Trends in new and persistent opioid use in older adults with and without cancer.

BACKGROUND: The impact of ongoing efforts to decrease opioid use on patients with cancer remains undefined. Our objective was to determine trends in new and additional opioid use in patients with and without cancer. METHODS: This retrospective cohort study used data from Surveillance, Epidemiology, and End Results program-Medicare for opioid-naive patients with solid tumor malignancies diagnosed from 2012 through 2017 and a random sample of patients without cancer. We identified 238 470 eligible patients with cancer and further focused on 4 clinical strata: patients without cancer, patients with metastatic cancer, patients with nonmetastatic cancer treated with surgery alone ("surgery alone"), and patients with nonmetastatic cancer treated with surgery plus chemotherapy or radiation therapy ("surgery+"). We identified new, early additional, and long-term additional opioid use and calculated the change in predicted probability of these outcomes from 2012 to 2017. RESULTS: New opioid use was higher in patients with cancer (46.4%) than in those without (6.9%) (P < .001). From 2012 to 2017, the predicted probability of new opioid use was more stable in the cancer strata (relative declines: 0.1% surgery alone; 2.4% surgery+; 8.8% metastatic cancer), than in the noncancer stratum (20.0%) (P < .001 for each cancer to noncancer comparison). Early additional use declined among surgery patients (‒14.9% and ‒17.5% for surgery alone and surgery+, respectively) but was stable among patients with metastatic disease (‒2.8%, P = .50). CONCLUSIONS: Opioid prescribing declined over time at a slower rate in patients with cancer than in patients without cancer. Our study suggests important but tempered effects of the changing opioid climate on patients with cancer.

Post-operative radiation therapy for non-small cell lung cancer: A comparison of radiation therapy techniques.

OBJECTIVES: Post-operative radiation therapy (PORT) in locally advanced non-small cell lung cancer (LA-NSCLC) has historically been associated with toxicity. Conformal techniques like intensity modulated radiation therapy (IMRT) have the potential to reduce acute and long-term toxicity from radiation therapy. Among patients receiving PORT for LA-NSCLC, we identified factors associated with receipt of IMRT and evaluated the association between IMRT and toxicity. METHODS: We queried the Surveillance, Epidemiology, and End Results (SEER)-Medicare database between January 1, 2006 to December 31, 2014 to identify patients diagnosed with Stage II or III NSCLC and who received upfront surgery and subsequent PORT. Baseline differences between patients receiving 3-dimentional conformal radiation therapy (3D-CRT) and IMRT were assessed using the chi-squared test for proportions and the t-test for means. Multivariable logistic regression was used to identify predictors of receipt of IMRT and pulmonary, esophageal, and cardiac toxicity. Propensity-score matching was employed to reduce the effect of known confounders. RESULTS: A total of 620 patients met the inclusion criteria, among whom 441 (71.2%) received 3D-CRT and 179 (28.8%) received IMRT. The mean age of the cohort was 73.9 years and 54.7% were male. The proportion of patients receiving IMRT increased from 6.2% in 2006 to 41.4% in 2014 (P < 0.001). IMRT was not associated with decreased pulmonary (OR 0.89; 95% CI, 0.62-1.29), esophageal (OR 1.09; 95% CI, 0.0.75-1.58), or cardiac toxicity (OR 1.02; 95% CI, 0.69-1.51). These findings held on propensity-score matching. Clinical risk factors including comorbidity and prior treatment history were associated with treatment toxicity. CONCLUSION: In a cohort of elderly patients, the use of IMRT in the setting of PORT for LA-NSCLC was not associated with a difference in toxicity compared to 3D-CRT. This finding suggests that outcomes from PORT may be independent of radiotherapy treatment technique.

Financial relationships between industry and principal investigators of US cooperative group randomized cancer clinical trials.

Financial conflicts of interest (FCOIs) could bias the potentially practice-changing oncologic randomized clinical trials (RCTs) of tomorrow. This investigation characterized the FCOIs of the principal investigators (PIs) of all currently accruing trials of the four (adult) cooperative groups of the National Clinical Trials Network. For our study, the PI list was first compiled, and each name was then searched in the CMS Open Payments database. For each transaction (general payments (GPs) or research funding (RF)), the amount/number/source of payments was recorded. Results showed that from 2014 to 2019, the 91 PIs collectively accepted nearly one-third of a billion dollars ($10 477 023 GPs and $320 096 233 RF). The mean and median GP was $6505 and $945, respectively, and $301 693 and $49 824 RF, respectively. Multivariable Gamma regression analysis revealed that higher GP sums were associated with RCTs involving any type of systemic therapy, and higher RF sums with medical oncologist PIs, trials with phase III components, and RCTs involving radiotherapy (P < .05 for all). Both higher-volume GPs and RF were predicted by PIs having accepted payment(s) from the manufacturer of the drug utilized in their RCT (P < .001 GP, P = .008 RF). Taken together, the main message of this investigation is that FCOIs may be particularly high in PIs of phase III systemic therapy trials, especially if the PI accepted payments from the manufacturer of the drug utilized in their trial. Such RCTs should be thoroughly scrutinized by medical journals, the FDA, and insurance companies for potential "industry bias" that could influence the integrity of their conclusions.

Temporal Trends in Opioid Prescribing Patterns Among Oncologists in the Medicare Population.

BACKGROUND: In the wake of the US opioid epidemic, there have been efforts to curb opioid prescribing. However, it is unknown whether these efforts have affected prescribing among oncologists, whose patients often require opioids for symptom management. We investigated temporal patterns in opioid prescribing for Medicare beneficiaries among oncologists and nononcologists. METHODS: We queried the Centers for Medicare and Medicaid Services Part D prescriber dataset for all physicians between January 1, 2013, and December 31, 2017. We used population-averaged multivariable negative binomial regression to estimate the association between time and per-provider opioid and gabapentinoid prescribing rate, defined as the annual number of drug claims (original prescriptions and refills) per beneficiary, among oncologists and nononcologists on a national and state level. RESULTS: From 2013 to 2017, the national opioid-prescribing rate declined by 20.7% (P < .001) among oncologists and 22.8% (P < .001) among non oncologists. During this time frame, prescribing of gabapentin increased by 5.9% (P < .001) and 23.1% (P < .001) among oncologists and nononcologists, respectively. Among palliative care providers, opioid prescribe increased by 15.3% (P < .001). During the 5-year period, 43 states experienced a decrease (P < .05) in opioid prescribing among oncologists, and in 5 states, opioid prescribing decreased more among oncologists than nononcologists (P < .05). CONCLUSIONS: Between 2013 and 2017, the opioid-prescribing rate statistically significantly decreased nationwide among oncologists and nononcologists, respectively. Given similar declines in opioid prescribing among oncologists and nononcologists, there is concern that opioid-prescribing guidelines intended for the noncancer population are being applied inappropriately to patients with cancer and cancer survivors.

Emergency Department Visits for Opioid Overdoses Among Patients With Cancer.

BACKGROUND: Patients with cancer may be at risk of high opioid use due to physical and psychosocial factors, although little data exist to inform providers and policymakers. Our aim is to examine overdoses from opioids leading to emergency department (ED) visits among patients with cancer in the United States. METHODS: The Healthcare Cost and Utilization Project Nationwide Emergency Department Sample was queried for all adult cancer-related patient visits with a primary diagnosis of opioid overdose between 2006 and 2015. Temporal trends and baseline differences between patients with and without opioid-related ED visits were evaluated. Multivariable logistic regression analysis was used to identify risk factors associated with opioid overdose. All statistical tests were two-sided. RESULTS: Between 2006 and 2015, there were a weighted total of 35 339 opioid-related ED visits among patients with cancer. During this time frame, the incidence of opioid-related ED visits for overdose increased twofold (P < .001). On multivariable regression (P < .001), comorbid diagnoses of chronic pain (odds ratio [OR] 4.51, 95% confidence interval [CI] = 4.13 to 4.93), substance use disorder (OR = 3.54, 95% CI = 3.28 to 3.82), and mood disorder (OR = 3.40, 95% CI = 3.16 to 3.65) were strongly associated with an opioid-related visit. Patients with head and neck cancer (OR = 2.04, 95% CI = 1.82 to 2.28) and multiple myeloma (OR = 1.73, 95% CI = 1.32 to 2.26) were also at risk for overdose. CONCLUSIONS: Over the study period, the incidence of opioid-related ED visits in patients with cancer increased approximately twofold. Comorbid diagnoses and primary disease site may predict risk for opioid overdose.

Treatment-Related Complications of Systemic Therapy and Radiotherapy.

IMPORTANCE: Systemic therapy and radiotherapy can be associated with acute complications that may require emergent care. However, there are limited data characterizing complications and the financial burden of cancer therapy that are treated in emergency departments (EDs) in the United States. OBJECTIVES: To estimate the incidence of treatment-related complications of systemic therapy or radiotherapy, examine factors associated with inpatient admission, and investigate the overall financial burden. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of the Healthcare Cost and Utilization Project Nationwide Emergency Department Sample was performed. Between January 2006 and December 2015, there was a weighted total of 1.3 billion ED visits; of these, 1.5 million were related to a complication of systemic therapy or radiotherapy for cancer. Data analysis was conducted from February 22 to December 23, 2018. External cause of injury codes, Clinical Classifications Software, International Classification of Diseases, Ninth Revision, Clinical Modification, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10), Clinical Modification codes were used to identify patients with complications of systemic therapy or radiotherapy. MAIN OUTCOMES AND MEASURES: Patterns in treatment-related complications, patient- and hospital-related factors associated with inpatient admission, and median and total charges for treatment-related complications were the main outcomes. RESULTS: Of the 1.5 million ED visits included in the analysis, 53.2% of patients were female and mean age was 63.3 years. Treatment-related ED visits increased by a rate of 10.8% per year compared with 2.0% for overall ED visits. Among ED visits, 90.9% resulted in inpatient admission to the hospital and 4.9% resulted in death during hospitalization. Neutropenia (136 167 [8.9%]), sepsis (128 171 [8.4%]), and anemia (117 557 [7.7%]) were both the most common and costliest (neutropenia: $5.52 billion; sepsis: $11.21 billion; and anemia: $6.78 billion) complications diagnosed on presentation to EDs; sepsis (odds ratio [OR], 21.00; 95% CI, 14.61-30.20), pneumonia (OR, 9.73; 95% CI, 8.08-11.73), and acute kidney injury (OR, 9.60; 95% CI, 7.77-11.85) were associated with inpatient admission. Costs related to the top 10 most common complications totaled $38 billion and comprised 48% of the total financial burden of the study cohort. CONCLUSIONS AND RELEVANCE: Emergency department visits for complications of systemic therapy or radiotherapy increased at a 5.5-fold higher rate over 10 years compared with overall ED visits. Neutropenia, sepsis, and anemia appear to be the most common complications; sepsis, pneumonia, and acute kidney injury appear to be associated with the highest rates of inpatient admission. These complications suggest that significant charges are incurred on ED visits.

Differences in Funding Sources of Phase III Oncology Clinical Trials by Treatment Modality and Cancer Type.

OBJECTIVES: Given the limited resources available to conduct clinical trials, it is important to understand how trial sponsorship differs among different therapeutic modalities and cancer types and to consider the ramifications of these differences. METHODS: We searched clinicaltrials.gov for a cross-sectional register of active, phase III, randomized controlled trials (RCTs) studying treatment-related endpoints such as survival and recurrence for the 24 most prevalent malignancies. We classified the RCTs into 7 categories of therapeutic modality: (1) chemotherapy/other cancer-directed drugs, (2) targeted therapy, (3) surgery, (4) radiation therapy (RT), (5) RT with other modalities, (6) multimodality therapy without RT, and (7) other. RCTs were categorized as being funded by one or more of the following groups: (1) government, (2) hospital/university, (3) industry, and (4) other. χ analysis was performed to detect differences in funding source distribution between modalities and cancer types. RESULTS: The percentage of multimodality trials (5%) and radiation RCTs (4%) funded by industry was less than that for chemotherapy (32%, P<0.01) or targeted therapy (48%, P<0.01). Trials studying targeted therapy were less likely to have hospital/university funding than any of the other modalities (P<0.01 in each comparison). Trials of chemotherapy were more likely to be funded by industry if they also studied targeted therapy (P<0.01). CONCLUSION: RCTs studying targeted therapies are more likely to be funded by industry than trials studying multimodality therapy or radiation. The impact of industry funding versus institutional or governmental sources of funding for cancer research is unclear and requires further study.

Examination of Industry Payments to Radiation Oncologists in 2014 Using the Centers for Medicare and Medicaid Services Open Payments Database.

PURPOSE: To use the Centers for Medicare and Medicaid Services Open Payments database to characterize payments made to radiation oncologists and compare their payment profile with that of medical and surgical oncologists. METHODS AND MATERIALS: The June 2015 release of the Open Payments database was accessed, containing all payments made to physicians in 2014. The general payments dataset was used for analysis. Data on payments made to medical, surgical, and radiation oncologists was obtained and compared. Within radiation oncology, data regarding payment category, sponsorship, and geographic distribution were identified. Basic statistics including mean, median, range, and sum were calculated by provider and by transaction. RESULTS: Among the 3 oncologic specialties, radiation oncology had the smallest proportion (58%) of compensated physicians and the lowest mean ($1620) and median ($112) payment per provider. Surgical oncology had the highest proportion (84%) of compensated physicians, whereas medical oncology had the highest mean ($6371) and median ($448) payment per physician. Within radiation oncology, nonconsulting services accounted for the most money to physicians ($1,042,556), whereas the majority of the sponsors were medical device companies (52%). Radiation oncologists in the West accepted the most money ($2,041,603) of any US Census region. CONCLUSIONS: Radiation oncologists in 2014 received a large number of payments from industry, although less than their medical or surgical counterparts. As the Open Payments database continues to be improved, it remains to be seen whether this information will be used by patients to inform choice of providers or by lawmakers to enact policy regulating physician-industry relationships.