Search

Supplement: S, Meeting Abstract: GS3-04.Wos title: A randomized phase III study of adjuvant trastuzumab for a duration of 9 weeks versus 1 year, combined with adjuvant taxane-anthracycline chemotherapy, for early HER2-positive breast cancer (the SOLD study)

Background More than 50% of breast cancer patients are diagnosed before the age of 65. Returning to work after treatment is, therefore, of interest for both the individual and society. The aim was to study the effect of support group intervention on sick leave and health care utilization in economic terms. Material and Methods Of 382 patients with newly diagnosed breast cancer, 191 + 191 patients were randomized to an intervention group or to a routine control group respectively. The intervention group received support intervention on a residential basis for one week, followed by four days of follow-up two months later. The support intervention included informative-educational sections, relaxation training, mental visualization and non-verbal communication. Patients answered a questionnaire at baseline, 2, 6 and 12 months about sick leave and health care utilization. Result There was a trend towards longer sick leave and more health care utilization in the intervention group. The difference in total costs was statistically significantly higher in the intervention group after 12 months (p= 0.0036). Conclusion Costs to society were not reduced with intervention in its present form.

Background: Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Materials and methods: Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5. years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30) and the Breast Cancer Module questionnaire (BR23), the Hospital Anxiety and Depression Scale (HAD) and the Norwegian version of the fatigue scale (FQ). Results: After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Conclusion: Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group.

Background Previous studies have demonstrated that between 20 and 30% of women treated for breast cancer have measurable signs of anxiety and depression compared with 6% in a population of healthy women. Depression has been proposed as a predictive factor for recurrence and survival. The aim of the present study was to evaluate if psychosocial support intervention could influence anxiety and depression during the first year after diagnosis. Material and methods Newly diagnosed breast cancer patients were randomised between April 2002 and November 2007 and stratified by adjuvant chemotherapy. Of 382 eligible patients, 191 + 191 patients were randomised to intervention group or control group, respectively. Control patients were subjected to standard follow-up routines. The Intervention group had support intervention at the Foundation Lustgarden Malardalen. The rehabilitation lasted one week on a residential basis followed by four days of follow-up two months later. We used the Swedish version of the HAD scale with a cut-off value greater than 10 for clinical symptoms of depression and anxiety. Results Support group intervention lowered anxiety over time (p < 0.001) but depression was unaffected (p = 0.610). Conclusion This prospective randomised trial of support group intervention in a large homogenous group of breast cancer women showed a statistically significant effect on lowering anxiety over time. No statistically significant effect of intervention could be seen on depression.

BACKGROUND: When diagnosed with breast cancer, most women's lives change as well as their perspectives on and appreciation of life. The aim of the present study was to evaluate whether psychosocial support intervention could influence health-related quality of life (HRQOL) and fatigue during the first year after diagnosis. MATERIAL AND METHODS: Of 382 patients with newly diagnosed breast cancer, 191 patients were randomized to an intervention group and 191 patients were randomized to a routine control group. The intervention group received support intervention that lasted 1 week on a residential basis, followed by 4 days of follow-up 2 months later. The support intervention included informative educational parts, relaxation training, mental visualization, and nonverbal communication. HRQOL was measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 questionnaires and fatigue with the Norwegian version of the fatigue scale at baseline and at 2, 6, and 12 months after intervention. RESULT: There was a time-dependent improvement in both functional and symptom scales between baseline and 12 months as measured by the EORTC QLQ-C30 and BR23 questionnaires and there was a decrease in fatigue between baseline and after 2 months with further improvement up to 12 months in both groups, but there were no differences between the intervention and control groups at any point in time. CONCLUSION: HRQOL improves and symptoms of fatigue decrease over time, but we could not see any additional effect from the rehabilitation program in this setting.

Breast cancer is globally the most common malignancy in women. Her2-targeted monoclonal antibodies are established treatment modalities, and vaccines are in late-stage clinical testing in patients with breast cancer and known to promote tumour-killing through mechanisms like antibody-dependent cellular cytotoxicity. It is therefore increasingly important to study immunological consequences of conventional treatment strategies. In this study, functional tests and four-colour flow cytometry were used to detect natural killer (NK)-cell functions and receptors as well as T-cell signal transduction molecules and intracellular cytokines in preoperative breast cancer patients, and patients who had received adjuvant radiotherapy or adjuvant combined chemo-radiotherapy as well as in age-matched healthy controls. The absolute number of NK cells, the density of NK receptors as well as in vitro quantitation of functional NK cytotoxicity were significantly higher in preoperative patients than the post-treatments group and controls. A similar pattern was seen with regard to T-cell signalling molecules, and preoperative patients produced significantly higher amounts of cytokines in NK and T cells compared to other groups. The results indicate that functions of NK and T cells are well preserved before surgery but decrease following adjuvant therapy, which may speak in favour of early rather than late use of immunotherapeutic agents such as trastuzumab that may depend on intact immune effector functions.