Percutaneous Ablation Versus Partial and Radical Nephrectomy for T1a Renal Cancer: A Population-Based Analysis.

Background: Stage T1a renal cell carcinoma (RCC) (tumors <4 cm) is usually curable. Nephron-sparing partial nephrectomy (PN) has replaced radical nephrectomy (RN) as the standard of care for these tumors. Radical nephrectomy remains the first alternative treatment option, whereas percutaneous ablation (PA), a newer, nonsurgical treatment, is recommended less strongly because of the relative paucity of comparative PA data. Objective: To compare PA, PN, and RN outcomes. Design: Observational cohort analysis using inverse probability of treatment-weighted propensity scores. Setting: Population-based SEER (Surveillance, Epidemiology, and End Results) cancer registry data linked to Medicare claims. Patients: Persons aged 66 years or older who received treatment for T1a RCC between 2006 and 2011. Interventions: PA versus PN and RN. Measurements: RCC-specific and overall survival, 30- and 365-day postintervention complications. Results: 4310 patients were followed for a median of 52 months for overall survival and 42 months for RCC-specific survival. After PA versus PN, the 5-year RCC-specific survival rate was 95% (95% CI, 93% to 98%) versus 98% (CI, 96% to 99%); after PA versus RN, 96% (CI, 94% to 98%) versus 95% (CI, 93% to 96%). After PA versus PN, the 5-year overall survival rate was 77% (CI, 74% to 81%) versus 86% (CI, 84% to 88%); after PA versus RN, 74% (CI, 71% to 78%) versus 75% (CI, 73% to 77%). Cumulative rates of renal insufficiency 31 to 365 days after PA, PN, and RN were 11% (CI, 8% to 14%), 9% (CI, 8% to 10%), and 18% (CI, 17% to 20%), respectively. Rates of nonurologic complications within 30 days after PA, PN, and RN were 6% (CI, 4% to 9%), 29% (CI, 27% to 30%), and 30% (CI, 28% to 32%), respectively. Ten percent of patients in the PN group had intraoperative conversion to RN. Seven percent of patients in the PA group received additional PA within 1 year of treatment. Limitations: Analysis of observational data may have been affected by residual confounding by provider or from selection bias toward younger, healthier patients in the PN group. Findings from this older study population are probably less applicable to younger patients. Use of SEER-Medicare linked files prevented analysis of patients who received treatment after 2011, possibly reducing generalizability to the newest PA, PN, and RN techniques. Conclusion: For well-selected older adults with T1a RCC, PA may result in oncologic outcomes similar to those of RN, but with less long-term renal insufficiency and markedly fewer periprocedural complications. Compared with PN, PA may be associated with slightly shorter RCC-specific survival but fewer periprocedural complications. Primary Funding Source: Association of University Radiologists GE Radiology Research Academic Fellowship and Society of Interventional Radiology Foundation.

Preventable and mitigable adverse events in cancer care: Measuring risk and harm across the continuum.

BACKGROUND: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings. METHODS: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012. Candidate AEs, or injuries due to medical care, were identified by trained nurse reviewers over the course of 1 year from medical records and safety-reporting databases. Physicians determined the AE harm severity and the likelihood of preventability and harm mitigation. RESULTS: The 400-patient sample represented 133,358 days of follow-up. Three hundred four AEs were identified for an overall rate of 2.3 events per 1000 patient days (91.2 per 1000 inpatient days and 0.9 per 1000 outpatient days). Thirty-four percent of the patients had 1 or more AEs (95% confidence interval, 29%-39%), and 16% of the patients had 1 or more preventable or mitigable AEs (95% confidence interval, 13%-20%). The AE rate for patients with breast cancer was lower than the rate for patients with colorectal or lung cancer (P ≤ .001). The preventable or mitigable AE rate was 0.9 per 1000 patient days. Six percent of AEs and 4% of preventable AEs resulted in serious harm. Examples included lymphedema, abscess, and renal failure. CONCLUSIONS: A heavy burden of AEs, including preventable or mitigable events, has been identified. Future research should examine risk factors and improvement strategies for reducing their burden. Cancer 2017;123:4728-4736. © 2017 American Cancer Society.

Facilitating informed decisions about breast cancer screening: development and evaluation of a web-based decision aid for women in their 40s.

BACKGROUND: Expert groups and national guidelines recommend individualized decision making about screening mammography for women in their 40s at low-to-average risk of breast cancer. We created Breast Screening Decisions (BSD), a personalized, web-based decision aid, to help women decide when to start and how often to have routine screening mammograms. We evaluated BSD in a large, prospective pilot trial of women and their clinicians. METHODS: Women ages 40-49 were invited to use BSD before a scheduled preventive care visit. One month post-visit, users were asked about decisional conflict, knowledge, perceptions and worry about breast cancer and screening. They were also asked whether they had a screening mammogram since their visit, scheduled an appointment for a screening mammogram, or if they were planning to schedule an appointment within the next six months. Women who responded "no" to each of these successive questions were considered to have no plan for a screening mammogram within the next 6 months, unless they explicitly stated that they were unsure about screening mammography. Clinicians were surveyed regarding mammography discussions and perceived patient knowledge and anxiety. RESULTS: Of 1,100 women invited to use BSD, 253 accessed the website, and 168 were eligible to participate in the pilot study. One-fifth had a family history of breast cancer, and at least 76% had any prior mammogram. At follow-up, 88% of BSD users reported discussing mammography at their visit, and 77% said they had a screening mammogram since the visit or that they made or were planning to make a screening mammogram appointment. The average decisional conflict score was 22.5, within the threshold for implementing decisions. Decisional conflict scores were lowest in women who said that they had or planned to have a mammogram (mean 21.4, 95% CI 18.3-24.6), higher in those who did not (mean 24.8, 95% CI 19.2-30.5), and highest in those who were unsure (mean 31.5, 95% CI 13.9-49.1). Most BSD users expressed accurate perceptions of their breast cancer risk and the benefits and limitations of screening. CONCLUSIONS: A web-based decision aid may support informed, individualized decisions about screening mammography and facilitate discussions about screening between women in their 40s and their clinicians.

Patterns of surveillance imaging after nephrectomy in the Medicare population.

OBJECTIVES: To characterize patterns of imaging surveillance after nephrectomy in a population-based cohort of older patients with kidney cancer. PATIENTS AND METHODS: Using the Surveillance, Epidemiology and End Results (SEER)-Medicare database, we identified patients aged ≥ 66 years who underwent partial or radical nephrectomy for localized kidney cancer diagnosed between 2000 and 2009. Primary outcomes were chest imaging (X-ray or computed tomography [CT]) and abdominal imaging (CT, MRI or ultrasonography) in Medicare claims from 4 to 36 months after surgery. We estimated the frequency of imaging in three time periods (postoperative months 4-12, 13-24, 25-36), stratified by tumour stage. Repeated-measures logistic regression was used to identify the patient and disease characteristics associated with imaging. RESULTS: Rates of chest imaging were 65-80%, with chest X-ray surpassing CT in each time period. Rates of abdominal imaging were 58-76%, and cross-sectional imaging was more common than ultrasonography in each time period. Use of cross-sectional chest and abdominal imaging increased over time, while the use of chest X-ray decreased (P < 0.01). Ultrasonography use remained stable for patients with T1 and T2 disease, but the rate of use decreased in patients with T3 disease (P < 0.05). Rates of chest and abdominal imaging increased with tumour stage (P < 0.001). CONCLUSIONS: Patterns of imaging suggest possible overuse in patients at low risk of recurrence and underuse in those at greater risk. New surveillance imaging guidelines may reduce unwarranted variability and promote risk-based, cost-effective management after nephrectomy.

Treatment-related toxicities in older adults with head and neck cancer: A population-based analysis.

BACKGROUND: Despite advantages in terms of cancer control and organ preservation, the benefits of chemotherapy and radiation therapy (CTRT) may be offset by potentially severe treatment-related toxicities, particularly in older patients. The objectives of this study were to assess the types and frequencies of toxicities in older adults with locally or regionally advanced head and neck squamous cell carcinoma (HNSCC) who were receiving either primary CTRT or radiation therapy (RT) alone. METHODS: With Surveillance, Epidemiology, and End Results cancer registry data linked with Medicare claims, patients who were 66 years old or older with locally advanced HNSCC, were diagnosed from 2001 to 2009, and received CTRT or RT alone were identified. Differences in the frequency of toxicity-related hospital admissions and emergency room visits as well as feeding tube use were examined, and controlling for demographic and disease characteristics, this study estimated the impact of chemotherapy on the likelihood of toxicity. RESULTS: Among patients who received CTRT (n = 1502), 62% had a treatment-related toxicity, whereas 46% of patients who received RT alone (n = 775) did. When the study controlled for demographic and disease characteristics, CTRT patients were twice as likely to experience an acute toxicity in comparison with their RT-only peers. Fifty-five percent of CTRT patients had a feeding tube placed during or after treatment, whereas 28% of the RT-only group did. CONCLUSIONS: In this population-based cohort of older adults with HNSCC, the rates of acute toxicities and feeding tube use in patients receiving CTRT were considerable. It is possible that for certain older patients, the potential benefit of adding chemotherapy to RT does not outweigh the harms of this combined-modality therapy.

Provider Differences in Use of Implanted Ports in Older Adults With Cancer.

BACKGROUND: Identifying unwarranted variation in health care can highlight opportunities to reduce harm. One often discretionary process in oncology is use of implanted ports to administer intravenous chemotherapy. While there are benefits, ports carry risks. This study's objective was to assess provider-driven variation in port use among cancer patients receiving chemotherapy. RESEARCH DESIGN: Retrospective assessment using population-based SEER-Medicare data to assess differences in port use across health care providers of older adults with cancer. Participants included over 18,000 patients ages 66 and older diagnosed with breast, colorectal, lung, or pancreatic cancer in 2005-2007, treated by approximately 2900 providers. We identified port use for patients receiving treatment from hospital outpatient facilities versus physicians' offices. Our main analysis assessed the likelihood of a patient receiving a port given port use by the provider's last patient. For a subset of high-use providers, we examined individual provider-level variation by estimating the risk-adjusted likelihood of insertion. RESULTS: Patients receiving chemotherapy in hospital outpatient facilities were significantly less likely to receive a port than those treated in physicians' offices, with adjusted odds ratios (AOR) varying from 0.50 to 0.75 across cancer sites. Implanting a port was associated with increased likelihood of port insertion in the provider's next patient (AOR varied from 1.71 to 2.25). Significant between-provider variation was found among providers with at least 10 patients. CONCLUSIONS: Our findings support the idea that there is provider-driven variation in the use of ports for chemotherapy administration. This variation highlights an opportunity to standardize practice and reduce unnecessary use.

Gender disparities in hematuria evaluation and bladder cancer diagnosis: a population based analysis.

PURPOSE: Men are diagnosed with bladder cancer at 3 times the rate of women. However, women present with advanced disease and have poorer survival, suggesting delays in bladder cancer diagnosis. Hematuria is the presenting symptom in most cases. We assessed gender differences in hematuria evaluation in older adults with bladder cancer. MATERIALS AND METHODS: Using the SEER (Surveillance, Epidemiology and End Results) cancer registry linked with Medicare claims we identified Medicare beneficiaries 66 years old or older diagnosed with bladder cancer between 2000 and 2007 with a claim for hematuria in the year before diagnosis. We examined the impact of gender, and demographic and clinical factors on time from initial hematuria claim to urology visit and on time from initial hematuria claim to hematuria evaluation, including cystoscopy, upper urinary tract imaging and urine cytology. RESULTS: Of 35,646 patients with a hematuria claim in the year preceding bladder cancer diagnosis 97% had a urology visit claim. Mean time to urology visit was 27 days (range 0 to 377). Time to urology visit was longer for women than for men (adjusted HR 0.9, 95% CI 0.87-0.92). Women were more likely to undergo delayed (after greater than 30 days) hematuria evaluation (adjusted OR 1.13, 95% CI 1.07-1.21). CONCLUSIONS: We observed longer time to a urology visit for women than for men presenting with hematuria. These findings may explain stage differences in bladder cancer diagnosis and inform efforts to decrease gender disparities in bladder cancer stage and outcomes.

Changes in the availability of screening mammography, 2000-2010.

BACKGROUND: Rates of screening mammography have plateaued, and the number of mammography facilities has declined in the past decade. The objective of this study was to assess changes over time and geographic disparities in the availability of mammography services. METHODS: Using information from the US Food and Drug Administration and the US Census, county-level mammography capacity was defined as the number of mammography machines per 10,000 women aged ≥ 40 years. Cross-sectional variation and longitudinal changes in capacity were examined in relation to county characteristics. RESULTS: Between 2000 and 2010, the number of mammography facilities declined 10% from 9434 to 8469, the number of mammography machines declined 10% from 13,100 to 11,762, and the median county mammography capacity decreased nearly 20% from 1.77 to 1.42 machines per 10,000 women aged ≥ 40 years. In cross-sectional analysis, counties with greater percentages of uninsured residents, less educated residents, greater population density, and higher managed care penetration had lower mammography capacity. Conversely, counties with more hospital beds per 100,000 population had higher capacity. High initial mammography capacity, growth in both the percentage of the population aged ≥ 65 years and the percentage living in poverty, and increased managed care penetration were all associated with a decrease in mammography capacity between 2000 and 2010. Only the percentage of rural residents was associated with an increase in capacity. CONCLUSIONS: Geographic variation in mammography capacity and declines in capacity over time are associated with demographic, socioeconomic, and health care market characteristics. Maldistribution of mammography resources may explain geographic disparities in breast cancer screening rates.

Changes in access to screening mammography, 2008-2011.

Screening mammography is a cornerstone of preventive health care for adult women in the United States. As rates of screening mammography have declined and plateaued in the past decade, access to services remains a concern. In 2011, we repeated a survey of mammography facilities initially surveyed in 2008 in six states. The availability of digital mammography increased and appointment wait times generally improved between the two survey periods, but more facilities required payment upfront. Provisions of the federal healthcare reform law that eliminate cost sharing for selected preventive health services may improve access to screening mammography and prevent further declines in the rate of breast cancer screening.

Risk of incisional hernia after minimally invasive and open radical prostatectomy.

PURPOSE: The number of radical prostatectomies has increased. Many urologists have shifted from the open surgical approach to minimally invasive techniques. It is not clear whether the risk of post-prostatectomy incisional hernia varies by surgical approach. MATERIALS AND METHODS: In the linked Surveillance, Epidemiology and End Results (SEER)-Medicare data set we identified men 66 years old or older who were treated with minimally invasive or open radical prostatectomy for prostate cancer diagnosed from 2003 to 2007. The main study outcome was incisional hernia repair, as identified in Medicare claims after prostatectomy. We also examined the frequency of umbilical, inguinal and other hernia repairs. RESULTS: We identified 3,199 and 6,795 patients who underwent minimally invasive and open radical prostatectomy, respectively. The frequency of incisional hernia repair was 5.3% at a median 3.1-year followup in the minimally invasive group and 1.9% at a 4.4-year median followup in the open group, corresponding to an incidence rate of 16.1 and 4.5/1,000 person-years, respectively. Compared to the open technique, the minimally invasive procedure was associated with more than a threefold increased risk of incisional hernia repair when controlling for patient and disease characteristics (adjusted HR 3.39, 95% CI 2.63-4.38, p<0.0001). Minimally invasive radical prostatectomy was associated with an attenuated but increased risk of any hernia repair compared with open radical prostatectomy (adjusted HR 1.48, 95% CI 1.29-1.70, p<0.0001). CONCLUSIONS: Minimally invasive radical prostatectomy was associated with a significantly increased risk of incisional hernia compared with open radical prostatectomy. This is a potentially remediable complication of prostate cancer surgery that warrants increased vigilance with respect to surgical technique.

Trends in the use of incontinence procedures after radical prostatectomy: a population based analysis.

PURPOSE: Urinary incontinence is a frequent complication of radical prostatectomy with a detrimental impact on quality of life. We identified predictors and trends in the use of procedures for post-prostatectomy incontinence. MATERIALS AND METHODS: Using SEER (Surveillance, Epidemiology and End Results) cancer registry data linked with Medicare claims, we identified men 66 years old or older who were treated with radical prostatectomy in 2000 to 2007. The primary outcome was performance of an incontinence procedure. Demographic and clinical predictors of incontinence surgery were evaluated by multivariable regression analysis. RESULTS: Of 16,348 men treated with radical prostatectomy 1,057 (6%) had undergone at least 1 incontinence procedure by a median of 20 months after the procedure, including 61% who underwent the first incontinence procedure within 2 years of prostatectomy. Older age and residence in the South were associated with greater probability of an incontinence procedure. Black men and those living in nonmetropolitan areas were less likely than their peers to undergo an incontinence procedure. Of men treated with any incontinence procedure 15% underwent more than 1 type. Of those treated with bulking agents 39% also received a urethral sling or artificial urinary sphincter and 13% who received a sling also had an artificial urinary sphincter. In 34% of the men who underwent any incontinence surgery artificial urinary sphincter placement was the only procedure performed. CONCLUSIONS: In this population based cohort of older men with prostate cancer only 6% underwent an incontinence procedure after prostatectomy. This low rate may reflect the underuse of potentially beneficial procedures.

Costs and trends in pancreatic cancer treatment.

BACKGROUND: Pancreatic cancer poses a substantial morbidity and mortality burden in the United States, and predominantly affects older adults. The objective of this study was to estimate the direct medical costs of pancreatic cancer treatment in a population-based cohort of Medicare beneficiaries, and the contribution of different treatment modalities and health care services to the total cost of care and trends in costs over time. METHODS: In the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, pancreatic cancer patients were identified who were aged 66 years or older and who were diagnosed from 2000 to 2007. Total direct medical costs were estimated from Medicare payments overall and within categories of care. Costs attributable to pancreatic cancer were estimated by subtracting the costs of medical care in a matched cohort of cancer-free beneficiaries. RESULTS: A total of 15,037 patients were identified, of whom 97% were observed from diagnosis until death. Mean total direct medical costs were $65,500. Mean total costs were greater for patients with resectable locoregional disease ($134,700) than for those with unresectable locoregional or distant disease ($65,300 and $49,000, respectively). Hospitalizations and cancer-directed procedures collectively accounted for the largest fraction of health care costs. The total cost of care appeared to increase slightly over the study period (P = .05). The mean costs attributable to pancreatic cancer were $61,700. CONCLUSIONS: Despite poor prognosis and short survival, the economic burden of pancreatic cancer in the elderly is substantial. Demographic trends, greater use of targeted therapies, and possible implementation of screening strategies are likely to impact treatment patterns and costs in the future.

Androgen deprivation and thromboembolic events in men with prostate cancer.

BACKGROUND: Androgen deprivation therapy (ADT) improves prostate cancer outcomes in specific clinical settings, but is associated with adverse effects, including cardiac complications and possibly thromboembolic complications. The objective of this study was to estimate the impact of ADT on thromboembolic events (TEs) in a population-based cohort. METHODS: In the linked Surveillance, Epidemiology and End Results-Medicare database, we identified men older than 65 who were diagnosed with nonmetastatic prostate cancer between 1999 and 2005. Medical or surgical ADT was identified by Medicare claims for gonadotropin-releasing hormone agonists or bilateral orchiectomy at any time following diagnosis. TEs included deep venous thrombosis, pulmonary embolism, and arterial embolism. The impact of ADT on the risk of any TE and on total number of events was estimated, controlling for patient and tumor characteristics. RESULTS: Of 154,611 patients with prostate cancer, 58,466 (38%) received ADT. During a median follow-up of 52 months, 15,950 men had at least 1 TE, including 8829 (55%) who had ADT and 7121 (45%) with no ADT. ADT was associated with increased risk of a TE (adjusted hazard ratio = 1.56; 95% confidence interval, 1.50-1.61; P < .0001), and duration of ADT was associated with the total number of events (P < .0001). CONCLUSIONS: In this population-based cohort, ADT was associated with increased risk of a TE, and longer durations of ADT were associated with more TEs. Men with intermediate- and low-risk prostate cancer should be assessed for TE risk factors before starting ADT and counseled regarding the risks and benefits of this therapy.

Mammography capacity and appointment wait times: barriers to breast cancer screening.

OBJECTIVE: To assess the impact of mammography capacity on appointment wait times. METHODS: We surveyed by telephone all mammography facilities federally certified in 2008 in California, Connecticut, Georgia, Iowa, New Mexico, and New York using a simulated patient format. County-level mammography capacity, defined as the number of mammography machines per 10,000 women aged 40 and older, was estimated from FDA facility certification records and US Census data. RESULTS: 1,614 (86%) of 1,882 mammography facilities completed the survey. Time until next available screening mammogram appointment was <1 week at 55% of facilities, 1-4 weeks at 34% of facilities, and >1 month at 11% of facilities. Facilities in counties with lower capacity had longer wait times, and a one-unit increase in county capacity was associated with 21% lower odds of a facility reporting a wait time >1 month (p < 0.01). There was no association between wait time and the availability of evening or weekend appointments or digital mammography. CONCLUSION: Lower mammography capacity is associated with longer wait times for screening mammograms. IMPACT: Enhancement of mammography resources in areas with limited capacity may reduce wait times for screening mammogram appointments, thereby increasing access to services and rates of breast cancer screening.

Locally advanced prostate cancer: a population-based study of treatment patterns.

UNLABELLED: Study Type--Therapy (practice patterns). Level of Evidence 2b. What's known on the subject? And what does the study add? The treatment of locally advanced prostate cancer varies widely even though there is level one evidence supporting the use of multimodality therapy as compared with monotherapy. This study defines treatment patterns of locally advanced prostate cancer within the United States and identifies predicators of who receives multimodality therapy rather than monotherapy. OBJECTIVE: • To identify treatment patterns and predictors of receiving multimodality therapy in patients with locally advanced prostate cancer (LAPC). PATIENTS AND METHODS: • The cohort comprised patients ≥66 years with clinical stage T3 or T4 non-metastatic prostate cancer diagnosed between 1998 and 2005 identified from the Surveillance, Epidemiology and End Results (SEER) cancer registry records linked with Medicare claims. • Treatments were classified as radical prostatectomy (RP), radiation therapy (RT) and androgen deprivation therapy (ADT) received within 6 and 24 months of diagnosis. • We assessed trends over time and used multivariable logistic regression to identify predictors of multimodality treatment. RESULTS: • Within the first 6 months of diagnosis, 1060 of 3095 patients (34%) were treated with a combination of RT and ADT, 1486 (48%) received monotherapy (RT alone, ADT alone or RP alone), and 461 (15%) received no active treatment. • The proportion of patients who received RP increased, exceeding 10% in 2005. • Use of combined RT and ADT and use of ADT alone fluctuated throughout the study period. • In all 6% of patients received RT alone in 2005. • Multimodality therapy was less common in patients who were older, African American, unmarried, who lived in the south, and who had co-morbidities or stage T4 disease. CONCLUSIONS: • Treatment of LAPC varies widely, and treatment patterns shifted during the study period. • The slightly increased use of multimodality therapy since 2003 is encouraging, but further work is needed to increase combination therapy in appropriate patients and to define the role of RP.

Risk Factors for Adverse Events in Patients With Breast, Colorectal, and Lung Cancer.

OBJECTIVE: The aim of the study was to identify risk factors associated with medical errors and iatrogenic injuries during an initial course of cancer-directed treatment. METHODS: In this retrospective cohort study of 400 patients 18 years or older undergoing an initial course of treatment for breast, colorectal, or lung cancer at a comprehensive cancer center, we abstracted patient, disease, and treatment-related variables from the electronic medical record. We examined adverse events (AEs) and preventable AEs by risk factor using the χ2 or Fisher exact tests. We estimated the association between risk factors and the relative risk of an additional AE or preventable AE in multivariable negative binomial regression models with backwards selection (P < 0.1). RESULTS: There were 304 AEs affecting 136 patients (34%) and 97 preventable AEs affecting 53 patients (13%). In multivariable analyses, AEs were overrepresented in those with lung cancer compared with patients with breast cancer (incident rate ratio = 1.9, 95% confidence interval = 1.1-3.2). Nonwhite race (1.6, 1.0-2.6), Hispanic or Latino ethnicity (2.0, 0.9-4.1), advanced disease (1.7, 1.1-2.6), use of each additional class of high-risk nonchemotherapy medication (1.6, 1.3-1.9), and chemotherapy (2.1, 1.3-3.3) were all associated with risk of an additional AE. Preventable AEs were associated with lung cancer (7.4, 2.4-23.2), Hispanic or Latino ethnicity (5.5, 1.7-17.9), and high-risk nonchemotherapy medications (1.5, 1.2-2.0). CONCLUSIONS: Risk factors for AEs among patients with cancer reflected patients' underlying disease, cancer-directed therapy, and high-risk noncancer medications. The association of AEs with ethnicity merits further research. Risk factor models could be used prospectively to identify patients with cancer at increased risk of harm.

Practice Patterns for Older Adult Patients With Advanced Cancer: Physician Office Versus Hospital Outpatient Setting.

PURPOSE: A shift in outpatient oncology care from the physician's office to hospital outpatient settings has generated interest in the effect of practice setting on outcomes. Our objective was to examine whether medical oncologists' prescribing of drugs and services for older adult patients with advanced cancer is used more in physicians' offices compared with hospital outpatient departments. METHODS: This was a retrospective comparative study. SEER-Medicare data (2004 to 2011) were used to identify Medicare beneficiaries diagnosed with advanced breast, colon, esophagus, non-small-cell lung, pancreatic, or stomach cancer. Between physicians' offices and hospital outpatient departments, we compared use of selected likely low-value supportive drugs, low-value therapeutic drugs, chemotherapy-related hospitalizations, and hospice. We used hierarchical modeling to assess differences between settings to account for correlation within physicians. RESULTS: Compared with patients treated in a hospital outpatient department, those treated in a physician's office setting were more likely to receive erythropoiesis-stimulating agents (odds ratio, 1.72; 95% CI, 1.53 to 1.94) and granulocyte colony-stimulating factors (odds ratio, 1.28; 95% CI, 1.18 to 1.38). For combination chemotherapy and nanoparticle albumin-bound-paclitaxel in patients with breast cancer, there was a trend toward higher use in physicians' offices, although this was not statistically significant. Chemotherapy-related hospitalizations and hospice did not vary by setting. CONCLUSION: We found somewhat higher use of several drugs for patients with advanced cancer in physicians' office settings compared with hospital outpatient departments. Findings support research to dissect the mechanisms through which setting might influence physicians' behavior.

Delays in the Publication of Important Clinical Trial Findings in Oncology.

Importance: The complete and timely dissemination of clinical trial data is essential to all fields of medicine, with delayed or incomplete data release having potentially deleterious effects on both patient care and scientific inquiry. While prior analyses have noted a substantial lag in the reporting of final clinical study results, we sought to refine these observations through use of a novel starting point for the measurement of dissemination delays: the date of a corporate press release regarding a phase 3 study's results. Objective: To measure the length of time elapsed between when a sponsor had results of study findings they deemed important to announce, and when the medical community had access to them. Design and Setting: Covering the years 2011 through 2016, we measured the delay from when 8 large pharmaceutical companies issued a press release announcing completed analyses of phase 3 clinical trials in oncology, and the public sharing of those results either on ClinicalTrials.gov or in a peer-reviewed biomedical journal as found via PubMed or Google Scholar. Press releases announcing regulatory steps and presentation schedules for conferences were excluded, as were those announcing results from preclinical trials, follow-up analyses, and studies of supportive care therapies or various modes of infusion for the same therapy. Main Outcomes and Measures: Time to public dissemination of clinical trial data. Results: Of the 100 press releases in our sample, 70 (70%) reported positive results, but only 31 (31%) included the magnitude of study findings. Through the end of follow-up, 99 (99%) of press releases had an associated peer-reviewed publication, complete data posting to ClinicalTrials.gov, or both, with a median time to reporting of 300 days (95% CI, 263-348 days). Positive findings were reported more quickly than negative ones (median of 272; 95% CI, 211-318 days vs 407; 95% CI, 298-705 days; log-rank P < .001). Conclusions and Relevance: Even for the most pressing study findings, median publication delays approach 1 year. As publication delays hinder research progress and advancements in clinical care, policies that enable early preprint release or public posting of completed data analysis should be pursued.

Long-term quality of life in older patients with HPV-related oropharyngeal cancer.

BACKGROUND: We explored if age affects quality of life (QOL) in survivors of locally advanced human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (SCC). METHODS: In a cross-sectional survey of 185 patients, at least 12 months from radiation, we evaluated generic (EuroQOL-5D questionnaire [EQ-5D]) and head and neck specific (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35-questions [EORTC-QLQ-H&N35]) QOL questionnaires and compared differences between younger (<65) and older (≥65) patients. RESULTS: The median age was 57.0 years (range 25-77 years), and 31 patients (16.8%) were ≥65 years old. There was no significant difference in EQ-5D global QOL scores by age (P = .53). Patients ≥65 years reported more immobility (P < .01), problems with social eating (P < .0001), and coughing (P < .01). Patients ≥65 years were not more likely to ever require a gastrostomy (P = .24) but were more likely to remain gastrostomy-dependent at the time of the survey (P = .02). CONCLUSION: Despite similar generic QOL, older survivors may have more mobility problems and issues with social eating compared with younger survivors deserving of further evaluation.

Influence of renal biopsy results on the management of small kidney cancers in older patients: Results from a population-based cohort.

BACKGROUND AND OBJECTIVE: Small kidney cancers are a heterogeneous group with varying malignant potential. Pathologic information obtained from a renal biopsy may guide decision-making for small kidney cancers. We sought to assess the effect of pathologic information from renal biopsy on the nonsurgical management of small kidney cancers in a population-based cohort of patients over 65 years of age. METHODS: In the Surveillance, Epidemiology and End Results-Medicare dataset, we identified patients ≥66 years diagnosed with a kidney cancer<4cm between 2002 and 2011. Diagnostic biopsy was defined by a Medicare claim within 1 month prior through 6 months following cancer diagnosis or before surgery. Nonsurgical management was defined by the absence of a claim for partial or radical nephrectomy or tumor ablation in the first 6 months following diagnosis. The relationship between patient and tumor characteristics and the likelihood of nonsurgical management by receipt of diagnostic biopsy was assessed by multivariable logistic regression models. RESULTS: From 8,933 patients, 2,782 (31%) had a diagnostic renal biopsy of whom 616 (22%) were managed nonsurgically. Controlling for patient, disease, and provider specialty, biopsy was associated with nonsurgical management (adjusted odds ratio = 1.61, 95% Cl: 1.43-1.82) in patients with low-grade tumors but also with more aggressive histology (clear cell renal cell carcinoma). Older age (85+) and geographic region were significantly associated with greater odds of diagnostic biopsy. Patients whose initial renal tumor diagnosis was made by a urologist (vs. other type of provider) were less likely to receive a biopsy (adjust odds ratio = 0.73, 95% Cl: 0.60-0.89). CONCLUSIONS: Although the use of renal biopsy has increased over time and is associated with the use of nonsurgical management of small kidney cancers, the use of the pathologic findings remains limited. Further advances, particularly with prognostic markers, are necessary before renal biopsy can be routinely implemented for treatment decision-making for small kidney cancers.