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Shared decision making with breast cancer patients: impact on patient engagement and fear of recurrence. Protocol for a Danish randomized trial in radiotherapy (DBCG RT SDM)

24 BoneBio: The variable sensitivity of breast cancer patients to zoledronic acid Presenting author: Anaïs Marie Julie Møller Presenting author's affiliation: Clinical Cell Biology, Department of Pathology, Odense University Hospital; Department of Clinical Research, University of Southern Denmark Authors: Møller, A. M. J. (1), Bechmann, T. (2), Madsen, J. M. (3), Jakobsen E. H. (2), Søe K. (4) Affiliations: 1: Clinical Cell Biology, Department of Pathology, Odense University Hospital; Department of Clinical Research,University of Southern Denmark 2: Department of Oncology, Vejle Hospital; Department of Oncology, Hospital of South West Jutland 3: Department of Clinical Immunology and Biochemistry, Vejle Hospital 4: Clinical Cell Biology, Department of Pathology, Odense University Hospital; Department of Clinical Research, University of Southern Denmark; OPEN – Open patient data Explorative Network Abstract: Introduction Breast cancer (BC) is the most prevalent cancer among women in Denmark. BC cells frequently metastasize to bone tissue, where they initiate a “vicious cycle” involving the bone resorbing osteoclasts. This results in local bone loss, increased fracture risk, resistance of cancer cells, a reduced quality of life, and survival. Questions Can bone biomarkers (CTX: degradation, PINP: formation) be used for diagnosis and monitoring? Can it detect those patients that are least sensitive to zoledronic acid? Materials and methods 50 BC patients with newly diagnosed bone metastases (80 years or younger). Primary variables: absolute and delta‐values of CTX and PINP, progression of bone disease, and death. Preliminary results Start of recruitment: May 2016 ‐ status: 49/50 pts. After 3 months of treatment with zoledronic acid the median CTX levels are decreased by 69% from baseline (p

ObjectiveThe aim of this study was to develop and test a patient decision aid (PtDA) template that could be adapted to different clinical encounters.Methods A systematic development process guided by the International Patient Decision Aid Standards (IPDAS) model was adopted and a collaboration with a design school was established. Scope and purpose of prototypes were defined, steering groups were established and a PtDA template was designed. Alpha testing was conducted by structured interviews with patients and health care professionals. ResultsIn the alpha test, 39 patients and 24 health care professionals participated. Patients and health care professionals rated the PtDA highly for usability and acceptability and the PtDAs were found suitable for preparing patients to make preference-sensitive decisions.Qualitative findings were used to refine the PtDA.ConclusionUsing a systematic process and high user involvement we developed a PtDA template and two prototypes that meet the IPDAS criteria. Testing of the PtDA prototypes, showed that the template can be adapted to other clinical settings without affecting the quality of the PtDA.The PtDA template will be made available in a web-based “build-your-own-PtDA” software platform, making development of PtDAs more accessible for all health care professionals.

Background: Retrospective studies have suggested that chemotherapy-induced leukopenia is associated with improved recurrence-free or overall survival. The SBG 2000–1 trial was designed to verify the favorable prognosis associated with chemotherapy-induced leukopenia in early breast cancer. Patients not experiencing chemotherapy-induced leukopenia were randomized into standard dosed or individually escalated chemotherapy doses based on the grade of leukopenia after a first standard dose. Patients and methods: 1452 women in Sweden and Denmark with operable node-positive or high-risk node-negative breast cancer aged 18–60 years were recruited to participate in this trial. Participants received a first FEC cycle at standard doses (600/60/600 mg/m2). Patients (n = 1052) with nadir leukopenia grade 0–2 after the first cycle were randomized between either 6 standard FEC or 6 tailored FEC courses with doses of epirubicin and cyclophosphamide escalated during courses 2 and 3 and thereafter aimed at achieving grade 3 leukopenia. Patients with nadir leukopenia grade 3–4 after the first course continued treatment with standard FEC. Results of the randomized comparison has been published previously. The present study focuses on chemotherapy-induced leukopenia as a covariable with outcome in randomized and non-randomized patients. The prognostic value of leukopenia after course 3, was studied in a Cox model adjusted for cumulative doses of epirubicin and cyclophosphamide. The association of chemotherapy-induced leukopenia with prognosis was a preplanned secondary endpoint for this trial. Results: The eight-year distant disease-free survival was 73%, 77%, 78% and 83% for patients with leucocyte nadir grade 0, 1, 2 and 3–4, respectively. Higher degree of leukopenia was highly significantly associated to improved distant disease-free survival (HR 0.84, 95% CI 0.74–0.96, p = .008) and overall survival (HR 0.87 (0.76–0.99, p = .032). Conclusion: This prospective study confirms that chemotherapy-induced leukopenia is a covariable with outcome in primary breast cancer, even after adjustment for chemotherapy doses.

Background: Retrospective studies have suggested that chemotherapy-induced leukopenia is associated with improved recurrence-free or overall survival. The SBG 2000–1 trial was designed to verify the favorable prognosis associated with chemotherapy-induced leukopenia in early breast cancer. Patients not experiencing chemotherapy-induced leukopenia were randomized into standard dosed or individually escalated chemotherapy doses based on the grade of leukopenia after a first standard dose. Patients and methods: 1452 women in Sweden and Denmark with operable node-positive or high-risk node-negative breast cancer aged 18–60 years were recruited to participate in this trial. Participants received a first FEC cycle at standard doses (600/60/600 mg/m2). Patients (n = 1052) with nadir leukopenia grade 0–2 after the first cycle were randomized between either 6 standard FEC or 6 tailored FEC courses with doses of epirubicin and cyclophosphamide escalated during courses 2 and 3 and thereafter aimed at achieving grade 3 leukopenia. Patients with nadir leukopenia grade 3–4 after the first course continued treatment with standard FEC. Results of the randomized comparison has been published previously. The present study focuses on chemotherapy-induced leukopenia as a covariable with outcome in randomized and non-randomized patients. The prognostic value of leukopenia after course 3, was studied in a Cox model adjusted for cumulative doses of epirubicin and cyclophosphamide. The association of chemotherapy-induced leukopenia with prognosis was a preplanned secondary endpoint for this trial. Results: The eight-year distant disease-free survival was 73%, 77%, 78% and 83% for patients with leucocyte nadir grade 0, 1, 2 and 3–4, respectively. Higher degree of leukopenia was highly significantly associated to improved distant disease-free survival (HR 0.84, 95% CI 0.74–0.96, p = .008) and overall survival (HR 0.87 (0.76–0.99, p = .032). Conclusion: This prospective study confirms that chemotherapy-induced leukopenia is a covariable with outcome in primary breast cancer, even after adjustment for chemotherapy doses.