Time to add screening for financial hardship as a quality measure?

Cancer treatment is associated with financial hardship for many patients and families. Screening for financial hardship and referrals to appropriate resources for mitigation are not currently part of most clinical practices. In fact, discussions regarding the cost of treatment occur infrequently in clinical practice. As the cost of cancer treatment continues to rise, the need to mitigate adverse consequences of financial hardship grows more urgent. The introduction of quality measurement and reporting has been successful in establishing standards of care, reducing disparities in receipt of care, and improving other aspects of cancer care outcomes within and across providers. The authors propose the development and adoption of financial hardship screening and management as an additional quality metric for oncology practices. They suggest relevant stakeholders, conveners, and approaches for developing, testing, and implementing a screening and management tool and advocate for endorsement by organizations such as the National Quality Forum and professional societies for oncology care clinicians. The confluence of increasingly high-cost care and widening disparities in ability to pay because of underinsurance and lack of health insurance coverage makes a strong argument to take steps to mitigate the financial consequences of cancer.

Modifiable Barriers and Facilitators for Breast Cancer Care: A Thematic Analysis of Patient and Provider Perspectives.

INTRODUCTION: We sought to examine patient and provider perspectives regarding modifiable contributors to breast cancer treatment and to assess perceptual alignment between these two groups. MATERIALS: Participants were women≥18 y with stage 0-IV breast cancer who received all oncologic care in a single health system and physicians and advanced practice providers who provided medical, radiation, or surgical oncology care for breast cancer. All completed ∼45-min semistructured interviews that were recorded and transcribed verbatim. A 5-stage approach to thematic analysis was conducted, with emergent themes and exemplar quotes placed into clinical, psychological, social/logistical, financial, and lifestyle categories using a multilevel conceptual framework. RESULTS: Eighteen patients (9 Black, 9 White, and median age 60 y) and 10 providers (6 physicians and 4 advanced practice providers) were interviewed from May to November 2018. Both patients and providers perceived suboptimal communication, parking and transportation, and competing family-caregiving responsibilities as modifiable barriers to care. Treatment costs were cited by patients as barriers that were inadequately addressed even with referrals to financial counselors, but providers did not raise the issue of cost unless prompted by patients and did not feel prepared to discuss the topic when it arose. Providers cited obesity as a barrier to treatment, a view not shared by patients. CONCLUSIONS: Several modifiable factors were recognized by both patients and providers as either promoting or detracting from treatment receipt, but there was also significant incongruence and asymmetry. Alignment of provider and patient perceptions regarding contributors to guideline-concordant care receipt could mitigate disparities in breast cancer treatment and outcomes.

A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers.

PURPOSE: Mobile health interventions can improve patient care. We developed the Digital Supportive Care Awareness and Navigation (D-SCAN) application (app) to facilitate symptom monitoring and use/awareness of cancer supportive care resources. This study tested feasibility, usability/satisfaction, and preliminary efficacy of D-SCAN. METHODS: We randomized 50 patients with advanced cancer to receive the D-SCAN intervention or usual care; 10 caregivers also received D-SCAN. The primary feasibility outcome was determined by weekly symptom survey completion and end of study procedures. We assessed secondary outcomes including usability/satisfaction, awareness/use of supportive care resources, patient activation, and quality of life via various questionnaires including the Net Promoter Score (NPS), Patient Activation Measure (PAM-13), Functional Assessment of Cancer Therapy-General (FACT-G), and Caregiver Oncology Quality of Life (CarGOQOL) questionnaire. RESULTS: Seventy-six percent of intervention patients met feasibility criteria, exceeding our pre-determined threshold of 75%. Usability/satisfaction by NPS was high, at 14.3% and 12.5% for patients and caregivers, respectively. Intervention patient and caregiver resource awareness increased by a mean of 3.7 (p = 0.27) and 4.1 items, respectively. Supportive care resource utilization increased by a mean of 0.8 items for intervention patients (p = 0.70) and 0.6 for caregivers. PAM-13 increased by a mean of 1.6 for intervention patients (p = 0.65). FACT-G increased by a mean of 1.1 for intervention patients (p = 0.91), and CarGOQoL increased by a mean of 2.2 (p = 0.41). CONCLUSION: D-SCAN is a feasible, usable, and satisfactory intervention for augmenting patient and caregiver supportive care. Further testing is necessary to formally assess D-SCAN's efficacy and impact on patients and caregivers. CLINICAL TRIAL REGISTRATION NUMBER: NCT03628794. Registered on August 14th, 2018.

Cabozantinib and Panitumumab for RAS Wild-Type Metastatic Colorectal Cancer.

LESSONS LEARNED: Antitumor activity was observed in the study population. Dose modifications of cabozantinib improve long-term tolerability. Biomarkers are needed to identify patient populations most likely to benefit. Further study of cabozantinib with or without panitumumab in patients with metastatic colorectal cancer is warranted. BACKGROUND: The epidermal growth factor receptor (EGFR) antibody panitumumab is active in patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC), but nearly all patients experience resistance. MET amplification is a driver of panitumumab resistance. Cabozantinib is an inhibitor of multiple kinases, including vascular endothelial growth factor receptor 2 (VEGFR2) and c-MET, and may delay or reverse anti-EGFR resistance. METHODS: In this phase Ib clinical trial, we established the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of cabozantinib and panitumumab. We then treated an expansion cohort to further describe the tolerability and clinical activity of the RP2D. Eligibility included patients with KRAS WT mCRC (later amended to include only RAS WT mCRC) who had received prior treatment with a fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab. RESULTS: Twenty-five patients were enrolled and treated. The MTD/RP2D was cabozantinib 60 mg p.o. daily and panitumumab 6 mg/kg I.V. every 2 weeks. The objective response rate (ORR) was 16%. Median progression free survival (PFS) was 3.7 months (90% confidence interval [CI], 2.3-7.1). Median overall survival (OS) was 12.1 months (90% CI, 7.5-14.3). Five patients (20%) discontinued treatment due to toxicity, and 18 patients (72%) required a dose reduction of cabozantinib. CONCLUSION: The combination of cabozantinib and panitumumab has activity. Dose reductions of cabozantinib improve tolerability.

Financial burden, distress, and toxicity in cardiovascular disease.

Cardiovascular disease (CVD) is a major source of financial burden and distress, which has 3 main domains: (1) psychological distress; (2) cost-related care non-adherence or medical care deferral, and (3) tradeoffs with basic non-medical needs. We propose 4 ways to reduce financial distress in CVD: (1) policymakers can expand insurance coverage and curtail underinsurance; (2) health systems can limit expenditure on low-benefit, high-cost treatments while developing services for high-risk individuals; (3) physicians can engage in shared-decision-making for high-cost interventions, and (4) community-based initiatives can support patients with system navigation and financial coping. Avenues for research include (1) analysis of how healthcare policies affect financial burden; (2) comparative effectiveness studies examining high and low-cost strategies for CVD management; and (3) studying interventions to reduce financial burden, financial coaching, and community health worker integration.

Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial.

BACKGROUND: As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. METHODS/DESIGN: The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. DISCUSSION: As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. TRIAL REGISTRATION: This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Does Cancer Treatment-Related Financial Distress Worsen Over Time?

BACKGROUND Patients with cancer are at risk for both objective and subjective financial distress. Financial distress during treatment is adversely associated with physical and mental well-being. Little is known about whether patients' subjective financial distress changes during the course of their treatment.method This is a cross-sectional study of insured adults with solid tumors on anti-cancer therapy for ≥1 month, surveyed at a referral center and three rural oncology clinics. The goal was to investigate how financial distress varies depending on where patients are in the course of cancer therapy. Financial distress (FD) was assessed via a validated measure; out-of-pocket (OOP) costs were estimated and medical records were reviewed for disease/treatment data. Logistic regression was used to evaluate the potential association between treatment length and financial distress.RESULTS Among 300 participants (86% response rate), median age was 60 years (range 27-91), 52.3% were male, 78.3% had stage IV cancer or metastatic recurrence, 36.7% were retired, and 56% had private insurance. Median income was $60,000/year and median OOP costs including insurance premiums were $592/month. Median FD score (7.4/10, SD 2.5) corresponded to low FD with 16.3% reporting high/overwhelming distress. Treatment duration was not associated with the odds of experiencing high/overwhelming FD in single-predictor (OR = 1.01, CI [.93, 1.09], P = .86) or multiple predictor regression models (OR = .98, CI [.86, 1.12], P = .79). Treatment duration was not correlated with FD as a continuous variable (P = .92).LIMITATIONS This study is limited by its cross-sectional design and generalizability to patients with early-stage cancer and those being treated outside of a major referral center.CONCLUSION Severity of cancer treatment-related financial distress did not correlate with time on treatment, indicating that patients are at risk for FD throughout the treatment continuum. Screening for and addressing financial distress should occur throughout the course of cancer therapy.

Current Practices for Screening and Management of Financial Distress at NCCN Member Institutions.

BACKGROUND: Financial distress from medical treatment is an increasing concern. Healthcare organizations may have different levels of organizational commitment, existing programs, and expected outcomes of screening and management of patient financial distress. PATIENTS AND METHODS: In November 2018, representatives from 17 (63%) of the 27 existing NCCN Member Institutions completed an online survey. The survey focused on screening and management practices for patient financial distress, perceived barriers in implementation, and leadership attitudes about such practices. Due to the lack of a validated questionnaire in this area, survey questions were generated after a comprehensive literature search and discussions among the study team, including NCCN Best Practices Committee representatives. RESULTS: Responses showed that 76% of centers routinely screened for financial distress, mostly with social worker assessment (94%), and that 56% screened patients multiple times. All centers offered programs to help with drug costs, meal or gas vouchers, and payment plans. Charity care was provided by 100% of the large centers (≥10,000 unique annual patients) but none of the small centers that responded (<10,000 unique annual patients; P=.008). Metrics to evaluate the impact of financial advocacy services included number of patients assisted, bad debt/charity write-offs, or patient satisfaction surveys. The effectiveness of institutional practices for screening and management of financial distress was reported as poor/very poor by 6% of respondents. Inadequate staffing and resources, limited budget, and lack of reimbursement were potential barriers in the provision of these services. A total of 94% agreed with the need for better integration of financial advocacy into oncology practice. CONCLUSIONS: Three-fourths of NCCN Member Institutions reported screening and management programs for financial distress, although the actual practices and range of services vary. Information from this study can help centers benchmark their performance relative to similar programs and identify best practices in this area.

Perspectives on the Costs of Cancer Care: A Survey of the American Society of Breast Surgeons.

BACKGROUND: Cancer treatment costs are not routinely addressed in shared decisions for breast cancer surgery. Thus, we sought to characterize cost awareness and communication among surgeons treating breast cancer. METHODS: We conducted a self-administered, confidential electronic survey among members of the American Society of Breast Surgeons from 1 July to 15 September 2018. Questions were based on previously published or validated survey items, and assessed surgeon demographics, cost sensitivity, and communication. Descriptive summaries and cross-tabulations with Chi-square statistics were used, with exact tests where warranted, to assess findings. RESULTS: Of those surveyed (N = 2293), 598 (25%) responded. Surgeons reported that 'risk of recurrence' (70%), 'appearance of the breast' (50%), and 'risks of surgery' (47%) were the most influential on patients' decisions for breast cancer surgery; 6% cited out-of-pocket costs as significant. Over half (53%) of the surgeons agreed that doctors should consider patient costs when choosing cancer treatment, yet the majority of surgeons (58%) reported 'infrequently' (43%) or 'never' (15%) considering patient costs in medical recommendations. The overwhelming majority (87%) of surgeons believed that patients should have access to the costs of their treatment before making medical decisions. Surgeons treating a higher percentage of Medicaid or uninsured patients were more likely to consistently consider costs (p < 0.001). Participants reported that insufficient knowledge or resources (61%), a perceived inability to help with costs (24%), and inadequate time (22%) impeded cost discussions. Notably, 20% of participants believed that discussing costs might impact the quality of care patients receive. CONCLUSIONS: Cost transparency remains rare, however in shared decisions for breast cancer surgery, improved cost awareness by surgeons has the potential to reduce financial hardship.

A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer.

BACKGROUND: Patients with chemotherapy refractory metastatic colorectal cancer (CRC) have a poor prognosis and limited therapeutic options. In this phase Ib/II clinical trial, we established the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) for the combination of capecitabine and ziv-aflibercept, and then we evaluated the efficacy of the combination in patients with chemotherapy refractory metastatic CRC. METHODS: All patients were required to have a Karnofsky Performance Status > 70% and adequate organ function. The phase Ib dose escalation cohort included patients with advanced solid tumors who had progressed on all standard therapies. Using a standard 3 + 3 design, we identified the MTD and RPTD for the combination. Fifty patients with metastatic CRC who had progressed on or were intolerant of a fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab were then enrolled in a single-arm phase II expansion cohort, and were treated at the RPTD. Prior EGFR antibody therapy was required for subjects with RAS wildtype tumors. The primary endpoint for the expansion cohort was progression-free survival (PFS) at two months. Secondary endpoints included objective response rate (ORR) and overall survival (OS). RESULTS: A total of 63 patients were enrolled and evaluable for toxicity (13 dose escalation; 50 expansion). The MTD and RPTD were: capecitabine 850 mg/m2, P.O. bid, days 1-14, and ziv-aflibercept 6 mg/kg I.V., day 1, of each 21-day cycle. In the expansion cohort, 72% of patients were progression-free at two months (95% confidence interval [CI], 60-84%). Median PFS and OS were 3.9 months (95% CI, 2.3-4.5) and 7.1 months (95% CI: 5.8-10.0), respectively. Among all patients evaluable for toxicity, the most common treatment related adverse events (all grade [%]; grade ≥ 3 [%]) included palmar-plantar erythrodysesthesia (41%; 6%), hypertension (33%; 22%), and mucositis (19%; 5%). RNA was isolated from archived tumor specimens and gene expression analyses revealed no association between angiogenic biomarkers and clinical outcomes. CONCLUSION: The combination of capecitabine and ziv-aflibercept at the RPTD demonstrated acceptable safety and tolerability. PFS at 2 months in patients with chemotherapy refractory metastatic CRC was significantly greater than that in historical controls, indicating that this combination warrants further study. TRIAL REGISTRATION: This clinical trial was registered in the www.clinicaltrials.gov system as NCT01661972 on July 31, 2012.

Place of death for patients with cancer in the United States, 1999 through 2015: Racial, age, and geographic disparities.

BACKGROUND: Place of death is an essential component of high quality cancer care and comprehensive national trends and disparities in place of death are unknown. METHODS: Deidentified death certificate data were obtained via the National Center for Health Statistics. All cancer deaths from 1999 through 2015 were included. Multivariate logistic regression was used to test for disparities in place of death associated with sociodemographic variables. RESULTS: From 1999 through 2015, a total of 9,646,498 cancer deaths occurred. Hospital deaths decreased (from 36.6% to 24.6%), whereas the rate of home deaths (38.4% to 42.6%) and hospice facility deaths (0% to 14.0%) both increased (all P<.001). On multivariate logistic regression, all assessed variables were found to be associated with place of death. Specifically, younger age (age birth-14 years: odds ratio [OR], 2.39; age 25-44 years: OR, 1.62), black (OR, 1.83) or Asian (OR, 1.74) race, and Hispanic ethnicity (OR, 1.41) were associated with hospital death. Being married (OR, 2.17) or widowed (OR, 1.56) was associated with home death whereas increasing educational level (OR, 1.15-1.19) was associated with hospice death (all P<.001). Despite overall improvements, certain disparities were found to increase. For young patients, the likelihood of a hospital death increased from 2.3 times to 3.4 times that of older patients (50.9% for those aged 15-24 years vs 15.0% for those aged ≥85 years in 2015). For black patients, the likelihood of a hospital death increased from 1.29 times to 1.42 times that of white patients (32.8% for black patients vs 23.1% for white patients in 2015). CONCLUSIONS: Hospital cancer deaths decreased by approximately one-third with commensurate increases in home and hospice facility deaths. Many sociodemographic groups experience significant disparities with regard to place of death and may benefit from targeted efforts to improve goal-concordant care.

A Phase I Trial of the IGF-1R Antibody Ganitumab (AMG 479) in Combination with Everolimus (RAD001) and Panitumumab in Patients with Advanced Cancer.

PURPOSE: This study evaluated the maximum tolerated dose or recommended phase II dose (RPTD) and safety and tolerability of the ganitumab and everolimus doublet regimen followed by the ganitumab, everolimus, and panitumumab triplet regimen. MATERIALS AND METHODS: This was a standard 3 + 3 dose escalation trial. Doublet therapy consisted of ganitumab at 12 mg/kg every 2 weeks; doses of everolimus were adjusted according to dose-limiting toxicities (DLTs). Panitumumab at 4.8 mg/kg every 2 weeks was added to the RPTD of ganitumab and everolimus. DLTs were assessed in cycle 1; toxicity evaluation was closely monitored throughout treatment. Treatment continued until disease progression or undesirable toxicity. Pretreatment and on-treatment skin biopsies were collected to assess insulin-like growth factor 1 receptor and mammalian target of rapamycin (mTOR) target modulation. RESULTS: Forty-three subjects were enrolled. In the doublet regimen, two DLTs were observed in cohort 1, no DLTs in cohort -1, and one in cohort -1B. The triplet combination was discontinued because of unacceptable toxicity. Common adverse events were thrombocytopenia/neutropenia, skin rash, mucositis, fatigue, and hyperglycemia. In the doublet regimen, two patients with refractory non-small cell lung cancer (NSCLC) achieved prolonged complete responses ranging from 18 to >60 months; one treatment-naïve patient with chondrosarcoma achieved prolonged stable disease >24 months. In dermal granulation tissue, the insulin-like growth factor receptor and mTOR pathways were potently and specifically inhibited by ganitumab and everolimus, respectively. CONCLUSION: The triplet regimen of ganitumab, everolimus, and panitumumab was associated with unacceptable toxicity. However, the doublet of ganitumab at 12 mg/kg every 2 weeks and everolimus five times weekly had an acceptable safety profile and demonstrated notable clinical activity in patients with refractory NSCLC and sarcoma. IMPLICATIONS FOR PRACTICE: This trial evaluated the maximum tolerated dose or recommended phase II dose and safety and tolerability of the ganitumab and everolimus doublet regimen followed by the ganitumab, everolimus, and panitumumab triplet regimen. Although the triplet regimen of ganitumab, everolimus, and panitumumab was associated with unacceptable toxicity, the doublet of ganitumab at 12 mg/kg every 2 weeks and everolimus at five times weekly had an acceptable safety profile and demonstrated notable clinical activity in patients with refractory non-small cell lung cancer and sarcoma.

Ask Early and Ask Often: How Discussing Costs Could Save Your Patient's Life.

Out-of-pocket spending continues to increase, particularly in cancer care. High out-of-pocket expenditures are associated with increased psychosocial distress, lower adherence, and higher mortality. In order to improve cancer-related outcomes, we must come up with interventions directed at reducing cancer-related financial toxicity. In this article, we highlight the most promising interventions.

Neoadjuvant long-course chemoradiation remains strongly favored over short-course radiotherapy by radiation oncologists in the United States.

BACKGROUND: Short-course radiotherapy (SC-RT) and long-course chemoradiotherapy (LC-CRT) are accepted neoadjuvant treatments of rectal cancer. In the current study, the authors surveyed US radiation oncologists to assess practice patterns and attitudes regarding SC-RT and LC-CRT for patients with rectal cancer. METHODS: The authors distributed a survey to 1701 radiation oncologists regarding treatment of neoadjuvant rectal cancer. Respondents were asked questions regarding the number of patients with rectal cancer treated, preference for SC-RT versus LC-CRT, and factors influencing regimen choice. RESULTS: Of 1659 contactable physicians, 182 responses (11%) were received. Approximately 83% treated at least 5 patients with rectal cancer annually. The majority of responding radiation oncologists (96%) preferred neoadjuvant LC-CRT for the treatment of patients with locally advanced rectal cancer and 44% never used SC-RT. Among radiation oncologists using SC-RT, respondents indicated they would not recommend this regimen for patients with low (74%) or bulky tumors (70%) and/or concern for a positive circumferential surgical resection margin (69%). The most frequent reasons for not offering SC-RT were insufficient downstaging for sphincter preservation (53%) and a desire for longer follow-up (45%). Many radiation oncologists indicated they would prescribe SC-RT for patients not receiving chemotherapy (62%) or patients with a geographic barrier to receiving LC-CRT (82%). Patient comorbidities appeared to influence regimen preferences for 79% of respondents. Approximately 20% of respondents indicated that altered oncology care reimbursement using capitated payment by diagnosis would impact their consideration of SC-RT. CONCLUSIONS: US radiation oncologists rarely use neoadjuvant SC-RT despite 3 randomized controlled trials demonstrating no significant differences in outcome compared with LC-CRT. Further research is necessary to determine whether longer follow-up coupled with the benefits of lower cost, increased patient convenience, and lower acute toxicity will increase the adoption of SC-RT by radiation oncologists in the United States. Cancer 2017;123:1434-1441. © 2016 American Cancer Society.

A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer.

OBJECTIVE: This study aims to test the feasibility and preliminary efficacy of a couple-based communication intervention for advanced GI cancer delivered via videoconference. METHODS: Thirty-two couples were randomly assigned to either couples communication skills training (CCST) or an education comparison intervention, both delivered via videoconference. Participation was limited to couples who reported communication difficulties at screening. Patients and partners completed measures of relationship functioning and individual functioning at baseline and post-intervention. RESULTS: Eighty-eight percent of randomized dyads completed all six sessions and reported high levels of satisfaction with the intervention. Between-group effect sizes suggested that the CCST intervention led to improvements in relationship satisfaction for patients and partners and to improvements in intimacy and communication for patients. CONCLUSIONS: A couples-based communication intervention delivered via videoconference is feasible and acceptable in the context of advanced cancer. Preliminary findings suggest that the intervention shows promise in contributing to enhanced relationship functioning. Copyright © 2016 John Wiley & Sons, Ltd.

Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome.

AIMS: Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. METHODS AND RESULTS: The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8% had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5%) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5%). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7%; HR = 1.04; 95% CI 0.77-1.42; P = 0.79). CONCLUSIONS: Neoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00699998.

Identifying cancer patients who alter care or lifestyle due to treatment-related financial distress.

BACKGROUND: Cancer patients may experience financial distress as a side effect of their care. Little is known about which patients are at greatest risk for altering their care or lifestyle due to treatment-related financial distress. METHODS: We conducted a cross-sectional survey study to determine which patients are at greatest risk for altering their care or lifestyle due to treatment-related financial distress. Eligible patients were adults receiving cancer treatment enrolled between June 2010 and May 2011. We grouped coping strategies as lifestyle altering or care altering. We assessed coping strategies and relationships between covariates using descriptive statistics and analysis of variance. RESULTS: Among 174 participants, 89% used at least one lifestyle-altering coping strategy, while 39% used a care-altering strategy. Care-altering coping strategies adopted by patients included the following: not filling a prescription (28%) and taking less medication than prescribed (23%). Lifestyle-altering strategies included the following: spending less on leisure activities (77%), spending less on basics like food and clothing (57%), borrowing money (54%), and spending savings (50%). Younger patients were more likely than older patients to use coping strategies (p < 0.001). Lower-income patients adopted care-altering strategies more than higher-income patients (p = 0.03). Participants with more education and shorter duration of chemotherapy used lifestyle-altering strategies more than their counterparts (both p < 0.05). CONCLUSIONS: As a means of coping with treatment-related financial distress, patients were more likely to use lifestyle-altering approaches, but more than one-third adopted potentially harmful care-altering strategies. Younger age, lower income, higher education, and shorter duration of chemotherapy were characteristics associated with greater use of coping strategies. Copyright © 2015 John Wiley & Sons, Ltd.

The Parity Paradigm: Can Legislation Help Reduce the Cost Burden of Oral Anticancer Medications?

Over the last decade, there has been increased development and use of oral anticancer medications, which sometimes leads to high cost sharing for patients. Drug parity laws require insurance plans to cover oral anticancer medications with the same cost sharing as intravenous/injected chemotherapy or have a capped limit on out-of-pocket costs. There are currently 36 enacted state laws (plus the District of Columbia) addressing drug parity, but no federal laws. In this policy perspective piece, we discuss the history, opportunities, and limitations of drug parity laws in oncology. We also discuss the implications of provisions of the Affordable Care Act and other proposed policy reforms on financing oral chemotherapy.

Does comparative effectiveness research promote rationing of cancer care?

Comparative effectiveness research aims to inform health-care decisions by patients, clinicians, and policy makers. However, questions related to what information is relevant, and how to view the relative attributes of alternative interventions have political, social, and medical considerations. In particular, questions about whether cost is a relevant factor, and whether cost-effectiveness is a desirable or necessary component of such research, have become increasingly controversial as the area has gained prominence. Debate has emerged about whether comparative effectiveness research promotes rationing of cancer care. At the heart of this debate are questions related to the role and limits of patient autonomy, physician discretion in health-care decision making, and the nature of scientific knowledge as an objective good. In this article, we examine the role of comparative effectiveness research in the USA, UK, Canada, and other health-care systems, and the relation between research and policy. As we show, all health systems struggle to balance access to cancer care and control of costs; comparative effectiveness data can clarify choices, but does not itself determine policy or promote rationing of care.