Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study.

BACKGROUND: Radical prostatectomy and external beam radiotherapy are the two major therapeutic options for treating clinically localized prostate cancer. Because survival is often favorable regardless of therapy, treatment decisions may depend on other therapy-specific health outcomes. In this study, we compared the effects of two treatments on urinary, bowel, and sexual functions and on general health-related quality-of-life outcomes over a 2-year period following initial treatment. METHODS: A diverse cohort of patients aged 55-74 years who were newly diagnosed with clinically localized prostate cancer and received either radical prostatectomy (n = 1156) or external beam radiotherapy (n = 435) were included in this study. A propensity score was used to balance the two treatment groups because they differed in some baseline characteristics. This score was used in multivariable cross-sectional and longitudinal regression analyses comparing the treatment groups. All statistical tests were two-sided. RESULTS: Almost 2 years after treatment, men receiving radical prostatectomy were more likely than men receiving radiotherapy to be incontinent (9.6% versus 3.5%; P:<.001) and to have higher rates of impotence (79.6% versus 61.5%; P:<.001), although large, statistically significant declines in sexual function were observed in both treatment groups. In contrast, men receiving radiotherapy reported greater declines in bowel function than did men receiving radical prostatectomy. All of these differences remained after adjustments for propensity score. The treatment groups were similar in terms of general health-related quality of life. CONCLUSIONS: There are important differences in urinary, bowel, and sexual functions over 2 years after different treatments for clinically localized prostate cancer. In contrast to previous reports, these outcome differences reflect treatment delivered to a heterogeneous group of patients in diverse health care settings. These results provide comprehensive and representative information about long-term treatment complications to help guide and inform patients and clinicians about prostate cancer treatment decisions.

Differences between black and white women with breast cancer in time from symptom recognition to medical consultation. Black/White Cancer Survival Study Group.

BACKGROUND: Studies in the United States have reported that Black women have higher fatality rates than White women following a diagnosis of breast cancer and are more likely to be diagnosed with late-stage cancers. PURPOSE: To evaluate reasons for these racial differences, we explored the difference between Black and White women in the length of time from symptom recognition to initial medical consultation. We also evaluated the extent to which other factors related to the length of this interval might contribute to any observed racial difference. METHODS: As part of a collaborative study of differences in the survival rates of Black patients and White patients with cancer, we interviewed a sample of 410 Black women and 325 White women from Atlanta, New Orleans, and San Francisco/Oakland who were newly diagnosed in 1985 or 1986 with invasive breast cancer. Retrospective data were collected on symptoms, dates of symptom recognition and initial medical consultation, and several other factors which may affect the interval between symptom recognition and medical consultation. Data were analyzed as if from a follow-up study, using product limit procedures and proportional hazards regression. RESULTS: At diagnosis, Black women with breast cancer were two times more likely to have stage IV breast cancer and one and one-half times more likely to have stage III breast cancer than White women with breast cancer and were only approximately one-half as likely to have stage I breast cancer. Similarly, Black women were almost twice as likely as White women to have tumors that were larger than 5 cm or tumors that had extensions to the chest wall or skin at presentation. However, the average rate at which Black women with breast cancer obtained an initial medical consultation lagged behind that for White women by only a slight but statistically significant difference (15%). The median time between symptom recognition and medical consultation was slightly longer for Black women (16 days) than for White women (14 days) (P = .06). Adjustment for other characteristics predictive of the length of this interval had little effect on racial differences. The racial differences tended to vary somewhat by age and metropolitan area, suggesting that the results may not apply equally to all demographic subgroups and regions in the United States. CONCLUSION: This small difference in the time from symptom recognition to medical consultation is unlikely to account for the large racial differences in survival rates and in stage of disease at the time of diagnosis.

Race, nutritional status, and survival from breast cancer.

The effects of nutritional status on differences in the survival of black and white women with breast cancer were studied in a cohort of 1,960 Georgia women diagnosed during 1975-1979. After data were adjusted for stage of disease, socioeconomic status, and other prognostic factors, poorer survival rates were shown in black women. Within each stage classification, lower levels of serum albumin and hemoglobin and higher relative body weight were more common among blacks and were independently associated with poorer survival. Among women with stage 3 disease, adjustment for these variables substantially reduced the excess mortality rate among blacks, suggesting that racial differences in survival may be partly explained by differences in nutritional status or extent of disease within stage.

Factors associated with initial therapy for clinically localized prostate cancer: prostate cancer outcomes study.

BACKGROUND: Because of the lack of results from randomized clinical trials comparing the efficacy of aggressive therapies with that of more conservative therapies for clinically localized prostate cancer, men and their physicians may select treatments based on other criteria. We examined the association of sociodemographic and clinical characteristics with four management options: radical prostatectomy, radiation therapy, hormonal therapy, and watchful waiting. METHODS: We studied 3073 participants of the Prostate Cancer Outcomes Study diagnosed from October 1, 1994, through October 31, 1995, with clinically localized disease (T1 or T2). Participants completed a baseline survey, and diagnostic and treatment information was abstracted from medical records. Multiple logistic regression analysis identified factors associated with initial treatment. All statistical tests were two-sided. RESULTS: Patients with clinically localized disease received the following treatments: radical prostatectomy (47.6%), radiation therapy (23.4%), hormonal therapy (10.5%), or watchful waiting (18.5%). Men aged 75 years or older more often received conservative treatment (i.e., hormonal therapy alone or watchful waiting; 57.9% of men aged 75-79 years and 82.1% of men aged 80 years and older) than aggressive treatment (i.e., radical prostatectomy or radiation therapy) (for all age groups, P

Racial and ethnic differences in advanced-stage prostate cancer: the Prostate Cancer Outcomes Study.

BACKGROUND: African-Americans have twice the risk of non-Hispanic whites for presenting with advanced-stage prostate cancer. To investigate the reasons for this difference, we evaluated the association between race/ethnicity and advanced-stage prostate cancer, adjusting for demographic, socioeconomic, clinical, and pathologic factors. METHODS: A population-based cohort of 3173 men diagnosed with prostate cancer between October 1, 1994, and October 31, 1995, was analyzed. Medical record abstracts and self-administered survey questionnaires were used to obtain information regarding race/ethnicity, age, marital status, insurance status, educational level, household income, employment status, comorbidity, urinary function, prostate-specific antigen level, tumor grade, and clinical stage. The odds ratio (OR) for advanced-stage prostate cancer was estimated with weighted logistic regression analysis. All P: values were two-sided. RESULTS: Clinically advanced-stage prostate cancers were detected more frequently in African-Americans (12.3%) and Hispanics (10.5%) than in non-Hispanic whites (6.3%). Socioeconomic, clinical, and pathologic factors each accounted for about 15% of the increased relative risk. After adjusting for all covariates, the risk remained statistically significantly increased for African-Americans (OR = 2.26; 95% confidence interval [CI] = 1.43 to 3.58) but not for Hispanics (OR = 1.23; 95% CI = 0.73 to 2.08). CONCLUSION: Traditional socioeconomic, clinical, and pathologic factors accounted for the increased relative risk for presenting with advanced-stage prostate cancer in Hispanic but not in African-American men.

Health outcomes after external-beam radiation therapy for clinically localized prostate cancer: results from the Prostate Cancer Outcomes Study.

PURPOSE: Studies reporting effects of radiotherapy for prostate cancer on sexual, bowel, and urinary function have been conducted primarily in referral centers or academic institutions. Effects of external-beam radiotherapy for prostate cancer among a population-based cohort were assessed. PATIENTS AND METHODS: The study population included 497 white, Hispanic, and African-American men with localized prostate cancer from six US cancer registries who were diagnosed between October 1, 1994, and October 31, 1995, and treated initially with external-beam radiotherapy. They were interviewed at regular intervals, and medical records were reviewed. Distributions of responses for bowel-, urinary-, and sexual-related functions at 6, 12, and 24 months after diagnosis and adjusted mean composite change scores for each domain were analyzed. RESULTS: Declines of 28.9% in the sexual function score and 5.4% in the bowel function score occurred by 24 months, whereas at this time, the urinary function score was relatively unchanged. A total of 43% of those who were potent before diagnosis became impotent after 24 months. More than two thirds of the men were satisfied with their treatment and would make the same decision again. CONCLUSION: Sexual function was the most adversely affected quality-of-life domain, with problems continuing to increase between 12 and 24 months. Bowel function problems increased at 6 months, with partial resolution observed by 24 months. Despite the side effects, satisfaction with therapy was high. These results are representative of men in community practice settings and may be of assistance to men and to clinicians when making treatment decisions.

Quality-of-life outcomes after primary androgen deprivation therapy: results from the Prostate Cancer Outcomes Study.

PURPOSE: To compare health-related quality-of-life outcomes after primary androgen deprivation (AD) therapy with orchiectomy versus luteinizing hormone-releasing hormone (LHRH) agonists for patients with prostate cancer. PATIENTS AND METHODS: Men (n = 431) newly diagnosed with all stages of prostate cancer from six geographic regions who participated in the Prostate Cancer Outcomes Study and who received primary AD therapy but no other treatments within 12 months of initial diagnosis were included in a study of health outcomes. Comparisons were statistically adjusted for patient sociodemographic and clinical characteristics, timing of therapy, and use of combined androgen blockade. RESULTS: More than half of the patients receiving primary AD therapy had been initially diagnosed with clinically localized prostate cancer. Among these patients, almost two thirds were at high risk of progression on the basis of prognostic factors. Sexual function outcomes were similar by treatment group both before and after implementation of AD therapy. LHRH patients reported more breast swelling than did orchiectomy patients (24.9% v 9.7%, P <.01). LHRH patients reported more physical discomfort and worry because of cancer or its treatment than did orchiectomy patients. LHRH patients assessed their overall health as fair or poor more frequently than did orchiectomy patients (35.4% v 28.1%, P =.01) and also were less likely to consider themselves free of prostate cancer after treatment. CONCLUSION: Most endocrine-related health outcomes are similar after surgical versus medical primary hormonal therapy. Stage at diagnosis had little effect on outcomes. These results provide representative information comparing surgical and medical AD therapy that may be used by physicians and patients to inform treatment decisions.

Histological characteristics of breast carcinoma in blacks and whites.

Tumor characteristics of 963 newly diagnosed invasive breast cancer cases from the population-based Black/White Cancer Survival Study were evaluated. Representative slides of the tumors were requested from all participating hospitals of three metropolitan areas and reviewed by one expert pathologist, blinded in regard to the age and race of patients. Nine tumor characteristics were evaluated for black and white patients. After adjusting for age, stage, and metropolitan area, blacks were significantly more likely to have high grade nuclear atypia [odds ratio (OR) = 1.97, 95% confidence interval (CI) = 1.27-3.04]; high mitotic activity (OR = 2.05, 95% CI = 1.34-3.14), grade 3 tumors (OR = 1.58, 95% CI = 1.02-2.45), and more necrosis (OR = 1.51, 95% CI = 1.16-1.98); and less likely to have well defined tubular formation (OR = 0.57, 95% CI = 0.42-0.77), marked fibrosis (OR = 0.65, 95% CI = 0.45-0.94), and positive estrogen receptor status (OR = 0.78, 95% CI = 0.58-1.05). These black/white differences remained after controlling for socioeconomic status (SES), body mass index, use of alcohol and tobacco, reproductive experience, and health care access and utilization. No significant racial differences were found for blood vessel invasion and lymphatic invasion. Although white women of high SES had more favorable tumors than those of low SES, the same pattern was not observed for blacks. High SES black women had statistically nonsignificant elevated ORs of a high mitotic index and tumor grade. These racial differences in tumor biology may have etiological and clinical implications.

Racial differences in endometrial cancer survival: the black/white cancer survival study.

OBJECTIVE: To identify factors that explain a lower survival rate among black women with endometrial cancer when compared to white women. METHODS: Data are from the National Cancer Institute's Black/White Cancer Survival Study, a population-based study of racial differences in cancer survival. Subjects included 329 white and 130 black women, ages 20-79 years, residing in the metropolitan areas of Atlanta, New Orleans, or San Francisco-Oakland, diagnosed with endometrial cancer from 1985 to 1987. Known prognostic factors were assessed as potential explanatory variables for the black-white survival difference using proportional hazards regression. Information was derived from interviews, abstracts of hospital and physicians' records, and a centralized review of biopsy and surgical specimens. RESULTS: Adjusting for age and geographic location, risk of death among black women was 4.0 times (95% confidence interval [CI] 2.8, 5.6) that of white women. Approximately 40% of this difference could be attributed to a more advanced stage at diagnosis among black women, and 23% to tumor characteristics and treatment. Further adjustment for all remaining factors reduced the hazard ratio to 1.6 (95% CI 1.0, 2.6). CONCLUSION: Eighty percent of the excess mortality among black women is explained by racial differences in stage at diagnosis, tumor characteristics, treatment, sociodemographic characteristics, hormonal and reproductive factors, and factors related to comorbidities and health behavior. Difference in stage at diagnosis is prominent in explaining the disparity in endometrial cancer survival rates in black and white women. Potential differences in treatment within stage merit further exploration.

Cine-MRI-aided endomyocardectomy in idiopathic hypereosinophilic syndrome.

The idiopathic hypereosinophilic syndrome is a leukoproliferative disorder marked by a predilection to damage specific organs, including the heart. This report describes a patient with extensive endocardial fibrosis accompanying this syndrome. Right ventricular endomyocardectomy with preservation of the tricuspid valve was performed. The procedure was aided by cine-magnetic resonance imaging for preoperative assessment and follow-up of surgical results.

High dose cyclophosphamide, fractionated total body irradiation with involved field irradiation and autologous bone marrow transplantation in malignant lymphoma.

The objective of this clinical trial was to determine if radiation to areas of recurrence or bulky disease prior to total body irradiation (TBI) and chemotherapy followed by autologous bone marrow transplantation (ABMT) altered the site of relapse and/or prolonged survival. Forty-eight patients with recurrent or refractory malignant lymphoma were treated with high-dose cyclophosphamide and fractionated TBI followed by ABMT. Thirty-four patients were eligible to receive involved field radiation therapy (IF-RT) to sites of recurrence or bulky disease. The overall response rate in 46 evaluable patients was 89% with 33 complete remissions (CR) and 8 partial remissions (PR). In a multivariant analysis increasing LDH, decreased serum albumin, older age, and lack of sensitivity to prior chemotherapy were associated with poorer survival. There were 10 deaths due to treatment related complications, 8 died of pulmonary complications of whom 6 were in CR. Of 11 who had received IF-RT and subsequently relapsed, 4 recurred in or adjacent to the involved field. We conclude that intensive chemo-radiotherapy proved to be an effective salvage therapy for patients with recurrent malignant lymphoma, resulting in a projected actuarial 33% DFS at 5 years, but was associated with a high transplant-related mortality.

Linking health services research to education at an academic health center.

Academic health centers (AHCs) face numerous challenges as they prepare students, housestaff, and faculty for the rapidly changing health care environment. An already overburdened curriculum makes it difficult to provide medical students with skills in outcomes assessment, health economics, clinical decision making, epidemiology, and basic statistics. Practicing physicians may find it difficult to expend the time and resources needed for degree programs in public health or the evaluative clinical sciences. AHCs may need to tap into existing resources in the health evaluation sciences, as Emory University (Atlanta, Georgia) has done by establishing the Emory University Center for Clinical Evaluation Sciences. Although the Center's primary missions are to be an analytical resource for Emory's health care delivery system and to promote health services research across the university, the authors illustrate its potential as a resource for training medical students, housestaff, and faculty in the evaluative clinical sciences.

Analyzing costs and benefits of mammography screening in the workplace.

Mammography is considered a very sensitive test for breast cancer, but all women with a positive mammogram will not have breast cancer. A more specific confirmatory test, a biopsy, is often the next recommended test for a woman with a positive mammogram. The utility of a screening test is influenced not only by the test characteristics, sensitivity, and specificity, but also by the prevalence of the condition in the population and the consequences of obtaining a positive result. Benefits may be calculated as reduction in mortality, reduction in morbidity, reduction in years of productive life lost, enhancement in quality of life, financial savings, or days of work saved. Risk factors for breast cancer include age, nulliparity, early onset of menstruation, late menopause, family history of breast cancer, late age of first childbirth, obesity, a high-fat diet, and certain types of benign breast disease.

Validation study of retrospective recall of disease-targeted function: results from the prostate cancer outcomes study.

OBJECTIVES: This was an ancillary methodological study within the Prostate Cancer Outcomes Study (PCOS) to assess the validity of 6-month retrospective recall of prediagnostic disease-targeted function among men diagnosed with prostate cancer. METHODS: A convenience sample of 133 prostate cancer cases were administered a baseline questionnaire shortly after diagnosis that asked about prediagnostic urinary, sexual, and bowel function. They were surveyed again concerning the same items 6 months later and asked to recall their prediagnostic function. Reports of prediagnostic function obtained at baseline and 6 months are compared, as are measures of change derived from these reports. Percent agreement and weighted kappas are calculated to measure the extent of agreement. RESULTS: Over 70% of the men reported prediagnostic functioning at the highest level on 12 of 17 survey items. For each of these items, recall at 6 months was identical to the baseline survey response for > or =69% of the men. The values of the weighted kappas for changes computed with baseline reports (prospective) and changes computed with 6-month recall (retrospective) ranged from 0.396 to 0.919 for the 17 individual items. Intraclass correlations for the retrospective versus prospective changes in the multi-item function scores were 0.828 for urinary, 0.618 for bowel, and 0.692 for sexual function. CONCLUSIONS: At baseline, men recently diagnosed with prostate cancer report few disease-related problems before diagnosis, and a high percentage of men recall this accurately 6 months later. There is reasonably high agreement between baseline and 6-month estimates of prediagnostic function and between prospective and retrospective measures of change over 6 months.

Case-control assessment of the association between non-Hodgkin's lymphoma and occupational radiation with doses assessed using a job exposure matrix.

BACKGROUND: Epidemiologic data for an association between radiation exposure and non-Hodgkin's lymphoma (NHL) have been inconclusive though the strongest evidence has been provided by studies of patients treated with radiotherapy. METHODS: We evaluated the association between occupational radiation exposure and non-Hodgkin's lymphoma in men using a population-based case-control study with 1,056 case and 1,860 control subjects sampled from eight geographic areas in the United States. Because dosimetry data were not available, doses were estimated for individuals who reported occupational radiation exposure using a radiation job exposure matrix developed for this purpose. Conditional logistic regression was used to model the association between reported occupational radiation exposure and NHL incidence. RESULTS: We found that most men (> 90%) did not report exposure to occupational sources of radiation. Among those who reported exposure, estimated cumulative doses were low, with an estimated mean of less than 0.02 Gray and a maximum of 0.12 Gray. The risk for NHL was not associated with ever having reported an occupational radiation exposure (OR = 0.90, 95% CI = 0.74-1.10) nor was there evidence of a dose-response relationship between risk and either the estimated cumulative doses or duration of exposure. CONCLUSIONS: The findings in this study are consistent with results from most current research on occupational radiation and NHL risk that have found no increased risk of NHL at low levels of occupational radiation exposure. While it should be noted that exposure misclassification likely biased our results toward the null, this large population-based case-control study adds to existing evidence which suggests that there is little to no increased risk for NHL associated with exposure to low levels of radiation such as that commonly found in many occupational settings.

A survey of alcohol use in an inner-city ambulatory care setting.

OBJECTIVE: To measure the prevalence of current drinking and potential problem drinking in an inner-city ambulatory care setting, using the CAGE questionnaire. DESIGN: Survey of patients attending ambulatory care clinics, using structured personal interviews. SETTING: Three ambulatory care clinics serving an indigent, predominantly black population of metropolitan Atlanta: a general medical appointment clinic, a walk-in clinic, and a neighborhood primary care clinic. PATIENTS/PARTICIPANTS: Patients over the age of 18 who attended one of the above clinics on a day when interviewers were available and who were estimated to have more than a 45-minute wait prior to seeing their health provider. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 15.3% of subjects had CAGE scores greater than or equal to 2 (95% CI 12.2, 19.0). A CAGE score of greater than or equal to 2 was almost three times more common in men than in women, 26.7% vs. 9.5%. Only 8.6% (95% CI 6.3, 11.7) of subjects reported drinking greater than or equal to 2 drinks per day. These findings suggest that problem drinking may affect as many as one in six people seeking care in inner-city ambulatory care clinics and provide support for the use of screening instruments such as the CAGE questionnaire for improved sensitivity in detecting alcoholism in these practice settings.

Non-Hodgkin's lymphomas in patients with human immunodeficiency virus infection. Presence of Epstein-Barr virus by in situ hybridization, clinical presentation, and follow-up.

The authors studied all patients with serologic evidence of human immunodeficiency virus (HIV) infection and malignant non-Hodgkin's lymphoma (NHL) that presented at a single hospital from 1982 to 1989. Sixteen patients were identified, all white homosexual men with a mean age of 38.2 years. Lymphoma was the initial presentation of HIV infection in 37.5%. Sixty-two percent of the cases had a high-grade NHL, 31% had intermediate-grade, and 6% (one patient) had a low-grade lymphoplasmacytoid lymphoma. Extranodal involvement was present in 43.7%, with the gastrointestinal tract and liver being the most common sites. Actuarial survival was increased by treatment with methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B). Colorimetric in situ hybridization identified Epstein-Barr virus (EBV) in nine of the 14 cases hybridized. A statistically significant association of EBV with diffuse small noncleaved type (i.e., Burkitt's-like) (six of six) compared with other morphologic types (three of eight) was found (P = 0.025).

Dietary glutathione intake in humans and the relationship between intake and plasma total glutathione level.

Glutathione may function as an anticarcinogen by acting as an antioxidant or by binding with cellular mutagens. Orally administered glutathione increases plasma glutathione levels, and plasma glutathione is also synthesized in the liver. To investigate the associations between glutathione intake and plasma glutathione level, we compared dietary intake estimates from food frequency questionnaire data and measured concentrations of plasma total glutathione and other serum antioxidants in 69 white men and women. Daily glutathione intake ranged from 13.0 to 109.9 mg (mean 34.8 mg). Fruits and vegetables were found to contribute over 50% of usual dietary glutathione intake, whereas meats contributed less than 25%. Small negative correlations were observed between dietary and plasma glutathione and, although they were usually not statistically significant, they were generally consistent by different time periods of dietary intake assessment. Adjustment for sex, age, caloric intake, and dietary intake of the sulfur-containing amino acids methionine and cystine did not alter the observed associations. The correlations appeared to be modified, however, by serum vitamin C concentration, with little or no association between dietary and plasma glutathione among those with lower levels of serum vitamin C and stronger negative correlations among those with higher serum vitamin C levels. These findings indicate that factors regulating plasma glutathione concentration are complex and not simply related to dietary glutathione intake or supply of precursor amino acids.

An evaluation of a food frequency questionnaire for assessing dietary intake of specific carotenoids and vitamin E among low-income black women.

The National Cancer Institute diet questionnaire was evaluated for use in a low-income black population. Data were collected from 91 women aged 30-69 years who were hospital outpatients in Atlanta, Georgia, June through August, 1988. Six ethnic and regional foods added to the questionnaire were found to be important contributors to intakes of several nutrients. Although 17 records were identified as containing probable recording or reporting errors, intakes of carotenes, alpha-carotene, beta-carotene, cryptoxanthin, and vitamin E were significantly and positively associated with serum levels of their referent nutrients. Among nonsmokers, correlation coefficients ranged from 0.32 to 0.45, adjusted for age, body mass index, alcohol and calorie intakes, medications and vitamin supplement use, and serum cholesterol and triglycerides. When questionnaires containing identified errors were omitted, correlations ranged from 0.30 to 0.54. There were no correlations between dietary intakes of lycopene and lutein and blood levels (-0.06 to 0.09). Among smokers, diet-serum correlations were reduced (0.00 to 0.32). These correlations are similar to those reported in research on vitamin E and carotenoids in other populations. These results suggest that the questionnaire is as valid for use in this population as it is in other populations.