Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS)

Background: Patients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent. Aims: This study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS). Method: Thirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview. Results: Women found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding. Conclusions: This study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates

The experience of making treatment decisions for women with early stage breast cancer: a diagrammatic representation

Article first published online: 8 JUN 2005Women who are making decisions about treatment for early stage breast cancer interact with a number of people when they are considering their treatment options and the impact breast cancer will have on their lives. Previous research has considered patient preferences for involvement in treatment decision-making and proposed factors that may influence breast cancer treatment decisions. However, to date, there has been a paucity of research focusing on the experience of making treatment decisions from the women's perspective. The aim of this paper is to describe the relationships between the women, the medical practitioners and other people, and to consider features that may be influential in the experience of making treatment decisions. Two models are proposed to represent concepts that are linked to the experience of making treatment decisions. The first model proposed has been formulated to represent factors that may influence the treatment decision. The second model highlights aspects of the women's lives that may be affected. This paper discusses concepts that are presented in the conceptual models and makes suggestions for future studies relating to the experience of making treatment decisions for women with breast cancer

Neoadjuvant chemotherapy with sequential anthracycline-docetaxel with gemcitabine for large operable or locally advanced breast cancer: ANZ 0502 (NeoGem)

Background: Neoadjuvant chemotherapy has a sound rationale for use in women with large operable breast cancer, and achievement of pathological complete response (pCR) is prognostic. Epirubicin and cyclophosphamide followed by docetaxel is a standard chemotherapy regimen for early breast cancer. In metastatic breast cancer the combination of gemcitabine and a taxane has shown promising results. This phase II study investigated the efficacy and safety of incorporating gemcitabine into neoadjuvant therapy. Methods: Female patients with operable breast cancer that was clinically T2 (≥3 cm) or T3-4, N0-1, M0 were enrolled to receive 24 weeks of neoadjuvant chemotherapy using epirubicin and cyclophosphamide followed by docetaxel and gemcitabine, plus trastuzumab if HER2-positive. The primary endpoint was the pathological complete response (pCR) rate in the breast in separate HER2-negative and HER2-positive cohorts. Secondary endpoints included pCR in both the breast and axillary lymph nodes, clinical and radiological response rates, disease free survival and safety. Results: 81 patients were enrolled: 63 HER2-negative and 18 HER2-positive. 67 (84%) completed all cycles of chemotherapy, and 78 (96%) proceeded to surgery. pCR was achieved by 12 (20%) patients with HER2-negative, and 9 (53%) with HER2-positive disease. At the first interim analysis, addition of prophylactic G-CSF was recommended due to excess neutropenia. The HER2-negative cohort was closed to accrual because it did not meet the pre-specified target for pCR, and the HER2-positive cohort was closed due to slow accrual. At a median follow-up of 24 months, 12 of 81 (15%) patients had experienced a relapse of their breast cancer. Conclusion: Neoadjuvant gemcitabine, when added to docetaxel, after epirubicin and cyclophosphamide, did not reach the pre-specified expectations for pCR rate in HER2-negative tumours. Excess neutropenia was observed, requiring growth factor support. Addition of gemcitabine to docetaxel in this schedule cannot be recommended

Observation versus late reintroduction of letrozole as adjuvant endocrine therapy for hormone receptorpositive breast cancer (ANZ0501 LATER): An open-label randomised, controlled trial

Background: Despite the effectiveness of adjuvant endocrine therapy in preventing breast cancer recurrence, breast cancer events continue at a high rate for at least 10 years after completion of therapy. Patients and methods: This randomised open label phase III trial recruited postmenopausal women from 29 Australian and New Zealand sites, with hormone receptor-positive early breast cancer, who had completed ≥4 years of endocrine therapy [aromatase inhibitor (AI), tamoxifen, ovarian suppression, or sequential combination] ≥1 year prior, to oral letrozole 2.5 mg daily for 5 years, or observation. Treatment allocation was by central computerised randomisation, stratified by institution, axillary node status and prior endocrine therapy. The primary outcome was invasive breast cancer events (new invasive primary, local, regional or distant recurrence, or contralateral breast cancer), analysed by intention to treat. The secondary outcomes were disease-free survival (DFS), overall survival, and safety. Results: Between 16 May 2007 and 14 March 2012, 181 patients were randomised to letrozole and 179 to observation (median age 64.3 years). Endocrine therapy was completed at a median of 2.6 years before randomisation, and 47.5% had tumours of >2 cm and/or node positive. At 3.9 years median follow-up (interquartile range 3.1– 4.8), 2 patients assigned letrozole (1.1%) and 17 patients assigned observation (9.5%) had experienced an invasive breast cancer event (difference 8.4%, 95% confidence interval 3.8% to 13.0%, log-rank test P = 0.0004). Twenty-four patients (13.4%) in the observation and 14 (7.7%) in the letrozole arm experienced a DFS event (log-rank P = 0.067). Adverse events linked to oestrogen depletion, but not serious adverse events, were more common with letrozole. Conclusion: These results should be considered exploratory, but lend weight to emerging data supporting longer duration endocrine therapy for hormone receptor-positive breast cancer, and offer insight into reintroduction of AI therapy.N. Zdenkowski, J. F. Forbes, F. M. Boyle, G. Kannourakis, P. G. Gill, E. Bayliss, C. Saunders, S. Della-Fiorentina, N. Kling, I. Campbell, G. B. Mann, A. S. Coates, V. Gebski, L. Davies, R. Thornton, L. Reaby, J. Cuzick, M. Green, on behalf of the Australia and New Zealand Breast Cancer Trials Grou

Psychological impact and cosmetic outcome of surgical breast cancer strategies

The definitive version is available at www.blackwell-synergy.comBackground: Current surgical treatment modalities for breast cancer include breast conserving surgery, mastectomy alone and mastectomy with breast reconstruction. There are recognized benefits of breast conservation and breast reconstruction over mastectomy but there are few studies assessing this area in Australia. The aim of the present study was to compare the various surgical strategies for breast cancer treatment in terms of quality of life, cosmesis and patient satisfaction. Methods: A chart analysis was conducted of all patients who underwent Breast Cancer Reconstruction at the Royal Adelaide Hospital Breast Unit between 1990 and 2002. Patients were then traced and asked to take part in an interview. Mastectomy and breast conservation patients who attended outpatient clinic for follow up were also approached. All three groups were interviewed and self-assessment quality of life questionnaires (Functional Assessment of Cancer Therapy−Breast, body image) were administered. The breast conservation and reconstruction groups also underwent assessment of satisfaction and cosmesis. Results: A total of 78 mastectomy, 109 breast conservation and 123 breast reconstruction patients were interviewed. Quality of life assessment was similar between the three groups but the breast conservation and reconstruction patients’ body image scores were superior to the mastectomy group. Patient satisfaction was higher in the reconstruction group than the breast conservation group of patients, while cosmesis was similar. Conclusion: While little difference was seen on quality of life assessment, body image is improved with the use of breast conservation and reconstruction. The high satisfaction and cosmesis scores in the breast reconstruction group are an indication of the superior results that can be achieved with breast reconstruction.Maria Teresa Nano, Peter Grantley Gill, James Kollias, Melissa Anne Bochner, Peter Malycha and Helen R. Winefiel