Measurement of health-related quality-of-life (HRQOL) in randomized clinical trials in breast cancer has become common. In this review, we take stock of the contribution that HRQOL measurement in breast cancer clinical trials makes to clinical decision making regarding selection of optimal treatment. A series of MEDLINE searches was conducted to identify all randomized trials in breast cancer that included self-reported HRQOL or psychosocial outcomes. A total of 256 citations were identified that included HRQOL or psychosocial outcomes in breast cancer patients, and 66 of these involved randomized clinical trials of treatment. These 66 reports of breast cancer clinical trials of treatment are discussed in this review. Forty-six of the trials evaluated biomedical interventions, and 20 evaluated psychosocial interventions. Among the biomedical trials, eight trials evaluated HRQOL in primary management of breast cancer, seven trials evaluated HRQOL in adjuvant therapy of breast cancer patients, 20 trials involved metastatic breast cancer, eight trials involved symptom control/supportive care, and three trials evaluated different approaches to investigation or follow-up of breast cancer patients. Among the psychosocial trials, 13 trials evaluated HRQOL in adjuvant therapy of breast cancer patients, and their partners or spouses, six trials involved metastatic breast cancer, and one trial focused on symptom control. We found that the contribution of HRQOL measurement to clinical decision making depended on the clinical setting. In primary management of breast cancer, where medical outcomes of several treatment options are equivalent, HRQOL measurement provided added information for clinical decision making beyond that of traditional medical outcomes. In trials in the adjuvant setting, HRQOL measurement did not influence clinical decision making. In metastatic disease, HRQOL outcomes provided little information beyond that obtained from traditional medical outcomes, including toxicity. In the symptom control/supportive care setting, results of HRQOL questionnaires targeting specific symptoms (e.g., emesis) guided treatment decisions. In psychosocial intervention trials, psychosocial and/or HRQOL measurements often provided the only outcome information; therefore, selection of instruments that captured attributes likely to be altered by the intervention was essential. Until results of ongoing trials in breast cancer are available, caution is recommended in initiating new HRQOL studies unless treatment equivalency is expected, or unless the HRQOL questions target unique or specific issues that can only be addressed through patient self-report, including outcomes of psychosocial interventions.

Women with a BRCA1 or BRCA2 mutation face high risks of breast and ovarian cancer. In the current study, we report on uptake of cancer screening and risk-reduction options in a cohort of BRCA mutation carriers from ten countries over two time periods (1995 to 2008 and 2009 to 2017). Eligible subjects were identified from an international database of female BRCA mutation carriers and included women from 59 centres from ten countries. Subjects completed a questionnaire at the time of genetic testing, which included past use of cancer prevention options and screening tests. Biennial follow-up questionnaires were administered. Six-thousand two-hundred and twenty-three women were followed for a mean of 7.5 years. The mean age at last follow-up was 52.1 years (27–96 years) and 42.3% of the women had a prior diagnosis of breast cancer. In all, 27.8% had a prophylactic bilateral mastectomy and 64.7% had a BSO. Screening with breast MRI increased from 70% before 2009 to 81% at or after 2009. There were significant differences in uptake of all options by country. For women who received genetic testing more recently, uptake of prophylactic mastectomy and breast MRI is significantly higher than those who received genetic testing more than 10 years ago. However, uptake of both BSO and breast MRI is not optimal, and interventions to increase uptake are needed.

Purpose: Nonhormonal pharmacologic interventions are recommended for the treatment of hot flashes in breast cancer survivors. Antidepressants and gabapentin have been shown to be both effective and well tolerated; however, it is not clear which is preferred. Patients and Methods: This was a group-sequential, open-label, randomized, cross-over trial of 4 weeks of venlafaxine (37.5 mg daily for 7 days followed by 75 mg daily for 21 days) versus gabapentin (300 mg once per day for 3 days, then 300 mg twice per day for 3 days, then 300 mg three times per day for 22 days), with patient preference as the primary outcome. Postmenopausal women with at least 14 bothersome hot flashes per week for the prior month were eligible. A 2-week baseline period and a 2-week tapering/washout time was used before the first and second treatment periods, respectively. Diaries were used to measure hot flashes and potential toxicities throughout the study. Participants completed a preference questionnaire at the end of the study. A predefined Pocock stopping rule was applied. Patient preference and hot flash and toxicity outcomes were compared between treatments. Results: Sixty-six patients were randomly assigned, 56 of whom provided a preference (eight dropped out and two had no preference); 18 (32%) preferred gabapentin and 38 (68%) preferred venlafaxine (P = .01). Both agents reduced hot flash scores to a similar extent (66% reduction). Venlafaxine was associated with increased nausea, appetite loss, constipation, and reduced negative mood changes compared with gabapentin, whereas gabapentin was associated with increased dizziness and appetite compared with venlafaxine (all P < .05). Conclusion: Breast cancer survivors prefer venlafaxine over gabapentin for treating hot flashes.

Purpose: To evaluate the effect of a standardized group psychosocial intervention on health-related quality of life (HrQOL) in women with metastatic breast cancer and to explore the effect of missing data in HrQOL analyses. Patients and Methods: Between 1993 and 1998, seven Canadian centers randomly assigned 235 eligible women to participate in a weekly, 90-minute, therapist-led support group that adhered to principles of supportive-expressive (SE) therapy or to a control arm (no SE). All women received educational material and any type of medical or psychosocial care deemed necessary. HrQOL data were prospectively collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) at baseline, 4, 8, and 12 months. The primary HrQOL analyses compared scores in the two study arms. Analyses were limited to women with appropriate baseline HrQOL information (n = 215). Results: Baseline EORTC QLQ-C30 scores were not different between the two study arms (all P > .05). Primary analysis of all subscales failed to show a significant influence of the intervention on HrQOL (all P > .05). There was a significant deterioration over time in several functional scales of the EORTC QLQ-C30: global (P = .03), physical (P = .0002), role (P = .01), and cognitive functioning (P = .04); and in symptom scales: dyspnea (P = .007), appetite loss (P = .04), and fatigue (P = .003); these changes were independent of randomization allocation. Results were similar in additional analyses of overall HrQOL using a variety of approaches to handling missing data. Conclusion: Supportive-expressive group therapy in patients with metastatic breast cancer does not appear to influence HrQOL, as measured by the EORTC QLQ-C30.

Background: Temozolomide is an oral alkylating agent that crosses the blood–brain barrier, and has preclinical activity in breast cancer. This phase II trial sought to determine the activity and toxicity of temozolomide in metastatic breast cancer (MBC). Temozolomide was administered in a dose dense schedule of 150 mg/m² on days 1–7 and 15–21 in a 28-day cycle. Materials and methods: Patients had unidimensional disease for response assessment by RECIST criteria, up to two prior chemotherapy regimens for MBC, and may have had brain metastases if radiation was not expected to be required within 4 weeks. Results: Nineteen women were entered on the study. All were evaluable for toxicity and 18 were evaluable for response. The median age was 54 years; 14 had prior chemotherapy for MBC and 12 had prior hormones. Sites of disease included bone, brain, liver and lung. Treatment was well tolerated with 14/19 receiving >90% planned dose intensity. Common grade 1–3 drug-related effects included nausea, fatigue, vomiting, anorexia and skin rash. Grade 3–4 hematologic toxicities included granulocytopenia and thrombocytopenia. Of the 18 evaluable patients, there were no objective responses; three had stable disease and 15 progressive disease. Conclusions: No responses to temozolomide were documented in these heavily pretreated women with extensive MBC including brain metastases.