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  • 1
    Language: English
    In: Community Oncology, 7/2011, Vol.8(7), pp.304-305
    ISSN: 15485315
    Source: Elsevier (via CrossRef)
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  • 2
    In: Journal Of The National Cancer Institute, 2016, Vol. 108(4)
    Description: BACKGROUND: Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations.METHODS: P-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76-100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided.RESULTS: Participants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity.CONCLUSIONS: Promoting QOL and managing symptoms early in therapy may be important strategies to improve adherence.
    Keywords: Medicine;
    ISSN: 0027-8874
    E-ISSN: 1460-2105
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  • 3
    Language: English
    In: Surgical Oncology Clinics of North America, 2010, Vol.19(3), pp.463-473
    Description: The chemoprevention of breast cancer using pharmacologic agents has had substantial clinical success. Randomized clinical trials evaluating selective estrogen-receptor modulators (SERMs) have shown that these agents reduce the incidence of breast cancer by up to 50% in healthy women at increased risk for the development of the disease. SERMs have been of particular value in women with biopsy-proven risk factors, including atypical hyperplasia or lobular carcinoma in situ of the breast. The agents of established value are important options for women today, and efforts are under way to identify additional more effective therapies.
    Keywords: Breast Cancer ; Chemoprevention ; Tamoxifen ; Raloxifene
    ISSN: 1055-3207
    E-ISSN: 1558-5042
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  • 4
    Language: English
    In: American Journal of Obstetrics and Gynecology, 2011, Vol.205(6), pp.535.e1-535.e5
    Description: This study reports the gynecologic conditions in postmenopausal women (intact uterus on enrollment) in the National Surgical Adjuvant Breast and Bowel Project (NSABP) study of tamoxifen and raloxifene (STAR)/P-2 trial. This study, with a median follow-up period of 81 months, evaluated the incidence rates/risks of gynecologic conditions among women who were treated with tamoxifen and raloxifene. Compared with women who received tamoxifen therapy, women who received raloxifene therapy had a lower incidence of uterine cancer (relative risk, 0.55)/endometrial hyperplasia (relative risk, 0.19), leiomyomas (relative risk, 0.55), ovarian cysts (relative risk, 0.60), and endometrial polyps (relative risk, 0.30) and had fewer procedures performed. Women receiving tamoxifen therapy had more hot flashes ( 〈 .0001), vaginal discharge ( 〈 .0001), and vaginal bleeding ( 〈 .0001). Our results suggest that tamoxifen has more of an estrogenic effect on the gynecologic reproductive organs. These effects should be considered in counseling women on options for breast cancer prevention.
    Keywords: Breast Cancer Prevention ; Gynecologic Condition ; Raloxifene ; Tamoxifen ; Medicine
    ISSN: 0002-9378
    E-ISSN: 1097-6868
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  • 5
    Language: English
    In: Cancer, 01 August 2010, Vol.116(15), pp.3569-3576
    Description: BACKGROUND: The purpose of this study was to examine factors influencing a woman's decision to participate in a breast cancer prevention clinical trial. Nine healthcare organizations in Massachusetts cooperated in the present project.METHODS: The authors performed a case-control study to compare responses between the study group (Study of Tamoxifen and Raloxifene [STAR] trial eligible, but not enrolled) and the control group (STAR trial participants) on 12 factors previously identified as barriers to accrual for clinical trials. Eight hypotheses were tested using multiple logistic regression to estimate the strength of the association for each factor on the dependent variable (study participation).RESULTS: The study samples were similar to the general population of eligible breast cancer prevention clinical trial subjects in the counties where the participating organizations were located, the state of Massachusetts, and nationally published STAR trial data. Results of a mailed questionnaire showed that when adjusting for subject demographics, and in the presence of other questions, 4 factors significantly influenced a woman's decision to enroll onto a breast cancer prevention clinical trial more than other eligible subjects: 1) clinician expertise and qualifications (P=.012; odds ratio [OR], 4.903; 95% confidence interval [CI], 1.41-17.04); 2) personal desire to participate (P=.033; OR, 3.16; 95% CI, 1.10-9.06); 3) perceived value of the trial (P=.020; OR, 2.92; 95% CI, 1.18-7.21); and 4) level of trial inconvenience (P=.002; OR, 0.10; 95% CI, 0.02-0.44).CONCLUSIONS: Addressing these issues in the relationship between patients and clinicians should improve accrual to breast cancer prevention clinical trials.
    Keywords: Breast Cancer ; Clinical Trials ; Cancer Prevention ; Clinical Trials Accrual ; Trial Barriers ; Accrual Barriers
    ISSN: 0008-543X
    E-ISSN: 1097-0142
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  • 6
    Language: English
    In: The Lancet, 25 May 2013, Vol.381(9880), pp.1827-1834
    Description: Tamoxifen and raloxifene reduce the risk of breast cancer in women at elevated risk of disease, but the duration of the effect is unknown. We assessed the effectiveness of selective oestrogen receptor modulators (SERMs) on breast cancer incidence. We did a meta-analysis with individual participant data from nine prevention trials comparing four selective oestrogen receptor modulators (SERMs; tamoxifen, raloxifene, arzoxifene, and lasofoxifene) with placebo, or in one study with tamoxifen. Our primary endpoint was incidence of all breast cancer (including ductal carcinoma in situ) during a 10 year follow-up period. Analysis was by intention to treat. We analysed data for 83 399 women with 306 617 women-years of follow-up. Median follow-up was 65 months (IQR 54–93). Overall, we noted a 38% reduction (hazard ratio [HR] 0·62, 95% CI 0·56–0·69) in breast cancer incidence, and 42 women would need to be treated to prevent one breast cancer event in the first 10 years of follow-up. The reduction was larger in the first 5 years of follow-up than in years 5–10 (42%, HR 0·58, 0·51–0·66; p〈0·0001 25%, 0·75, 0·61–0·93; p=0·007), but we noted no heterogeneity between time periods. Thromboembolic events were significantly increased with all SERMs (odds ratio 1·73, 95% CI 1·47–2·05; p〈0·0001). We recorded a significant reduction of 34% in vertebral fractures (0·66, 0·59–0·73), but only a small effect for non-vertebral fractures (0·93, 0·87–0·99). For all SERMs, incidence of invasive oestrogen (ER)-positive breast cancer was reduced both during treatment and for at least 5 years after completion. Similar to other preventive interventions, careful consideration of risks and benefits is needed to identify women who are most likely to benefit from these drugs. Cancer Research UK.
    Keywords: Medicine
    ISSN: 0140-6736
    E-ISSN: 1474-547X
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  • 10
    Language: English
    In: Journal of the National Cancer Institute, 16 October 2013, Vol.105(20), pp.1521-2
    Description: Until the late 1970s or early 1980s, the treatment of what was then called noninvasive intraductal carcinoma was relatively straightforward. Patients were told they had a very good prognosis, and they were treated with a mastectomy. At some centers, they received a radical mastectomy, "just to be cautious." What is now called ductal carcinoma in situ (DCIS) was an uncommon breast cancer, representing less than 5% of new cases, and most of these were palpable lesions. Here, Wickerham and Julian point out that making drastic changes in nomenclature with the hope that those changes will improve the situation may be an interesting semantic and sociological exercise, but it is doubtful that they will, at least in the immediate future, result in different decisions being made by women diagnosed with this entity.
    Keywords: Breast Neoplasms -- Diagnosis ; Carcinoma, Ductal, Breast -- Diagnosis ; Carcinoma, Intraductal, Noninfiltrating -- Diagnosis ; Neoplasm Recurrence, Local -- Diagnosis ; Secondary Prevention -- Methods
    ISSN: 00278874
    E-ISSN: 1460-2105
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