Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate.

BACKGROUND: The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers' efforts to accrue patients to clinical trials has not been well described. METHODS: First, members of cancer research centers and community-based institutions (n = 252) were surveyed to assess the status of insurance denials, and then, a focused survey (n = 77) collected denial details. Univariate and multivariate analyses were used to examine associations between the receipt of denials and site characteristics. RESULTS: Overall, 62.7% of the initial survey respondents reported at least 1 insurance denial during 2014. Sites using a precertification process were 3.04 times more likely to experience denials (95% confidence interval, 1.55-5.99; P ≤ .001), and similar rates of denials were reported from sites located in states with preexisting clinical trial coverage laws versus states without them (82.3% vs 85.1%; χ = 50.7; P ≤ .001). Among the focused survey sites, academic centers reported denials more often than community sites (71.4% vs 46.4%). The failure of plans to cover trial participation was cited as the most common reason provided for denials (n = 33 [80.5%]), with nearly 80% of sites (n = 61) not receiving a coverage response from the insurer within 72 hours. CONCLUSIONS: Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts. Cancer 2017;123:2893-900. © 2017 American Cancer Society.

Status of oncologic specialties: global survey of physicians treating cancer.

BACKGROUND: In the United States, medical oncologists play a central role in the management of systemic therapy for cancer patients. Medical oncology as a specialty is not as established in Japan and several other European nations according to recent surveys, and little is known about this specialty in developing nations. We aimed to identify global differences in the roles of physicians treating cancer; specifically, how the management of advanced disease differs among nations. METHODS: In March 2016, a self-administered internet survey was conducted with degreed physicians who prescribed systemic agents for adult cancer treatment within the past 5 years. Physicians were identified from the American Society of Clinical Oncology active member online directory. RESULTS: Among 3907 members in 55 nations, 376 (9.6%) responded to the survey. The 310 respondents who provided an answer to the recognition of medical oncology were dominated by male MDs that have practiced for more than 5 years at academic centers, and ~60% were medical oncologists. A majority of the respondents in all four regions reported that medical oncology was established in their corresponding nations. However, there are several outlying nations where oncologic specialties play a minimal role in the management of systemic therapy. CONCLUSION: Despite general recognition of medical oncology, the role is not globally established as the primary point of care for delivery of systemic therapy. Nations lacking this specialty should be assisted by the international community to develop medical oncology.

An Event-Related Potential (ERP) Examination of the Neural Responses to Emotional and Movement-Related Images.

Previous research has suggested that the perception of emotional images may also activate brain regions related to the preparation of motoric plans. However, little research has investigated whether these emotion-movement interactions occur at early or later stages of visual perception. In the current research, event-related potentials (ERPs) were used to examine the time course of the independent - and combined - effects of perceiving emotions and implied movement. Twenty-five participants viewed images from four categories: 1) emotional with implied movement, 2) emotional with no implied movement, 3) neutral with implied movement, and 4) neutral with no implied movement. Both emotional stimuli and movement-related stimuli led to larger N200 (200-300 ms) waveforms. Furthermore, at frontal sites, there was a marginal interaction between emotion and implied movement, such that negative stimuli showed greater N200 amplitudes vs. neutral stimuli, but only for images with implied movement. At posterior sites, a similar effect was observed for images without implied movement. The late positive potential (LPP; 500-1000 ms) was significant for emotion (at frontal sites) and movement (at frontal, central, and posterior sites), as well as for their interaction (at parietal sites), with larger LPPs for negative vs. neutral images with movement only. Together, these results suggest that the perception of emotion and movement interact at later stages of visual perception.

Giant PMMA Foreign Body Granulomas with Imaging.

Filler complications have a wide array of presentations including early and late manifestations. A rare late complication is the foreign body granuloma or granulomatous foreign body reaction. We present a case of giant foreign body granulomas developing 7 years after polymethylmethacrylate (PMMA) filler injection. The patient had an excellent response to a single intralesional injection of triamcinolone acetonide and 5-fluorouracil. The unique opportunity to have pretreatment and posttreatment magnetic resonance imaging (MRI) allows for appreciation of the multidirectional expansion of these granulomas as well as the response in this case. Updated treatment recommendations based on the literature review support the use of oral antibiotics, oral steroids, and intralesional therapies. Surgical excision is reserved as an absolute last resort due to potential complications.

Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices.

BACKGROUND: Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients of guideline-concordant care each year. Existing strategies to increase urologists' offer of clinical trials are designed for resource-rich environments and are not feasible for many community urologists. We sought to design an implementation intervention for dissemination in under-resourced community urology practices and to compare its acceptability, appropriateness and adoption appeal among trial-naïve and trial-experienced urologists. METHODS: We used a design-for-dissemination approach, informed by the Theoretical Domains Framework and Behavior Change Wheel, to match determinants of the clinical trial offer to theoretically informed implementation strategies. We described the implementation intervention in evaluation workshops offered at urology professional society meetings. We surveyed participants to assess the implementation intervention's acceptability and appropriateness using validated instruments. We also measured adoption appeal, intention to adopt and previous trial offer. RESULTS: Our design process resulted in a multi-modal implementation intervention, comprised of multiple implementation strategies designed to address six domains from the Theoretical Domains Framework. Evaluation workshops delivered at four meetings, convened five separate professional societies. Sixty-one percent of those offered an opportunity to participate in the implementation intervention indicated intention to adopt. Average implementation intervention acceptability and appropriateness ratings were 4.4 and 4.4 (out of 5), respectively. Acceptability scores were statistically significantly higher among those offering trials compared to those not (p = 0.03). Appropriateness scores did not differ between those offering trials and those not (p = 0.24). After urologists ranked their top three innovation attributes, 43% of urologists included practice reputation in their top three reasons for offering clinical trials; 30% listed practice differentiation among their top three reasons. No statistically significant differences were found between those who offered trials and those who did not among any of the innovation attributes. CONCLUSIONS: LEARN|INFORM|RECRUIT is a promising implementation intervention to address low accrual to clinical trials, poised for implementation and effectiveness testing. The implementation intervention is appealing to its target audience and may have equal uptake among trial-naïve and trial-experienced practices.

Science in the Heartland: Exploring determinants of offering cancer clinical trials in rural-serving community urology practices.

OBJECTIVE: Engaging community urologists in referring patients to clinical trials could increase the reach of cancer trials and, ultimately, alleviate cancer disparities. We sought to identify determinants of referring patients to clinical trials among urology practices serving rural communities. METHODS: We conducted semistructured qualitative interviews based on the Theoretical Domains Framework at nonmetropolitan urology practices located in communities offering urological cancer trials. Participants were asked to consider barriers and strategies that might support engaging their patients in discussions about urological cancer clinical trials and referring them appropriately. Recorded interviews were transcribed and coded using template analysis. RESULTS: Most participants were not aware of available trials and had no experience with trial referral. Overall, participants held positive attitudes toward clinical trials and recognized their potential roles in accrual, but limited local resources reduced opportunities for offering trials. Most participants expressed a need for increased human, financial, and other resources to support this role. Many participants requested information and training to increase their knowledge of clinical trials and confidence in offering them to patients. Participants highlighted the need to build efficient pathways to identify available trials, match eligible patients, and facilitate communication and collaboration with cancer centers for patient follow-up and continuity of care. CONCLUSIONS: With adequate logistical and informational support, community urology practices could play an important role in clinical trial accrual, advancing cancer research and increasing treatment options for rural cancer patients. Future studies should explore the effectiveness of strategies to optimize urology practices' role in clinical trial accrual.

Who treats lung cancer? Results from a global survey.

BACKGROUND: In most Western nations, the medical oncologist plays a significant role in the administration of systemic therapy for lung cancer. In Japan however, treatment for lung cancer has historically been provided by pulmonologists and thoracic surgeons. A comparison of the management of advanced disease between Japan and other nations has not been described. METHODS: An online, self-administered, international survey was sent to 3907 active members of the American Society of Clinical Oncology. Eligible participants were degreed physicians who prescribed systemic agents for adult cancer treatment within the past five years. RESULTS: In total, 281 respondents answered the questions regarding management of lung cancer. Thorough analysis demonstrated that pulmonologists play a significant role in Japan and the Netherlands, where the role of oncologic specialists is not well established. Of note, all the respondents from the Netherlands reported that pulmonary medicine primarily manages systemic chemotherapy in stage IV, adjuvant chemotherapy, and targeted therapy. CONCLUSION: We found there are several nations where non-oncologic specialists play a critical role in the systemic treatment of lung cancer. We expect this practice pattern to continue until the global adoption of the oncologic specialty role.

Clinical trial insurance coverage for cancer patients under the Affordable Care Act.

BACKGROUND: Participation in cancer clinical trials has been shown to increase overall survival with minimal increase in cost, but enrollment in adult cancer clinical trials remains low. One factor limiting enrollment is lack of insurance coverage, but this barrier should be reduced under the 2010 Patient Protection and Affordable Care Act (ACA), which includes a provision requiring coverage for clinical trial participation as of 2014. METHODS: To assess the number of Kansas adults aged 19-64, newly covered with health insurance for participation in oncology clinical trials as a result of the ACA, a cross sectional design using extracted data from the 2012 American Community Survey, Public Use Microdata Sample to estimate the number of individuals covered by insurance and data from the 2014 Department of Health and Human Services Health Insurance Marketplace enrollment to estimate those newly enrolled through ACA. RESULTS: In 2014, there was an estimated increase of 3% (54,397; 95% CI: 44,149-64,244) for a total of 72% (1,171,041) of Kansans aged 19 to 64 with health insurance coverage for clinical trial participation. CONCLUSION: Three main factors limit the effectiveness of the ACA provisions in expanding clinical trial coverage: 1) 'grandfathered' self-funded employer plans not subject to state Employee Retirement Income Security Act (ERISA) regulations, 2) Medicaid coverage limits not addressed under the ACA, 3) populations that remain uninsured. Kansas saw a negligible increase in insurance coverage as a result of the ACA thus lack of insurance coverage is likely to remain a concern for cancer patients.

A phase I study of intraperitoneal nanoparticulate paclitaxel (Nanotax®) in patients with peritoneal malignancies.

PURPOSE: This multicenter, open-label, dose-escalating, phase I study evaluated the safety, tolerability, pharmacokinetics and preliminary tumor response of a nanoparticulate formulation of paclitaxel (Nanotax®) administered intraperitoneally for multiple treatment cycles in patients with solid tumors predominantly confined to the peritoneal cavity for whom no other curative systemic therapy treatment options were available. METHODS: Twenty-one patients with peritoneal malignancies received Nanotax® in a modified dose-escalation approach utilizing an accelerated titration method. All patients enrolled had previously received chemotherapeutics and undergone surgical procedures, including 33 % with optimal debulking. Six doses (50-275 mg/m(2)) of Cremophor-free Nanotax® were administered intraperitoneally for one to six cycles (every 28 days). RESULTS: Intraperitoneal (IP) administration of Nanotax® did not lead to increases in toxicity over that typically associated with intravenous (IV) paclitaxel. No patient reported ≥Grade 2 neutropenia and/or ≥Grade 3 neurologic toxicities. Grade 3 thrombocytopenia unlikely related to study medication occurred in one patient. The peritoneal concentration-time profile of paclitaxel rose during the 2 days after dosing to peritoneal fluid concentrations 450-2900 times greater than peak plasma drug concentrations and remained elevated through the entire dose cycle. Best response assessments were made in 16/21 patients: Four patients were assessed as stable or had no response and twelve patients had increasing disease. Five of 21 patients with advanced cancers survived longer than 400 days after initiation of Nanotax® IP treatment. CONCLUSIONS: Compared to IV paclitaxel administration, Cremophor-free IP administration of Nanotax® provides higher and prolonged peritoneal paclitaxel levels with minimal systemic exposure and reduced toxicity.