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In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans.Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview.Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07-2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07-2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65-69 years and those with an adequate health literacy level.In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels.

Objectives: Clinical guidelines recommending the use of myeloid growth factors are largely based on the prescribed chemotherapy regimen. The guidelines suggest that oncologists consider patient-specific characteristics when prescribing granulocyte-colony stimulating factor (G-CSF) prophylaxis; however, a mechanism to quantify individual patient risk is lacking. Readily available electronic health record (EHR) data can provide patient-specific information needed for individualized neutropenia risk estimation. An evidence-based, individualized neutropenia risk estimation algorithm has been developed. This study evaluated the automated extraction of EHR chemotherapy treatment data and externally validated the neutropenia risk prediction model. Materials and Methods: A retrospective cohort of adult patients with newly diagnosed breast, colorectal, lung, lymphoid, or ovarian cancer who received the first cycle of a cytotoxic chemotherapy regimen from 2008 to 2013 were recruited from a single cancer clinic. Electronically extracted EHR chemotherapy treatment data were validated by chart review. Neutropenia risk stratification was conducted and risk model performance was assessed using calibration and discrimination. Results: Chemotherapy treatment data electronically extracted from the EHR were verified by chart review. The neutropenia risk prediction tool classified 126 patients (57%) as being low risk for febrile neutropenia, 44 (20%) as intermediate risk, and 51 (23%) as high risk. The model was well calibrated (Hosmer-Lemeshow goodness-of-fit test = 0.24). Discrimination was adequate and slightly less than in the original internal validation (c-statistic 0.75 vs 0.81). Conclusion: Chemotherapy treatment data were electronically extracted from the EHR successfully. The individualized neutropenia risk prediction model performed well in our retrospective external cohort.

Perillyl alcohol (POH) is a naturally occurring lipid with preclinical activity against mammary carcinomas. We conducted a phase II multi-institutional study of oral POH administered four times daily in women with advanced treatment-refractory breast cancer.Eligible women were treated with POH four times daily at 1,200-1,500 mg m(-2) dose(-1) on a 28-day cycle. Patients tolerating 1,200 mg m(-2) day(-1) four times daily after one cycle were dose-escalated to 1,500 mg/m(2). The primary endpoint was 1-year freedom-from-progression (FFP) rate. Secondary endpoints were response rate, tolerability and correlative evaluations.Twenty-nine cycles of POH were administered to 14 women. Three patients were dose-escalated to 1,500 mg/m(2). Grade 1 and grade 2 gastrointestinal effects and fatigue were predominant toxicities. Of seven patients receiving up to one cycle, three stopped therapy due to intolerance. Only two patients received more than two cycles, with disease stabilization of 3 and 8 months. Thirteen patients were evaluable for response. One-year FFP rate was zero. No objective responses were seen. The median time to progression was 35 days (95% CI, 29-123 days). Median overall survival was 389 days (95% CI, 202-776 days). Pharmacokinetic parameters were similar to previous investigations. The ability to correlate plasma TGF-beta1 levels with outcome was limited by lack of clinical benefit and inter- and intra-patient variability.Enrollment was suspended short of planned accrual because of lack of response and poor tolerance to POH. This regimen does not appear to provide benefit in advanced treatment-refractory breast carcinoma.

Background/Aims The colony stimulating factors (CSFs), filgrastim and its long-acting form, pegfilgrastim, are indicated by the Food and Drug Administration to decrease infections in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. Roughly 25–40% of treatment-naive patients receiving common chemotherapy regimens develop febrile neutropenia (FN). FN is associated with treatment delays, dose reductions, hospitalizations, and a high cost burden. CSFs decrease the incidence, length and severity of chemotherapy-related neutropenia in several solid tumors and prophylactically, decrease infection rates and neutropenia, infection-related mortality, and early deaths associated with chemotherapy. A reduction in absolute and relative risk for all-cause mortality is associated with CSF use and in combination with antibiotics for the treatment of FN, CSFs decrease the length of hospitalization; however, recent studies have shown these agents are frequently administered in a manner inconsistent with the recommended guidelines. The high costs associated with FN treatment, the high cost of CSFs and administration of CSFs in a manner inconsistent with scientific evidence creates both a clinical and economic challenge for health plans. To date, CSF data within the Virtual Data Warehouse (VDW) has not been evaluated for accuracy.

Multiple myeloma (MM) in patients aged greater than 80 years poses an increasingly common challenge for oncology providers. A multidisciplinary workshop was held in which MM-focused hematologists/oncologists, geriatricians, and associated health-care team members discussed the state of research for MM therapy, as well as themes from geriatric medicine that pertain directly to this patient population. A summary statement of our discussions is presented here, in which we highlight several topics. MM disproportionately affects senior adults, and demographic trends indicate that this trend will accelerate. Complex issues impact cancer in seniors, and although factors such as social environment, comorbidities, and frailty have been well characterized in nononcological geriatric medicine, these themes have been inadequately explored in cancers such as MM, despite their clear relevance to this field. Therapeutically, novel agents have improved survival for MM patients of all ages, but less so for seniors than younger patients for a variety of reasons. Lastly, both MM- and treatment-related symptoms and toxicities require special attention in senior adults. Existing research provides limited insight into how best to manage these often complex patients, who are often not reflected in typical clinical trial populations. We hence offer suggestions for clinical trials that address knowledge gaps in how to manage very old and/or frail patients with MM, given the complicated issues that often surround this patient population.

Background: Previous research has shown colorectal cancer (CRC) screening disparities by gender. Little research has focused primarily on gender differences among older Black individuals, and reasons for existing gender differences remain poorly understood. Methods: We used baseline data from the Cancer Prevention and Treatment Demonstration Screening Trial. Participants were recruited from November 2006 to March 2010. In-person interviews were used to assess self-reported CRC screening behavior. Up-to-date CRC screening was defined as self-reported colonoscopy or sigmoidoscopy in the past 10 years or fecal occult blood testing in the past year. We used multivariable logistic regression to examine the association between gender and self-reported screening, adjusting for covariates. The final model was stratified by gender to examine factors differentially associated with screening outcomes for males and females. Results: The final sample consisted of 1,552 female and 586 male Black Medicare beneficiaries in Baltimore, Maryland. Males were significantly less likely than females to report being up-to-date with screening (77.5% vs. 81.6%, P = 0.030), and this difference was significant in the fully adjusted model (OR: 0.72; 95% confidence interval, 0.52–0.99). The association between having a usual source of care and receipt of cancer screening was stronger among males compared with females. Conclusions: Although observed differences in CRC screening were small, several factors suggest that gender-specific approaches may be used to promote screening adherence among Black Medicare beneficiaries. Impact: Given disproportionate CRC mortality between White and Black Medicare beneficiaries, gender-specific interventions aimed at increasing CRC screening may be warranted among older Black patients. Cancer Epidemiol Biomarkers Prev; 22(6); 1037–42. ©2013 AACR.

The purpose of this study was to determine the activity of topotecan given by 21-day continuous infusion in patients previously treated with one prior therapy for a diffuse large-cell lymphoma or immunoblastic lymphoma. Patients with appropriate histology and measurable disease who had been treated with one prior chemotherapy regimen were eligible for study. Slides of tumor biopsies were submitted for central review of pathology. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and adequate bone marrow function. Patients were treated with continuous infusion topotecan, 0.4 mg/m(2)/day × 21 days. Therapy could be escalated to 0.5 and then 0.6 mg/m(2)/day in subsequent cycles if there was no dose-limiting toxicity at the initial dose level. Patients were treated with two cycles after achieving a complete response or until disease progression or unacceptable toxicity occurred. Thirty-seven patients were enrolled. However, only 26 cases were eligible due to a performance status of2 (n = 2), more than one prior chemotherapy (n = 1) and wrong histology on review (n = 8). Due to the unexpectedly high ineligibility rate, two sets of analysis were done for all 37 patients enrolled and for the 26 eligible patients, respectively. Of the 37 patients (15 males and 22 females), the International Prognostic Index included 11% low risk, 30% low intermediate risk, 46% high intermediate risk and 8% high risk. The median follow-up was 77 months. A total of 136 cycles of therapy were given with a median of 3 cycles per patient. Grade 4 toxicities included: 14% grade 4 thrombocytopenia; 14% grade 4 granulocytopenia, 8% leukopenia, 3% each anemia, hemorrhage, infection, vomiting, thrombosis, liver toxicity and neuromotor toxicity. The response analysis including all 37 patients showed five complete responses (CRs) and four partial responses (PRs) for a total response rate of 24% (90% two-stage confidence interval 13-39%). Median progression-free survival (PFS) was 3.7 months, with 1- and 2-year PFS of 21% and 6%, respectively (90% confidence interval 11-34% and 2-15%). Median overall survival (OS) was 10.5 months, with 1- and 2-year OS of 41% and 27%, respectively (90% confidence interval 27-53% and 16-39%). Analysis including only eligible patients showed similar response rates and survival outcomes. Single agent topotecan has moderate activity for previously treated high-grade lymphoma equivalent to that of several newer agents, and should be considered for incorporation into multi-drug salvage chemotherapy programs.

Background: Prostate specific antigen (PSA) testing is frequently used for early detection of prostate cancer, including among older adults. Since both race and socioeconomic status are associated with prostate cancer incidence and outcomes, it is often difficult to separate race from socioeconomic status as a determinant of prostate cancer screening. We sought to describe the relationship between socioeconomic status and PSA testing in a sample of urban, African American Medicare beneficiaries, and to examine factors that may contribute to this relationship. Methods: We examined baseline questionnaire data collected from the Cancer Prevention and Treatment Demonstration, a community-based randomized, controlled trial in Baltimore, MD. The study population consisted of 511 community-dwelling African-American men, age 65–75, without a history of prostate cancer. Our main outcome was PSA testing within the past year. Sequential multivariate logistic regression models were performed to study factors that may mediate the relationship between socioeconomic status and PSA screening. Results: Eighty percent of participants reported having had at least one PSA test in their lifetime, and approximately 50% reported having one within the past year. About half of the sample population reported a household income of less than $30,000 a year and one-third reported education past high school, but only 14% reported a bachelor's degree or higher. In bivariate analyses both higher income ($30,000 vs. < $10,000) (Odds Ratio [OR] 3.14, 95% Confidence Interval [CI] 1.79, 5.52) and higher levels of education (Bachelor's degree vs. less than high school) (OR 3.19, CI 1.72, 5.71) were associated with screening in the past year. In a multivariable regression model, which controlled for marital status, family history, and self-reported health status, income was no longer a significantly associated with PSA testing while the association between educational attainment and PSA testing was reduced (OR 2.13, 95% CI 1.07–4.22). The addition of increased healthcare access and patient-provider relationship measures in sequential models did not alter the relationship between educational attainment and screening. However, upon inclusion of cancer knowledge and belief measures the association between education and PSA testing was no longer significant (OR 1.84, 95% CI 0.90–3.75). Conclusions: In this urban, African American Medicare population, socioeconomic status was associated with PSA testing. This relationship may be explained, in part, by demographic factors and cancer knowledge and beliefs. Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):B23.

We evaluated the outcome of seven severe hemophilic patients who underwent four total hip and four total knee arthroplasties since 1976. These patients have been followed at regular intervals over a period of 2.5-9.5 years (mean 5.8). Of the four total hip replacements, one had to be removed because of loosening and secondary infection 3 years after the initial surgery but was salvaged by pseudoarthrosis; the other three are pain-free and radiologically stable and have an excellent range of motion 2.5, 5, and 7 years postoperatively. Of the four total knee replacements, one had to be removed because of infection but was successfully salvaged by arthrodesis; one patient has loose components, but the prosthesis is still functional; and the final patient with bilateral knee prostheses is pain-free with limited but functional range of motion. Clotting-factor replacement therapy was effective in controlling intraoperative bleeding, even in a patient with an inhibitor, and only one procedure was complicated by hematoma formation. We conclude that prosthetic joint replacement may be safely performed in hemophilic patients but should be reserved for those who have limited function because of severe pain, joint destruction, and deformity. Total hip arthroplasty is as successful in these patients as in nonhemophiliacs. Total knee arthroplasty provides relief of pain, reduces the frequency of hemarthroses, and corrects most of the deformity, but it is usually associated with a limited range of motion.