Elizabeth Maunsell

Exemestane for Breast-Cancer Prevention in Postmenopausal Women

BACKGROUND Tamoxifen and raloxifene have limited patient acceptance for primary prevention of breast cancer. Aromatase inhibitors prevent more contralateral breast cancers and cause fewer side effects than tamoxifen in patients with early-stage breast cancer. METHODS In a randomized, placebo-controlled, double-blind trial of exemestane designed to detect a 65% relative reduction in invasive breast cancer, eligible postmenopausal women 35 years of age or older had at least one of the following risk factors: 60 years of age or older; Gail 5-year risk score greater than 1.66% (chances in 100 of invasive breast cancer developing within 5 years); prior atypical ductal or lobular hyperplasia or lobular carcinoma in situ; or ductal carcinoma in situ with mastectomy. Toxic effects and health-related and menopause-specific qualities of life were measured. RESULTS A total of 4560 women for whom the median age was 62.5 years and the median Gail risk score was 2.3% were randomly assigned to either exemestane or placebo. At a median follow-up of 35 months, 11 invasive breast cancers were detected in those given exemestane and in 32 of those given placebo, with a 65% relative reduction in the annual incidence of invasive breast cancer (0.19% vs. 0.55%; hazard ratio, 0.35; 95% confidence interval [CI], 0.18 to 0.70; P=0.002). The annual incidence of invasive plus noninvasive (ductal carcinoma in situ) breast cancers was 0.35% on exemestane and 0.77% on placebo (hazard ratio, 0.47; 95% CI, 0.27 to 0.79; P=0.004). Adverse events occurred in 88% of the exemestane group and 85% of the placebo group (P=0.003), with no significant differences between the two groups in terms of skeletal fractures, cardiovascular events, other cancers, or treatment-related deaths. Minimal quality-of-life differences were observed. CONCLUSIONS Exemestane significantly reduced invasive breast cancers in postmenopausal women who were at moderately increased risk for breast cancer. During a median follow-up period of 3 years, exemestane was associated with no serious toxic effects and only minimal changes in health-related quality of life. (Funded by Pfizer and others; NCIC CTG MAP.3 ClinicalTrials.gov number, NCT00083174.).

Canadian-French, German and UK versions of the Child Health Questionnaire: methodology and preliminary item scaling results

Using emerging international guidelines, stringent procedures were used to develop and evaluate Canadian-French, German and UK translations/ adaptions of the 50 item, parent-completed Child Health Questionnaire (CHQ-PF50). Multitrait analysis was used to evaluate the convergent and discriminant validity of the hypothesized item sets across countries relative to the results obtained for a representative sample of children in the US. Cronbachs a coefficient was used to estimate the internal consistency reliability for each of the health scales. Floor and ceiling effects were also examined. Seventy-nine percent of all the item-scale correlations achieved acceptable internal consistency (0.40 or higher). The tests of the item convergent and discriminant validity were successful at least 87% of the time across all scales and countries. Equal item variance was observed 90% of the time across all countries. The reliability coefficients ranged from a low of 0.43 (parental time impact, Canadian English) to a high of 0.97 (physical functioning index, Canadian French) across all scales (median 0.80). Negligible floor effects were observed across countries. Noteworthy ceiling effects were observed, as expected, for the hypothesized physical scales (mean effect 73%). Conversely, fewer ceiling effects were observed for the psychosocial scales (range 3–17% behaviour parental emotional impact). The item-scaling results obtained in these pilot studies support the psychometric properties of the American-English CHQ-PF50 and its respective translations.

Evaluating Survivorship Care Plans: Results of a Randomized, Clinical Trial of Patients With Breast Cancer

PURPOSE An Institute of Medicine report recommends that patients with cancer receive a survivorship care plan (SCP). The trial objective was to determine if an SCP for breast cancer survivors improves patient-reported outcomes. PATIENTS AND METHODS Women with early-stage breast cancer who completed primary treatment at least 3 months previously were eligible. Consenting patients were allocated within two strata: less than 24 months and ≥ 24 months since diagnosis. All patients were transferred to their own primary care physician (PCP) for follow-up. In addition to a discharge visit, the intervention group received an SCP, which was reviewed during a 30-minute educational session with a nurse, and their PCP received the SCP and guideline on follow-up. The primary outcome was cancer-related distress at 12 months, assessed by the Impact of Event Scale (IES). Secondary outcomes included quality of life, patient satisfaction, continuity/coordination of care, and health service measures. RESULTS Overall, 408 survivors were enrolled through nine tertiary cancer centers. There were no differences between groups on cancer-related distress or on any of the patient-reported secondary outcomes, and there were no differences when the two strata were analyzed separately. More patients in the intervention than control group correctly identify their PCP as primarily responsible for follow-up (98.7% v 89.1%; difference, 9.6%; 95% CI, 3.9 to 15.9; P = .005). CONCLUSION The results do not support the hypothesis that SCPs are beneficial for improving patient-reported outcomes. Transferring follow-up to PCPs is considered an important strategy to meet the demand for scarce oncology resources. SCPs were no better than a standard discharge visit with the oncologist to facilitate transfer.

Social support and survival among women with breast cancer

Background. Two recently reported randomized trials, one among patients with advanced breast cancer and the other among patients with early stage melanoma, suggested that social support may affect survival favorably. This study assesses relationships of social support indicators with 7‐year survival among women diagnosed with localized or regional stage breast cancer.

Educational and social late effects of childhood cancer and related clinical, personal, and familial characteristics.

The objectives of this study were to compare educational and social outcomes for young survivors of childhood cancer with a population control group of individuals who were never diagnosed with cancer and to identify risk and protective factors for these outcomes.

Work problems after breast cancer: an exploratory qualitative study.

People treated for cancer have reported a variety of problems at work. However, there is little data on work experience after breast cancer, particularly for women treated in recent years. This exploratory qualitative study was conducted among 13 breast cancer survivors who had paid employment at diagnosis, returned to work afterwards, and mentioned work‐related problems to a clinic nurse or physician. Unstructured, thematic interviews were undertaken. Qualitative thematic content analysis was conducted to identify and group themes which emerged from participants’ discourse. Women in various types of jobs reported experiencing job loss, demotion, unwanted changes in tasks, problems with the employer and co‐workers, personal changes in attitudes to work and diminished physical capacity. These work problems also preoccupied people treated for cancer more than two decades ago. New areas of concern also emerged: possible positive and negative effects of learning (implicitly or explicitly) about the diagnosis while at work and lack of discussion with health professionals about work and return‐to‐work issues, suggesting that health professionals’ behaviour may influence womens work experience right from diagnosis. The identification of these new problems and confirmation of previously reported ones underlines the pertinence of determining how important and widespread these problems are in women now being treated for breast cancer. Copyright

Psychological distress after initial treatment of breast cancer. Assessment of potential risk factors.

Background. Patient and disease characteristics are often mentioned by clinicians as possible risk factors for psychological distress among women with breast cancer. However, either these factors have not been evaluated or when they were evaluated, results were inconclusive.

Dietary Change After Breast Cancer: Extent, Predictors, and Relation With Psychological Distress

PURPOSE Some women may try to cope with breast cancer by making lifestyle modifications, possibly in the hope of improving disease outcome. We assessed extent, predictors, and effect on psychological distress of dietary changes in the year after diagnosis among 250 women with newly diagnosed, nonmetastatic breast cancer. PATIENTS AND METHODS Data came from medical records, and from interviews 3 days and 12 months after initial treatment. RESULTS At 12 months, 41% (n = 103) reported dietary changes at some time since diagnosis, with decreases in meat (77%) and increases in fruit and vegetable intake (72%) being the most frequent. Women reporting changes were more likely to be younger, to have positive nodes, to be receiving adjuvant therapy, and to be more distressed initially. The mean 0 to 12 month decrease in psychological distress was greater in women who reported changes (9 points) than those who did not (4.7 points) (P =.03), although regression toward the mean cannot be excluded. CONCLUSION A sizable proportion of women made dietary changes on their own initiative. Most changes reported were generally consistent with current scientific hypotheses about dietary changes that might favorably affect prognosis. The profile of women reporting changes suggests a group with more concerns about recurrence, who may have initiated dietary change to help cope with and gain a sense of control over the disease, and possibly to improve prognosis. Our results suggest that newly diagnosed women could be receptive to explicit attention to diet as part of psychosocial care. However, this interest in dietary change may not, as yet, have been maximally channeled into trying to improve the care and quality of life of women facing diagnosis, treatments, and fears about recurrence.

Randomized clinical trial on cognitive therapy for depression in women with metastatic breast cancer: Psychological and immunological effects

OBJECTIVE Depression is particularly prevalent in patients with advanced cancer. Cognitive therapy (CT) is an empirically supported treatment for depression in the general population. However, efficacy remains to be demonstrated in patients with advanced cancer. A prior controlled trial of CT in a group format showed improvements in depression, mood disturbance, and self-esteem; however, these effects were not maintained over time. Studies examining the efficacy of individual format CT interventions that may ensure more long-term maintenance of benefits are necessary. This study assessed the efficacy of CT for depression administered individually in women with metastatic breast cancer and its effect on immune function. METHOD Forty-five women were randomly assigned to either individual CT or to a waiting-list control (WLC) condition. CT was composed of eight weekly sessions of CT and three booster sessions administered at 3-week intervals following the end of treatment. RESULTS Patients treated with CT had significantly lower scores on the Hamilton Depression Rating Scale at posttreatment compared to untreated patients. Pooled data from both groups indicated significant reductions of depressive symptoms from pre- to posttreatment, as well as reduction of associated symptoms including anxiety, fatigue, and insomnia symptoms. These effects were well sustained at the 3- and 6-month follow-up evaluations. CT for depression did not appear to have a significant impact on immune functioning. SIGNIFICANCE OF RESULTS Findings of this study support the efficacy of CT for depression in this population and suggest that the administration of individual and booster sessions after treatment termination may be instrumental in sustaining the treatment effects over time.

Quality of Life Among Long-Term Adolescent and Adult Survivors of Childhood Cancer

PURPOSE We assessed effects of childhood or adolescent cancer on quality of life among adolescent and adult cancer survivors, a group who are thought to be at particular risk for adverse late effects. PATIENTS AND METHODS We studied 1,334 survivors and 1,477 age- and sex-matched, general population controls from across Canada using a mailed questionnaire which included the Short Form-36 (SF-36) and measures of self-esteem, optimism, and life satisfaction. General linear models and logistic regression were used. Survivor-control differences corresponding to an effect size (ES) > or = 0.5 were considered clinically important. RESULTS Participants were age 15 years to 37 years. Most survivors (83.8%) were diagnosed > or = 10 years earlier. Fewer survivors (62.1%) than controls (71.1%) reported very good or excellent general health (adjusted odds ratio, 0.6; 95% CI, 0.5 to 0.7). However, quality of life differences between survivors and controls were small, and for the most part probably not clinically important. Three clinical characteristics-having had CNS or bone cancer, more than one treatment series, and > or = two organs with a dysfunction at treatment end-were independently associated with poorer quality of life in the physical dimensions. Only survivors with > or = two organs with dysfunction (8.7%) reported poorer quality of life in both physical and psychosocial domains, with several clinically important ES. The largest ES for the SF-36 physical summary scores were found in the 8% of survivors with two or three of these characteristics simultaneously, compared with those survivors who had none (-0.79 and -1.13, respectively). CONCLUSION Overall, a sizeable majority of adolescent and adult long-term survivors of childhood cancer in Canada appear to have adapted well.