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    • The current sub study is purely

    2019-04-28

    The current sub-study is purely exploratory in nature and the current biomarker hypotheses were not pre-specified, nor was the study powered to detect significant differences in biomarkers or their associations. As such these results should be considered UNC 0642 Supplier generating. Our sample sizes are also relatively small, and due to study design, we were limited to measuring circulating biomarker levels at baseline. Further, over 20% of study patients declined participation in the correlative sub-study. Many studies have suggested that changes in biomarkers from baseline to on treatment are more predictive of treatment response [36–39]. In the current sub-study we were unable to interrogate this question, however given the possible association of sVEGFR2 with clinical outcome in bone metastatic breast cancer patients treated with an anti-angiogenic agent, changes in sVEGFR2 levels from baseline to on treatment should be evaluated in bone metastatic breast cancer patients in the future.
    Conclusions
    Acknowledgments This work was funded by a grant to CLA from the Ontario Institute of Cancer Research High Impact Clinical Trials Program with support from the Government of Ontario.
    Introduction The Bone and Oncologist New Updates (BONUS) meeting is an annual conference, based in Canada that focuses on new advances in the multidisciplinary management of cancer related bone disease. An important goal of the meeting has been to drive research collaboration within the attending audience of basic scientists and clinicians, but also to produce guidelines and recommendations to the broader audience of health care workers involved in the care of cancer patients. The meeting has previous produced a number of documents covering basic science [1], translational research [2–4], clinical research [5–10] and practice guidelines [11,12]. Each year a debate is held on a controversial bone-related topic and so for the 2014 BONUS meeting, the debate focused on the recently presented meta-analysis by the Early Breast Cancer Trialists Collaborative Group (EBCTCG) on the use of adjuvant bisphosphonates in early stage breast cancer [13]. Given the recognized effects of bisphosphonates in metastatic breast cancer [14,15] and that potential anticancer effects have been demonstrated in preclinical [16], translational [17], patients with cancer therapy-induced bone loss [18] and population based-studies [19,20] a number of clinical trials assessing bisphosphonates\' effect on outcome in early stage breast cancer have been performed. Many of these trials presented conflicting results [21,24], but a consistent trend of beneficial effect on breast cancer recurrence was seen in older women. Of concern was that a useful clinical effect might have been missed because of trial design, end-points used, and under-powering of clinical trials for sub-group analyses [16]. Hence, an individual patient data meta analysis was performed and presented at the San Antonio Breast Cancer Symposium, December 2013 [13]. As this was considered by the BONUS meeting organizers an important, but potentially controversial topic, a debate format was used to best demonstrate contrasting views. While the original title for the debate was “This house believes that adjuvant bisphosphonates represent a gold-standard for post-menopausal women with higher risk breast cancer” the debaters asked if they could amend the title. In this commentary, we summarize the debates findings, and incorporate comments from the audience.
    All women with invasive breast cancer over 50 should be offered a bisphosphonate
    Discussion While a debate can offer a light hearted means of assessing a particular topic labia minora does provide an arena for opposing views to be presented. Sadly, it is unlikely that more definitive data will answer the question of whether adjuvant bisphosphonates are standard of care for women with early stage breast cancer. The D-CARE study [44] is evaluating the role of adjuvant denosumab and if positive would likely lead to denosumab being the standard of care. However, if positive in only a subgroup of patients, this will lead further confusion to the topic. Initial results for the primary outcome of bone metastases free survival are expected in 2016. The SWOG 0307 trial [36], comparing adjuvant clodronate with ibandronate and zoledronic acid, is expected to present results in 2015. While this trial may answer the question of which bisphosphonate is preferable, the absence of a placebo arm means that the question of this debate will remain unclear unless one arm is significantly superior to the others. In addition, the results of the SOFT [45] and TEXT [46] trials mean that increasing numbers of premenopausal women are going to undergo ovarian suppression, should these women also receive a bisphosphonate? To date we are unaware of the incorporation of adjuvant bisphosphonates into any practice guidelines but whether that changes when the EBCTCG meta-analysis is published in peer-reviewed format remains to be seen.