The Master of Science in clinical epidemiology degree program of the Perelman School of Medicine at the University of Pennsylvania: a model for clinical research training.

An innovative training program to provide clinical research training for clinicians was created in 1979 at the University of Pennsylvania School of Medicine, now the Perelman School of Medicine. The program's principal and continuing aim is to provide trainees mentored experiences and the training needed to become skilled independent investigators able to conduct clinical research and develop academic careers as independent clinical investigators.The authors identify the vision that led to the creation of the master of science in clinical epidemiology (MSCE) degree program and describe today's training program, including administration, oversight, participating faculty, and trainees.

Oral contraceptive formulation and risk of breast cancer.

Background: While evidence on the association between oral contraceptive (OC) use and breast cancer generally suggests little or no increased risk, the question of whether breast cancer risk varies by OC formulation remains controversial. Few studies have examined this issue because large samples and extensive OC histories are required.

Study Design: We used data from a multicenter, population-based, case-control investigation.

Obesity and survival among black women and white women 35 to 64 years of age at diagnosis with invasive breast cancer.

Purpose: To evaluate the effect of obesity on survival among black women and white women with invasive breast cancer and to determine whether obesity explains the poorer survival of black women relative to white women.

Patients And Methods: We observed 4,538 (1,604 black, 2,934 white) women who were 35 to 64 years of age when diagnosed with incident invasive breast cancer between 1994 and 1998. Multivariate Cox regression models were used to examine the effect of body mass index (BMI, in kilograms per square meter) 5 years before diagnosis on risk of death from any cause and from breast cancer.

Oral contraceptive use and survival in women with invasive breast cancer.

Background: Oral contraceptives (OC) are widely used in the United States. Although the relation between OC use and breast cancer incidence has been widely studied, the few studies examining associations between OC use prior to breast cancer diagnosis and survival are inconsistent.

Methods: Women with invasive breast cancer participating in the Women's Contraceptive and Reproductive Experiences (CARE) Study, a population-based case-control study (4565 women ages 35-64 years), and the California Teachers Study (CTS) cohort (3929 women ages 28-91 years) were followed for vital status.

Breast cancer risk and ovariectomy, hysterectomy, and tubal sterilization in the women's contraceptive and reproductive experiences study.

Removal or impairment of ovaries before menopause may affect a woman's breast cancer risk by altering her cumulative exposure to ovarian hormones. The Women's Contraceptive and Reproductive Experiences Study, a population-based, multicenter case-control study of incident invasive breast cancer, recruited women aged 35-64 years (4,490 cases and 4,611 controls) who provided data on ovariectomy, hysterectomy, and tubal sterilization during in-person interviews. Controls were frequency-matched to cases by age, race, and study site.

Risk factors for lymphedema after breast cancer treatment.

Background: As cancer treatments evolve, it is important to reevaluate their effect on lymphedema risk in breast cancer survivors.

Methods: A population-based random sample of 631 women from metropolitan Philadelphia, Pennsylvania, diagnosed with incident breast cancer in 1999 to 2001, was followed for 5 years. Risk factor information was obtained by questionnaire and medical record review.

Hormone therapy and fatal breast cancer.

Purpose: Among unanswered questions is whether menopausal use of estrogen therapy (ET) or estrogen-plus-progestin therapy (CHT) increases risk of developing fatal breast cancer i.e., developing and dying of breast cancer.

Lymphedema in breast cancer survivors: incidence, degree, time course, treatment, and symptoms.

Purpose: To examine the incidence, degree, time course, treatment, and symptoms of lymphedema in breast cancer survivors.

Methods: We conducted a 5-year, population-based prospective study of 631 randomly selected Philadelphia and Delaware County, Pennsylvania female residents with incident breast cancer who were diagnosed from 1999 to 2001. Using a questionnaire previously validated against physical therapists' measurement-based clinical criteria, we assigned a score indicating the degree of lymphedema (none, mild, or moderate/severe) to each month of follow-up based on the respondent's perceived differences in hand/arm size.

Projecting individualized absolute invasive breast cancer risk in African American women.

Background: The Breast Cancer Risk Assessment Tool of the National Cancer Institute (NCI) is widely used for counseling and determining eligibility for breast cancer prevention trials, although its validity for projecting risk in African American women is uncertain. We developed a model for projecting absolute risk of invasive breast cancer in African American women and compared its projections with those from the Breast Cancer Risk Assessment Tool.

Methods: Data from 1607 African American women with invasive breast cancer and 1647 African American control subjects in the Women's Contraceptive and Reproductive Experiences (CARE) Study were used to compute relative and attributable risks that were based on age at menarche, number of affected mother or sisters, and number of previous benign biopsy examinations.

Protection of mammography screening against death from breast cancer in women aged 40-64 years.

Objective: This study assessed the efficacy of community-based screening mammography in protecting against breast cancer death, asking whether age differences in efficacy persisted in the 1990s.

Methods: In a case-control study with follow-up, odds ratios (OR) were used to estimate the relative mortality rates from invasive breast cancer among women with at least one screening mammogram in the two years prior to a baseline reference date compared to non-screened women, adjusting for potential confounding. The multicenter population-based study included 553 black and white women diagnosed during 1994-1998 who died in the following five years, and 4016 controls without breast cancer.

The intersection of cancer and aging: establishing the need for breast cancer rehabilitation.

The increasing success of treatments for common cancers has resulted in growing awareness of the unique health care needs of cancer survivors. Cancer treatments can be toxic and have long-lasting effects on health, potentially accelerating the aging process and producing associated declines in physical function. In this synthesis of the literature, we critically examine the strength of existing evidence that breast cancer diagnosis and treatment are associated with a disproportionate decline in physical function compared with the effects of living without cancer for the same number of years.

Modifiable risk factors for breast cancer recurrence: what can we tell survivors?

The potential for recurrence causes considerable distress for breast cancer survivors. Major information sources for survivors and providers offer few clear recommendations for postdiagnosis lifestyle change related to recurrence. To design interventions to improve long-term survivors' care and quality of life, we must know what survivors are doing to prevent recurrence in the absence of solid evidence, whether survivors' perceptions and behaviors correspond to hypothesized modifiable risk factors for recurrence, and whether survivors are adopting behaviors that could otherwise be harmful to their health.

Risk of breast cancer associated with short-term use of oral contraceptives.

Objective: To estimate breast cancer risk associated with short-term (<6 months) oral contraceptive use, and explore variation in estimates by use characteristics and medical, menstrual, and reproductive history.

Methods: We analyzed data from the Women's Contraceptive and Reproductive Experiences Study. Case subjects were white women and black women, 35-64 years old, diagnosed with invasive breast cancer in July 1994-April 1998.

Prevalence and predictors of BRCA1 and BRCA2 mutations in a population-based study of breast cancer in white and black American women ages 35 to 64 years.

Although well studied in families at high-risk, the roles of mutations in the BRCA1 and BRCA2 genes are poorly understood in breast cancers in the general population, particularly in Black women and in age groups outside of the very young. We examined the prevalence and predictors of BRCA1 and BRCA2 mutations in 1,628 women with breast cancer and 674 women without breast cancer who participated in a multicenter population-based case-control study of Black and White women, 35 to 64 years of age. Among cases, 2.

Benefit of screening mammography in reducing the rate of late-stage breast cancer diagnoses (United States).

Objective: We studied the benefit of modern mammography screening in community settings, evaluating age-related differences in rates of late-stage breast cancer detection.

Methods: Our multicenter population-based case-control study included 931 black and white women with incident breast cancer (American Joint Commission on Cancer Stage IIB or higher) diagnosed 1994-1998 and 4,016 randomly sampled controls never diagnosed with breast cancer. Adjusted odds ratios (ORs) estimated the relative rate of late-stage diagnosis in screened and non-screened women.

Measuring screening intensity in case-control studies of the efficacy of mammography.

Of great interest in studies of screening for breast cancer is the relative efficacy of different screening frequencies (intensities). Prior work has suggested that estimates of the association between screening intensity and outcome in case-control studies would not produce valid results and that only binary indicators (no screens vs. one or more) of exposure can be used.

Lifetime recreational exercise activity and breast cancer risk among black women and white women.

Background: Physical inactivity is a potentially modifiable breast cancer risk factor. Because few data on this relationship exist for black women, we examined the relationship between breast cancer risk and lifetime and time- or age-specific measures of recreational exercise activity among white women and among black women.

Methods: The Women's Contraceptive and Reproductive Experiences Study was a multicenter population-based case-control study of black women and white women aged 35-64 years with newly diagnosed invasive breast cancer.

Practical aspects of sharing controls between case-control studies.

Purpose: We discuss the practical advantages and challenges of sharing controls among two or more concurrently conducted case-control studies.

Methods: We conducted two case-control studies, one of breast cancer and the other of endometrial cancer, with overlapping, shared control groups. The studies had overlapping geographic areas, identical telephone questionnaires and biosample collection, and identical age and race eligibility.

Racial differences in the familial aggregation of breast cancer and other female cancers.

Although breast cancer familial aggregation has been studied in Caucasians, information for African-Americans is scant. We used family cancer history from the Women's Contraceptive and Reproductive Experiences study to assess the aggregation of breast and gynecological cancers in African-American and Caucasian families. Information was available on 41,825 first and second-degree relatives of Caucasian and 28,956 relatives of African-American participants.

Alcohol exposure and breast cancer: results of the women's contraceptive and reproductive experiences study.

Objectives: To explore associated biological outcomes and clarify the role of timing of exposure in the alcohol-breast cancer relationship.

Methods: In a population-based study of 4,575 women ages 35 to 64 years diagnosed with invasive breast cancer between 1994 and 1998 and 4,682 controls, we collected details of lifetime alcohol use and factors that could confound or modify the alcohol-breast cancer relationship. We used conditional logistic regression to compute the odds of breast cancer among drinkers relative to nondrinkers at all ages and at ages 35 to 49 and 50 to 64 years separately.

Reproductive factors and risk of breast carcinoma in a study of white and African-American women.

Background: Few studies have investigated the association between reproductive factors and the risk of breast carcinoma among African-American women. The authors assessed whether the number of full-term pregnancies, age at first full-term pregnancy, and total duration of breastfeeding were associated with similar relative risk estimates in white and African-American women in a large multicenter, population-based case-control study of breast carcinoma.

Methods: Case patients were 4567 women (2950 white women and 1617 African-American women) ages 35-64 years with newly diagnosed invasive breast carcinoma between 1994 and 1998.

Absence of an effect of injectable and implantable progestin-only contraceptives on subsequent risk of breast cancer.

Animal data indicate that both estrogens and progestins could be carcinogenic and that progestins could serve as tumor promoters. Human studies have not confirmed an increased risk of breast cancer from long-term use of oral contraceptives, but have shown an increased risk from hormone replacement therapy including progestins. The present study analyzed the relationship between breast cancer and use of injectable and implantable progestin-only contraceptives.

Combined effect of oral contraceptive use and hormone replacement therapy on breast cancer risk in postmenopausal women.

Objective: We examined breast cancer risk related to lifetime exposure to oral contraceptives (OCs) and hormone replacement therapy (HRT) in postmenopausal women.

Methods: The Women's Contraceptive and Reproductive Experiences (CARE) Study was a population-based case-control study that included 1847 postmenopausal women with incident invasive breast cancer, and 1932 control subjects, identified using random digit dialing.

Results: 45% of cases and 49% of controls used both OCs and HRT.

Association of regimens of hormone replacement therapy to prognostic factors among women diagnosed with breast cancer aged 50-64 years.

This study was conducted to assess the histopathological features of breast cancers in women diagnosed with breast cancer at 50-64 years of age who have and have not used hormone replacement therapy (HRT). A case-case analysis of the tumors from women aged 50-64 years who participated in a multicenter population-based case-control study of invasive breast cancer was conducted. In-person interviews collected a detailed history of all episodes of hormone use.

Validation of self-reported screening mammography histories among women with and without breast cancer.

As part of a case-control study of the efficacy of screening mammography, the authors validated the mammography histories of 2,495 women aged 40-64 years with incident breast cancer diagnosed in 1994-1998 and a 25% random sample of 615 controls never diagnosed with breast cancer, all reporting a mammogram in the past 5 years. Subjects from five metropolitan areas of the United States were cross-classified by facility records ("gold standard") and self-report according to history of a recent screening mammogram (within 1 year or within 2 years). Sensitivity and specificity of self-reported screening at 1 year were 0.