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Background: Contralateral prophylactic mastectomy (CPM) is the removal of a nonaffected breast in a woman with unilateral breast cancer and is effective in reducing the risk of recurrences. Little is known about women's decision-making roles regarding CPM. Methods: Women aged 18-80 years with CPM performed at one of six health maintenance organizations between 1979 and 1999 were surveyed. We determined women's reported decision-making roles at the time of CPM, analyzed their trends over time, and explored the association between decision-making roles and psychosocial outcomes following CPM. Results: We received 562 responses (response rate = 73%); 431 completed items needed for this analysis. Most respondents were white, younger than 55 years at CPM, married, and had CPM within 10 years of completing the survey. Forty-five percent made the decision to undergo CPM alone, 37% considered their doctor's opinion, 15% shared the decision with their doctor and only 3% reported their doctor primarily made the decision. Women reporting active roles were more likely to be younger (P

To assess barriers to physician participation in cancer clinical trials among oncologists, oncology leaders, and health plan leaders.Mail survey of 221 oncologists combined with semistructured telephone interviews with oncology and plan leaders at 10 integrated healthcare systems.The survey instrument examined physicians' involvement in clinical trials; their perception of the value of trials to them, their patients, and their organization; and the presence of infrastructure support for trials and associated resource constraints. The interviews investigated similar issues from the leaders' perspective. We used linear regression to model trial enrollment and standard qualitative techniques to analyze the interviews.Oncologists estimated they enrolled 7% of patients in trials. They expressed extremely favorable attitudes toward trials as a source of high-quality patient care and a benefit to themselves professionally. While positive attitudes toward trials were common, and were significant bivariate predictors of enrollment, organizational factors were the predominant predictors in multivariate analysis. The best combination of factors independently predicting enrollment related to organizational support for trials, subspecialty of the oncologist, and limitations of trial eligibility requirements.To increase trial participation, there is a critical need for infrastructure to support trials, especially additional support staff and research nurses. In addition, there is a need for better intra-organizational communication and consideration of the impact of trial design on internal health plan resources. This research supports the need to continue a national dialogue about the broadly defined benefits and costs of clinical trials to patients, physicians, and health plans.

Background: The effi cacy of breast cancer screening in the community may differ from that suggested by the results of randomized trials, and no data have been available on effi cacy among women who have different levels of breast cancer risk. Methods: We conducted a matched case – control study among women enrolled in six health plans in Washington, Oregon, California, Massachusetts, and Minnesota. We examined the effi cacy of screening by mammography and/or clinical breast examination among women in two age cohorts (40 – 49 years and 50 – 65 years) and in two breast cancer risk levels (average and increased risk). Women who died from breast cancer from January 1, 1983, through December 31, 1998, (N = 1351; case subjects) were matched to control subjects (N = 2501) on age and risk level. Increased risk was defi ned as a family history of breast cancer or a breast biopsy noted in the medical records before the index date (defi ned as date of fi rst suspicion of breast abnormalities in case subjects, with the same date used for matched control subjects). Data on screening, risk status, and other variables were abstracted from medical records. Conditional logistic regression was used to examine the association between breast cancer mortality and receipt of screening. All statistical tests were two-sided. Results: There were small, non- statistically signifi cant associations between breast cancer mortality and receipt of screening during the 3 years prior to the index date for both the younger women [odds ratio (OR) = 0.92; 95% confi dence interval (CI) = 0.76 to 1.13] and the older women (OR = 0.87; 95% CI = 0.68 to 1.12). The association among women at increased risk (OR = 0.74; 95% CI = 0.50 to 1.03) was stronger than that among women at average risk (OR = 0.96; 95% CI = 0.80 to 1.14), but the difference was not statistically signifi cant ( P = .17). Conclusions: In this communitybased study, screening history was not associated with breast cancer mortality. However, potential limitations of this study argue for a cautious interpretation of these fi ndings. [J Natl Cancer Inst 2005;97:1035 – 43]

Findings from several studies suggest that bilateral prophylactic mastectomy reduces breast cancer incidence by 90% or more, but the studies used highly selected patients from referral centers, and the comparison groups were not population based. We studied the efficacy of bilateral prophylactic mastectomy in women with elevated breast cancer risk cared for in community practices.We conducted a retrospective case-cohort study of women aged 18 to 80 years with 1 or more breast cancer risk factors (family history of breast cancer, history of atypical hyperplasia, oror =1 breast biopsies with benign findings). Using computerized data and medical records, we identified 276 women with bilateral prophylactic mastectomy and a stratified random sample of 196 women representing an underlying cohort of 666 800 women with elevated breast cancer risk without prophylactic mastectomy, and then we determined who developed breast cancer.Breast cancer developed in 1 woman (0.4%) after bilateral prophylactic mastectomy vs 26 800 women (4.0%) without prophylactic mastectomy. Stratifying by birth year, the hazard ratio for breast cancer occurrence after bilateral prophylactic mastectomy was 0.005 (95% confidence interval, 0.001-0.044). No woman with bilateral prophylactic mastectomy died of breast cancer vs a calculated 0.2% of women without prophylactic mastectomy.Bilateral prophylactic mastectomy reduced breast cancer incidence in women at elevated risk for breast cancer cared for in community-based practices. However, the absolute risk of breast cancer incidence and death in women who did not undergo the procedure in these settings was relatively low.

To describe the characteristics of participants who completed a mailed survey, compared to those initial non-responders who completed the same survey over the telephone. STUDY DESIGN AND PATIENT POPULATIONS: We conducted a mailed survey, in both Spanish and English, among women with abnormal Pap smears, who were members of a large managed care organization. Telephone follow up for non-responders was performed by a bilingual interviewer. A 20-minute long distance telephone card was offered as an incentive to individuals who completed the telephone survey. We used bivariate and multivariate analyses to describe the population characteristics of respondents who replied by mail, as compared to those who completed the survey by telephone.Of the 1049 potentially eligible participants, 733 women completed the survey, for an overall response rate of 70%. Fifty-six percent (N=411) of the surveys were received by mail, and 44% (N=322) were completed by telephone. Thirty-four percent of the telephone surveys were completed in Spanish, compared to 13% of the mailed surveys (P.001). Telephone respondents were less satisfied with their health care than were those who responded by mail.Among this insured cohort of women, Latinas who completed the survey in Spanish were more likely to participate in a telephone survey that offered an incentive, than in a mailed survey. These findings should be considered when planning health surveys in this population.

Mammography screening increases the detection of early-stage breast cancers. Therefore, implementing screening should reduce the percentage of women who are diagnosed with late-stage disease. However, despite high national mammography screening rates, late-stage breast cancers still occur, possibly because of failures in screening implementation.Using data from seven health care plans that included 1.5 million women aged 50 years or older, we conducted retrospective reviews of chart and automated data for 3 years before 1995-1999 diagnoses of late-stage (metastatic and/or tumor sizeor =3 cm; case subjects, n = 1347) and early-stage breast cancers (control subjects, n = 1347). We categorized the earliest screening mammogram during the period 13-36 months before diagnosis as none (absence of screening), negative (absence of detection), or positive (potential breakdown in follow-up). We compared the proportion of case and control subjects in each category of screening implementation and estimated the likelihood (odds ratio [OR] with 95% confidence intervals [CIs]) of late-stage breast cancer. We also evaluated demographic characteristics associated with absence of screening in women with late-stage disease. All statistical tests were two-sided.Absence of screening, absence of detection, and potential breakdown in follow-up were distributed differently among case (52.1%, 39.5%, and 8.4%, respectively) and control subjects (34.4%, 56.9%, and 8.8%, respectively) (P = .03). Among all women, the odds of having late-stage cancer were higher among women with an absence of screening (OR = 2.17, 95% CI = 1.84 to 2.56; P.001). Among case patients, women were more likely to be in the absence-of-screening group if they were aged 75 years or older (OR = 2.77, 95% CI = 2.10 to 3.65), unmarried (OR = 1.78, 95% CI = 1.41 to 2.24), or without a family history of breast cancer (OR = 1.84, 95% CI = 1.45 to 2.34). A higher proportion of women from census blocks with less education (58.5% versus 49.4%; P = .003) or lower median annual income (54.4% versus 42.9%; P = .004) were in the absence-of-screening category compared with the proportion for the other two categories combined.To reduce late-stage breast cancer occurrence, reaching unscreened women, including elderly, unmarried, low-income, and less educated women, should be made a top priority for screening implementation.

To determine the sensitivity and positive predictive value (PPV) of computerized diagnostic data from health maintenance organizations (HMOs) in identifying incident breast cancer cases.An HMO without a cancer registry developed an algorithm identifying incident breast cancer cases using computerized diagnostic codes. Two other HMO sites with Surveillance, Epidemiology, and End Results (SEER) registries duplicated this case-identification approach. Using the SEER registries as the criterion standard, we determined the sensitivity and PPV of the computerized data.Data were collected from HMO computerized data-bases between January 1, 1996, and December 31, 1999. Surveillance, Epidemiology, and End Results data were also used.The overall sensitivity of the HMO databases was between 0.92 (95% confidence interval [CI], 0.91-0.96) and 0.99 (95% CI, 0.98-0.99). Sensitivity was high (range, 0.94-0.98), for the first 3 (of 4) years, dropping slightly (range, 0.81-0.94) in the last year. The overall PPV ranged from 0.34 (95% CI, 0.32-0.35) to 0.44 (95% CI, 0.42-0.46). Positive predictive value rose sharply (range, 0.18-0.20) after the first year to 0.83 and 0.92 in the last year because prevalent cases were excluded. Review of a random sample of 50 cases identified in the computerized data-bases but not by SEER data indicated that, while SEER usually identified the cases, the registry did not associate every case with the health plan.Health maintenance organization computerized databases were highly sensitive for identifying incident breast cancer cases, but PPV was low in the initial year because the systems did not differentiate between prevalent and incident cases. Health maintenance organizations depending solely on SEER data for cancer case identification will miss a small percentage of cases.

To describe the systems strategies used to reduce failures in delivery of breast and cervical cancer screening services in HMOs with high performance rates for these services.Multiple case study.Seven HMOs participated in an assessment of their breast and cervical cancer screening policies and procedures. Current clinical practice guidelines were analyzed, and key informants were interviewed about organizational policies and procedures that ensure initial screening and follow-up of abnormal results. Data were analyzed across plans for several theoretically relevant domains, including leadership and policies, clinical decision support, delivery system design, clinical information systems, and patient self-management support.Practice guidelines were fundamentally similar across plans for both cancer screenings, although operationalization of risk and formatting of the written documents differed. These plans adopted a wide array of strategies, particularly in the clinical decision support, clinical information systems, and patient self-management support domains, but there is room for improvement. Differences among plans and between strategies for breast and cervical cancer screening provide new understanding of how to approach this problem.Organizations seeking to improve performance of breast and cervical cancer screening should consider multiple strategies aimed at multiple targets and should ensure that strategies used for one type of cancer are considered for others.

Purpose: To describe referral guidelines for hereditary breast and ovarian cancer (HBOC) counseling among a group of Health Maintenance Organizations (HMOs) and awareness of such among primary care clinicians. Methods: An organizational assessment of plan policies and a primary care clinician survey. Results: Five of the 7 HMOs reported having HBOC referral guidelines. Differences between plan’s criteria included age of breast cancer onset, inclusion of male breast cancer, and second-degree relatives. Of the 91% clinicians responding, only half were aware of the HBOC guidelines. Awareness was higher in the plan with the most intense implementation effort (OR 3.0, 1.5–5.9) and among gynecologists (OR 2.8, 1.5–5.4). Conclusions: Although HBOC counseling guidelines within participating HMOs identify persons for referral that can be easily incorporated into routine practice, continued work is needed to better understand how to help primary care providers identify high-risk persons, and new models of providing genetic services may need to be considered. Genet Med 2003:5(6):444–450.

To implement a computerized system to gather and transmit medical record information from six sites to a centralized database for two cancer prevention studies.Microsoft Access 97 was selected as the application for the system. Sites purchased Access and hardware meeting technical specifications required for the system. A developer worked with the lead investigator and medical record abstractors to develop a 'back-end' database to hold the desired data while maintaining a user-friendly 'front-end' interface. Abstractors trained on a paper version of the abstraction form were then trained to use the system. Meeting minutes and technical notes were used in summarizing the approach and process. Observations were collected through discussions.We overcame multiple obstacles to develop computerized systems supporting medical record data collection at multiple sites. Although system development slowed implementation of the study, the system produced data for cleaning and analysis immediately. Overall the approach decreased the time from study implementation to manuscript submission. Development time for a second system was substantially reduced.Computerized systems for medical record abstraction at multiple sites convey substantial benefit. We present a schematic approach to facilitate development of similar systems in the future.

Clinical studies using medical record review should include careful training and quality assurance methods to enhance the reliability and validity of data obtained from the records. Because of time and budget constraints, comprehensive assessments of data quality and reliability, including masking of medical record abstractors, are not always possible. This paper describes the abstractor training and quality control methods and results of a masked medical record review study. The medical record review study was carried out within a larger multisite study of the effectiveness of screening mammography in preventing breast cancer mortality with an observation period within 1983 and 1993, with mortality follow-up through 1998. An eight-step program was developed to train medical record abstractors and monitor the quality of their work. A key follow-up component to the training protocol was a 5% reabstraction of medical records (n = 160), masked and reviewed by a second abstractor. High agreement was found between initial (unmasked) abstractors and masked abstractors for all key exposure variables (kappa ranged from 0.76 to 0.91), with no evidence of biased directionality by unmasked reviewers. Rigorous ongoing training programs for medical record abstractors provide assurance of good quality control in large multisite studies. Additionally, a masking study with a subsample of subjects may be a feasible and cost-effective alternative to the time- and cost-intensive methodological approach of masking all medical records.

ContextWomen from racial and ethnic minorities in the United States have higher rates of cervical cancer and present with later stage disease compared to whites. Delays in care for abnormal Papanicolaou (Pap) smears can lead to missed cases of cervical cancer or late-stage presentation and may be one explanation for these differences.ObjectiveTo determine if race and ethnicity, health beliefs, and cancer knowledge are associated with delays in care for abnormal Pap smears.Design, participants, and settingWe conducted a mailed survey with telephone follow-up of all women with an abnormal Pap smear who received care at Kaiser Permanente Los Angeles Medical Center between October 1998 and October 1999 (n = 1,049).Measurements and main resultsA delay in care was defined as not attending the first scheduled clinic visit to follow up on an abnormal Pap smear, or requiring multiple contact attempts, including a certified letter, to schedule a follow-up visit. Our response rate was 70% (n = 733) and the sample was 51% Latina. Spanish-speaking Latinas and women of Asian descent were more likely to endorse fatalistic beliefs and misconceptions about cancer. Thirteen percent of the sample delayed follow-up on their abnormal Pap smear. Women who delayed care were more fatalistic and endorsed more misconceptions about cervical cancer. Delays in care were not independently associated with race and ethnicity.ConclusionsHealth beliefs and cancer knowledge differed by race and ethnicity among women in a large managed care organization. Fatalistic health beliefs and misconceptions about cancer, but not race and ethnicity, were independently associated with delays in care.

Purpose: After completing primary treatment for breast cancer, regular follow-up care is recommended to monitor for recurrence and second primary cancers, and to manage late and long-term effects of cancer and its treatment, comorbidities, and psychosocial issue. Lack of follow-up care may be particularly concerning for African American women, who have higher breast cancer mortality despite lower incidence rates compared to White women. Reasons why survivors may not receive follow-up care are poorly understood; therefore we describe breast cancer survivors' perceived barriers to follow-up care, including differences between African American and White women, and examine factors associated with perceived barriers to care. Methods: We conducted a mailed cross-sectional survey of women identified from an institutional cancer registry and treated for non-metastatic breast cancer 6 to 24 months post-treatment. Survivors were asked whether each of 14 potential barriers presented a big problem, somewhat of a problem or no problem in receiving follow-up care. The list of barriers was adapted from an earlier survey of follow-up care among cancer survivors. We created two dichotomous measures: any barrier to care (any barrier rated as “somewhat of a problem” or “a big problem,” vs. all 14 barriers reported as “no problem”) and cost-related barriers to care (any of three cost-related barriers rated as “somewhat of a problem” or “big problem versus all three barriers reported as “no problem). We used logistic regression analysis to explore associations between barriers (any barrier and cost-related barriers) and race, adjusting for age at diagnosis, current residence, marital status, education, employment, health insurance coverage, and time since diagnosis. Results: Thirty-one African American and 160 White survivors made up our analytic sample. The mean age at diagnosis was 58.5 (SD=11.4), all had surgery, 37% received chemotherapy, 51% received radiation therapy, and 53% received hormone therapy. Sixty-two percent of survivors reported at least one barrier to follow-up care. African American survivors were more likely to identify the following barriers to care compared to White survivors: out of pocket medical costs (52% vs. 28%), cannot afford other associated costs (45% vs. 21%), feeling anxious or worried (52% vs. 29%), and lack of transportation to doctor (16% vs. 4%). Compared to African American survivors, White survivors were more likely to report distance to travel to see doctor as a barrier (3% vs. 19%). Overall, African American survivors were more likely to report at least one barrier (81% vs. 58%) and at least one cost-related barrier (59% vs. 33%). In models adjusting for sociodemographic and clinical characteristics, African Americans were more likely to report any barrier (OR=3.3, 95% CI=1.1-10.1). For cost-related barriers, race was not significant after adjusting for other factors (OR=2.5, 95% CI=0.9-6.6); however, having public health insurance coverage (OR=4.8, 95% CI=1.1-20.4) and no insurance (OR=31.0, 95% CI=2.7-360.5) remained significant predictors compared to having both public and private health insurance. Conclusions: A majority of breast cancer survivors report barriers to follow-up care, most commonly anxiety or worry or financial concerns. African American breast cancer survivors were more likely to report any barrier to care, even after adjustment for sociodemographic and clinical factors. Different interventions are likely needed to help survivors overcome barriers to care. Enhancing insurance coverage or addressing out of pocket costs may reduce financial barriers, but psychosocial care aimed at reducing fear of cancer recurrence may reduce barriers associated with anxiety or fear. Citation Format: Nynikka Palmer, Kathryn Weaver, Sally Hauser, Jennifer Talton, L. Douglas Case, Julia Lawrence, Kimberly Dezern, Ann Geiger. Racial disparities in barriers to follow-up care among breast cancer survivors. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr C35. doi:10.1158/1538-7755.DISP13-C35

Objective.—To study the efficacy of intranasal lidocaine for the treatment of migraine when administered by subjects in a nonclinic setting. Design.—A 1-month, randomized, controlled, double-blind trial, followed by a 6-month open-label follow-up. Setting.—Ambulatory subjects treating themselves outside of a medical setting. Subjects.—One hundred thirty-one adult subjects with migraine, diagnosed according to International Headache Society criteria, were enrolled in the study: 113 treated at least one headache in the controlled trial, and 74 treated at least one headache in the open-label phase. All subjects were members of the Kaiser Permanente Southern California Medical Care Program and were recruited at two urban medical centers. Intervention.—Intranasal lidocaine 4% or saline placebo 0.5 mL was dropped into the nostril on the side of the headache, or bilaterally for bilateral headache, according to study protocol. Main Outcome Measures.—Trial: percent of headaches relieved to mild or none at 15 minutes and relapse of headache within 24 hours. Open-label: percent of headaches relieved to mild or none at 15 and 30 minutes and relapse within 24 hours. Results.—In the controlled trial, headache was relieved within 15 minutes in 34 (35.8%) of 95 subjects treated with 4% intranasal lidocaine compared with 8 (7.4%) of 108 subjects receiving placebo (P

Epidemiologic evidence and several case reports suggest that Escherichia coli causing urinary tract infection (UTI) may be transmitted between sex partners. In order to test this hypothesis, urinary, vaginal, and fecal E. coli isolates from 19 women with UTI were compared with E. coli found in random initial voids from their most recent male sex partner. E. coli was isolated from 4 of 19 male sex partners. In each case, the E. coli isolated from the man was identical by pulsed-field gel electrophoresis and bacterial virulence profile to the urinary E. coli from his sex partner.

Background Abstractor training is a key element in creating valid and reliable data collection procedures. The choice between in-person vs. remote or simultaneous vs. sequential abstractor training has significant consequences for time and resource utilization. We conducted a web-based (webinar) abstractor training session to standardize training across six individual Cancer Research Network (CRN) sites for a study of breast cancer treatment effects in older women (BOWII).

Abstract 1535 Background: Acute myelogenous leukemia (AML) is a disease which largely affects older adults, for whom optimal therapy is unclear. Evidence-based strategies to identify those older adults who may tolerate and benefit from standard therapies are lacking. Objective: Evaluate the predictive value of bedside geriatric assessment (GA) on overall survival (OS) for older adults receiving induction therapy for AML. Methods: Ongoing prospective study of patients ≥60 years of age with newly diagnosed AML and planned induction chemotherapy admitted to Wake Forest University. Bedside GA was performed during inpatient work-up for AML. GA measures included the Modified Mini-Mental Status Exam (3MS), Center for Epidemiologic Studies Depression Scale (CES-D), Distress thermometer, Pepper Assessment Tool for Disability ([PAT-D], includes self- reported activities of daily living (ADL), instrumental activities of daily living (IADL), and mobility questions), Short Physical Performance Battery ([SPPB], includes timed 4-meter walk, chair stands, standing balance), and grip strength. Cox proportional hazards models were fit for each GA measure as a predictor of OS, controlling for age, gender, Eastern Cooperative Oncology Group (ECOG) score, Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score, and cytogenetic risk group. The median follow-up was 4.7 months. Results: Among 53 consecutive patients the mean age was 69 (SD 11.5) years, 59.3% were female, and 46.3% had significant comorbidity (HCT-CI score >1). The majority had intermediate (72.6%) or poor risk (23.6%) cytogenetics. Approximately two thirds (64.7%) received standard induction therapy with anthracycline, cytarabine ± etoposide. Mean baseline GA scores included: 3MS 82.4 (SD 9.6), CES-D 13.5 (SD 11.3), Distress 4.2 (SD 3.3), PAT-D 1.6 (SD 0.6), SPPB 6.4 (SD 4.2), grip strength 32.0 kilograms (SD 8.5). In adjusted analyses, better performance on the cognitive screen (3MS) was associated with improved OS (HR 0.94, 95% CI 0.89–0.99). There was a trend towards worse OS among individuals who screened positive for depression at baseline (CES-D>16) (HR 2.3, 95% CI 0.75–6.80) and among those with a slower gait speed (< 1 meter/second) (HR 5.9, 95% CI 0.80–45.3). Additional baseline GA measures were not associated with OS in this analysis. Conclusions: Geriatric assessment measures may independently predict OS among older adults receiving induction therapy for AML. If validated in future studies, these screening measures may improve risk stratification and inform interventions to improve outcomes for older adults with AML. Supported by the American Society of Hematology Scholar Award, Atlantic Philanthropies, the John A. Hartford Foundation, ASP, and the WFU Pepper Center (P30 AG-021332). Disclosures: No relevant conflicts of interest to declare.

Abstract 1401 Poster Board I-423 Background: Acute myelogenous leukemia (AML) is a disease which largely affects older adults, for whom optimal therapy is unclear. Evidence-based strategies to identify those older adults who may tolerate and benefit from standard therapies are lacking. Objective: Test the utility of a bedside geriatric assessment (GA) to detect impairment in multiple geriatric domains among older adults initiating induction chemotherapy for AML. Methods: Ongoing prospective study of patients ≥60 years of age with newly diagnosed AML and planned induction chemotherapy admitted to Wake Forest University. Bedside geriatric assessment (GA) was performed during inpatient work-up for AML. GA measures included the Modified Mini-Mental Status Exam (3MS), Center for Epidemiologic Studies Depression Scale (CES-D), Distress thermometer, Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI), Pepper Assessment Tool for Disability ([PAT-D], includes self- reported activities of daily living (ADL), instrumental activities of daily living (IADL), and mobility questions), Short Physical Performance Battery ([SPPB], includes timed 4-meter walk, chair stands, standing balance), and grip strength. Results: 26 of 29 eligible patients enrolled between 1/2009 and 8/2009. The median age was 68 (range 60-82) years, and 42.3% were female. Prior myelodysplastic syndrome was present in 34.6%, with intermediate or poor-risk cytogenetics in 95.6%. Baseline laboratory measures included white blood cell count (mean 17.3×103/mm3, SD 25.0×103), hemoglobin (mean 9.2g/dl, SD 1.5), lactate dehydrogenase (mean 282.4 U/L, SD 168.8). Mean baseline GA scores included: 3MS 83.0 (SD 14.7), CES-D 9.4 (SD 9.3), Distress 3.8 (SD 3.4), HCT-CI 1.3 (SD 1.6), PAT-D 1.4 (SD 0.7), SPPB 7.1 (SD 3.9), grip strength 32.4 kilograms (SD 9.2). Although 84.6% of subjects had an Eastern Cooperative Oncology Group (ECOG) Performance score Conclusions: GA measures detect abnormalities which are not adequately reflected by the ECOG performance score in older adults with AML. Future analyses from this ongoing study will evaluate whether these abnormalities are independently associated with treatment-related morbidity and survival. Disclosures: No relevant conflicts of interest to declare.

Introduction Randomized trials indicate that adjuvant radiotherapy plus tamoxifen decrease the five-year risk of recurrence among ductal carcinoma in situ patients treated with breast-conserving surgery from about 20% to 8%. The aims of this study were to examine the use and impact of these therapies on risk of recurrence among ductal carcinoma in situ patients diagnosed and treated in the community setting. Methods We identified 2,995 patients diagnosed with ductal carcinoma in situ between 1990 and 2001 and treated with breast-conserving surgery at three large health plans. Medical charts were reviewed to confirm diagnosis and treatment and to obtain information on subsequent breast cancers. On a subset of patients, slides from the index ductal carcinoma in situ were reviewed for histopathologic features. Cumulative incidence curves were generated and Cox regression was used to examine changes in five-year risk of recurrence across diagnosis years, with and without adjusting for trends in use of adjuvant therapies. Results Use of radiotherapy increased from 25.8% in 1990-1991 to 61.3% in 2000-2001; tamoxifen increased from 2.3% to 34.4%. A total of 245 patients had a local recurrence within five years of their index ductal carcinoma in situ. The five-year risk of any local recurrence decreased from 14.3% (95% confidence interval 9.8 to 18.7) for patients diagnosed in 1990-1991 to 7.7% (95% confidence interval 5.5 to 9.9) for patients diagnosed in 1998-1999; invasive recurrence decreased from 7.0% (95% confidence interval 3.8 to 10.3) to 3.1% (95% confidence interval 1.7 to 4.6). In Cox models, the association between diagnosis year and risk of recurrence was modestly attenuated after accounting for use of adjuvant therapy. Between 1990-1991 and 2000-2001, the proportion of patients with tumors with high nuclear grade decreased from 46% to 32% (P = 0.03) and those with involved surgical margins dropped from 15% to 0% (P = 0.03). Conclusions The marked increase in the 1990s in the use of adjuvant therapy for ductal carcinoma in situ patients treated with breast-conserving surgery in the community setting only partially explains the 50% decline in risk of recurrence. Changes in pathology factors have likely also contributed to this decline.

9548 Background: Although advances in systemic treatment for metastatic colorectal cancer (CRC) have improved survival, it is unclear if this treatment is administered routinely among vulnerable individuals. Our objective was to describe treatment patterns for low income individuals with metastatic CRC and evaluate the influence of age on delivery of treatment in the context of patient, community, and health care setting characteristics. Methods: Matched North Carolina Cancer Registry and Medicaid claims data were used to identify a cohort of 390 patients with metastatic CRC diagnosed between 1999 and 2002. We assessed the relationship between treatment delivered within one year of diagnosis and characteristics of the patient (age, gender, race/ethnicity, comorbidity), community (percent poverty, percent rural), and health care setting (academic medical center, surgery volume). Treatment delivery was categorized into: 1) receipt of any chemotherapy, 2) local therapy only, and 3) no treatment. We fit a logistic regression model comparing receipt of any chemotherapy to local treatment only and another comparing receipt of any chemotherapy to no treatment. Results: Patients' mean age was 65.1±14.6 years; 56.0% were female and 45.5% were non-white. Only 27.7% received chemotherapy, while 50.3% received local therapy only and 22.0% received no treatment. After adjusting for comorbidity and all other covariates, patients aged No significant financial relationships to disclose.

9553 Background: Optimal treatment for older cancer patients remains unclear due to a poor understanding of which clinical characteristics predict toxicity and survival. Our objective was to examine baseline physical performance measures as predictors of future disability or death in older adults with incident cancer diagnoses. Methods: Among 3,075 individuals aged ≥70 years participating in the Health ABC observational study, 431 had a confirmed cancer diagnosis in the first 6 years of follow-up. Measures of physical performance included usual gait speed over 20 meters, 400 meter long distance corridor walk, and grip strength. We assessed the relationship between measures of physical performance most closely preceding cancer diagnosis and progression to major disability or death at 2 years after diagnosis. Major disability is defined by any of the following: requiring cane or walker for ambulation, inability to walk a quarter mile and/or climb 10 steps, or requiring assistance with activities of daily li...

10006 Background: Paradoxically, HL is the paradigm of treatment success, yet HL survivors are at an increased risk of premature death. We aimed to characterize risks factors associated with mortal...

To conduct neurologic, immunologic, and virologic studies in patients with a chronic debilitating illness of acute onset.Cohort study with comparison to matched, healthy control subjects.We studied 259 patients who sought care in one medical practice; 29% of the patients were regularly bedridden or shut-in.Detailed medical history, physical examination, conventional hematologic and chemistry testing, magnetic resonance imaging (MRI) studies, lymphocyte phenotyping studies, and assays for active infection of patients' lymphocytes with human herpesvirus type 6 (HHV-6).Patients had a higher mean (+/- SD) CD4/CD8 T-cell ratio than matched healthy controls (3.16 +/- 1.5 compared with 2.3 +/- 1.0, respectively; P less than 0.003). Magnetic resonance scans of the brain showed punctate, subcortical areas of high signal intensity consistent with edema or demyelination in 78% of patients (95% CI, 72% to 86%) and in 21% of controls (CI, 11% to 36%) (P less than 10(-9)). Primary cell culture of lymphocytes showed active replication of HHV-6 in 79 of 113 patients (70%; CI, 61% to 78%) and in 8 of 40 controls (20%; CI, 9% to 36%) (P less than 10(-8], a finding confirmed by assays using monoclonal antibodies specific for HHV-6 proteins and by polymerase chain reaction assays specific for HHV-6 DNA.Neurologic symptoms, MRI findings, and lymphocyte phenotyping studies suggest that the patients may have been experiencing a chronic, immunologically mediated inflammatory process of the central nervous system. The active replication of HHV-6 most likely represents reactivation of latent infection, perhaps due to immunologic dysfunction. Our study did not directly address whether HHV-6, a lymphotropic and gliotropic virus, plays a role in producing the symptoms or the immunologic and neurologic dysfunction seen in this illness. Whether the findings in our patients, who came from a relatively small geographic area, will be generalizable to other patients with a similar syndrome remains to be seen.

INTRODUCTION--Although as many as 5% of all women complain of chronic vulvovaginitis, little is known about these women. They may often be misdiagnosed and the role of vaginal yeast culture in diagnosing vulvovaginal candidiasis (VVC) among them has not been clearly defined. METHODS--To address these deficiencies, we tabulated initial diagnoses among new patients and conducted a medical record-based, unmatched case-control study among women reporting a history of chronic vulvovaginitis (four or more episodes in the past year) at a vulvovaginitis specialty clinic. Clinical presentation and medical history were compared for women who had a positive vaginal yeast culture for either Candida albicans or C glabrata, or who had a negative culture. RESULTS--One-third of the women had no apparent vulvovaginal disease at their initial visit. All women reported similar symptoms, except for an increased prevalence of painful sexual intercourse in women with C albicans (chi 2 p = 0.014 versus women with C glabrata and p < 0.001 versus women with no candida). Women with C glabrata were more likely to be non-white (chi 2 p = 0.071 compared with women with C albicans) and to report an underlying medical condition (chi 2 p < or = 0.001 versus both women with C albicans and women with no candida). Physical examination was normal only in women with no candida. C albicans cases were more likely to have positive potassium hydroxide microscopy (chi 2 p = 0.016) and a pH < or = 4.5 (chi 2 p = 0.011) than were C glabrata cases. CONCLUSIONS--These results suggest that reliance on symptoms and signs alone will result in significant misdiagnosis of chronic vulvovaginitis. Among women with VVC, subtle differences in clinical presentation do not reliably distinguish women with C albicans from those with C glabrata. Our study also indicates that vaginal yeast cultures, while not necessary for every patient, are valuable in confirming negative diagnoses, detecting microscopy false-negatives, and identifying non-C albicans isolates.

We studied the relation between sexual and health behaviors of women and first-time urinary tract infection (UTI). The study population was women using a university health service who were unmarried, had no UTI history, and who had engaged in sexual activity at least once. We found 86 cases of UTI, defined as one or more urinary symptoms and > or = 1,000 colony-forming units per ml urine of a known pathogen. We randomly sampled 288 controls from the student body. Vaginal intercourse increased the risk of UTI; this risk was further increased with condom use. After adjusting for vaginal intercourse with other birth control methods and recentness of current sexual partnership, a single sex act with a condom in the past 2 weeks increased UTI risk by 43%. Having a sex partner for less than 1 year vs 1 year or more, after adjustment for frequency of vaginal intercourse and birth control method, was associated with about twice the risk of UTI [odds ratio (OR) = 1.97; 95% confidence interval (CI) = 1.04-3.74]. After adjusting for frequency of vaginal intercourse, regular drinking of cranberry juice was protective against UTI (OR = 0.48; 95% CI = 0.19-1.02), whereas drinking carbonated soft drinks appeared to be associated with increased risk (OR = 2.37; 95% CI = 0.75-7.81). Using deodorant sanitary napkins or tampons was associated with a slight increase in risk of UTI (OR = 1.51; 95% CI = 0.74-3.06). Blacks had five times greater risk of UTI than whites after adjusting for frequency of vaginal intercourse (OR = 5.2; 95% CI = 1.89-24.63). We observed only modest differences in health behavior between racial groups.