Factors influencing prostate cancer treatment decisions for African American and white men.

BACKGROUND: Prostate cancer racial disparities in mortality outcomes are the largest in all of oncology, and less aggressive treatment received by African American (AA) patients versus white patients is likely a contributing factor. However, the reasons underlying the differences in treatment are unclear. METHODS: This study examined a prospective, population-based cohort of 1170 men with newly diagnosed nonmetastatic prostate cancer enrolled from 2011 to 2013 before treatment throughout North Carolina. By phone survey, each participant was asked to rate the aggressiveness of his cancer, and his response was compared to the actual diagnosis based on a medical record review. Participants were also asked to rate the importance of 10 factors for their treatment decision-making process. RESULTS: Among AA and white patients with low-risk cancer (according to National Comprehensive Cancer Network guidelines), 78% to 80% perceived their cancers to be "not very aggressive." However, among high-risk patients, 54% of AA patients considered their cancers to be "not very aggressive," whereas 24% of white patients did (P < .001). Although both AA and white patients indicated that a cure was a very important decision-making factor, AAs were significantly more likely to consider cost, treatment time, and recovery time as very important. In a multivariable analysis, perceived cancer aggressiveness and cure as the most important factor were significantly associated with receiving any aggressive treatment and were associated with surgery (vs radiation). After adjustments for these factors and sociodemographic factors, race was not significantly associated with the treatment received. CONCLUSIONS: Racial differences in perceived cancer aggressiveness and factors important in treatment decision making provide novel insights into reasons for the known racial disparities in prostate cancer as well as potential targets for interventions to reduce these disparities.

Black Pastors' Views on preaching about sex: barriers, facilitators, and opportunities for HIV prevention messaging.

OBJECTIVES: Despite the disproportionately high rates of heterosexually transmitted HIV infection among US Blacks and ongoing need for effective inexpensive behavioral interventions, the use of sermons as an HIV prevention tool in Black churches has received little research attention. The Black church plays an important role in Black communities and is a potential ally in development and delivery of sexual risk prevention messages. The objective of this study was to examine Black pastors' thoughts about whether sermons should address issues related to heterosexual relationships - and the barriers and facilitators to discussing these topics in a sermon setting. DESIGN: We conducted in-depth semi-structured, individual interviews among 39 pastors of Black churches in North Carolina and analyzed the interview data using thematic analysis strategies based on grounded theory. RESULTS: Pastors expressed widely ranging opinions, especially about discussion of condom use, but generally agreed that sermons should discuss marriage, abstinence, monogamy, dating, and infidelity - behaviors that impact sexual networks and HIV transmission. The major barriers to incorporation of these subjects into sermons include the extent to which a concept undermines their religious beliefs and uncertainty about how to incorporate it. However, scriptural support for a prevention message and the pastor's perception that the message is relevant to the congregation facilitate incorporation of related topics into sermons. CONCLUSIONS: These findings have implications for the potential utility of sermons as an HIV prevention tool and suggest that it is possible for public health professionals and pastors of Black churches to form partnerships to develop messages that are consonant with pastors' religious convictions as well as public health recommendations.

Phase II trial of palbociclib in patients with metastatic urothelial cancer after failure of first-line chemotherapy.

BACKGROUND: The majority of urothelial cancers (UC) harbor alterations in retinoblastoma (Rb) pathway genes that can lead to loss of Rb tumour suppressor function. Palbociclib is an oral, selective inhibitor of CDK 4/6 that restores Rb function and promotes cell cycle arrest. METHODS: In this phase II trial, patients with metastatic platinum-refractory UC molecularly selected for p16 loss and intact Rb by tumour immunohistochemistry received palbociclib 125 mg p.o. daily for 21 days of a 28-day cycle. Primary endpoint was progression-free survival at 4 months (PFS4) using a Simon's two-stage design. Next-generation sequencing including Rb pathway alterations was conducted. RESULTS: Twelve patients were enrolled and two patients (17%) achieved PFS4 with insufficient activity to advance to stage 2. No responses were seen. Median PFS was 1.9 months (95% CI 1.8-3.7 months) and median overall survival was 6.3 months (95% CI 2.2-12.6 months). Fifty-eight percent of patients had grade ≥3 hematologic toxicity. There were no CDKN2A alterations found and no correlation of Rb pathway alterations with clinical outcome. CONCLUSIONS: Palbociclib did not demonstrate meaningful activity in selected patients with platinum-refractory metastatic UC. Further development of palbociclib should only be considered with improved integral biomarker selection or in rational combination with other therapies.

Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer.

Importance: Patients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects. Objective: To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance. Design, Setting, and Participants: Population-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015. Exposures: Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance. Main Outcomes and Measures: Quality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point. Results: Of 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI, 27.8-39.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI, 8.7-14.8]) and brachytherapy (20.5 [95% CI, 15.1-25.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains. Conclusions and Relevance: In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.

Responding to a Community's Concern: A Comparison of Breast Cancer Characteristics and Initial Treatment in Three Selected North Carolina Counties.

BACKGROUND A 2007 national report identified North Carolina's Edgecombe County as having among the highest breast cancer incidence and mortality rates nationally, motivating the initiation of a task force and other local efforts to address the problem. The goal of this study is to examine county breast cancer characteristics before and after the report, including whether geographic variation may mask racial disparities in this majority African American community.METHOD With guidance from community partners, breast cancer cases from 2000 to 2012 in Edgecombe, Nash, and Orange Counties (N = 2,641) were obtained from the North Carolina Central Cancer Registry. Bivariate and trend analyses of tumor and treatment characteristics were examined by county and race.RESULTS Women in Edgecombe and Nash Counties were diagnosed with more advanced stage, higher grade tumors. African Americans in Edgecombe and Nash Counties were diagnosed with advanced disease more often than African Americans in Orange County. Average time-to-treatment was well within guideline recommendations. Incidence and mortality rates appear to have declined, with variation in measures of racial differences over time.LIMITATIONS Changes in coding standards across the observation period required reliance on coarse measures that may partially mute useful findings.CONCLUSIONS Racial disparities remain a concern in North Carolina; however, they appear to be less profound than in the 2007 national report. The portentous statistics in the report represent an all-time high, after which some, but not all, measures reflect positive change amidst ongoing local efforts to improve breast cancer knowledge and care.

Long-term survival of participants in the prostate cancer prevention trial.

BACKGROUND: In the Prostate Cancer Prevention Trial (PCPT), finasteride significantly reduced the risk of prostate cancer but was associated with an increased risk of high-grade disease. With up to 18 years of follow-up, we analyzed rates of survival among all study participants and among those with prostate cancer. METHODS: We collected data on the incidence of prostate cancer among PCPT participants for an additional year after our first report was published in 2003 and searched the Social Security Death Index to assess survival status through October 31, 2011. RESULTS: Among 18,880 eligible men who underwent randomization, prostate cancer was diagnosed in 989 of 9423 (10.5%) in the finasteride group and 1412 of 9457 (14.9%) in the placebo group (relative risk in the finasteride group, 0.70; 95% confidence interval [CI], 0.65 to 0.76; P<0.001). Of the men who were evaluated, 333 (3.5%) in the finasteride group and 286 (3.0%) in the placebo group had high-grade cancer (Gleason score, 7 to 10) (relative risk, 1.17; 95% CI, 1.00 to 1.37; P=0.05). Of the men who died, 2538 were in the finasteride group and 2496 were in the placebo group, for 15-year survival rates of 78.0% and 78.2%, respectively. The unadjusted hazard ratio for death in the finasteride group was 1.02 (95% CI, 0.97 to 1.08; P=0.46). Ten-year survival rates were 83.0% in the finasteride group and 80.9% in the placebo group for men with low-grade prostate cancer and 73.0% and 73.6%, respectively, for those with high-grade prostate cancer. CONCLUSIONS: Finasteride reduced the risk of prostate cancer by about one third. High-grade prostate cancer was more common in the finasteride group than in the placebo group, but after 18 years of follow-up, there was no significant between-group difference in the rates of overall survival or survival after the diagnosis of prostate cancer. (Funded by the National Cancer Institute.).

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.

Perceptions of Cancer Clinical Research Among African American Men in North Carolina.

ACKNOWLEDGEMENTS: The authors are grateful to the men and women who participated in our Focus Groups and shared with us their very personal cancer experience. Their insight is valuable, and will inform and improve cancer care for future generations. The authors thank the Greensboro area Community Research Advocates - especially April Durr, Elvira Mebane, Marie McAdoo, Kathy Norcott, and Cindy Taylor - who assisted in the conduct of the study, including interpretation of results. They also thank Gratia Wright of First Research Group for her expertise in moderating and executing all of the focus groups, and Lindsey Haynes-Maslow for her assistance in responding to reviewer comments. The study was funded as a part of the Carolina Community Network program, funded by a grant from the National Cancer Institute (U01-CA114629). This study was reviewed and approved by the Institutional Review Board (IRB) at the University of North Carolina at Chapel Hill. OBJECTIVE: The problem of cancer health disparities is substantial. Clinical trials are widely advocated as a means of reducing disparities and bringing state-of-the-art care to the broader community, where most cancer care is delivered. This study sought to develop a better understanding of why disproportionately few African American men enroll in clinical trials given their substantial cancer burden. DESIGN: This study applied community-based participatory research (CBPR) methods to design and conduct four focus groups of African American male cancer survivors and their caregivers in North Carolina. RESULTS: Among major themes, participants expressed confusion about the relationship between clinical trials, treatment, and research: signifying patient confusion and misinterpretation of common clinical trial terminology. Social norms including gender barriers and generational differences remain problematic; participants often reported that men do not talk about health issues, are unwilling to go to the doctor, and exhibit misapprehension and distrust regarding trials. Participants perceived this misunderstanding as detrimental to community health and expressed the need for more clarity in clinical trials information and a more fundamental social openness and communication about cancer detection and treatment. CONCLUSION: Findings indicate the importance of clinical trial education in both traditional provider referral to trials and also in general patient navigation. To dispel pervasive misapprehension regarding placebos, clinical trial information should emphasize the role of standard care in modern cancer treatment trials. Many participants described willingness to participate in a trial upon physician recommendation, suggesting merit in improving patient-physician communication through culturally competent terminology and trial referral systems.

Examining characteristics of congregation members willing to attend health promotion in African American churches.

BACKGROUND: Although churches are an important partner for improving health within the African American community, it is not known how congregants are best reached by health promotion activities and thus how best to target members in recruitment. This study examined how characteristics of churches and congregants' beliefs and interests in faith-based health promotion related to their willingness to attend church-based health promotion activities. METHOD: We surveyed adult congregants (n = 1,204) of 11 predominately African American churches in North Carolina. Surveys collected data within four domains: demographics (age, sex, education), behavioral (church attendance, respondent food choices, and physical activity), cognitive (church-based health promotion belief, Bible-based healthy living interest, healthy living resource interest), or environmental (family health, church travel distance, church health ministry activity, church members' food choices). Analyses used a dichotomous outcome, interest in attending programs offered by the health ministry. Domain-specific models were constructed. Logistic generalized estimating equations adjusted for clustering. RESULTS: Of the 1,204 congregants, 72% were female, 57% were 50 years or older, 84% had a high school education or more, and 77% had a chronic health condition. In bivariate analyses and in models adjusting for all four domains, cognitive factors had the highest odds of willingness to attend. CONCLUSION: Congregants' belief in the church's role in health promotion and their desire to learn about healthy behaviors highlight the role of the African American church as a partner in addressing health disparities and the need to capitalize on this expectation through stronger partnerships between medical and faith communities.

Receipt of National Comprehensive Cancer Network guideline-concordant prostate cancer care among African American and Caucasian American men in North Carolina.

BACKGROUND: African Americans have a higher incidence of prostate cancer and experience poorer outcomes compared with Caucasian Americans. Racial differences in care are well documented; however, few studies have characterized patients based on their prostate cancer risk category, which is required to differentiate appropriate from inappropriate guideline application. METHODS: The medical records of a population-based sample of 777 North Carolina men with newly diagnosed prostate cancer were studied to assess the association among patient race, clinical factors, and National Comprehensive Cancer Network (NCCN) guideline-concordant prostate cancer care. RESULTS: African Americans presented with significantly higher Gleason scores (P = .025) and prostate-specific antigen levels (P = .008) than did Caucasian Americans. However, when clinical T stage was considered as well, difference in overall risk category only approached statistical significance (P = .055). Across risk categories, African Americans were less likely to have surgery (58.1% versus 68.0%, P = .004) and more likely to have radiation (39.0% versus 27.4%, P = .001) compared with Caucasian Americans. However, 83.5% of men received guideline-concordant care within 1 year of diagnosis, which did not differ by race in multivariable analysis (odds ratio = 0.83; 95% confidence interval = 0.54-1.25). Greater patient-perceived access to care was associated with greater odds of receiving guideline-concordant care (odds ratio = 1.06; 95% confidence interval = 1.01-1.12). CONCLUSIONS: After controlling for NCCN risk category, there were no racial differences in receipt of guideline-concordant care. Efforts to improve prostate cancer treatment outcomes should focus on improving access to the health care system.

Racial differences in time from prostate cancer diagnosis to treatment initiation: a population-based study.

BACKGROUND: Timely delivery of care has been identified by the Institute of Medicine as an indicator for quality health care, and treatment delay is a potentially modifiable obstacle that can contribute to the disparities among African American (AA) and Caucasian patients in prostate cancer recurrence and mortality. Using the Surveillance, Epidemiologic and End Results (SEER)-Medicare linked database, we compared time from diagnosis to treatment in AA and Caucasian prostate cancer patients. METHODS: A total of 2506 AA and 21,454 Caucasian patients diagnosed with localized prostate cancer from 2004 through 2007 and treated within 12 months were included. Linear regression was used to assess potential differences in time to treatment between AA and Caucasian patients, after adjusting for sociodemographic and clinical covariates. RESULTS: Time from diagnosis to definitive (prostatectomy and radiation) treatment was longer for AA patients in all risk groups, and most pronounced in high-risk cancer (96 versus 105 days, P < .001). On multivariate analysis, racial differences to any and definitive treatment persisted (ß = 7.3 and 7.6, respectively, for AA patients). Delay to definitive treatment was longer in high-risk (versus low-risk) disease and in more recent years. CONCLUSIONS: AA patients with prostate cancer experienced longer time from diagnosis to treatment than Caucasian patients with prostate cancer. AA patients appear to experience disparities across all aspects of this disease process, and together these factors in receipt of care plausibly contribute to the observed differences in rates of recurrence and mortality among AA and Caucasian patients with prostate cancer.

Who makes the decision regarding the treatment of clinically localized prostate cancer--the patient or physician?: results from a population-based study.

BACKGROUND: The current study examined how patients' sociodemographic, cancer-related, and subjective affective factors impacted their role in treatment decision-making. METHODS: The patient sample (N = 788) was taken from a prospective follow-up study of a population-based cohort. Participants included 343 African American and 445 Caucasian-American patients with clinically localized prostate cancer. Multinomial logistic regression was used to investigate relations between the explanatory variables and the nominal 3-level decision-making variable: patient-only, patient-physician shared, and physician-only. RESULTS: Approximately 41% of patients reported patient-only decision-making, 45% reported shared decision-making, and 13% reported physician-only decision-making. The odds of patient-only over physician-only decision-making were greater for younger men (vs those aged ≥ 65 years) (odds ratio [OR], 1.68; 95% confidence interval [95% CI], 1.03-2.74), and were less for men with high (vs low) cancer aggressiveness (OR,0.29; 95% CI, 0.15-0.55). The odds of shared over physician-only decision-making were less for men with high (vs low) cancer aggressiveness (OR, 0.40; 95% CI, 0.22-0.73). Greater odds of patient-only and shared decision-making also were found to be associated with greater concerns about the physical impact of treatment and having enough time for decision-making and lower scores of receiving advice from others. CONCLUSIONS: The findings of the current study indicate that, to facilitate a more patient-oriented decision-making process regarding treatment in those with clinically localized prostate cancer, clinicians need to tailor their interventions according to patient age and cancer aggressiveness, help reduce patient concerns and misconceptions regarding the physical impact of treatments, allow sufficient time for patients to consider treatment options, and assist patients in balancing advice and information received from different sources.

How does health literacy affect quality of life among men with newly diagnosed clinically localized prostate cancer? Findings from the North Carolina-Louisiana Prostate Cancer Project (PCaP).

BACKGROUND: Health literacy deficits affect half of the US overall patient population, especially the elderly, and are linked to poor health outcomes among noncancer patients. Yet little is known about how health literacy affects cancer populations. The authors examined the relation between health-related quality of life (HRQOL) and health literacy among men with prostate cancer. METHODS: Data analysis included 1581 men with newly diagnosed clinically localized prostate cancer from a population-based study, the North Carolina-Louisiana Prostate Cancer Project (PCaP). Participants completed assessment of health literacy using Rapid Estimate of Adult Literacy in Medicine (REALM) and HRQOL using the Short Form-12 General Health Survey (SF12). Bivariate and multivariate regression was used to determine the potential association between REALM and HRQOL, while controlling for sociodemographic and illness-related variables. RESULTS: Higher health literacy level was significantly associated with better mental well-being (SF12-Mental Component Summary [MCS]; P < .001) and physical well-being (SF12-Physical Component Summary [PCS]; P < .001) in bivariate analyses. After controlling for sociodemographic (age, marital status, race, income, and education) and illness-related factors (types of cancer treatment, tumor aggressiveness, and comorbidities), health literacy remained significantly associated with SF12-MCS scores (P < .05) but not with SF12-PCS scores. CONCLUSIONS: Among patients with newly diagnosed localized prostate cancer, those with low health literacy levels were more vulnerable to mental distress than those with higher health literacy levels, but physical well-being was no different. These findings suggest that health literacy may be important in patients managing prostate cancer and the effects of treatment, and provide the hypothesis that supportive interventions targeting patients with lower health literacy may improve their HRQOL.

Impact of distance to a urologist on early diagnosis of prostate cancer among black and white patients.

PURPOSE: We examined whether an increased distance to a urologist is associated with a delayed diagnosis of prostate cancer among black and white patients, as manifested by higher risk disease at diagnosis. MATERIALS AND METHODS: North Carolina Central Cancer Registry data were linked to Medicare claims for patients with incident prostate cancer diagnosed in 2004 to 2005. Straight-line distances were calculated from the patient home to the nearest urologist. Race stratified multivariate ordinal logistic regression was used to examine the association between distance to a urologist and prostate cancer risk group (low, intermediate, high or very high/metastasis) at diagnosis for black and white patients while accounting for age, comorbidity, marital status and diagnosis year. An overall model was then used to examine the distance × race interaction effect. RESULTS: Included in analysis were 1,720 white and 531 black men. In the overall cohort the high risk cancer rate increased monotonically with distance to a urologist, including 40% for 0 to 10, 45% for 11 to 20 and 57% for greater than 20 miles. Correspondingly the low risk cancer rate decreased with longer distance. On race stratified multivariate analysis longer distance was associated with higher risk prostate cancer for white and black patients (p = 0.04 and <0.01, respectively) but the effect was larger in the latter group. The distance × race interaction term was significant in the overall model (p = 0.03). CONCLUSIONS: Longer distance to a urologist may disproportionally impact black patients. Decreasing modifiable barriers to health care access, such as distance to care, may decrease racial disparities in prostate cancer.

Phase I study of concurrent weekly docetaxel, high-dose intensity-modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for high-risk prostate cancer.

UNLABELLED: Study Type - Therapy (phase 1) Level of Evidence 2a What's known on the subject? and What does the study add? High-risk and locally advanced prostate cancers are difficult to cure with the standard regimen of radiation therapy (RT) with concurrent androgen-deprivation therapy (ADT). Multiple studies have explored the addition of docetaxel chemotherapy in attempt to improve patient outcomes. Prior Phase I studies have shown that docetaxel 20 mg/m(2) is a safe dose, when given concurrently with 70 Gy of radiation. But current standard RT for prostate cancer uses higher doses, and it is unclear if concurrent chemotherapy is safe with modern RT. This is a Phase I study that explored the addition of concurrent docetaxel chemotherapy to modern RT (intensity-modulated RT to 78 Gy) plus ADT. The study showed that weekly docetaxel at 20 mg/m(2) is safe with modern RT. At a median follow-up of 2.2 years, biochemical progression-free survival was 94%. This triple-therapy regimen is safe and promising for further evaluation in prospective trials. OBJECTIVE: • To evaluate in a phase I trial, the feasibility of adding concurrent weekly docetaxel chemotherapy to high-dose intensity modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for treatment of high-risk prostate cancer. PATIENTS AND METHODS: • Patients with high-risk prostate cancer were treated with a luteinising hormone-releasing hormone agonist (starting 2-3 months before IMRT and lasting 2 years), IMRT of 78 Gy to the prostate and seminal vesicles, and weekly docetaxel during RT. • All patients had computed tomography and bone scans to exclude metastatic disease. • A standard 3 + 3 design was used for docetaxel dose escalation. Successive patients were treated on dose levels of 10, 15, and 20 mg/m(2) of weekly docetaxel. RESULTS: • In all, 18 patients participated in the study: 15 (83%) had Gleason 8-10 disease; the other three had either clinical T3 disease and/or a prostate-specific antigen (PSA) level of >20 ng/mL. • Grade 3 diarrhoea (a defined dose-limiting toxicity, DLT) occurred in one patient in each of the first two dose levels. However, when the cohorts were expanded, no further DLT was seen. • Weekly docetaxel at 20 mg/m(2) (dose level 3) was successfully given without DLT. • No patient had grade 4 or 5 toxicity. • At a median follow-up of 2.2 years, all patients achieved a PSA nadir of <1 ng/mL, including 13 patients who had an undetectable PSA level. The 2-year biochemical progression-free survival was 94%. CONCLUSION: • A dose of 20 mg/m(2) of weekly docetaxel given concurrently with high-dose IMRT and ADT appears safe for further study in patients with high-risk prostate cancer.

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.

Intensity-modulated radiation therapy, proton therapy, or conformal radiation therapy and morbidity and disease control in localized prostate cancer.

CONTEXT: There has been rapid adoption of newer radiation treatments such as intensity-modulated radiation therapy (IMRT) and proton therapy despite greater cost and limited demonstrated benefit compared with previous technologies. OBJECTIVE: To determine the comparative morbidity and disease control of IMRT, proton therapy, and conformal radiation therapy for primary prostate cancer treatment. DESIGN, SETTING, AND PATIENTS: Population-based study using Surveillance, Epidemiology, and End Results-Medicare-linked data from 2000 through 2009 for patients with nonmetastatic prostate cancer. MAIN OUTCOME MEASURES: Rates of gastrointestinal and urinary morbidity, erectile dysfunction, hip fractures, and additional cancer therapy. RESULTS: Use of IMRT vs conformal radiation therapy increased from 0.15% in 2000 to 95.9% in 2008. In propensity score-adjusted analyses (N = 12,976), men who received IMRT vs conformal radiation therapy were less likely to receive a diagnosis of gastrointestinal morbidities (absolute risk, 13.4 vs 14.7 per 100 person-years; relative risk [RR], 0.91; 95% CI, 0.86-0.96) and hip fractures (absolute risk, 0.8 vs 1.0 per 100 person-years; RR, 0.78; 95% CI, 0.65-0.93) but more likely to receive a diagnosis of erectile dysfunction (absolute risk, 5.9 vs 5.3 per 100 person-years; RR, 1.12; 95% CI, 1.03-1.20). Intensity-modulated radiation therapy patients were less likely to receive additional cancer therapy (absolute risk, 2.5 vs 3.1 per 100 person-years; RR, 0.81; 95% CI, 0.73-0.89). In a propensity score-matched comparison between IMRT and proton therapy (n = 1368), IMRT patients had a lower rate of gastrointestinal morbidity (absolute risk, 12.2 vs 17.8 per 100 person-years; RR, 0.66; 95% CI, 0.55-0.79). There were no significant differences in rates of other morbidities or additional therapies between IMRT and proton therapy. CONCLUSIONS: Among patients with nonmetastatic prostate cancer, the use of IMRT compared with conformal radiation therapy was associated with less gastrointestinal morbidity and fewer hip fractures but more erectile dysfunction; IMRT compared with proton therapy was associated with less gastrointestinal morbidity.

Race and age disparities in receipt of sentinel lymph node biopsy for early-stage breast cancer.

To evaluate differences in use of sentinel lymph node biopsy (SLNB) by age and race in Medicare recipients with early-stage breast cancer, we examined Surveillance, Epidemiology and End Results-Medicare linked data for women undergoing breast conserving surgery for stage I or II breast cancer, including axillary staging, between January 2000 and December 2002. Multivariable generalized linear modeling with generalized estimating equations was used to identify predictors of receiving SLNB versus standard axillary lymph node dissection as the primary axillary staging modality. Women were significantly less likely to receive SLNB as their primary staging procedure if they were African American (OR 0.65), greater than 80 years of age (OR 0.71 vs. age <70), or dually eligible for Medicare and Medicaid (OR 0.61). Tumor characteristics, including well-differentiated histology and stage I disease, were associated with increased likelihood of SLNB, but estrogen receptor status was not a significant predictor. Women treated at an institution affiliated with an NCI cooperative research group had significantly greater likelihood of receiving SLNB (OR 2.31). Likelihood of receiving SLNB increased for women diagnosed in 2001 and 2002 compared with 2000. Significant disparities exist in receipt of SLNB in the Medicare population, with African Americans, the elderly, and economically disadvantaged patients being less likely to receive this innovative and morbidity-sparing procedure. These findings continue a previously observed pattern of reduced access to state of the art breast cancer care among underserved populations.

Getting cancer prevalence right: using state cancer registry data to estimate cancer survivors.

OBJECTIVE: Cancer incidence and mortality statistics provide limited insight regarding the cancer survivor population and its needs. Cancer prevalence statistics enumerate cancer survivors--those currently living with cancer. Commonly used limited-duration prevalence (LDP) methods yield biased estimates of the number of survivors. National estimates may not allow sufficient granularity to inform local survivorship programs. In this study, complete prevalence (CP) methods are applied to actual North Carolina Central Cancer Registry (NCCCR) data to generate better, more informative prevalence estimates than previous methods. METHODS: Data included all incident cases for 1995-2007 from the NCCCR and US Census population data. SEER*Stat software was used to calculate 13-year LDP. ComPrev software was used to estimate CP for each cancer site, gender, and race combination. RESULTS: CP methods estimated 362,810 survivors in North Carolina on January 1, 2008, 40% more than LDP estimates of 258,556, with substantial racial, regional, and gender differences in prevalence rankings of several cancers. CONCLUSION: CP estimates are substantially higher than previous prevalence estimates. This study found previously unrecognized racial, regional, and gender differences. State and local programs may apply these methods using their own data to develop better, more detailed estimates to improve planning for their specific survivor populations' needs.

The role of organizational affiliations and research networks in the diffusion of breast cancer treatment innovation.

INTRODUCTION: The National Institutes of Health (NIH) sees provider-based research networks and other organizational linkages between academic researchers and community practitioners as promising vehicles for accelerating the translation of research into practice. This study examines whether organizational research affiliations and teaching affiliations are associated with accelerated diffusion of sentinel lymph node biopsy (SLNB), an innovation in the treatment of early-stage breast cancer. METHODS: Surveillance Epidemiology and End Results-Medicare data were used to examine the diffusion of SLNB for treatment of early-stage breast cancer among women aged 65 years and older diagnosed between 2000 and 2002, shortly after Medicare approved and began reimbursing for the procedure. RESULTS: In this population, patients treated at an organization affiliated with a research network--the American College of Surgeons Oncology Group (ACOSOG) or other National Cancer Institute (NCI) cooperative groups--were more likely to receive the innovative treatment (SLNB) than patients treated at unaffiliated organizations (odds ratio: 2.70, 95% confidence interval: 1.77-4.12; odds ratio: 1.84, 95% confidence interval: 1.26-2.69, respectively). Neither hospital teaching status nor surgical volume was significantly associated with differences in SLNB use. DISCUSSION: Patients who receive cancer treatment at organizations affiliated with cancer research networks have an enhanced probability of receiving SLNB, an innovative procedure that offers the promise of improved patient outcomes. Study findings support the NIH Roadmap and programs such as the NCI's Community Clinical Oncology Program, as they seek to accelerate the translation of research into practice by simultaneously accelerating and broadening cancer research in the community.