Facing the rising cost of chemotherapy in an aging population: Proposed reform of the drug approval process

The emergence of new, effective therapeutic options has brought marked improvements in survival times and cure rates for many cancers. The cost of these advances, however, is staggering and has stretched thin the budget of the Centers for Medicare and Medicaid Services (CMS). In order to maintain its fiscal stability, CMS' s cost containment measures (e.g. the Medicare Modernization Act of 2003) have shifted cost to providers and health care consumers rather than restrict the availability of drugs or services. Such measures, however, fail to contain cost as they do not address the underlying etiology of soaring health care cost: unfettered access to exorbitantly priced drugs. I use the example of chemotherapy for colorectal cancer in the elderly to explore the cost of cancer care, and to demonstrate how current policies not only fail to contain cost, but also unintentionally increase the disparity between the wealthy who can afford optimal health care, and the average American senior who may be unable to afford stateof- the-art cancer care. I propose that in our system with finite resources, we must accept that we cannot provide all possible care to everyone. If cost containment measures are to be successful and equitable, we must redefine quality care as excellent care for all, rather than all care for some. Cost-effectiveness, in addition to comparative clinical effectiveness, must become a focus of the drug approval process. Reforms such as the establishment of an Effectiveness Committee to review the clinical and cost-effectiveness of all new drugs, use of these data through a new conditional FDA approval system and incorporation of cost-effectiveness in CMS's reimbursement decisions, and a cost-sharing policy with the pharmaceutical industry for drugs receiving only conditional approval by the FDA would begin to slow the growth in the cost of care. Although making cost-effectiveness a central consideration in drug approval and reimbursement decisions is likely to be unpopular, the American populace and its physicians are already quite dissatisfied with the extent to which they must shoulder the burden ofthe rising cost of medical care. Failure to act will only worsen this dissatisfaction, while allowing the growing divide between the care available to the wealthy and the care available to most Americans to widen.Master of Public Healt

Comparative effectiveness of postoperative chemotherapy among older patients with non-metastatic rectal cancer treated with preoperative chemoradiotherapy

Postoperative chemotherapy is standard following preoperative chemoradiation therapy (CRT) and curative resection for clinically staged II/III rectal cancer. Recent trials have questioned whether postoperative chemotherapy improves overall survival. We evaluated the comparative effectiveness of postoperative chemotherapy following CRT or radiation therapy (RT) with specific attention on the impact of age on postoperative chemotherapy effectiveness

Defining the toxicology of aging

Mammalian aging is complex and incompletely understood. While significant effort has been spent addressing the genetics or, more recently, the pharmacology of aging, the toxicology of aging has been relatively understudied. Just as an understanding of `carcinogens' has proven critical to modern cancer biology, an understanding of environmental toxicants that accelerate aging (`gerontogens') will inform gerontology. In this review, we discuss the evidence for the existence of mammalian gerontogens, as well as describe biomarkers needed to measure the age-promoting activity of a given toxicant. We focus on the effects of putative gerontogens on the in vivo accumulation of senescent cells, a characteristic feature of aging that plays a causal role in some age-associated phenotypes

Sorafenib Effectiveness in Advanced Hepatocellular Carcinoma

Phase III trials show sorafenib improves survival in advanced hepatocellular carcinoma (HCC). Because of narrow trial eligibility, results may not be generalizable to a broader HCC population. We sought to evaluate the effectiveness of initial sorafenib versus no treatment among Medicare beneficiaries with advanced HCC

Sleep quality in individuals diagnosed with colorectal cancer: Factors associated with sleep disturbance as patients transition off treatment

To identify patient characteristics associated with sleep disturbance and worsening of sleep in individuals diagnosed with localized colorectal cancer and assess heterogeneity in these relationships. Methods: Data were from the MY-Health study, a community-based observational study of adults diagnosed with cancer. Patient-Reported Outcomes Measurement Information System® Sleep Disturbance, Anxiety, Depression, Fatigue, and Pain Interference measures were administered. Participants self-reported demographics, comorbidities, and treatment information. Regression mixture and multiple regression models were used to evaluate the relationship between sleep disturbance and patient characteristics cross-sectionally at an average of 10 months after diagnosis (n = 613) as well as change in sleep disturbance over a 6-month period (n = 361). Results: Pain, anxiety, fatigue, and the existence of multiple comorbid conditions had statistically significant relationships with sleep disturbance (B = 0.09, 0.22, 0.29, and 1.53, respectively; P < 0.05). Retirement (B = -2.49) was associated with sleep quality in the cross-sectional model. Worsening anxiety (B = 0.14) and fatigue (B = 0.20) were associated with worsening sleep disturbance, and more severe sleep disturbance 10 months after diagnosis (B = -0.21) was associated with improvement in sleep quality after diagnosis (P < 0.05). No evidence of latent subgroups of patients (heterogeneity) was present. Conclusions: Pain, anxiety, fatigue, employment, and comorbid conditions were associated with sleep disturbance, but regression coefficients were small (< |2.5|). Results suggest that screening for anxiety, depression, fatigue, or pain is not sufficient for identifying sleep disturbance. Given the negative consequences of sleep disturbance, sleep disturbance screening may be warranted

Effectiveness of Initial Transarterial Chemoembolization for Hepatocellular Carcinoma Among Medicare Beneficiaries

Optimal administration of transarterial chemoembolization (TACE), the standard approach for intermediate stage hepatocellular carcinoma (HCC), requires clinical and technical expertise. We sought to evaluate if TACE retains its effectiveness when administered across a broad range of healthcare settings. With increasing use of yttrium90 radioembolization (Y90), we explored the effectiveness of Y90 compared with TACE

Effectiveness of Bevacizumab With First-Line Combination Chemotherapy for Medicare Patients With Stage IV Colorectal Cancer

Clinical trials have shown that adding bevacizumab to cytotoxic chemotherapy improves survival for patients with colorectal cancer, although its effectiveness in the Medicare population is uncertain

Psychometric Evaluation and Design of Patient-Centered Communication Measures for Cancer Care Settings

Objective To evaluate the psychometric properties of questions that assess patient perceptions of patient-provider communication and design measures of patient-centered communication (PCC). Methods Participants (adults with colon or rectal cancer living in North Carolina) completed a survey at 2 to 3 months post-diagnosis. The survey included 87 questions in six PCC Functions: Exchanging Information, Fostering Health Relationships, Making Decisions, Responding to Emotions, Enabling Patient Self-Management, and Managing Uncertainty. For each Function we conducted factor analyses, item response theory modeling, and tests for differential item functioning, and assessed reliability and construct validity. Results Participants included 501 respondents; 46% had a high school education or less. Reliability within each Function ranged from 0.90 to 0.96. The PCC-Ca-36 (36-question survey; reliability=0.94) and PCC-Ca-6 (6-question survey; reliability=0.92) measures differentiated between individuals with poor and good health (i.e., known-groups validity) and were highly correlated with the HINTS communication scale (i.e., convergent validity). Conclusion This study provides theory-grounded PCC measures found to be reliable and valid in colorectal cancer patients in North Carolina. Future work should evaluate measure validity over time and in other cancer populations. Practice implications The PCC-Ca-36 and PCC-Ca-6 measures may be used for surveillance, intervention research, and quality improvement initiatives

Relationship between sleep and exercise as colorectal cancer survivors transition off treatment

Purpose The primary objective of this study was to evaluate the relationship between exercise and sleep disturbance in a sample of individuals diagnosed with stage I, II, and III colorectal cancer (CRC) as patients transitioned off first-line treatment. We also sought to identify heterogeneity in the relationship between sleep disturbance and exercise. Methods Data were obtained from the MY-Health study, a community-based observational study of adults diagnosed with cancer. Patient-Reported Outcomes Measurement Information System® (PROMIS) measures (e.g., PROMIS Sleep) were administered, and participants self-reported demographics, comorbidities, cancer treatment, and exercise. Regression mixture and multiple regression models were used to evaluate the relationship between sleep disturbance and exercise cross-sectionally at an average of 10 months after diagnosis, and the change in sleep disturbance over a 7-month period, from approximately 10 to 17 months post-diagnosis. Results Patients whose exercise was categorized as likely at or above American College of Sports Medicine’s guidelines did not report statistically better sleep quality compared to patients who were classified as not active. However, retirement (B = − 2.4), anxiety (B = 0.21), and fatigue (B = 0.24) had statistically significant relationships with sleep disturbance (p < 0.05). Increase in exercise was not significantly associated with a decrease in sleep disturbance. No statistical heterogeneity was revealed in the relationship between sleep and exercise. Conclusions Further prospective research using an objective measure of exercise is warranted to confirm or refute the nature of the relationship between exercise and sleep disturbance in individuals diagnosed with CRC transitioning off first-line treatment