Cancer prevention trials and primary care physicians: factors associated with recommending trial enrollment

BACKGROUND: To explore the willingness of primary care providers (PCPs) to encourage enrollment of patients into cancer prevention trials. METHODS: A self-administered survey was mailed to a random sample of PCPs in three geographic regions. Physicians were asked questions about their knowledge and attitudes towards cancer prevention trials. We presented a clinical vignette of a woman at high risk for breast cancer and asked if they would encourage her enrollment into a breast cancer chemoprevention trial (yes/no). Each survey included one of 16 possible clinical vignettes where patient characteristics (age, race socioeconomic status, physical mobility and co-morbidity) varied dichotomously. Bivariate analyses and logistic models were used to examine the independent effects of patient and physician characteristics on physician decisions. RESULTS: Two hundred and sixty-six surveys (50% response) were analyzed. The mean age of respondents was 48; 54% were White, 35% Asian and 5% Black. By design physicians were evenly distributed by gender, specialty and geographic location. Overall, 53% would encourage enrollment into a breast cancer chemoprevention trial. Significant predictors of a recommendation to enroll were: geographic location in California or Georgia, younger vignette patient and anticipating an increase in patient trust after recommending enrollment. CONCLUSION: PCPs are less likely to encourage elderly patients to enroll into cancer chemoprevention trials. Decisions differ based on geographic location and perceived trust in the patient-provider relationship. To achieve successful enrollment, trial investigators must continue to educate PCPs and ensure a strong PCP-patient relationship is maintained.     

Cost-effectiveness and lung cancer clinical trials

BACKGROUND: Lung cancer is the leading cause of cancer death in the U.S., with an estimated annual economic burden of $5 billion. Clinical trials offer innovative therapeutic options with potentially better outcomes, but their effects on health care costs are disputed. METHODS: The authors analyzed the 1-year facility-based treatment cost and survival of 336 newly diagnosed nonsmall cell lung cancer patients who were deemed eligible for clinical trials between 1994 and 1998 at the Karmanos Cancer Institute. The incremental cost-effectiveness ratio (ICER) of clinical trial treatments with adjustment for confounders was calculated along with its 95% confidence interval (CI) using the bootstrap resampling method. RESULTS: Of the 336 patients, 76 (22.6%) were treated on clinical trials. Trial participation was associated significantly with race (P < 0.01), gender (P = 0.01), age (P = 0.02), and insurance type (P = 0.02). The average 1-year cost for trial enrollees was $41,734 with a median survival of 1.3 years, whereas the average 1-year cost for nonenrollees was $34,191 with a median survival period of 0.9 years. Differences in survival and 1-year cost between enrollees and nonenrollees were significant when controlling for age, race, gender, insurance, stage, performance status, and comorbidities. The ICER for trial participation after adjustment for confounders was $9741 per life year saved (95% CI, $3089-$19,149). CONCLUSIONS: Enrollment in lung cancer clinical trials was found to be associated with improved survival at a moderate incremental cost. Cancer 2003;98:1491-6.     

Lung carcinoma symptoms--an independent predictor of survival and an important mediator of African-American disparity in survival

BACKGROUND: The extent of disease in patients with lung carcinoma is reflected morphologically by stage and pathophysiologically by sign/symptoms. This study evaluates the associations between symptoms and stage, the independent impact of symptoms on survival, predictors of symptoms, and the extent to which symptoms mediate survival disparities. METHODS: Data from 1154 patients with lung carcinoma were collected from the authors' tumor registry and by abstraction of medical records. Associations were evaluated by logistic and Cox regression analyses. RESULTS: Symptomatic diagnoses were associated with advanced disease stage (odds ratio [OR], 4.53; 95% confidence interval [95%CI], 3.17-6.48). Hoarseness, hemoptysis, dyspnea, noncardiac chest pain, extrathoracic pain, neurologic symptoms, weight loss, and weakness/fatigue (adverse symptoms) were associated independently with relatively higher/advanced stage and/or reduced survival. Adverse symptoms (> or = 1 vs. 0) predicted reduced survival independently of stage and other prognosticators (hazard ratio [HR], 1.84; 95%CI, 1.52-2.21). Independent predictors of adverse symptoms included gender (OR(male vs. female), 1.50; 95%CI, 1.11-2.01), race/ethnicity (OR(black vs. white), 1.62; 95%CI, 1.18-2.21), and marital status (OR(spouseless vs. not), 1.79; 95%CI 1.31-2.45). The hazard ratios (HR; black vs white), univariate, adjusted for stage, and adjusted for stage and adverse symptoms, was 1.206 (95%CI, 1.05-1.38), 1.165 (95%CI, 1.01-1.34), and 1.075 (95%CI, 0.94-1.26), respectively. Adverse symptoms explained 43% of race/ethnic survival disparity beyond stage. CONCLUSIONS: Symptoms were associated with disease stage, yet both were important, independent predictors of survival; and symptoms explained an important amount of race/ethnic disparity in the survival of patients with lung carcinoma. Symptomatology needs to be incorporated into cancer clinical trials and into outcomes and disparities research.     

Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center.

PURPOSE: The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials. PATIENTS AND METHODS: From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment. RESULTS: The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P =.0005) and black women (21% of blacks offered v 42% of whites; P =.0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%). CONCLUSION: It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women.     

The impact of socioeconomic status and race on trial participation for older women with breast cancer

BACKGROUND: Older women, and older minorities in particular, are under represented in breast cancer trials. Although socioeconomic status (SES) is associated with both race and age, to the authors' knowledge little is known regarding the impact of SES on trial enrollment among older women with breast cancer. METHODS: The authors performed a case-control study comparing women who were participants in National Cancer Institute cooperative group breast cancer trials (cases) with a population-based sample of breast cancer patients (controls) obtained from the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data base. The sample was restricted to women age >/= 65 years who were living in SEER areas. Proxies for SES included the proportion of the population below poverty level (by zip code) and unemployed (by county) as well those with Medicaid insurance coverage. A multivariable logistic regression model was used to test the association of SES with trial participation after accounting for other patient and county characteristics. RESULTS: In bivariate analysis, trial participants were significantly less likely than community cancer patients to reside in high-poverty zip codes (20.9% vs. 24.9%, respectively; P < 0.001) or to have Medicaid insurance (2.0% vs. 10.0%; P < 0.0001). After adjusting for race, age, and county, trial participation remained inversely related to residing in areas with high poverty (odds ratio [OR] vs. residents of remaining counties, 0.78; 95% confidence interval [95% CI], 0.62-0.98), high unemployment rates (OR vs. residents of residents of counties in the lowest quartile, 0.50; 95% CI, 0.35-0.71), and having Medicaid insurance (OR vs. women without Medicaid, 0.22; 95% CI, 0.13-0.37); black race was not found to be related to trial participation (OR for black vs. white, 1.0; 95% CI, 0.67-1.47). CONCLUSIONS: Low SES was associated inversely with trial enrollment for older women with breast cancer and appeared to account for the enrollment disparities between black patients and white patients. Future efforts to enhance enrollment of elderly women in cancer research should identify specific barriers related to SES that may be amenable to intervention.     

Factors associated with enrollment in cancer genetics research.

Previous studies have identified low patient accrual in large-scale cancer clinical trials, particularly for underrepresented groups, such as ethnic minorities, females, and patients >65 years. As there have been few studies examining participation in cancer genetics epidemiologic research, our objective was to identify clinical and demographic factors predicting enrollment in these studies. A total of 1,111 patients diagnosed with colorectal cancer presenting to a gastrointestinal oncology clinic were approached to enroll in a study investigating the role of the MSH6 gene in familial colorectal cancer. Patient consent was sought for providing a blood specimen for DNA analysis and review of medical records/tumor specimens and contacting family members to confirm the family history of cancer. Seven predictor variables for enrollment (age, sex, ethnicity, family history of colorectal cancer in a first-degree relative, presence of children, insurance type, and type of visit) were analyzed using logistic regression analysis to determine the effect on decision to enroll. Of 1,111 patients approached, 696 (62.6%) enrolled in the study. Of these approached individuals, 4.2% were of nonwhite ethnicity and 33.5% were age > or =65 years. Patients of white ethnicity [odds ratio (OR), 2.10; P = 0.018], males (OR, 1.47; P = 0.002), those ages < or =65 years (OR, 1.42; P = 0.009), and those with a first-degree relative with colorectal cancer (OR, 1.57; P = 0.005) were significantly more likely to enroll. Fewer than 4% of all participants denied permission for the study researchers to access information from medical records or to be recontacted by researchers to discuss the enrollment of additional family members. Our data suggest that, once subjects decided to enroll, the majority (88%) was comfortable with consenting to all study components, including the creation of cell lines and future recontact. Low participation rates for ethnic minorities, females, and elderly patients are similar for both cancer genetics and clinical trial studies.     

Recruiting African American women to participate in hereditary breast cancer research.

PURPOSE: This study evaluated the process of recruiting African American women to participate in genetic counseling research for BRCA1 and BRCA2 (BRCA1/2) mutations with respect to referral, study enrollment, and participation in genetic counseling. PATIENTS AND METHODS: African American women (n = 783) were referred for study enrollment. RESULTS: Of 783 referrals, 164 (21%) women were eligible for enrollment. Eligible women were most likely to be referred from oncology clinics (44%) and were least likely to be referred from general medical practices (11%; chi(2) = 96.80; P = .0001). Overall, 62% of eligible women enrolled onto the study and 50% of enrollees completed genetic counseling. Women with a stronger family history of cancer (odds ratio [OR] = 3.18; 95% CI, 1.36 to 7.44; P = .01) and those referred from oncology clinics and community oncology resources (OR = 2.97; 95% CI, 1.34 to 6.58; P = .01) were most likely to enroll onto the study. Referral from oncology clinics was associated significantly with participation in genetic counseling (OR = 5.46; 95% CI, 1.44 to 20.60; P = .01). CONCLUSION: Despite receiving a large number of referrals, only a small subset of women were eligible for enrollment. Oncology settings were the most effective at identifying eligible African American women and general medical practices were the least effective. Factors associated with enrollment included having a stronger family history of cancer and being referred from oncology clinics and community oncology resources. Referral from oncology clinics was the only factor associated significantly with participation in genetic counseling. Education about hereditary breast cancer may be needed among primary care providers to enhance appropriate referral of African American women to genetic counseling for BRCA1/2 mutations.     

VEGF基因多态性与肺痛遗传危险因素的关系

Objective:We investigated the potential association between vascular endothelial growth factor (VEGF) poly-morphisms and the risk of lung cancer. Methods:In the case-control study, we used PCR-RFLP technique to determine two VEGF genotypes-2578C/A and 936C/T in 171 lung cancer patients and 172 healthy controls for conformation, and construct-ed haplotypes of the two gene sites by PHASE1.0 software. Unconditional logistic regression model was used to analyze the statistical association of genontypes or haplotypes in the two groups adjusted by gender and age. Results:Compared with at least one -2578A allele, individuals with-2578CC genotype found associated with a significantly decreased risk of lung can-cer [P=0.001;adjusted odds ratio (OR), 0.391;95% confidence interval (95% CI), 0.226-0.686]. Analyses stratified by gender showed that the combined -2578 CA and AA genotype were also associated with a significantly decreased risk of lung cancer. (P=0.016;OR 0.303;95% CI=0.153-0.601 and P=0.018;OR=0.547;95% CI=0.331-0.903, respectively). The distribu-tion of the two haplotypes (936C/-2578C and 936C/-2578A) were significantly different between case-and -control groups (P = 0.016, OR=0.317, 95% CI=0.124-0.809 and P=0.018, OR=0.547, 95% CI=0.331-0.903). Analyses categorized by tumor histology showed that Haplotype C-C was associated with a significantly decreased risk of adenocarcinoma compared with the reference haplotypes. (P=0.004;OR=0.237;95% CI=0.090-0.627). Conclusion:These results suggest that the VEGF polymorphisms may be a critical factor for the risk of lung cancer.     

Must patients with advanced cancer choose between a Phase I trial and hospice?

BACKGROUND: Phase I oncology trials offer no meaningful chance for direct medical benefit and they may prevent patients with advanced cancer from receiving palliative care in a hospice program. However, it is not known whether dual enrollment in a Phase I trial and hospice is feasible. METHODS: Five hundred thirty-four Phase I trials were identified in a national online database, of which 179 (34%) accepted patients with a life expectancy of less than 6 months. Of these, 50 were selected randomly. Their principal investigators were surveyed by fax, with follow-up telephone calls and e-mails. Ninety-two hospices were selected randomly from a national database. Surveys were conducted by telephone with intake coordinators. Principal investigators were asked whether patients enrolled in hospice could also enroll in their trials if they were eligible in all other respects. Hospice intake coordinators were asked whether a patient with advanced cancer who met hospice eligibility criteria could also enroll in a Phase I trial. RESULTS: Surveys were completed by 45 of 50 principal investigators (90%) and by 89 of 92 hospices (97%). Although both groups were in favor of dual enrollment, principal investigators (41 of 45; 91%) were more likely to support dual enrollment than hospices (60 of 89; 67%; chi-square test, P = 0.004). Most hospices that did not support dual enrollment cited reasons that were based on concerns about payment or misunderstandings about the nature of Phase I trials. CONCLUSIONS: Most hospices and Phase I principal investigators believe that eligible patients should be allowed to enroll simultaneously in hospice and Phase I trials. These results suggest that the choice between hospice and a Phase I trial is a false dilemma and that greater collaboration in this area is needed.     

A Prospective Analysis of the Influence of Older Age on Physician and Patient Decision-Making When Considering Enrollment in Breast Cancer Clinical Trials (SWOG S0316)

Purpose. Patients older than 65 years are underrepresented in clinical trials. We conducted a prospective study (SWOG S0316) to determine physician- and patient-perceived barriers to breast cancer clinical trial enrollment for older patients. Methods. Eight geographically diverse SWOG institutions participated. The study assessed patients' and physicians' decisions to enroll in or decline clinical treatment trials, including demographics, trial availability, and eligibility. Patient and physician questionnaires elicited concerns related to treatment, medical status, age, family, and financial or transportation concerns. Results. A total of 1,079 patients were registered and eligible and 909 (84%) returned for follow-up. The major reason for nonaccrual was either trial unavailability or ineligibility (60%). Older patients were less likely to be eligible for trials (65% for age ≥65 years vs. 78% for age <65 years). If eligible, trial participation rates did not differ significantly by age (34% for age ≥65 years vs. 40% for age <65 years). Patients ≥65 years more often were concerned about side effects, had friends opposed to participation, or believed that participation would not benefit other generations. When trials were available and patients were eligible, physicians discussed trial participation with 76% of patients <65 years versus 58% of patients ≥65 years of age. For patients ≥65 years, 11% of physicians indicated age as a reason they did not enroll a patient in a clinical trial. Conclusion. Trial unavailability or patient ineligibility were the major reasons for lack of enrollment in breast cancer clinical trials for patients of all ages in this prospective study. Older patients were less likely to be eligible for trials, but if eligible they participated at similar rates to younger patients.     

Lack of Association of Glutathione S-transferase M3 Gene Polymorphism with the Susceptibility of Lung Cancer

Objective: The conclusions of published reports on the relationship between the glutathione S-transferaseM3 (GSTM3) A/B gene polymorphism and the risk of lung cancer are still debated. This meta-analysis wasperformed to evaluate the association between GSTM3 and the risk of lung cancer. Methods: Associationinvestigations were identified from PubMed, Embase, and Cochrane Library, and eligible studies were includedand synthesized using a meta-analysis method. Results: Eight reports were included into this meta-analysis forthe association of GSTM3 A/B gene polymorphism and lung cancer susceptibility, covering 1,854 patients withlung cancer and 1,926 controls. No association between the GSTM3 A/B gene polymorphism and lung cancerwas found in this meta-analysis (B allele: OR = 1.25, 95% CI: 0.89-1.76, P = 0.20; BB genotype: OR = 1.53, 95%CI: 0.71-3.32, P = 0.28; AA genotype: OR = 0.85, 95% CI: 0.59-1.23, P = 0.39). Conclusions: The GSTM3 A/Bgene polymorphism is not associated with lung cancer susceptibility. However, more studies on the relationshipbetween GSTM3 A/B gene polymorphism and the risk of lung cancer should be performed in the future.     

Glutathione S-transferase P1 gene Ile105Val polymorphism might be associated with lung cancer risk in the Chinese Han population

Genetic variations in glutathione S-transferase P1 (GSTP1) gene have been suggested to be involved in the development of cancer. However, the results from the studies regarding the association between GSTP1 Ile105Val polymorphism and lung cancer risk in the Chinese population have been inconsistent. Thus, we conducted a meta-analysis to investigate the association. Published literature from PubMed, Chinese Biomedical Literature Database, Chinese Wanfang Data, and Chinese National Knowledge Infrastructure databases were searched for eligible publications. Pooled odds ratios (ORs) with 95?% confidence intervals (CIs) were calculated using random or fixed effect model. Ten studies (1,506 cases/1,714 controls) were included in the meta-analysis. The results suggested that GSTP1 Ile105Val polymorphism was marginally associated with lung cancer risk in the Chinese Han population under a multiplicative model (G vs. A, odds ratio (OR)?=?1.22, 95?% confidence interval?=?1.02?C1.46), under a homogeneous codominant model (GG vs. AA, OR?=?1.67, 95?% CI?=?1.14?C2.45), under a heterogeneous codominant model (GA vs. AA, OR?=?1.15, 95?% CI?=?0.98?C1.35), under a dominant model (GG + GA vs. AA, OR?=?1.21, 95?% CI?=?1.04?C1.39), and under a recessive model (GG vs. GA + AA, OR?=?1.59, 95?% CI?=?1.09?C2.31), respectively. Moreover, after adjusted for age, gender, and smoking status, the significant association under dominant model remained (OR?=?1.27, 95?% CI?=?1.07?C1.51). This meta-analysis suggested that there might be an association between GSTP1 Ile105Val polymorphism and lung cancer in the Chinese Han population.     

Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment.

PURPOSE: Well-conducted cancer clinical trials are essential for improving patient outcomes. Unfortunately, only 3% of new cancer patients participate in clinical trials. Barriers to patient accrual in cancer clinical trials must be identified and overcome to increase patient participation. MATERIALS AND METHODS: We prospectively tracked factors that potentially affected patient accrual into cancer clinical trials at the University of California Davis Cancer Center. Oncologists seeing new outpatients were asked to complete questionnaires regarding patient characteristics and the physician's decision-making on patient eligibility, protocol availability, and patient opinions on participation. Statistical analysis was performed to correlate these parameters with subsequent protocol accrual. RESULTS: There were 276 assessable patients. At the initial visits, physicians did not consider clinical trials in 38% (105/276) of patients principally because of a perception of protocol unavailability and poor performance status. Physicians considered 62% (171/276) of patients for participation in clinical trials. Of these, only 53% (91/171) had an appropriate protocol available for site and stage of disease. Seventy-six of 90 patients (84%) with available protocols met eligibility criteria for a particular study. Only 39 of 76 patients (51%) agreed to participate in cancer clinical trials, for an overall accrual rate of 14% (39/276). The remainder (37/76, 49%) declined trial participation despite meeting eligibility criteria. The most common reasons were a desire for other treatment (34%), distance from the cancer center (13%), patient refusal to disclose reason (11%), and insurance denial (8%). Patients with private insurance were less likely to enroll in clinical trials compared to those with government-funded insurance (OR, 0.34; P =.03; 95% CI, 0.13 to 0.9). CONCLUSION: Barriers to cancer clinical trial accrual can be prospectively identified and addressed in the development and conduct of future studies, which may potentially lead to more robust clinical trials enrollment. Investigation of patient perceptions regarding the clinical trials process and the role of third party-payers is warranted.     

A functional polymorphism in the promoter region of leptin gene increases susceptibility for non-small cell lung cancer

Leptin hormone and receptor have been associated to cancer development and were identified in lung tissue. In this study, a functional polymorphism in the 5' flanking region of the leptin gene (LEP -2548 G/A) was found to increase susceptibility for non-small cell lung cancer [odds ratio (OR), 1.97; 95% confidence interval (CI), 1.13-3.43]. Age-adjusted logistic regression analysis in men indicated an association of AA genotype with adenocarcinoma (OR, 4.29; CI, 1.64-11.72) and squamous cell carcinoma (OR, 3.19; CI, 1.26-8.13). Logistic regression analysis confirmed the AA genotype as an independent risk factor for lung cancer after adjustment for age and gender (OR, 2.57; CI, 1.34-4.92). The AA genotype was overrepresented only in patients with non-metastatic disease (OR, 1.86; CI, 1.13-3.04). Kaplan-Meier analysis demonstrated an earlier age of onset for lung cancer in AA carriers (P=0.023). Results suggest the existence of genetic susceptibility for lung cancer in carriers of this LEP functional polymorphism. Further studies are warranted to extend knowledge of leptin involvement in lung cancer.     

An educational video to increase clinical trials enrollment among breast cancer patients

Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients’ attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment.     

Enrolling older persons in cancer trials: the effect of sociodemographic, protocol, and recruitment center characteristics.

PURPOSE: To determine the effect of patient, protocol, geographic, and institutional factors on enrollment of older persons onto cancer trials. METHODS: We conducted a cross-sectional analysis of patients enrolled onto National Cancer Institute-sponsored lung, breast, colorectal, and prostate cancer trials during 1996 to 2002. We used a cross-classified logistic multilevel model to examine the associations between patient, hospital, county, and protocol characteristics, and the likelihood of participants being elderly (>or= 65 years old). RESULTS: The final study sample consisted of 36,167 patients enrolled onto 33 trials. After accounting for cancer type, only 6% of the variation in elderly enrollment onto cancer trials was at the protocol level. In contrast, more than 55% of the variation in elderly enrollment was attributable to patient level variation. In multivariate analysis, nonwhite patients were significantly less likely to be elderly than whites (odds ratio [OR] for blacks, 0.51; 95% CI, 0.44 to 0.58; and OR for Hispanics, 0.49; 95% CI, 0.40 to 0.59 v whites). Participants living less than 7 miles from their recruitment center were significantly more likely to be elderly (OR, 1.31; 95% CI, 1.24 to 1.38). Among the 910 recruitment centers, the median adjusted proportion of patients who were elderly was 24.9% (interquartile range, 24.0% to 26.9%). There were a significantly higher number of outlier centers (or= 29.3% elderly) than would be expected by a normal distribution (68 observed v six expected; P < .0001). CONCLUSION: Race and proximity to trial enrollment centers were significantly related to age of trial participants after adjusting for protocol factors. Additional work should explore why some recruitment centers were outliers regarding enrollment of older persons.     

Identifying Barriers Associated With Enrollment of Patients With Lung Cancer into Clinical Trials

BackgroundEnrollment of patients with lung cancer into clinical trials is required to accelerate the pace of new therapy development and contribute to a better understanding of the biological characteristics of cancer.MethodsWe conducted a retrospective chart review of all patients seen by the thoracic medical oncology team at the Vanderbilt Ingram Cancer Center (VICC) from November 2005 to November 2008 to determine the barriers associated with patient enrollment in to clinical trials.ResultsOne thousand forty-three patient charts were audited: 32% of patients were eligible for enrollment, and 14% enrolled in a study. There were no significant differences in protocol availability or eligibility by sex, smoking status, or age. Patients living further from the cancer center were significantly less likely to have a study protocol available (P = .009), but if a protocol was available they were more likely to be eligible for enrollment (P < .001). Significantly more protocols were available for patients with non–small-cell lung cancer (NSCLC) compared with those who had small-cell lung cancer (SCLC) (63% vs. 48%; P < .001). Patients with advanced disease were more likely to have a protocol available (P < .001) and enter a study (P = .031). The most common reasons for patients not being eligible for enrollment were poor performance status (32%) and presence of comorbid disease (27%). The most common reasons for potentially eligible patients not enrolling in a study included preference for treatment closer to home (49%) and patient refusal (43%).ConclusionAdditional strategies are required to increase accrual of patients into lung cancer trials, including development of protocols for early-stage disease and modifying eligibility and performance status criteria for this unique patient population.     

Association of Promoter Region Polymorphisms of IL-10 Gene with Susceptibility to Lung Cancer: Systematic Review and Meta-Analysis

Objective: Epidemiological studies have suggested that the promoter region polymorphisms of interleukin-10 (IL-10)gene may be associated with an increased risk of lung cancer. However, those studies results are controversial. Thus, acomprehensive meta-analysis was performed to evaluate the association of promoter region polymorphisms of IL-10gene with susceptibility to lung cancer. Methods: a comprehensive search of PubMed, EMBASE, and CNKI databaseswas performed to find all eligible studies up to September 15, 2018. The pooled odds ratios (ORs) with 95% confidenceintervals (CIs) were used to assess the strength of such association. Results: A total number of 19 case-control studies with4084 cases and 6,131 controls were selected. The overall meta-analysis results showed that the -592A>C polymorphismwas significantly associated with lung cancer risk under four genetic models, i.e., allele (CT vs. TT: OR= 1.17, 95% CI1.01-1.35, p=0.02), homozygote (CC vs. AA: OR= 1.64, 95% CI 1.29-2.02, p≤0.001), heterozygote (CA vs. AA: OR=1.26, 95% CI 1.06-1.50, p≤0.001), and dominant (CC+CA vs. AA: OR= 1.31, 95% CI 1.11-1.54, p=0.001). However,there was no significant association between -819T>C and -1082A>G polymorphisms of IL-10 and lung cancer risk.Similarly, subgroup analyses by ethnicity detected significant association between IL-10 -592A>C and lung canceramong Asians and Caucasians. Conclusions: Our meta-analysis suggests that the IL-10 -592A>C polymorphism mightbe risk factor for lung cancer, especially among Asian and Caucasians. In contrast, the IL-10 -819T>C and -1082A>Gpolymorphisms are not significantly associated with increased risk of lung cancer.     

Survival Disparities of Diffuse Large B-Cell Lymphoma in a Community-Based Inner-City Cancer Center

BackgroundDiffuse large B-cell lymphoma (DLBCL) comprises approximately 30% of all non-Hodgkin lymphomas. Multiple studies have demonstrated race-based disparities in survival among patients with DLBCL across all stages of disease, in the era both before and after rituximab. The etiology for the racial disparities in survival among patients with DLBCL is still unknown. Moreover, the Revised International Prognostic Index (R-IPI), a tool that predicts the DLBCL patients’ outcome, has not yet been validated in African Americans (AA).Patients and MethodsWe conducted a cohort study of patients diagnosed with DLBCL from January 1, 2007, to December 31, 2017, from our tumor registry in a single community-based inner-city cancer center. We abstracted demographic, clinical, histopathologic, treatment, and R-IPI variables. A total of 181 patients (47.5%) with biopsy-proven DLBCL were included in the retrospective analysis. The median age was 65 years, 47% were men, 41% were AA, and 44% were white.ResultsThe AA group had a younger median age, higher lactate dehydrogenase levels, higher frequency of B symptoms, and higher HIV infection than the non-AA group. The AA group had significantly decreased median overall survival than the non-AA group (15.7 months; 95% confidence interval, 10.3 to 23.9, vs. 93.6 months; 95% confidence interval, 61.5 to 142.6, respectively; P < .001). The survival disparities persisted after excluding patients with HIV and who did not receive chemotherapy. In addition, AA race predicts a reduced survival by univariate and multivariate analysis.ConclusionAA with DLBCL may have a poorer prognosis than the non-AA population. Further studies should investigate the biology of DLBCL in the AA population.