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Joan James

Bio: Joan James is an academic researcher from Fox Chase Cancer Center. The author has contributed to research in topics: Breast cancer & Tamoxifen. The author has an hindex of 7, co-authored 8 publications receiving 2443 citations.

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Journal ArticleDOI
TL;DR: Despite the potential bias caused by the unblinding of the P-1 trial, the magnitudes of all beneficial and undesirable treatment effects of tamoxifen were similar to those initially reported, with notable reductions in breast cancer and increased risks of thromboembolic events and endometrial cancer.
Abstract: Background: Initial fi ndings from the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (P-1) demonstrated that tamoxifen reduced the risk of estrogen receptor – positive tumors and osteoporotic fractures in women at increased risk for breast cancer. Side effects of varying clinical signifi cance were observed. The trial was unblinded because of the positive results, and follow-up continued. This report updates our initial fi ndings. Methods: Women (n = 13 388) were randomly assigned to receive placebo or tamoxifen for 5 years. Rates of breast cancer and other events were compared by the use of risk ratios (RRs) and 95% confi dence intervals (CIs). Estimates of the net benefi t from 5 years of tamoxifen therapy were compared by age, race, and categories of predicted breast cancer risk. Statistical tests were two-sided. Results: After 7 years of follow-up, the cumulative rate of invasive breast cancer was reduced from 42.5 per 1000 women in the placebo group to 24.8 per 1000 women in the tamoxifen group (RR = 0.57, 95% CI = 0.46 to 0.70) and the cumulative rate of noninvasive breast cancer was reduced from 15.8 per 1000 women in the placebo group to 10.2 per 1000 women in the tamoxifen group (RR = 0.63, 95% CI = 0.45 to 0.89). These reductions were similar to those seen in the initial report. Tamoxifen led to a 32% reduction in osteoporotic fractures (RR = 0.68, 95% CI = 0.51 to 0.92). Relative risks of stroke, deep-vein thrombosis, and cataracts (which increased with tamoxifen) and of ischemic heart disease and death (which were not changed with tamoxifen) were also similar to those initially reported. Risks of pulmonary embolism were approximately 11% lower than in the original report, and risks of endometrial cancer were about 29% higher, but these differences were not statistically signifi cant. The net benefi t achieved with tamoxifen varied according to age, race, and level of breast cancer risk. Conclusions: Despite the potential bias caused by the unblinding of the P-1 trial, the magnitudes of all benefi cial and undesirable treatment effects of tamoxifen were similar to those initially reported, with notable reductions in breast cancer and increased risks of thromboem bolic events and endometrial cancer. Readily identifi able sub sets of individuals comprising 2.5 million women could derive a net benefi t from the drug. [J Natl Cancer Inst 2005;97:1652 – 62]

1,230 citations

Journal ArticleDOI
TL;DR: Long-term raloxifene retained 76% of the effectiveness of tamoxifen in preventing invasive disease and grew closer over time to tamoxfene in preventing noninvasive disease, with far less toxicity.
Abstract: The selective estrogen-receptor modulator (SERM) tamoxifen became the first U.S. Food and Drug Administration (FDA)-approved agent for reducing breast cancer risk but did not gain wide acceptance for prevention, largely because it increased endometrial cancer and thromboembolic events. The FDA approved the SERM raloxifene for breast cancer risk reduction following its demonstrated effectiveness in preventing invasive breast cancer in the Study of Tamoxifen and Raloxifene (STAR). Raloxifene caused less toxicity (versus tamoxifen), including reduced thromboembolic events and endometrial cancer. In this report, we present an updated analysis with an 81-month median follow-up. STAR women were randomly assigned to receive either tamoxifen (20 mg/d) or raloxifene (60 mg/d) for 5 years. The risk ratio (RR; raloxifene:tamoxifen) for invasive breast cancer was 1.24 (95% confidence interval [CI], 1.05-1.47) and for noninvasive disease, 1.22 (95% CI, 0.95-1.59). Compared with initial results, the RRs widened for invasive and narrowed for noninvasive breast cancer. Toxicity RRs (raloxifene:tamoxifen) were 0.55 (95% CI, 0.36-0.83; P = 0.003) for endometrial cancer (this difference was not significant in the initial results), 0.19 (95% CI, 0.12-0.29) for uterine hyperplasia, and 0.75 (95% CI, 0.60-0.93) for thromboembolic events. There were no significant mortality differences. Long-term raloxifene retained 76% of the effectiveness of tamoxifen in preventing invasive disease and grew closer over time to tamoxifen in preventing noninvasive disease, with far less toxicity (e.g., highly significantly less endometrial cancer). These results have important public health implications and clarify that both raloxifene and tamoxifen are good preventive choices for postmenopausal women with elevated risk for breast cancer.

575 citations

Journal ArticleDOI
TL;DR: This study suggests that most women at high risk for breast cancer adhere to the recommended mammography screening guidelines of the National Cancer Institute, however, rates of adherence among high-risk women aged 50 years and older are suboptimal; only 63% of these women received annual screening mammograms, and 13% had never been screened.
Abstract: Background Previous studies estimate that first-degree relatives of women with breast cancer have a twofold to 10-fold increased risk of developing breast cancer. Recently, attention has focused on the mammography screening practices of women who are at high risk for breast cancer. Purpose Our purpose was to characterize mammography screening practices in a sample of first-degree relatives of breast cancer patients and to identify variables that may serve as barriers to or facilitators of adherence to mammography. Methods Cross-sectional (rather than prospective) data were collected by telephone interviews with 140 women aged 35-79 years who had a family history of breast cancer in at least one first-degree relative (mother, sister, or daughter). Data were recorded on mammography screening patterns, depression, stress impact, and breast cancer worries. Results Women whose mammography history adhered to age-specific recommendations varied by age: 76% of first-degree relatives aged 35-39 years, 86% aged 40-49 years, and 63% aged 50 years or more. In bivariate analyses, level of education (P = .001), employment (P = .046), and time since diagnosis of the index patient (P = .044) were significantly and positively associated with mammography adherence. Variables associated negatively with adherence included age (P = .019), intrusive thoughts about breast cancer (P = .042), and breast cancer worries that interfered with daily functioning (P = .004). Multivariate analysis by logistic regression indicated that only breast cancer worries (odds ratio [OR] = 2.5; 95% confidence interval [CI] = 1.09-5.9) and education (OR = 4.8; CI = 1.6-14.3) were significant independent predictors of mammography adherence. Conclusions This study suggests that most women at high risk for breast cancer adhere to the recommended mammography screening guidelines of the National Cancer Institute. However, rates of adherence among high-risk women aged 50 years and older are suboptimal; only 63% of these women received annual screening mammograms, and 13% had never been screened. Breast cancer worries may pose a barrier to mammography adherence among high-risk women, particularly those with less formal education. Implications Prospective longitudinal studies are needed to validate the present findings and to evaluate the impact of psychoeducational interventions for women with affected first-degree relatives.

421 citations

Journal ArticleDOI
TL;DR: There was no difference in total deaths, and causes of death were similarly distributed in the 2 groups, and no group differences were documented for invasive cancer at other sites, ischemic heart disease events, or strokes.
Abstract: The selective estrogen receptor modulator (SERM) tamoxifen has long been used to treat both early and advanced breast cancer. Raloxifene is a second-generation SERM that, in addition to combatting osteoporosis, may also lessen the risk of invasive breast cancer in postmenopausal women; The National Surgical Adjuvant Breast and Bowel Project (NSABP) Study of Tamoxifen and Raloxifene (STAR) is a prospective, randomized, double-blind trial conducted at nearly 200 clinical centers throughout North America. Participating were 19,747 postmenopausal women whose mean age was 58.5 years and whose 5-year breast cancer risk was increased at 4.03%. The minimal 5-year risk for entering the trial was 1.66%. The women received either 20 mg tamoxifen or 60 mg raloxifene daily for 5 years. During a mean follow up of 3.9 years, there were 163 cases of invasive breast cancer in women assigned to receive tamoxifen and 268 in those assigned to raloxifene, for respective incidence rates of 4.3 and 4.4 per 1000 and a risk ratio (RR) of 1.02 (95% confidence interval [CI], 0.82-1.28). Noninvasive breast cancers were less numerous in the tamoxifen group (RR, 1.40; 95% CI, 0.98-2.00), but uterine cancers were more frequent in this group (RR, 0.62; 95% CI, 0.35-1.08). No group differences were documented for invasive cancer at other sites, ischemic heart disease events, or strokes. Thromboembolic events were less frequent in raloxifene-treated women. Women in the 2 treatment groups had similar numbers of osteoporotic fractures. Those taking raloxifene had fewer cataracts and underwent fewer cataract surgeries. There was no difference in total deaths, and causes of death were similarly distributed in the 2 groups.

279 citations

Journal ArticleDOI
TL;DR: African American and white women appear to have the same risks of contralateral breast cancer and thromboembolic events in response to tamoxifen treatment.
Abstract: Background: Information about breast cancer treatment and prevention in African American women is scant, and recommendations for therapy from clinical trials for breast cancer are based primarily on data obtained from white women. Methods: We compared the effects of tamoxifen on risk of contralateral breast cancer and thromboembolic events in African American women and white women with a history of primary breast cancer. Data from 13 National Surgical Adjuvant Breast and Bowel Project clinical trials were pooled for analyses of time to contralateral breast cancer as a first event (eight trials and 10 619 patients) and of time to any thromboembolic phenomenon as a first event (all 13 trials and 20 878 patients). Risk factors for contralateral breast cancer and thromboembolic events among all women were determined using univariate proportional hazards models. (For each racial group, the rate of events associated with tamoxifen use was calculated as the ratio of the incidence rate with tamoxifen to that without tamoxifen.) Proportional hazards regression models were used to calculate 95% confidence intervals (CIs) and risk ratios. All statistical tests were two-sided. Results: Risk factors for contralateral breast cancer were body mass index (BMI) and lymph node positivity; those for thromboembolic events were BMI and age. In women of both ethnicities with estrogen receptor-positive breast cancer, those who took tamoxifen experienced a similar reduction in contralateral breast cancer (risk ratio for African American women = 0.74, 95% CI = 0.46 to 1.17, n = 690; risk ratio for white women = 0.76, 95% CI = 0.59 to 0.98, n = 9929; P = .92). Tamoxifen was also associated with an increase in thromboembolic events. The relative risk for thromboembolic events was higher in both African American and white women treated with tamoxifen and chemotherapy than in those who were treated with tamoxifen alone (risk ratio for African American women = 10.70, 95% CI = 5.94 to 19.28 versus 2.16, 95% CI = 1.26 to 3.71; n = 1842; risk ratio for white women = 15.49, 95% CI = 9.53 to 25.17 versus 3.13, 95% CI = 2.04 to 4.79, n = 19 036), and this effect was similar between the races (P = .10). Conclusions: African American and white women appear to have the same risks of contralateral breast cancer and thromboembolic events in response to tamoxifen treatment.

29 citations


Cited by
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Journal ArticleDOI
01 Jun 2008-Chest
TL;DR: This article discusses the prevention of venous thromboembolism (VTE) and is part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).

3,944 citations

Journal ArticleDOI
TL;DR: The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteiporosis Foundation in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF.
Abstract: The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteoporosis Foundation (NOF) in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF. Readers are urged to consult current prescribing information on any drug, device, or procedure discussed in this publication.

2,926 citations

Journal ArticleDOI
01 Feb 2012-Chest
TL;DR: In this article, the authors focus on optimal prophylaxis to reduce postoperative pulmonary embolism and DVT following major orthopedic surgery, and suggest the use of low-molecular-weight heparin in preference to the other agents we have recommended as alternatives.

2,516 citations

Journal ArticleDOI
TL;DR: The absolute risk reductions produced by tamoxifen depend on the absolute breast cancer risks (after any chemotherapy) without tamox ifen, so all-cause mortality was substantially reduced.

2,347 citations

Journal ArticleDOI
TL;DR: In this paper, the European Foundation for Osteoporosis and Bone disease (subsequently the International osteopo- rosis Foundation) published guidelines for the diagnosis and management of osteoporrosis in a European setting.
Abstract: Summary Guidance is provided in a European setting on the assessment and treatment of postmenopausal women with or at risk from osteoporosis. Introduction The European Foundation for Osteoporosis and Bone disease (subsequently the International Osteopo- rosis Foundation) published guidelines for the diagnosis and management of osteoporosis in 1997. This manuscript updates these in a European setting. Methods The following areas are reviewed: the role of bone mineral density measurement for the diagnosis of osteoporo- sis and assessment of fracture risk; general and pharmaco- logical management of osteoporosis; monitoring of treatment; assessment of fracture risk; case finding strategies; investigation of patients; health economics of treatment. Results and conclusions A platform is provided on which specific guidelines can be developed for national use.

2,292 citations