Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.
ABSTRACT Tamoxifen has been approved for breast cancer risk reduction in high-risk women, but how raloxifene compares with tamoxifen is unknown.
To compare the differences in patient-reported outcomes, quality of life [QOL], and symptoms in Study of Tamoxifen and Raloxifene (STAR) participants by treatment assignment. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: STAR was a double-blind, randomized phase 3 prevention trial designed to evaluate the relative efficacy of raloxifene vs tamoxifen in reducing the incidence of invasive breast cancer in high-risk postmenopausal women. Between July 1, 1999, and November 4, 2004, 19,747 participants were enrolled at centers throughout North America, with a median potential follow-up time of 4.6 years (range, 1.2-6.5 years). Patient-reported symptoms were collected from all participants using a 36-item symptom checklist. Quality of life was measured with the Medical Outcomes Study Short-Form Health Survey (SF-36), the Center for Epidemiologic Studies-Depression (CES-D), and the Medical Outcomes Study Sexual Activity Questionnaire in a substudy of 1983 participants, median potential follow-up 5.4 years (range, 4.6-6.0 years). Questionnaires were administered before treatment, every 6 months for 60 months and at 72 months.
Primary QOL end points were the SF-36 physical (PCS) and mental (MCS) component summaries.
Among women in the QOL analysis, mean PCS, MCS, and CES-D scores worsened modestly over the study's 60 months, with no significant difference between the tamoxifen (n = 973) and raloxifene (n = 1010) groups (P>.2). Sexual function was slightly better for participants assigned to tamoxifen (age-adjusted repeated measure odds ratio, 1.22%; 95% CI, 1.01-1.46). Of the women in the symptom assessment analyses, the 9769 in the raloxifene group reported greater mean symptom severity over 60 months of assessments than the 9743 in the tamoxifen group for musculoskeletal problems (1.15 vs 1.10, P = .002), dyspareunia (0.78 vs 0.68, P<.001), and weight gain (0.82 vs 0.76, P<.001). Women in the tamoxifen group reported greater mean symptom severity for gynecological problems (0.29 vs 0.19, P<.001), vasomotor symptoms (0.96 vs 0.85, P<.001), leg cramps (1.10 vs 0.91, P<.001), and bladder control symptoms (0.88 vs 0.73, P<.001).
No significant differences existed between the tamoxifen and raloxifene groups in patient-reported outcomes for physical health, mental health, and depression, although the tamoxifen group reported better sexual function. Although mean symptom severity was low among these postmenopausal women, those in the tamoxifen group reported more gynecological problems, vasomotor symptoms, leg cramps, and bladder control problems, whereas women in the raloxifene group reported more musculoskeletal problems, dyspareunia, and weight gain.
clinicaltrials.gov Identifier: NCT00003906.
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ABSTRACT: Purpose/Objectives: To conduct an investigation of women's experiences related to adjuvant endocrine therapy (AET) and managing AET-related symptoms. Research Approach: Qualitative, focus group design. Setting: Main campus of the University of Pittsburgh in Pennsylvania. Participants: 14 breast cancer survivors, aged 50 years or older, with AET-related symptoms. Methodologic Approach: Semistructured discussion guides were used to elicit recollections of conversations with healthcare providers about starting AET, symptom experiences, symptom management, and suggestions for improving management. Audiotaped discussions were transcribed and analyzed to identify themes. Findings: Women reported that, initially, AET was not viewed as a choice, but rather as the necessary next step to save their lives. After starting AET, women experienced difficulties making sense of, communicating about, and managing unanticipated AET-related symptoms. Women who experienced persistently bothersome symptoms began weighing the pros and cons of AET to decide whether to continue treatment. Conclusions: Focus group findings suggest multiple opportunities to better prepare patients for AET and to improve assessment and management of AET-related symptoms. Interpretation: By exploring AET-related symptom experiences, nurses may be able to promote AET adherence in breast cancer survivors.Oncology nursing forum 11/2014; 41(6):660-8. DOI:10.1188/14.ONF.660-668 · 2.83 Impact Factor
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ABSTRACT: The purpose of this study was to examine the relationship between self-reported exercise behavior, cardiorespiratory fitness (CRF), and cognitive function in early breast cancer patients. Thirty-seven breast cancer patients following completion of chemotherapy (median 16 months) and 14 controls were studied. Cognitive function was assessed using the Central Nervous System (CNS) Vital Signs software (CNS Vital Signs, LLC, Morrisville, N.C., USA), a computerized test battery consisting of 9 cognitive subtests. Exercise behavior was evaluated using the Godin Leisure Time Exercise Questionnaire, and CRF was assessed via a cardiopulmonary exercise test to assess peak oxygen consumption. Patients’ mean total exercise was 184 ± 141 min·week−1 compared with 442 ± 315 min·week−1 in controls (p p = 0.014). Patients’ peak oxygen consumption averaged 23.5 ± 6.3 mL·kg–1·min−1 compared with 30.6 ± 7.0 mL·kg–1·min−1 in controls (p p = 0.041). In patients, weak to moderate correlations were indicated between exercise, peak oxygen consumption, and the majority of cognitive subdomain scores; however, there was a significant positive correlation between exercise and visual memory (r = 0.47, p = 0.004). In conclusion, breast cancer patients following the completion of primary adjuvant chemotherapy exhibit, in general, worse cognitive performance than healthy women from the general population, and such performance may be related to their level of exercise behavior.Applied Physiology Nutrition and Metabolism 06/2014; 39(6). DOI:10.1139/apnm-2013-0380 · 2.23 Impact Factor
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ABSTRACT: Due to the high incidence of breast cancer in the United States, optimal strategies for its prevention are imperative. This entails identification of women who are at an increased risk for breast cancer and an integrative approach that includes effective screening methods as well as nutritional, pharmacologic, and surgical management. Several breast cancer risk-assessment tools, such as the Gail and Claus models, can help clinicians determine the quantitative risk of breast cancer. The role of selective estrogen receptor modulators, such as tamoxifen and raloxifene, for the prevention of breast cancer has been well established. Several other agents, such as aromatase inhibitors, are currently being investigated. The potential adverse effects of these chemopreventive agents, which include an impact on the quality of life, must be discussed with the patient before deciding on this approach. Additionally, breast cancer risk factors have been identified over the years; some of them are modifiable, but others are not. Although there is no conclusive evidence to suggest the protective role of specific dietary components, alcohol consumption and obesity are associated with an increased breast cancer risk; thus lifestyle changes can lead to a lower risk of developing breast cancer. Surgical approaches, including bilateral risk-reduction mastectomy and salpingo-oophorectomy, are usually limited to women with a hereditary predisposition to development of breast cancer. The objective of this review is to summarize the various approaches directed at reducing the incidence of breast cancer.Breast Cancer: Targets and Therapy 01/2014; 6:59-71. DOI:10.2147/BCTT.S39114