Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina.

BACKGROUND: Clinical trials provide access to innovative, high-quality cancer treatment. Simultaneously, broad access helps to ensure that trials include heterogeneous patient populations, which improves the generalizability of findings and the development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina. METHODS: For the period 1996-2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, sex, and year for each county, Area Health Education Center region, and the state overall. Enrollment rates for common cancers are presented. RESULTS: From 1996 to 2009, North Carolina NCI treatment trial enrollment rates were 2.4% and 2.2% for white patients and minority patients, respectively. From 2007 to 2009, rates were 3.8% for white women, 3.5% for minority women, 1.3% for white men, and 1.0% for minority men; there was greater enrollment among more urban populations (2.4%) than among the most rural populations (1.5%). LIMITATIONS: This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability. CONCLUSIONS: Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and sex disparities, particularly for certain cancers (eg, breast cancer). Programs in North Carolina and across the nation can use the methods we employed to assess their success in broadening clinical trial enrollment to include diverse populations.

Regional variation in colorectal cancer testing and geographic availability of care in a publicly insured population.

Despite its demonstrated effectiveness, colorectal cancer (CRC) testing is suboptimal, particularly in vulnerable populations such as those who are publicly insured. Prior studies provide an incomplete picture of the importance of the intersection of multilevel factors affecting CRC testing across heterogeneous geographic regions where vulnerable populations live. We examined CRC testing across regions of North Carolina by using population-based Medicare and Medicaid claims data from disabled individuals who turned 50 years of age during 2003-2008. We estimated multilevel models to examine predictors of CRC testing, including distance to the nearest endoscopy facility, county-level endoscopy procedural rates, and demographic and community contextual factors. Less than 50% of eligible individuals had evidence of CRC testing; men, African-Americans, Medicaid beneficiaries, and those living furthest away from endoscopy facilities had significantly lower odds of CRC testing, with significant regional variation. These results can help prioritize intervention strategies to improve CRC testing among publicly insured, disabled populations.

Trends in stage-specific incidence rates for urothelial carcinoma of the bladder in the United States: 1988 to 2006.

BACKGROUND: Bladder cancer is notable for a striking heterogeneity of disease-specific risks. Among the approximately 75% of incident cases found to be superficial to the muscularis propria at the time of presentation (non-muscle-invasive bladder cancer), the risk of progression to the lethal phenotype of muscle-invasive disease is strongly associated with stage and grade of disease. Given the suggestion of an increasing percentage of low-risk cases in hospital-based registry data in recent years, the authors hypothesized that population-based data may reveal changes in the stage distribution of early-stage cases. METHODS: Surveillance, Epidemiology, and End Results (SEER) data were used to examine trends for the stage-specific incidence of bladder cancer between 1988 and 2006, adjusted for age, race, and sex, using Joinpoint and nonparametric tests. RESULTS: The adjusted incidence rate of papillary noninvasive (Ta) predominantly low grade (77%) disease was found to increase from 5.52 to 9.09 per 100,000 population (P < .0001), with an average annual percentage change of +3.3. Over the same period, concomitant, albeit smaller, decreases were observed for flat in situ (Tis) and lamina propria-invasive (T1) disease (2.57 to 1.19 and 6.65 to 4.61 per 100,000 population [both P < .0001]; average annual percent change of -5.0 and -1.6, respectively). The trend was most dramatic among patients in the oldest age strata, suggesting a previously unappreciated cohort phenomenon. CONCLUSIONS: The findings of the current study should motivate further epidemiological investigations of differential associations of genetic and environmental factors with different bladder cancer phenotypes as well as further scrutiny of clinical practice guideline recommendations for the growing subgroup of predominantly older patients with lower-risk disease.

Patterns of care in older patients with squamous cell carcinoma of the head and neck: a surveillance, epidemiology, and end results-medicare analysis.

BACKGROUND: There is growing evidence in the literature that older patients may not benefit from more intensive therapy for head and neck squamous cell carcinoma (HNSCC). A growing number of patients with HNSCC are age 65 years or older; however, much of the evidence base informing treatment decisions is based on substantially younger and healthier clinical trial populations. The purpose of this study was to assess the patterns of care of older HNSCC patients to better understand how age is associated with treatment decisions. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database (1992­2007), we identified patients with non-metastatic HNSCC (n = 10,867) and categorized them by treatment: surgery vs. non-surgery and chemoradiotherapy (CRT) vs. radiotherapy (RT). Multivariate logistic regression models were used to identify variables associated with the receipt of surgery and CRT. RESULTS: Increasing age was associated with decreased odds of receiving CRT (OR = 0.94; 95% CI 0.93­0.94) but not surgery (OR 1.00; 95% CI 0.99­1.00). Co-morbidity and race were not associated with receipt of either surgery or CRT. Utilization of CRT increased while surgery decreased between 1992 and 2007. CONCLUSION: Age may influence the receipt of CRT for older HNSCC patients. There has been an increasing trend in the receipt of CRT and a decrease in primary surgery.

A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials.

BACKGROUND: The Institute of Medicine (IOM) has recommended that each person with cancer should have access to clinical trials, which have been associated with improving care quality and disparities. With no effective enrollment monitoring system, patterns of trial enrollment remain unclear. PURPOSE: We developed a population-based, statewide system designed to facilitate monitoring of cancer trial enrollment and targeting of future interventions to improve it. METHODS: Person-level cancer incidence data from the North Carolina Central Cancer Registry (NCCCR), person-level treatment trial accrual data from the National Cancer Institute (NCI), and county-level Area Resource Files (ARF) measures for 12 years, 1996-2007, were studied. Deidentified person-level data necessitated county-level analysis. Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for each race, gender, year, and county combination. Multivariable analysis examined factors associated with trial accrual. Sensitivity analyses examined spurious fluctuations and temporal discordance of incidence and enrollment. RESULTS: The NCI treatment trial enrollment rate was 2.39% for whites and 2.20% for minorities from 1996 to 2007, and 2.88% and 2.47%, respectively, from 2005 to 2007. Numerous counties had no minority enrollment. The 2005-2007 enrollment rates for white and minority females was 4.04% and 3.59%, respectively, and for white and minority males was 1.74% and 1.36%, respectively. Counties with a medical school or NCI Community Clinical Oncology Program (CCOP)-affiliated practice had higher trial enrollment. LIMITATIONS: We examined NCI trial accrual only - industry-sponsored and investigator-initiated trials were excluded; however, studies comprise the majority of all clinical trial participants. Delays in data availability may hinder the immediacy of population-based analyses. CONCLUSIONS: Model stability and consistency suggest that this system is effective for population-based enrollment surveillance. For North Carolina, it suggests a worsening disparity in minority trial enrollment, though our analyses elucidate targets for intervention. Regional enrollment variation suggests the importance of access to clinical research networks and infrastructure. Substantial gender differences merit further examination.

Increasing incidence of oral tongue squamous cell carcinoma in young white women, age 18 to 44 years.

PURPOSE: To evaluate the incidence of oral cavity squamous cell carcinoma (OCSCC) and oral tongue squamous cell carcinoma (OTSCC) in young white women, age 18 to 44 years. PATIENTS AND METHODS: We analyzed incidence and survival data from the Surveillance, Epidemiology and End Results (SEER) Program of the National Cancer Institute from 1975 to 2007 for OCSCC and OTSCC. Three cohorts were examined: all ages, age 18 to 44 years (ie, "young"), and age > 44 years. Individuals were stratified by sex and/or race. Percentage change (PC) and annual percentage change (APC) were calculated. Joinpoint regression analyses were performed to examine trend differences. RESULTS: Overall, incidence of OCSCC was decreasing for all ages. However, incidence was increasing for young white women (PC, 34.8; APC, 2.2; P < .05). Incidence of OTSCC was decreasing for all ages except in the age 18 to 44 years group (PC, 28.8; APC, 1.8; P < .05). Young white individuals had increasing incidence trends of OTSCC (white women: PC, 111.3; APC, 4; P < .05; young white men: PC, 43.7; APC, 1.6; P < .05). The APC of OTSCC was significantly greater in young white women compared with that in young white men (P = .007). Furthermore, incidence of SCC in all other subsites of the oral cavity was decreasing. Nonwhites had a decreasing incidence of OCSCC and OTSCC. Cause-specific survival was similar among whites age 18 to 44 and individuals older than age 44 years. CONCLUSION: OTSCC is increasing among young white individuals age 18 to 44 years, particularly among white women. Young white women may be a new, emerging head and neck cancer patient population.