women; 60.5% with MCI). Amyloid PET results were positive in 3817 patients with MCI (55.3%) and 3154 patients with dementia (70.1%). The composite end point changed in 4159 of 6905 patients with MCI (60.2% [95% CI, 59.1%-61.4%]) and 2859 of 4504 patients with dementia (63.5% [95% CI, 62.1%-64.9%]), significantly exceeding the 30% threshold in each group (P < .001, 1-sided). The etiologic diagnosis changed from Alzheimer disease to non-Alzheimer disease in 2860 of 11 409 patients (25.1% [95% CI, 24.3%-25.9%]) and from non-Alzheimer disease to Alzheimer disease in 1201 of 11 409 (10.5% [95% CI, 10.0%-11.1%]). Conclusions and Relevance: Among Medicare beneficiaries with MCI or dementia of uncertain etiology evaluated by dementia specialists, the use of amyloid PET was associated with changes in clinical management within 90 days. Further research is needed to determine whether amyloid PET is associated with improved clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02420756.

Hospice Admission and Survival After 18F-Fluoride PET Performed for Evaluation of Osseous Metastatic Disease in the National Oncologic PET Registry.

We have previously reported that PET using 18F-fluoride (NaF PET) for assessment of osseous metastatic disease was associated with substantial changes in intended management in Medicare beneficiaries participating in the National Oncologic PET Registry (NOPR). Here, we use Medicare administrative data to examine the association between NaF PET results and hospice claims within 180 d and 1-y survival. Methods: We classified NOPR NaF PET results linked to Medicare claims by imaging indication (initial staging [IS]; detection of suspected first osseous metastasis [FOM]; suspected progression of osseous metastasis [POM]; or treatment monitoring [TM]) and type of cancer (prostate, lung, breast, or other). Results were classified as definitely positive scan findings versus probably positive scan findings versus negative scan findings for osseous metastasis for IS and FOM; more extensive disease versus no change or less extensive disease for POM; and worse prognosis versus no change or better prognosis for TM, based on the postscan assessment. Our study included 21,167 scans obtained from 2011 to 2014 of consenting NOPR participants aged 65 y or older. Results: The relative risk of hospice claims within 180 d of a NaF PET scan was 2.0-7.5 times higher for patients with evidence of new or progressing osseous metastasis than for those without, depending on indication and cancer type (all P < 0.008). The percentage difference in hospice claims for those with a finding of new or more advanced osseous disease ranged from 3.9% for IS prostate patients to 28% for FOM lung patients. Six-month survival was also associated with evidence of new or increased osseous disease; risk of death was 1.8-5.1 times as likely (all P ≤ 0.0001), with percentage differences of approximately 30% comparing positive and negative scans in patients with lung cancer imaged for IS or FOM. Conclusion: Our analyses demonstrated that NaF PET scan results are highly associated with subsequent hospice claims and, ultimately, with patient survival. NaF PET provides important information on the presence of osseous metastasis and prognosis to assist patients and their physicians when making decisions on whether to select palliative care and transition to hospice or whether to continue treatment.

Intended Versus Inferred Treatment After 18F-Fluoride PET Performed for Evaluation of Osseous Metastatic Disease in the National Oncologic PET Registry.

We have previously reported that PET with 18F-fluoride (NaF PET) for assessment of osseous metastatic disease led to changes in intended management in a substantial fraction of patients with prostate or other types of cancer participating in the National Oncologic PET Registry. This study was performed to assess the concordance of intended patient management after NaF PET and inferred management based on analysis of Medicare claims. Methods: We analyzed linked post-NaF PET data of consenting National Oncologic PET Registry participants age 65 y or older from 2011 to 2014 and their corresponding Medicare claims. Post-NaF PET treatment plans, including combinations of 2 modes of therapy, were assessed for their concordance with clinical actions inferred from Medicare claims. NaF PET studies were stratified by indication (initial staging [IS] or suspected first osseous metastasis [FOM]) and cancer type (prostate, lung, or other cancers). Agreement was assessed between post-NaF PET intended management plans for treatment (surgery, radiotherapy, or systemic therapy) within 90 d for lung and 180 d for prostate or other cancers, and for watching (the absence of treatment claims for ≥60 d) as compared with claims-inferred care. Results: Actions after 9,898 scans were assessed. After NaF PET for IS, there was claims agreement for planned surgery in 76.0% (19/25) lung, 75.4% (98/130) other cancers, and 58.9% (298/506) prostate cancer. Claims confirmed chemotherapy plans after NaF PET done for IS or FOM in 81.0% and 73.5% for lung cancer (n = 148 and 136) and 69.4% and 67.5% for other cancers (n = 111 and 228). For radiotherapy plans, agreement ranged from 80.0% to 84.4% after IS and 68.4% to 74.0% for suspected FOM. Concordance was greatest for androgen deprivation therapy (ADT) (86.0%, n = 308) alone or combined with radiotherapy in prostate cancer IS (80.8%, n = 517). In prostate FOM, the concordance across all treatment plans was lower if the patients had ADT claims within 180 d before NaF PET. Agreement with nontreatment plans was high for FOM (87.2% in other cancers and 78.6% if no prior ADT in prostate) and low after IS (40.7%-62.5%). Conclusion: Concordance of post-NaF PET plans and claims was substantial and higher overall for IS than for FOM.

Impact on Patient Management of [18F]-Fluorodeoxyglucose-Positron Emission Tomography (PET) Used for Cancer Diagnosis: Analysis of Data From the National Oncologic PET Registry.

INTRODUCTION: We assessed the impact of [(18)F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) on intended management of patients in the National Oncologic PET Registry (NOPR) for three different diagnostic indications: (a) determining whether a suspicious lesion is cancer (Dx), (b) detecting an unknown primary tumor site when there is confirmed or strongly suspected metastatic disease (cancer of unknown primary origin [CUP]), and (c) detecting a primary tumor site when there is a presumed paraneoplastic syndrome (PNS). METHODS: We reviewed a sample of randomly selected reports of NOPR subjects who underwent PET for Dx and CUP and all reports for PNS to find subjects for analysis. For these studies, we evaluated the impact of PET on referring physicians' intended management, based on their management plans reported before and after PET. RESULTS: Intended management was changed more frequently in the CUP group (43.1%) than in the Dx (23.9%) and PNS (25.4%) groups (CUP vs. Dx, p < .0001; PNS vs. Dx, p < .0001; CUP vs. PNS, p < .0002). Referring physicians reported that, in light of PET results, they were able to avoid further testing in approximately three-fourths of patients (71.8%-74.6%). At the time when the post-PET forms were completed, biopsies of suspicious sites had been performed in 21.2%, 32.4%, and 23.2%, respectively, of Dx, CUP, and PNS cases. CONCLUSION: Our analysis of NOPR data shows that PET appears to have a substantial impact on intended management when used for three common diagnostic indications. IMPLICATIONS FOR PRACTICE: [(18)F]-fluorodeoxyglucose-positron emission tomography appears to have a substantial impact on intended management when used for three targeted diagnostic indications: (a) determining whether a suspicious lesion is cancer, (b) detecting an unknown primary tumor site in a patient with confirmed or strongly suspected metastatic disease, and (c) detecting a primary tumor site in a patient with a presumed paraneoplastic syndrome.

Real-World Conundrums and Biases in the Use of White Cell Growth Factors.

We present the 2015 American Society of Clinical Oncology (ASCO) white cell growth factors, or colony-stimulating factor (CSF), guidelines, updated from 2006. One new indication has been added-dose-intense chemotherapy for bladder cancer-to accompany the existing use for dose-dense breast cancer chemotherapy. Colony-stimulating factors remain appropriate for any regimen where the risk of febrile neutropenia is about 20% per cycle and dose reduction is not appropriate. Based on new evidence from multiple trials, CSF use is no longer indicated in treatment of lymphoma unless there are special risk factors. The United States accounts for 78% of the sales of CSF. The panel approved the use of all biosimilars, but the cost savings will be small as the price is about 80% of the branded CSFs. More biosimilars at lower cost are awaited. Methods to reduce use without harm to patients, by requiring justification according to accepted guidelines, are ongoing.

18F-fluoride PET used for treatment monitoring of systemic cancer therapy: results from the National Oncologic PET Registry.

UNLABELLED: In a national prospective registry, we previously studied the impact of (18)F-sodium fluoride PET (NaF PET) on the intended management of cancer patients with osseous metastases. The clinical impact of NaF PET for monitoring the response to systemic therapies in such patients is unknown. The objective of this study was to assess the impact of NaF PET results obtained for treatment monitoring of systemic cancer therapy. METHODS: Before and after NaF PET, we collected prospective data from referring and interpreting physicians for cancer patients 65 y or older receiving systemic therapy (use of 1 or more categories including hormonal, chemotherapy, bisphosphonates, or immunotherapy). The analysis set consisted of 2,217 patients who underwent 2,839 scans (68% prostate, 17% breast, 6% lung, and 8% other cancers) ordered for treatment monitoring. Two or more categories of systemic therapy were planned in 56% of prostate and 43% of breast cancer patients. RESULTS: The overall rates of prior radionuclide bone imaging were 78%, 76%, and 66% for prostate, breast, and other cancers, respectively. Fifty-seven percent of patients underwent prior NaF PET. Overall change in management associated with NaF PET was 40%. In patients with prior NaF PET scans for comparison, continuing current therapy was planned in 79% when scans showed no change or a decrease or absence of osseous metastasis. Treating physicians planned to switch therapy in 59% of patients after scans showed evidence of new or progressive metastasis. When an additional parameter, estimated prognosis, was worse, switching therapy was even more common (76%). CONCLUSION: The impact of NaF PET used for treatment monitoring was high in patients with evidence of progressive osseous metastasis. Most such patients had plans to switch to a new cancer-directed therapy.

Impact of (18)F-Fluoride PET on Intended Management of Patients with Cancers Other Than Prostate Cancer: Results from the National Oncologic PET Registry.

UNLABELLED: The National Oncologic PET Registry prospectively assessed the impact of PET with (18)F-sodium fluoride (NaF PET) on intended management of Medicare patients with suspected or known osseous metastasis. We report our findings for cancers other than prostate and make selected comparisons to our previously reported prostate cancer cohort. METHODS: Data were collected from both referring and interpreting physicians before and after NaF PET in patients (age ≥ 65 y) stratified for initial staging (IS; n = 570), for suspected first osseous metastasis (FOM; n = 1,814; breast, 781 [43%]; lung, 380 [21%]; and all other cancers, 653 [36%]), and for suspected progression of osseous metastasis (POM; n = 435). RESULTS: The dominant indication was bone pain. If NaF PET were unavailable, conventional bone scintigraphy would have been ordered in 85% of patients. In IS, 28% of patients had suspected or confirmed nonosseous metastasis. If neither conventional bone scintigraphy nor NaF PET were available, referring physicians would have ordered other advanced imaging more than 70% of the time rather than initiate treatment for suspected FOM (11%-16%) or POM (18%-22%). When intended management was classified as either treatment or nontreatment, the intended management change for each cancer type was highest in POM, lower in IS, and lowest in FOM. For suspected FOM, intended management change was lower in breast (24%), lung (36%), or other cancers (31%), compared with prostate cancer (44%) (P < 0.0001), but the NaF PET finding (normal/benign/equivocal, probable, or definite metastases) frequencies were similar across cancer types. After normal/benign/equivocal PET results, 15% of breast, 30% lung, and 38% prostate cancer patients had treatment, likely reflecting differences in management of nonosseous disease. For patients with definite metastasis on NaF PET, nonprostate, compared with prostate, cancer patients had post-PET plans for more frequent biopsy, alternative imaging, chemotherapy, and radiotherapy. In the smaller IS and POM cohorts, differences among cancer types were not significant. CONCLUSION: Overall, NaF PET led to change in intended management in a substantial fraction of nonprostate cancer patients. In the setting of suspected FOM, NaF PET had a lower immediate impact on the treat/nontreat decision in nonprostate versus prostate cancer patients, which is consistent with current practice guidelines.

Impact of 18F-fluoride PET in patients with known prostate cancer: initial results from the National Oncologic PET Registry.

UNLABELLED: Under Medicare's Coverage with Evidence Development policy, PET using (18)F-sodium fluoride (NaF PET) to identify osseous metastasis became a covered service if prospective registry data were collected. The National Oncologic PET Registry (NOPR) developed a NaF PET registry built on the foundation of its prior registry for PET with (18)F-FDG. Men with prostate cancer represented 72% of the cases. METHODS: Prospective data before and after NaF PET were collected from referring and interpreting physicians. The analysis set consisted of consenting men age 65 y or older with prostate cancer undergoing NaF PET for initial staging (IS, n = 1,024), suspected first osseous metastasis (FOM, n = 1,997), or suspected progression of osseous metastasis (POM, n = 510). RESULTS: Referring physicians indicated that if NaF PET were not available, other advanced imaging (body CT, MR imaging, or (18)F-FDG PET) would be their plan in about half of the cases. After NaF PET, the postimaging plan was revised to treatment in 77%, 52%, and 71% for IS, FOM, and POM, respectively. When intended management was classified as either treatment or nontreatment, the overall change in intended management ranged from 44% to 52% and from 12% to 16% if no effect was assumed for those cases with pre-PET plans for other imaging (imaging-adjusted impact). Interpreting physicians recorded definite findings of bone metastasis in 14%, 29%, and 76% for IS, FOM, and POM, respectively. The intended care patterns varied widely across indication and scan abnormality category combinations. CONCLUSION: NaF PET has high overall impact, principally related to its effect on replacing intended use of other advanced imaging. Its imaging-adjusted impact was similar to that observed with (18)F-FDG PET for restaging or suspected recurrence in other cancer types.

Intended versus inferred care after PET performed for initial staging in the National Oncologic PET Registry.

UNLABELLED: The National Oncologic PET Registry (NOPR) collected data on intended management before and after PET in cancer patients. We have previously reported that PET was associated with a change in intended management of about one third of patients and was consistent across cancer types. It is uncertain if intended management plans reflect the actual care these patients received. One approach to assess actual care received is using administrative claims to categorize the type and timing of clinical services. METHODS: NOPR data from 2006 to 2008 were linked to Medicare claims for consenting patients aged 65 y or older undergoing initial-staging PET scanning for bladder, ovarian, pancreatic, small cell lung, or stomach cancers. We determined the 60-d agreement between claims-inferred care and NOPR treatment plans. RESULTS: Patients (n = 4,661) were assessed, and 30%-52% had metastatic disease. Planned treatments were about two-thirds monotherapy, of which 46% was systemic therapy only, and one-third combinations. Claims paid by 60 d confirmed the NOPR plan of any systemic therapy, radiotherapy, or surgery in 79.3%, 64.7%, and 63.6%, respectively. Single-mode plans were much more often confirmed: systemic therapy in more than 85% of patients with ovarian, pancreatic, and small cell lung cancers and surgery in more than 73% of those with bladder, pancreatic, and stomach cancers. Intended combination treatments had claims for both in only 28% of patients receiving surgery-based combinations and in 55% receiving chemoradiotherapy. About 90% of patients with NOPR-planned systemic therapy had evaluation or management claims from a medical oncologist. An age of less than 75 y was associated more often with confirmation of chemotherapy, less often for radiotherapy but not with confirmation of surgery. Performance status or comorbidity did not explain confirmation rates within action categories, but confirmation rates were higher if the referrer specialized in the planned treatment. CONCLUSION: Claims confirmations of NOPR intent for initial staging were widely variable but were higher than previously reported for restaging PET, suggesting that measuring change in intended management is a reasonable method for assessing the impact diagnostic tests have on actual care.

The lack of evidence for PET or PET/CT surveillance of patients with treated lymphoma, colorectal cancer, and head and neck cancer: a systematic review.

UNLABELLED: PET and PET/CT are widely used for surveillance of patients after cancer treatments. We conducted a systematic review to assess the diagnostic accuracy and clinical impact of PET and PET/CT used for surveillance in several cancers. METHODS: We searched MEDLINE and Cochrane Library databases from 1996 to March 2012 for English-language studies of PET or PET/CT used for surveillance of patients with lymphoma, colorectal cancer, or head and neck cancer. We included prospective or retrospective studies that reported test accuracy and comparative studies that assessed clinical impact. RESULTS: Twelve studies met our inclusion criteria: 6 lymphoma (n = 767 patients), 2 colorectal cancer (n = 96), and 4 head and neck cancer (n = 194). All studies lacked a uniform definition of surveillance and scan protocols. Half the studies were retrospective, and a third were rated as low quality. The majority reported sensitivities and specificities in the range of 90%-100%, although several studies reported lower results. The only randomized controlled trial, a colorectal cancer study with 65 patients in the surveillance arm, reported earlier detection of recurrences with PET and suggested improved clinical outcomes. CONCLUSION: There is insufficient evidence to draw conclusions on the clinical impact of PET or PET/CT surveillance for these cancers. The lack of standard definitions for surveillance, heterogeneous scanning protocols, and inconsistencies in reporting test accuracy preclude making an informed judgment on the value of PET for this potential indication.

Intended versus inferred management after PET for cancer restaging: analysis of Medicare claims linked to a coverage with evidence development registry.

BACKGROUND: The National Oncologic PET Registry (NOPR) ascertained changes in the intended management of cancer patients using questionnaire data obtained before and after positron emission tomography (PET) under Medicare's coverage with evidence development policy. OBJECTIVE: To assess the concordance between intended care plans and care received as ascertained through administrative claims data. RESEARCH DESIGN: Analysis of linked data of NOPR participants from 2006 to 2008 and their corresponding Medicare claims. SUBJECTS: Consenting patients aged older than 65 years having their first PET for restaging of bladder, kidney, ovarian, pancreas, prostate, small cell lung, or stomach cancer. MEASURES: : Agreement (positive predictive values and κ) between NOPR post-PET intended management plans for treatment (systemic therapy, radiotherapy, surgery, or combinations), biopsy, or watching as compared to claims-inferred care 30 days after PET. RESULTS: A total of 8460 patients with linked data were assessed. A total of 43.5% had metastatic disease and 45.3% had treatment planned (predominantly systemic therapy only), 11.1% biopsy and 43.5% watching. Claims-confirmed intended plans (positive predictive value) for single-mode systemic therapy in 62.0%, radiation in 66.0%, surgery in 45.6%, and biopsy in 55.7%. A total of 25.7% of patients with a plan of watching had treatment claims. By cancer type, κ ranged for systemic therapy only from 0.17 to 0.40 and for watching from 0.21 to 0.41. Agreement rates varied by cancer types but were minimally associated with patient age, performance status, comorbidity, or stage. CONCLUSIONS: Among elderly cancer patients undergoing PET for restaging, there was moderate concordance between their physicians' planned management and claims-inferred actions within a narrow time window. When higher accuracy levels are required in future coverage with evidence development studies, alternative designs will be needed.

Geographic and sociodemographic disparities in PET use by Medicare beneficiaries with cancer.

PURPOSE: PET use for cancer care has increased unevenly, possibly because of regional health care market characteristics or underlying population characteristics. The aim of this study was to examine variation in advanced imaging use among individuals with cancer in relation to population and hospital service area (HSA) characteristics. METHODS: A retrospective national study of fee-for-service Medicare beneficiaries with diagnoses of 1 of 5 cancers covered by Medicare for PET (2004-2008) was conducted. Crude and adjusted rates of PET, CT, and MRI were estimated for HSAs and sociodemographic subgroups. Generalized linear mixed models were used to assess the effects of race/ethnicity, area-level income, and HSA-level physician supply and spending on imaging utilization. RESULTS: On the basis of an annual average of 116,452 beneficiaries with cancer, adjusted PET rates (imaging days per person-year) showed significantly higher use for whites compared with blacks in both 2004 (whites, 0.35 [95% confidence interval, 0.34-0.36]; blacks, 0.31 [95% confidence interval, 0.30-0.33]) and 2008 (whites, 0.64 [95% confidence interval, 0.63-0.65]; blacks, 0.57 [95% confidence interval, 0.55-0.59]). This trend was similar for the highest quartile of group-level median household income but was opposite for CT use, with blacks having higher rates than whites. The highest Medicare-spending HSAs had significantly higher adjusted PET rates compared with lower spending areas (0.57 [95% confidence interval, 0.55-0.60] vs 0.69 [95% confidence interval, 0.67-0.71] imaging days/person-year). CONCLUSIONS: The use of PET among Medicare beneficiaries with cancer increased from 2004 to 2008, with higher rates observed among whites, among higher socioeconomic groups, and in higher Medicare spending areas. Sociodemographic differences in advanced imaging use are modality specific.