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Sökning: WFRF:(Granstam Bjorneklett H)

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1.
  • Joensuu, Heikki, et al. (författare)
  • Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer The SOLD Randomized Clinical Trial
  • 2018
  • Ingår i: JAMA Oncology. - : AMER MEDICAL ASSOC. - 2374-2437 .- 2374-2445. ; 4:9, s. 1199-1206
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance: Trastuzumab plus chemotherapy is the standard adjuvant treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. While the standard duration of trastuzumab treatment is 12 months, the benefits and harms of trastuzumab continued beyond the chemotherapy are unclear.Objective: To evaluate the efficacy and safety of adjuvant trastuzumab continued beyond chemotherapy in women treated with up-front chemotherapy containing a taxane and trastuzumab.Design, Setting, and Participants: Open-label, randomized (1:1) clinical trial including women with HER2-positive breast cancer. Chemotherapy was identical in the 2 groups, consisting of 3 cycles of 3-weekly docetaxel (either 80 or 100 mg/m2) plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide. Thereafter, no trastuzumab was administered in the 9-week group, whereas controls received trastuzumab to complete 1 year of administration. Disease-free survival (DFS) was compared between the groups using a Cox model and the noninferiority approach. The estimated sample size was 2168 patients (1-sided testing, with a relative noninferiority margin of 1.3). From January 3, 2008, to December 16, 2014, 2176 patients were accrued from 7 countries.Intervention: Docetaxel plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide in both groups. Controls continued trastuzumab to 1 year.Main Outcomes and Measures: The primary objective was DFS; secondary objectives included distant disease–free survival, overall survival, cardiac DFS, and safety.Results: In the 2174 women analyzed, median age was 56 (interquartile range [IQR], 48-64) years. The median follow-up was 5.2 (IQR, 3.8-6.7) years. Noninferiority of the 9-week treatment could not be demonstrated for DFS (hazard ratio, 1.39; 2-sided 90% CI, 1.12-1.72). Distant disease–free survival and overall survival did not differ substantially between the groups. Thirty-six (3%) and 21 (2%) patients in the 1-year and the 9-week groups, respectively, had cardiac failure; the left ventricle ejection fraction was better maintained in the 9-week group. An interaction was detected between the docetaxel dose and DFS; patients in the 9-week group treated with 80 mg/m2 had inferior and those treated with 100 mg/m2 had similar DFS as patients in the 1-year group.Conclusions and Relevance: Nine weeks of trastuzumab was not noninferior to 1 year of trastuzumab when given with similar chemotherapy. Cardiac safety was better in the 9-week group. The docetaxel dosing with trastuzumab requires further study.Trial Registration: ClinicalTrials.gov Identifier: NCT00593697
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2.
  • Mozaffari, Fariba, et al. (författare)
  • Systemic immune effects of adjuvant chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide and/or radiotherapy in breast cancer : a longitudinal study
  • 2009
  • Ingår i: Cancer Immunology and Immunotherapy. - 0340-7004 .- 1432-0851. ; 58:1, s. 111-120
  • Tidskriftsartikel (refereegranskat)abstract
    • Immunotherapy is being increasingly utilized for adjuvant treatment for breast cancer (BC). We have previously described immune functions during primary therapy for BC. The present study describes immune recovery patterns during long-term, unmaintained follow-up after completion of adjuvant therapy. A group of patients with primary BC had been treated with adjuvant radio-chemotherapy therapy (RT + CT) 5-fluorouracil, epirubicin and cyclo-phosphamide (FEC) (n = 21) and another group with radiotherapy (RT) (n = 20) alone. Immunological testing of NK and T-cell functions was performed initially at the end of adjuvant treatment and repeated after 2, 6 and 12 months. NK cell cytotoxicity was significantly higher (P < 0.05) at all time-points in patients than in age-matched controls and did not differ between the two treatments groups during one year observation. In contrast, lower numbers of CD4 T-cells and lower expression of CD28 on T-cells was observed particularly in RT + CT patients and did not normalize during the observation period. The numbers of T-reg cells (CD4(+) CD25(high)) were low in the RT + CT group during follow-up, as well as expression of TCR xi, Zap70, p56(lck), P59(fyn) and PI3 k in CD4+ cells. In contrast, expression of intracellular cytokines (IFN-gamma, IL-2, IL-4) in CD4 and CD8 T cells were signiWcantly higher in RT + CT patients than in the RT group and the difference increased during follow-up. In conclusion, NK-cell cytotoxicity increased during unmaintained long-term follow-up whereas CD4 and regulatory T cells as well as signal transduction molecules remained low following adjuvant radio-chemotherapy.
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4.
  • Lindemalm, Christina, et al. (författare)
  • Immune response, depression and fatigue in relation to support intervention in mammary cancer patients
  • 2008
  • Ingår i: Supportive Care in Cancer. - 0941-4355 .- 1433-7339. ; 16:1, s. 57-65
  • Tidskriftsartikel (refereegranskat)abstract
    • Goal of work To study the effect of support intervention on immune function in breast cancer patients. Materials and methods Breast cancer patients from an ongoing prospective randomised quality-of -life study were chosen for assaying immune functions in relation to a support-group intervention program running on a residential basis. Twenty-one women received adjuvant-combined radio-chemotherapy (CT-RT) and 20 women radiotherapy (RT). Eleven CT-RT and ten RT patients were randomised to support-group intervention, the rest served as controls. Immune tests for NK cells and NK-cell cytotoxicity, as well as lymphocyte subpopulations and response to antigen were performed before intervention, 2, 6, and 12 months later, in parallel to controls and healthy volunteers (n=11). Depression, anxiety and fatigue were evaluated by the Hospital Anxiety and Depression (HAD) and the Norwegian Fatigue questionnaire. The density of NK cell receptors and in vitro quantitation of functional NK cytotoxicity against K562 cell line were evaluated. Four-colour flow cytometry was used to detect signal transduction molecules and cytokine expression. T-cell proliferate response to purified protein derivate (PPD) antigen was evaluated. Results No significant immune effect of support intervention could be found. The immune variables were severely disarranged compared to healthy volunteers but showed a statistically significant improvement over time. The majority of patients suffered from fatigue but had low scores for depression and anxiety. Conclusion No effect on immune parameters could be detected from support intervention. The long-lasting immune suppression might override a putative effect of the intervention. Low depression scores may contribute to the absence of a detectable effect.
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5.
  • Mozaffari, F, et al. (författare)
  • NK-cell and T-cell functions in patients with breast cancer : effects of surgery and adjuvant chemo- and radiotherapy
  • 2007
  • Ingår i: British Journal of Cancer. - 0007-0920 .- 1532-1827. ; 97:1, s. 105-111
  • Tidskriftsartikel (refereegranskat)abstract
    • 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.
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6.
  • Granstam Björneklett, Helena, et al. (författare)
  • A randomised controlled trial of support group intervention after breast cancer treatment : Results on anxiety and depression
  • 2012
  • Ingår i: Acta Oncologica. - 0284-186X .- 1651-226X. ; 51:2, s. 198-207
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundPrevious 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 methodsNewly 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.ResultsSupport group intervention lowered anxiety over time (p < 0.001) but depression was unaffected (p = 0.610).ConclusionThis 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.
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7.
  • Granstam Björneklett, Helena, et al. (författare)
  • A randomized controlled trial of a support group intervention on the quality of life and fatigue in women after primary treatment for early breast cancer
  • 2012
  • Ingår i: Supportive Care in Cancer. - 0941-4355 .- 1433-7339. ; 20:12, s. 3325-3334
  • Tidskriftsartikel (refereegranskat)abstract
    • 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.
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8.
  • Granstam Björneklett, Helena, 1962-, et al. (författare)
  • A randomized controlled trial of support group intervention after breast cancer treatment : Results on sick leave, health care utilization and health economy
  • 2013
  • Ingår i: Acta Oncologica. - 0284-186X .- 1651-226X. ; 52:1, s. 38-47
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundMore 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 MethodsOf 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.ResultThere 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.
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9.
  • Granstam Björneklett, Helena, et al. (författare)
  • Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer
  • 2013
  • Ingår i: Journal of Psychosomatic Research. - 0022-3999 .- 1879-1360. ; 74:4, s. 346-353
  • Tidskriftsartikel (refereegranskat)abstract
    • 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.
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